Monday, November 29, 2010

Americans for Nonsmokers' Rights Claims There Are Virtually No Differences Between Health Effects of Active and Passive Smoking

A leading national advocacy group which promotes smoke-free policies and educates the public about the health effects of secondhand smoke is claiming that there are virtually no differences in health effects between active and passive smoking. Americans for Nonsmokers' Rights (ANR) makes the claim on its online fact sheet entitled: "Secondhand Smoke: The Science."

Specifically, ANR claims that: "there are virtually no health disparities between active and passive smoking."

ANR further claims that: "The risks of heart disease associated with secondhand smoke are twice what were previously thought and are virtually indistinguishable from those associated with active smoking."

ANR supports both claims by citing a single article (see: Whincup PH, et al. Passive smoking and risk of coronary heart disease and stroke: prospective study with cotinine measurement. BMJ 2004; 329:200-205).

The Rest of the Story

ANR's claim that there are virtually no health disparities between active and passive smoking is unfortunately (or fortunately, depending on how you look at it) a lie.

I say fortunately because if ANR were being truthful in claiming that passive smoking has virtually the same level of health effects as active smoking, then there would be tens of thousands more deaths from secondhand smoke than we currently observe.

I honestly don't understand how ANR can claim that there are virtually no health disparities between active and passive smoking. That implies that active smoking is virtually no more dangerous than exposure to secondhand smoke. We know this is not true, because there is a dose-response relationship between tobacco smoke exposure and lung cancer. The relative risk of lung cancer among active smokers is about 17, while the relative risk of lung cancer among passive smokers is about 1.3. How ANR can claim that 17 is "virtually" the same as 1.3 is beyond my understanding of basic mathematics.

Even if we restrict ourselves to the risk of heart disease, the scientific evidence simply doesn't support the conclusion that the risk of heart disease is "virtually" the same for active and passive smokers.

ANR acknowledges that the relative risk for heart disease associated with passive smoking is about 1.5 or 1.6. A very large and perhaps the most recent study of the relative risk of heart disease among active smokers (the Nurses Health Study) revealed a relative risk of 3.12 for women smoking 1-14 cigarettes per day and 5.48 for women smoking 15 or more cigarettes per day. The CDC estimates that the overall relative risk for heart disease mortality associated with secondhand smoke exposure is about 2.0 (this is going to be lower than the relative risk associated with the incidence of heart disease). There are a few studies which suggest that the long-term relative risk for heart disease may be on the order of about 1.3 for light active smokers of just 1-9 cigarettes per day (this is what Whincup et al. found). Thus, even if we restrict ourselves to the risk for heart disease, it is not accurate to state that the effects of secondhand smoke and active smoking are virtually the same. There appears to be a clear dose-response relationship (albeit a non-linear one, unlike for lung cancer), and for active smokers of a half pack per day or more, the risk of heart disease is undeniably substantially higher than for passive smokers.

The Whincup study itself does not support ANR's contention that there are virtually no health disparities between active and passive smoking. The article makes no such claim.

Moreover, the Whincup article does not even claim that there are no health disparities between active and passive smoking with regards to heart disease. While the article does find that for very light active smokers (less than half pack per day), the short-term relative risks for heart disease are similar to those among passive smokers, it is very misleading to represent this finding as establishing that there are no health disparities in the risk of heart disease between active and passive smokers. First, the risk of heart disease among the majority of active smokers (who smoke half pack per day or more) is substantially higher than among passive smokers. Second, if you examine Table 3 in the Whincup paper, you'll see that even among light active smokers, upon long-term follow-up there is a clear divergence in the heart disease risk compared to passive smokers.

If ANR were to inform an active smoker that his risk of heart disease was no different than that of a passive smoker, it would essentially represent malpractice, because unless this smoker is an extremely light smoker, the information is undeniably false. Such advice could encourage a smoker to continue smoking rather than to quit, because it minimizes the true health effects of active smoking.

It is also interesting to note that while ANR is apparently so impressed by the importance of the Whincup study, it fails to inform the public that the very same study found no significant increase in stroke risk among passive smokers. Yet ANR claims in its fact sheet that: "There is a link between secondhand smoke to an increased risk of stroke." Here, ANR cites a different study.

It appears that ANR is just cherry-picking the studies it wants to in order to support the claims that it wants to make. If the Whincup study is so reliable that it can be counted on in making the claim that passive smoking causes heart disease, then why is the very same study unreliable when it finds that passive smoking in the very same subjects did not increase their risk of stroke?

By the way, I am not arguing here that secondhand smoke is not related to stroke risk. I believe that if one looks at the overall evidence, there does appear to be a causal link. However, I am just pointing out that ANR's approach of simply citing a specific study here or there to support its claims is tantamount to cherry-picking, especially when they ignore findings from the very studies they are citing.

The rest of the story is that ANR's "fact sheet" which is purportedly bringing us "The Science" on secondhand smoke is actually telling us a lie when it claims that "there are virtually no health disparities between active and passive smoking." There are, in fact, very important dose-related health disparities, and it is critical that the public appreciate the dose-response nature of the relationship between tobacco smoke exposure and adverse health effects.

I do not believe it is necessary for ANR to lie like this in order to impress upon the public the damaging health effects associated with secondhand smoke. I think the truth is certainly enough.

Sunday, November 28, 2010

Ban on Hiring Smokers Blasted: Boston Herald

The Boston Herald ran an excellent article yesterday which comments on the recent trend of employers refusing to hire smokers. While not a representative sample, the poll associated with the article is currently showing that a majority of the public (about 70%) agree that this is a form of employment discrimination and therefore, employers should not continue to follow this trend. By showing that not everyone in the public health field supports such policies or believes that they represent a legitimate public health promotion strategy, hopefully this article will help generate more media coverage that educates the public about all sides of this important debate, not just the anti-smoking groups' position. Not everyone in public health thinks the way the anti-smoking groups tend to think.

Thursday, November 25, 2010

Wednesday, November 24, 2010

Physician Tells Public that Electronic Cigarettes Cause Lung Damage

A physician who heads New York University's Cardiac and Pulmonary Wellness and Rehabilitation Program has apparently told the public that electronic cigarettes cause lung damage and therefore should play no role in smoking cessation.

According to an article in the Washington Square News: "NYU Langone professor Jonathan Whiteson, medical director of the Culinary and Pulmonary Wellness and Rehabilitation Program, said the E-cigs are harmful to users' health. "Dangerous chemicals have been identified in the vapor, not just nicotine, and they can potentially cause lung damage," Whiteson said. ... As of now, few studies have been conducted or published on the health effects, but according to Whiteson, these cigarettes are not a valid method to quit smoking. "E-cigs play no role in the medical field of smoking cessation," he said."

The Rest of the Story

I would ask Dr. Whiteson to identify the specific chemicals in electronic cigarette vapor that he alleges cause lung damage in the user. I would also ask for the scientific evidence which documents that electronic cigarette vapor causes lung damage among users. Certainly, if one is going to make a public claim like that, one must have evidence to support it.

The rest of the story is that there simply is no evidence to support Dr. Whiteson's assertion. There is no evidence that electronic cigarettes cause lung damage.

Furthermore, what in the world does it mean to say that electronic cigarettes are not a "valid" method to quit smoking? What makes this an invalid method? If it works, it works. Perhaps what makes it an invalid method is that it is not manufactured by the big pharmaceutical companies which support many anti-smoking researchers and organizations. Other than that, it's perfectly valid. It appears to work for many people. There is no evidence that it causes lung damage. So how, exactly, do electronic cigarettes play no role in the medical field of smoking cessation?

There are literally thousands of ex-smokers who have quit smoking using electronic cigarettes. Many of them have experienced immediate improvement in their health. Their breathing has improved, their cough symptoms have resolved, and their doctors have told them that they are in much better health. Tell those individuals that electronic cigarettes are not a valid way to quit smoking and that they play no role in the medical field of smoking cessation.

Tuesday, November 23, 2010

Article Warns of Dangers of "Fourth-Hand" Smoke

An article at Bottom Line/Personal, based on an interview with a tobacco control researcher, warns the public about the potential hazards of fourth-hand smoke.

What is fourth-hand smoke, you ask?

Why, it is smoke exposure resulting from being in the presence of someone who themselves was in the presence of a smoker.

According to the article: "There are at least 250 poisonous gases, chemicals and metals in cigarette smoke, and they can cling to the hair and clothing of people who don’t smoke themselves but spend time among smokers. Young children (and adults, including at-risk adults, such as those with asthma, heart disease or COPD) may be exposed to these toxins when they are near people who smoke or who have spent time with smokers."

The Rest of the Story

So let's get this straight. If I do not smoke and I am not in the presence of secondhand smoke and I am not exposed to anyone who is a smoker, I can still obtain significant exposure to tobacco smoke by being near someone who has spent time with a smoker?

I guess before sitting down at the Thanksgiving dinner table, nonsmokers should first ask everyone at the table if they have recently spent time with anyone who is a smoker.

If fourth-hand smoke is such a hazard, then to promote a healthy workforce, the St. Francis Medical Center and Anna Jacques Hospital should not only refuse to employ people who smoke, but they should also refuse to employ anyone who spends time with smokers or who spends time with anyone who themselves spends time with smokers.

Should we continue to allow smokers to serve as teachers and day care providers, even if they do not smoke in the presence of children? Should we allow individuals who spend time with smokers to serve as day care providers, especially if they are taking care of infants and very young children? And perhaps we should refuse to allow individuals who spend time with people who spend time with smokers to serve as teachers and day care providers for young children.

Perhaps the Aberdeen City Council should not only disallow smokers to adopt children, but also individuals who spend time with smokers or who spend time with people who spend time with smokers. After all, if fourth-hand smoke is such a hazard to infants and young children, then how can we allow them to be exposed by placing them with parents who have associated with people who have been around smokers?

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

Monday, November 22, 2010

Two More Hospitals Will Refuse to Hire Smokers in Order to Promote Health and Wellness

Last week, two more hospitals joined the apparently rapidly growing trend of employers - especially hospitals and health care systems - refusing to offer employment to smokers, regardless of their qualifications for the job:
The policies in both hospitals call for job applications from anyone who uses tobacco products to be thrown in the garbage. Existing employees who smoke will not be terminated, however.

The St. Francis Medical Center noted that the purpose of its policy is to promote an environment and culture of health and wellness: "Because it is important for health care providers to promote a healthy environment and lifestyle, effective January 1, 2011, Saint Francis Medical Center has a nicotine-free hiring policy."

The purpose of the Anna Jacques Hospital policy is: "To take further steps in preserving and improving the health of all of our employees."

The Rest of the Story

If these hospitals were truly interested in promoting an atmosphere and culture of health and wellness and were willing to engage in employment discrimination in order to achieve it, then why are neither of these employers refusing to hire obese or overweight individuals? If the point is to preserve and improve the health of the workforce, then refusing to hire obese persons would be a step in the right direction, no?

The precise justification for the no-smokers policy - promoting healthy lifestyles - would also apply to refusing to hire individuals who are overweight or obese, or who engage in a number of other unhealthy behaviors, such as eating a poor diet, failing to get enough physical activity, not wearing seat belts, using tanning salons, and eating excessive quantities of Vienna Fingers.

That these hospitals are singling out smokers suggests that the true reason behind the policies is that they simply cannot tolerate the lifestyle decisions of smokers. In other words, this employment discrimination is actually a manifestation of bigotry, rather than public health promotion.

I don't understand how it sets a "good example" to refuse employment to smokers. In just what way is engaging in employment discrimination a good example? Why is hiring people based on the group to which they belong, when that group membership has no relevance to their qualifications for employment, a good example?

These hospitals are not genuinely interested in a healthy work environment. What they are interested in is selectively discriminating against smokers by tying employment to lawful, private health behavior that has no direct relationship to job qualifications. They are interested in selectively interfering in employee privacy, going so far as to demand the submission of bodily fluids in order to document a personal behavior choice that a person makes in his own home which has no bearing on his ability to perform his job duties.

Instead of applauding such actions, anti-smoking groups should speak out against this form of employment discrimination. The appropriate way to reduce health care costs related to smoking is to offer workplace wellness programs, including smoking cessation programs and benefits. Such programs have been shown to be cost-effective. Refusing to hire people with unhealthy behaviors is not an appropriate public health approach to the problem.

Thursday, November 18, 2010

IN MY VIEW: Campaign for Tobacco-Free Kids Misrepresents Master Settlement Agreement in Order to Blast New R.J. Reynolds Camel Campaign

The Campaign for Tobacco-Free Kids is attacking R.J. Reynolds for its latest campaign to promote Camel cigarettes, a campaign which ties Camel to the names of popular U.S. cities and places the names of those cities on Camel packs. In particular, the Campaign is attacking R.J. Reynolds for using themes that may appeal to kids, in what Tobacco-Free Kids alleges is a violation of the Master Settlement Agreement.

The Campaign writes: "Joe Camel may have been put out to pasture, but his spirit lives on in R.J. Reynolds' latest marketing campaign that once again tries to make Camel cigarettes cool, fun and rebellious – and appealing to kids. The new campaign cynically uses the names and images of trendy U.S. destinations, including Seattle, Austin, San Francisco, Las Vegas, New Orleans, and Brooklyn's Williamsburg neighborhood, in an attempt to make Camel cigarettes cool again. RJR has unveiled cigarette pack designs bearing the name of each city on its Camel web site and has told the media that it will sell limited edition cigarette packs with the city names in December and January." ...

"It is deeply disturbing that RJR is using the good name and hard-earned reputation of these great American cities to market deadly and addictive cigarettes, especially in a way that blatantly appeals to children. Certainly the citizens and leaders of these cities do not want to be associated with a product that kills more than 400,000 Americans every year. RJR showed truly shameless disregard for the death and suffering its products cause by calling this campaign a "celebration" of the locations involved. This campaign shows that RJR has not changed and continues to have blatant disregard for the health of America's children. We call on RJR to immediately end this marketing campaign and withdraw its plans to introduce the special edition cigarette packs."

"We also urge state attorneys general to investigate whether this promotion violates the 1998 state tobacco settlement's prohibition on tobacco marketing that targets children."

Images from the campaign can be seen here on the Campaign for Tobacco-Free Kids web site..

The Rest of the Story

I think that the Campaign for Tobacco-Free Kids' attack on R.J. Reynolds demonstrates a misunderstanding of the Master Settlement Agreement (MSA). The MSA prohibits the tobacco companies from targeting youth in their marketing. However, the MSA does not prohibit the companies from using marketing themes or images which may appeal to children.

I was actually an expert witness in a lawsuit against R.J. Reynolds alleging that the company violated the terms of the Master Settlement Agreement by advertising preferentially in magazines with high youth readership. In that case, I provided evidence that Reynolds placed magazine advertisements in such a way that it achieved a higher degree of exposure among 12-17 year-old youths than among adults. It was this disproportionate exposure which convinced the judge that this pattern of advertising targeted kids and thus violated the Master Settlement Agreement. The case was decided in favor of the plaintiff (the state of California).

This situation, however, is very different. The Campaign is not arguing that the new Camel campaign is "targeted" at kids or that is somehow has disproportionate appeal to children. Instead, the Campaign is complaining merely because there might be some appeal of the campaign's themes and images to young people.

Unfortunately, that is not a violation of the Master Settlement Agreement. Had it been the intention of the Attorneys General to prohibit cigarette advertising that has any appeal to youth, then they would have done so by including such a prohibition in the MSA. They chose not to.

It is sour grapes for the Campaign for Tobacco-Free Kids to come along now and complain that there are some images in Reynolds' marketing that might appeal to youth. Had the Campaign wished to eliminate such marketing, they could have insisted that such marketing restrictions be included in the FDA tobacco legislation that they negotiated with Philip Morris.

The Campaign had its chance. It was at the negotiating table with Philip Morris. It could have simply insisted that the legislation include a ban on any advertising images or themes that might appeal to children. It could have threatened to walk away from the table if Philip Morris did not agree to such a provision. But the Campaign did not do this. Instead, it agreed to the weak legislation as it is.

The Campaign can complain all it wants now, but it is sour grapes. If they felt it was so important to eliminate this type of marketing, then they should have eliminated this type of marketing when they negotiated the federal tobacco legislation.

Moreover, had the Campaign wanted to prohibit the tobacco companies from using the names of U.S. cities as advertising appeals on their cigarette packs and advertisements, it could have insisted upon such a provision in the FDA tobacco legislation. The legislation does in fact address the warning labels and content of the cigarette packages and advertisements. The Campaign had its chance at the negotiating table and it failed. Now it is sour grapes to complain that the companies are placing city names on cigarette packs. Why didn't the Campaign get rid of such marketing techniques when it was sitting at the negotiating table and in a perfect position to do so?

Frankly, I don't see this campaign as appealing in any particular way to youth. Moreover, all cigarette advertising tries to make smoking cool, fun, and rebellious. If the Campaign wanted to eliminate those themes from cigarette advertising, then it should have done so.

You don't sit at the negotiating table, on the verge of substantially changing the way cigarettes are marketed, and then walk away with the crap legislation that the Campaign for Tobacco-Free Kids settled for. And if you do, you have no business complaining when the tobacco companies do exactly what they are still permitted to do under the law.

The Campaign for Tobacco-Free has had its chance. It failed. Now it's time to stand out of the way and let the grassroots advocates who really care about the public's health, and not just about political victory, take back over the movement and try to create some real change.

Wednesday, November 17, 2010

New Study Concludes that Exposure to Maternal Smoking as Fetus Leads to Criminals Later in Life

A new study published online ahead of print in the Journal of Epidemiology and Community Health concludes that maternal smoking during pregnancy causes criminal behavior later in life (see: Paradis AD, Fitzmaurice GM, Koenen KC, Buka SL. Maternal smoking during pregnancy and criminal offending among adult offspring. J Epidemiol Community Health 2010).

The article's conclusion that exposure to maternal smoking during pregnancy creates criminals later in life has received widespread publicity, leading to headlines such as these:

Smoking in Pregnancy 'Breeds Criminals'

Smoking During Pregnancy 'Increases Risk of Children Turning to Crime'

The study methods are described as follows: "
The relationship between MSP [maternal smoking during pregnancy] and adult criminal offending was examined using data from 3766 members of the Providence, Rhode Island, cohort of the Collaborative Perinatal Project. Information on MSP and most potential confounders was collected prospectively throughout pregnancy. In 1999–2000 all offspring had reached 33 years of age and an adult criminal record check was performed. Because previous research has been criticised for not properly accounting for confounding influences, our primary aim was to determine whether the MSP–criminal offending relationship held after efficiently adjusting for a wide range of sociodemographic and family background characteristics using propensity score methods."

The results were as follows: "The association between MSP and adult criminal offending remained after controlling for propensity scores. Offspring of mothers who smoked heavily during pregnancy (≥20 cigarettes per day) had the greatest odds of an adult arrest record (OR 1.31, 95% CI 1.06 to 1.62)."

The study concludes: "Our findings suggest that the relationship between maternal smoking during pregnancy and adult criminal offending is causal."

The Rest of the Story

While it is interesting that there is an association between maternal smoking during pregnancy and criminal behavior among the offspring, there is no way one can draw a causal conclusion from this study. There is a far more likely explanation for this association, rather than the explanation that the smoke exposure caused some sort of brain damage that later led to criminal activity.

The more likely explanation is that mothers who smoke during pregnancy represent a very different population from those who do not, and that factors related to their decision to smoke during pregnancy, rather than the actual smoke exposure, is what predisposes their children to criminal behavior.

In particular, the most likely reason for the association is that mothers who smoke during pregnancy are probably more likely to themselves have a higher incidence of criminal activity. It should come as no surprise that there is a link between criminal activity among parents and their offspring. As the study did not control for parental criminal activity, it cannot possibly conclude that the observed association is a causal one.

Although the paper purports to have controlled for parental anti-social behavior - a critical potential confounding variable - this variable was only available for 720 out of the 3,766 subjects. The study used a multiple imputation procedure to "create" this variable for the subjects with missing data. While multiple imputation is reasonable to use when you have a small proportion of missing data, it is a huge stretch to impute data for the overwhelming majority of the sample. In my view, parental anti-social behavior was clearly not adequately controlled for in this study. Thus, once again, the paper cannot possibly conclude that the observed relationship is a causal one.

Furthermore, the paper didn't control for maternal substance use: the use of alcohol and illicit drugs. It is very likely that maternal substance abuse is related both to smoking during pregnancy and to an increased risk of subsequent criminal activity among the offspring.

Surprisingly, the paper reaches a causal conclusion despite its ready acknowledgment of the possibility that there was unmeasured and residual confounding. The study takes it on faith that this unmeasured and residual confounding is not of a magnitude that would negate the results, even though there is no evidence to support such an assumption.

The paper states: "Due to the potential for unmeasured and residual confounding, our results likely reflect the upper boundary of any true effect of MSP on adult ASB." This is equivalent to stating: "There is strong reason to believe that we did not adequately control for confounding variables. We can make no estimate of the magnitude of this confounding, but we are going to take it on faith that the magnitude of such confounding is not enough to negate our observed results, because then we would have to admit that the relationship is not causal and the paper might not be judged to be publishable."

This is the first time I have ever seen a paper in which it was assumed, on faith, that inadequate control for confounding must not have been of a magnitude that would negate the observed effect, in the absence of any analysis whatsoever of the likely magnitude of that confounding.

Essentially, such reasoning negates the entire point of doing the research in the first place. If you are going to simply assume that any unmeasured confounding does not negate the effect, then why even bother doing the study in the first place? Why not stick with the completely unadjusted estimates and simply make the same assumption?

The conclusion of the paper begins: "While we cannot definitively conclude that MSP (particularly heavy MSP) is a causal risk factor for adult criminal offending, the current findings do support a modest causal relationship." This is a cop out. If the study does not provide enough evidence to (definitively) conclude that maternal smoking during pregnancy causes adult criminal offending, then it cannot draw such a conclusion. What the paper is once again saying is: "We don't have enough evidence to conclude that the relationship is causal, because as we've pointed out, we are quite sure that we've missed important confounding variables. Nevertheless, we want to sensationalize the results as much as possible so we're going to draw a causal conclusion anyway."

The damage caused by the sensationalistic and unsupported conclusion of this study could be substantial. Newspapers are reporting that "exposure to cigarette in the womb may harm developing areas of the brain that affect behaviour, impairing the transmission of chemical signals important for attention and impulse control" and that "smoking in pregnancy can cause harm to the child's developing brain that puts them at greater risk of having a long-term criminal record."

That is quite a stretch for a study that failed to measure the criminal records of the parents themselves, did not adequately control for parental anti-smoking behavior, and readily admitted that "we most likely missed important variables."

Somehow, the scientific rigor of the paper ended just before the drafting of the study conclusion. This is not atypical, however, for modern-day tobacco control research.

Monday, November 15, 2010

Health Agencies Boast of Dramatic Impact of New Cigarette Warning Labels

The FDA last week announced a series of new, graphic warning labels that will soon appear on cigarette packs and advertisements. These warning labels are mandated by the Family Smoking Prevention and Tobacco Control Act enacted by Congress in 2009.

In announcing the new warning labels, both the FDA and its parent agency - the Department of Health and Human Services - widely proclaimed that this intervention would have a dramatic effect on both youth and adult smoking.

The head of the Department of Health and Human Services proclaimed: "Today marks an important milestone in protecting our children and the health of the American public."

A press release from the Department of Health and Human Services stated that "these health warnings on cigarettes and in cigarette advertisements will be the most significant change in more than 25 years."

The head of the FDA boasted that: "When the rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes."

The Rest of the Story

In my view, while these warning labels may have a marginal effect in terms of stimulating some smokers to quit, the overall impact will be minimal. Smokers are already aware of the harmful consequences of smoking and lack of knowledge of the health effects is not a significant factor in explaining why millions of Americans continue to smoke or why youths begin smoking. Research shows that warning labels have a limited impact on smoking behavior.

By the time smokers see the warning labels, they have already made the decision to smoke and are already highly addicted to cigarettes, for the most part. Reinforcing the adverse health consequences does very little to enhance the smoker's ability to overcome this addiction.

Financial analysts appear to agree with my assessment, rather than with that of the federal government. According to an article at, a number of stock analysts all agree that the warning labels are going to have a marginal effect, at best, on cigarette sales:

"Morningstar (MORN) analyst Philip Gorham doesn’t expect the rules to speed up the 3%-a-year decline in tobacco sales. "Obviously this isn't a good development for the tobacco industry," he said. "But if you take the U.K. as an example -- where such warning signs have been on packs for a while, even including pictures of diseased lungs -- then it doesn't affect demand all that much."

"Schaeffer's Research analyst Ryan Detrick said smoking addiction can't be broken with the addition new warning labels. "I don't see how this will change smokers' perceptions." Middleswart doesn’t expect the rules to hurt sales at companies such as Altria, Lorillard (LO) and Reynolds American (RAI), which have been carrying less-graphic warning labels for years. Philip Morris International (PM), which sells cigarettes outside the U.S., is also likely to be unscathed."

"Gorham said the labels aren't the best strategy for curbing smoking. "The single most effective way to reduce smoking is still through raising prices," he said."

Congress, of course, eschewed the strategy that Gorham called most effective - raising the cost of cigarettes and allocating the revenues to aggressive anti-smoking media campaigns - and instead chose to work around the margins. This was a well-chosen political strategy, as it protects cigarette sales, ensuring that cigarette tax revenues and tobacco company settlement payments to states will remain high, while making it appear that politicians actually care about reducing youth and adult smoking.

Philip Morris has been quite silent regarding the warning labels. Obviously, the company is not too concerned about the impact of these new labels on cigarette sales. In fact, these warning labels provide an immense benefit to the tobacco companies: virtual immunity from new lawsuits. With these graphic warning labels on the packs, no jury will find it necessary to impose punitive damages on the cigarette companies. This essentially ends the litigation threat and is a major reason why Philip Morris was willing to allow the warning label provision in the FDA tobacco legislation.

The real threat to the tobacco industry would have come from eliminating the warning labels on the packs, and thus opening up the companies to devastating lawsuits. Congress chose the weaker approach of requiring mildly stronger warning labels but completely immunizing the tobacco companies from any prospect of serious financial damage in future litigation.

While the FDA and HHS had nothing to do with the decision to enact this weak national tobacco control strategy, it is unfortunate that they join the politicians in spewing out this exaggerated rhetoric about how these marginal policies represent a huge milestone in protecting our children and the health of the American public. What they help to protect are the profits of Philip Morris and other major cigarette companies.

Thursday, November 11, 2010

San Francisco Board of Supervisors' Ban on Toys in Happy Meals is Yet Another Feel Good Policy that Does Nothing to Protect the Public's Health

This Tuesday, the San Francisco Board of Supervisors voted to ban the inclusion of toys in kids' meals (e.g., "Happy Meals") that do not meet certain nutritional criteria.

According to a CNN article: "The San Francisco, California, Board of Supervisors on Tuesday banned most McDonald's Happy Meals with toys, as they're now served. The ordinance, which requires McDonald's and other fast-food servings with toys to meet new nutritional standards, now goes to Mayor Gavin Newsom, who indicated before his election last week to California lieutenant governor that he would veto the law. That veto would be meaningless because the board approved the ordinance 8-3, a veto-proof margin. With eight votes, the board could override the veto." ...

"Under the law, McDonald's and other restaurants will have until December 2011 to improve their meals' nutrition by adding fruits and vegetables -- if the chains want to keep offering toys, including those promoting the latest films. The food and beverages will have to contain fewer than 600 calories, and less than 35 percent of total calories will come from fat. The meal must contain half a cup of fruit and three-fourths cup of vegetables, and offer less than 640 milligrams of sodium and less than 0.5 milligrams of trans fat. Breakfast will have the option of offering half cups of fruit or vegetables. City officials said they expect a legal challenge from McDonald's, which declined to comment on possible legal action."

The Rest of the Story

There are three major problems with the ban on toy giveaways with “Kids’ Meals.” First, this intervention will do absolutely nothing to reduce childhood obesity. The toys are not the reason why parents are taking their kids to fast food restaurants like McDonalds and Burger King. Parents are not going to suddenly stop taking their kids out to these fast food restaurants because toys are no longer given out with kids’ meals.

Second, the policy represents a large intrusion into the autonomy of businesses, and a rather severe restriction of marketing. Such an intrusion could be justified if the policy were necessary and effective to advance a substantial government interest, such as reducing childhood obesity. But the policy will not reduce childhood obesity. It will have no public health impact. Therefore, the intrusion is not justified.

Third, the policy represents a selective intrusion into the marketing of kids’ foods. If it is appropriate to prohibit restaurants from including toys as a marketing tool to sell kids’ meals, then why is the San Francisco Board of Supervisors not also prohibiting the sale of sugary cereals that contain toys in the package? Why is the San Francisco Board of Supervisors not also prohibiting soft drink vending machines in schools? What about junk food like Cracker Jacks that comes with toys? And how about promotions where soft drink or junk food companies offer coupons to activities that appeal to youths, such as discounts at movie theatres or amusement parks?

It appears that, just like the ban on tobacco sales in pharmacies, this is largely a feel-good policy that allows the Board of Supervisors to make it appear that they have tackled an important public health issue but without actually doing anything that will have an impact on the public’s health. It allows the Supervisors to garner political credit for tackling a problem without having to make the politically difficult, courageous decisions that would actually make a difference in the obesity epidemic, such as completely reforming school meal nutrition, implementing daily, universal physical activity programs in schools, addressing the geographic maldistribution of healthy food, and improving public parks and safety in urban neighborhoods.

It may come as a surprise to the San Francisco Board of Supervisors, but it is not the toys which are causing childhood obesity, it is the food. If this degree of intrusion into the marketing of legal products is justified, then so is a more direct approach of simply regulating the food that can or cannot be sold to children. Obviously, such an approach is beyond the appropriate role of government.

The rest of the story is that what might at first look like a courageous act to go after fast food companies is actually a cowardly maneuver to make it look like our politicians are doing something when in fact, the policy they have enacted will have no impact on the public’s health. In the mean time, the real solutions, which would actually reduce obesity and save lives, are being neglected. This is yet another feel-good policy that creates political gain by misleading the public into believing that something has been accomplished, when in fact there will be no impact on the public’s health.

Tuesday, November 09, 2010

Researcher Tells Public There is No Evidence that Secondhand Smoke Exposure is Any Worse than Electronic Cigarette Vapor

In an interview published by the journal Annals of Internal Medicine, one of the co-authors of a commentary urging physicians to counsel their patients against the use of electronic cigarettes as a tool for smoking cessation tells the public that there is no evidence that electronic cigarette vapor is any safer than exposure to secondhand smoke from regular cigarettes.

The researcher also tells the public that there is no evidence that the use of electronic cigarettes is any safer than cigarette smoking.

After noting that some electronic cigarette companies are using marketing terms which suggest that their products are safer than cigarettes to both users and nonusers, the researcher states: "There isn’t empirical data to suggest that that’s true."

Of course, what the researcher is therefore telling the public is that there is no evidence that smoking is any more hazardous than inhaling the trace levels of carcinogens in electronic cigarettes.

He is also telling the public that there is no evidence that secondhand smoke exposure is any more hazardous than exposure to the vapor from electronic cigarette use.

I have already argued that the advice to physicians to counsel their smoking patients not to quit smoking using electronic cigarettes is irresponsible and misguided. In instructing patients or smokers in general not to use electronic cigarettes, what these researchers are saying is that they would rather smokers continue to smoke cigarettes than to quit smoking via the help of electronic cigarettes.

The reality is that the majority of smokers are not going to be able to quit smoking using traditional therapy (i.e., pharmaceutical aids). For this overwhelming majority of smokers, the study authors are saying: "Don't try electronic cigarettes. We don't know what they are. Stick with the real ones. Don't put down your Marlboros, Camels, and Newports."

The Rest of the Story

Now, the story expands. Not only are these researchers providing misguided and irresponsible advice, but they are now misleading the public by suggesting that there is no evidence that smoking is any more harmful than vaping or that secondhand smoke is any more dangerous than exposure to exhaled electronic cigarette vapor.

These are dangerous and misleading statements. They imply that smoking is not all that hazardous, since if it is no worse than electronic cigarette use, it involves only exposure to minute levels of carcinogens (as has been documented to be the case with electronic cigarettes). And it implies that secondhand smoke exposure is not hazardous at all, since there is no evidence whatsoever that being in the presence of an e-cigarette user is harmful.

The researcher acknowledges that only trace levels of carcinogens were found in electronic cigarettes. He also acknowledges that the propylene glycol used in electronic cigarettes is not worrisome. How, then, can he go on to state that there is no evidence that electronic cigarettes are any safer than what we already know is the most dangerous and toxic consumer product on the market, which we know kills hundreds of thousands of Americans each year?

It is even less rational to suggest that secondhand smoke exposure is no worse than exposure to the greatly diluted, exhaled vapor from e-cigarette users. We know that the quantities of carcinogens delivered to the nonuser are miniscule.

It doesn't take a rocket toxicologist to figure out that the current data on the levels of carcinogens in cigarettes versus electronic cigarettes does provide strong evidence that vaping is less hazardous than smoking, and that exposure to the vapor exhaled by e-cigarette users is less hazardous than exposure to secondhand smoke.

In fact, I have estimated that the level of tobacco-specific nitrosamines in electronic cigarettes is about 1400 times lower than that in Marlboros. In light of these data, how can one possibly argue that there is no evidence that smoking Marlboros is any more dangerous than using an electronic cigarette?

It is problematic enough to disseminate irresponsible advice to the public about such an important a health issue as quitting smoking. But to base that advice on blatant misrepresentations of the available scientific data to the public is even worse.

Why are these researchers ignoring the available data which clearly show that the levels of carcinogens in electronic cigarettes are orders of magnitude lower than in regular cigarettes?

Unfortunately, there appears to be a very strong bias operating which does not allow anti-smoking researchers to objectively view the scientific evidence on electronic cigarettes. I believe that the very fact that these devices are similar to cigarettes blinds many anti-smoking researchers to the actual scientific evidence that is readily available. It is apparently not the documented hazards of vaping which are troubling the anti-smoking movement, but the fact that it looks like smoking.

How can anything which looks like smoking be a good thing, even if there is strong evidence that these products are bringing immense and immediate health benefits to thousands of users?

Monday, November 08, 2010

Aberdeen City Council to Smokers: We Will Not Allow You to Adopt or Foster Children

According to an article on the STV web site, the Aberdeen City Council is poised to prohibit smokers from fostering or adopting children, regardless of whether they smoke in the home or promise not to smoke in the home once they adopt.

In fact, under the proposal, prospective foster or adoptive parents would have to prove that they have quit smoking for at least one full year before being eligible to have children placed in their care.

Furthermore, according to the article, "no child born in a non-smoking family would be placed in the care of a smoker." Although I'm not clear on the interpretation, it appears this means that if the biological parents were nonsmokers, a child would not be placed even with a former smoker.

According to the article: "Stephanie Stone, assistant director of Barnardo's Scotland, said: "If Aberdeen City Council adopt the recommendations they will be falling in with the majority of agencies and councils in Scotland. "There are a number of agencies who will of course have existing carers who smoke. In this situation we would do our best to encourage them to cease smoking and offer them support in doing so. "Local authorities are looking at the impact of smoking on young children. Unless we take proactive steps to stop smoking, local authorities, in theory, in the best interest of the child or young person, could withdraw the placement of the young person. We have to make carers aware that this is a live possibility."

The Rest of the Story

I have to question the priorities of the Aberdeen City Council. Is it more important that a child’s parents do not smoke or is more important that a child has parents? There are many children without parents who will be denied a loving family because of this policy, or who will at least experience a delay in the provision of a loving family. There is a widespread shortage of foster and adoptive parents and the demand, unfortunately, generally outpaces the supply. So this policy is tantamount to saying that the City Council would rather children remain parentless than that they enter a loving family if the prospective parents are smokers.

Health has nothing to do with this policy because the adoption ban is not restricted to smokers who fail to promise not to smoke in the presence of the children. The very fact that a parent is a smoker is apparently the problem, rather than exposure to secondhand smoke. This is reinforced by the fact that the policy requires a smoker to have quit smoking for a full year prior to adopting or fostering a child. If the issue were merely protecting children from secondhand smoke, then ex-smokers should be welcomed to adopt children as soon as they quit. And even current smokers should be welcomed to adopt children as long as they agree to smoke outside or outside the presence of the child.

While promoting not smoking or cessation of smoking is a laudable goal, there is no excuse for pursuing this goal at the expense of the welfare and well-being of children. We must always act in the best interests of these children. Their needs and interests should not be sacrificed or compromised because the Aberdeen City Council wants to make a statement about the evils of smoking.

The policy is clearly based not on the interest of protecting the children from secondhand smoke, but on protecting the children from having a parent who smokes. Why, then, is the Aberdeen City Council not also prohibiting overweight or obese individuals from being adoptive or foster parents? Why is the Council not prohibiting people who don’t exercise sufficiently from becoming adoptive or foster parents? What about parents who don’t regularly use seat belts?

The selective inclusion of smoking as the only unhealthy behavior which automatically disqualifies you from being an adoptive parent suggests that the real intent of the policy is to punish smokers and deny them the joy and fulfillment of parenthood. That is despicable enough, but that the policy punishes children to carry out this intent is unconscionable and unacceptable.

Friday, November 05, 2010

Groups Warning Against E-Cigarettes Due to Propylene Glycol Should Also Warn the Public Not to Use Cough Medicine, Nasal Sprays, and Many More Meds

Many anti-smoking groups are publicly discouraging smokers from using electronic cigarettes as a tool to achieve smoking cessation because many of these devices use propylene glycol to vaporize the nicotine. These warnings are highlighted by the proclamation of one chemist, quoted in an article yesterday in the Casper Journal, who said that propylene glycol should not be ingested nor inhaled, because it causes respiratory irritation, convulsions, and gastrointestinal distress.

The article first documents the anecdotal finding that many electronic cigarette users experience a rapid improvement in their health as soon as they quit smoking and switch to e-cigarettes. According to the article: "Bar Nunn resident Duane Gray is also a vaper, having begun “smoking” the e-cigs eight months ago. He loves them, he says. “My lungs and sinuses have cleared up, there are no more tobacco stains on my fingers or the smell of smoke on my clothes.” ...

NSA manager, Tammy Waltemath, stopped smoking the day she tried the e-cig. ... “I believe in the product,” she says. “I had a pack of regular cigarettes in a drawer and I just opened the drawer and said, “Aha!...because I no longer needed them.” ... Waltemath reported her smoker’s cough was gone in less than a week."

Then, the article provides the other side of the story: "The e-cig’s are not without controversy, however, and have not yet been approved by the FDA. In July, 2009, the FDA’s Division of Pharmaceutical Analysis released a warning that a cartridge from one leading brand of e-cigarettes was found to contain one percent diethylene glycol, a chemical used in antifreeze, as well as detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed."

"Byron says that the e-cigs he sells do not contain diethylene glycol, but propylene glycol. However, chemist Michael S. Sommer from the University of Wyoming in Laramie says, “As far as saying that propylene glycol or ethylene glycol are detrimental to one’s health, it is safe to say that neither should be ingested. Both, if inhaled, seem to cause irritations to the respiratory system, and both can cause convulsions and gastro-intestinal distress.”"

"Sommer also says that there is no solid proof one way or the other as to whether these glycols cause cancer. He adds that diethylene glycol may be used in antifreeze but is more commonly found in hydraulic fluids, such as brake fluid. Propylene glycol, as ethylene glycol, is commonly used in antifreeze."

The Rest of the Story

For the sake of argument, let's stipulate that Sommer and the anti-smoking groups are correct and that propylene glycol is hazardous and should not be ingested or inhaled. Let's assume that it is essentially the equivalent of ingesting or inhaling antifreeze, as the FDA and many anti-smoking groups would like us to believe. Then, the question I would ask is:

Why isn't Sommer, and why aren't these anti-smoking groups, calling for the removal of cough medicines like Robitussin from the market?

Many formulations of Robitussin cough medicine contain propylene glycol. These include: Robitussin DM Max, Robitussin DM, Robitussin DM To Go, Robitussin Sugar-Free DM, Robitussin Long-Acting Cough Gels, Robitussin CF Max, Robitussin CF, Robitussin CF To Go, Robitussin Cough & Cold Long-Acting, Robitussin Night Time Cough & Cold, Robitussin Night Time Cough, Cold, & Flu, Robitussin Children's Cough & Cold Long-Acting, Robitussin Children's Cough Long-Acting, and Robitussin Children's Cough and Cold CF.

Numerous other common allergy, cough, and cold medications, for both adults and children, contain propylene glycol. These include: Advil Children's Suspension, CVS Flu and Severe Cold Nighttime, CVS Children's Chest Congestion Expectorant, CVS Tussin Cough Formula, Dimetapp Cold & Allergy for Children, Theraflu Warming Relief Cold & Chest Congestion, Theraflu Warming Relief Nighttime Severe Cold, TheraFlu Warming Relief Flu & Sore Throat Cherry, Triaminic Children's Chest & Nasal Congestion Syrup Tropical Flavor, Tylenol Sore Throat Liquid Daytime Cool Burst, CVS Children's Allergy Relief Oral Solution, CVS Children's Allergy Relief Cetirizine Hydrochloride Liquid Grape, and Claritin Children's Allergy Solution Grape Flavor.

Other medications which contain propylene glycol include Amantidine (which is used to treat Parkinson's disease), Epivir (used to treat HIV/AIDS infection), the Flector patch (used to treat pain), Qusetran (used to reduce cholesterol), Ursodiol (used to treat gallstones), metoclopramide (used to treat certain gastrointestinal disorders), Methadone (used to treat opiate dependence), and Invega (used to treat schizophrenia).

A number of eye drop formulations contain propylene glycol, which is presumably absorbed via the tissues of the eye. These include: Alcon Systane Lubricant Eye Drops and Alcon Systane Lubricant Eye Drops Vials.

Several nasal sprays contain propylene glycol, which presumably could deliver this chemical to the respiratory tract. These include: Afrin Nasal Spray No Drip Severe Congestion, Afrin Pump Mist Original, Afrin Nasal Spray Original, Ayr Saline Nasal Gel, and Ayr Saline Nasal Gel Moisturizing Swabs.

Propylene glycol is injected directly into the bloodstream when patients receive IV dilantin, an anti-seizure medication. It is also injected directly into the bloodstream when patients are treated with melphalan and istodax, which are chemotherapeutic agents. Fenoldopam, an intravenously-administered drug to treat high blood pressure, contains propylene glycol. Also containing propylene glycol for injection are IV valium and IV ativan.

Where are all these medications on the list that this chemist is warning people about because they contain propylene glycol, which should not be ingested or inhaled? Why is the FDA not warning us that all of these other medications contain a chemical that is used in anti-freeze? Why are the anti-smoking groups not instructing the public not to use the medications on this list because they contain a component of anti-freeze?

Thursday, November 04, 2010

Massachusetts Hospital Association Says "Smokers Need Not Apply"

According to a WBUR story, the Massachusetts Hospital Association (MHA) will no longer consider smokers for employment with the organization starting January 1.

According to the article: "For Lynn Nicholas, president and CEO of the MHA, this is personal. “I have lost my own father and many, many of my beloved relatives to smoke and secondhand smoke,” Nicholas said. The association says refusing to hire employees who use tobacco of any kind is an extension of its no smoking policy in and around the office. “We’re basically saying this is not an environment that we want in the future, so we’re not going to add individuals who use tobacco to our workforce,” she said. Nicholas hopes to become a model for hospitals in her association and other employers."

The Rest of the Story

The CEO of the Massachusetts Hospital Association states that the policy is justified because she has lost relatives due to smoking and secondhand smoke and wants to create a healthier workforce by not adding individuals who use tobacco.

But many of us have lost relatives due to obesity, to which a lack of exercise and poor nutrition contributed. Is the MHA also going to refuse to add individuals to its workforce who are obese, or who eat more calories than they expend through exercise? In Massachusetts, about 21% of residents are obese. Will the MHA limit employment opportunities with the Association to the 79% of Massachusetts residents who are not obese, and exclude the other 21% from employment?

Many of us have also lost relatives due to their failure to wear seat belts. In fact, in Massachusetts, only 66% of residents wear seat belts. Is the MHA also going to refuse to add individuals to its workforce who do not wear seat belts? Will the MHA limit employment opportunities with the Association to the 66% of Massachusetts residents who wear seat belts, and exclude the other 34% from employment?

Some of use have lost relatives due to their failure to have smoke detectors in their homes. Will the MHA also refuse employment to individuals who don't have smoke detectors in their homes?

Many individuals in Massachusetts use tanning salons, and research shows that the ultraviolet rays produced in tanning salons are much more powerful than those from the sun. The risk of skin cancer is therefore higher. Many people have lost loved ones due to melanoma. Will the Massachusetts Hospital Association also exclude from employment individuals who regularly use tanning salons?

Some researchers have concluded that excessive driver speed is the primary cause of the majority of motor vehicle crashes. Is the MHA going to throw into the garbage the applications from individuals who regularly drive at excessive speeds, or who have a history of motor vehicle accidents?

According to the article, the Massachusetts Hospital Association has made it clear that it has no intention of addressing any other personal behaviors that cause disease and death: "Nicholas said she has no plans to restrict hiring based on any other criteria." Thus, smoking is being singled out as the only behavior upon which the MHA will discriminate in its employment practices.

This suggests that a concern for the health of the workforce is not actually the driving force behind the policy. If it were, one would expect the MHA to address all the important behaviors that contribute to an unhealthy workforce. Instead, the MHA is just singling out one. Perhaps the real reason for the policy, then, is intolerance of the decision made by smokers and a desire to punish them for this decision by making it impossible for them to secure employment.

Wednesday, November 03, 2010

Physicians, Lung Association Prefer that Patients Smoke Cigarettes Rather than Quit Smoking with the Help of Electronic Cigarettes

An article written by physicians out of Brigham and Women's Hospital in Boston, published in this month's issue of the Annals of Internal Medicine, urges physicians to counsel patients against the use of electronic cigarettes, even as strong anecdotal evidence suggests that these devices may literally be a life-saver for smokers who are unable to quit via traditional means.

The article implores that: "Physicians should be aware of the popularity, questionable efficacy claims, and safety concerns of e-cigarettes so that they may counsel patients against use and advocate for research to inform an evidence-based regulatory approach."

At the same time, according to yesterday's article from the Bloomberg News web site, the American Lung Association is also urging smokers not to use electronic cigarettes as a smoking cessation tool.

According to the article: "Unless e-cigarette companies can prove the gadgets are safe, “people should not use them because we don’t know what they are,” said Paul Billings, vice president of national policy and advocacy at the American Lung Association in Washington."

The Rest of the Story

In instructing patients or smokers in general not to use electronic cigarettes, what these physicians as well as the American Lung Association are saying is that they would rather smokers continue to smoke cigarettes than to quit smoking via the help of electronic cigarettes.

The reality is that the majority of smokers are not going to be able to quit smoking using traditional therapy (i.e., pharmaceutical aids). For this overwhelming majority of smokers, the physicians and the Lung Association are saying: "Don't try electronic cigarettes. We don't know what they are. Stick with the real ones. Don't put down your Marlboros, Camels, and Newports."

I would argue that this advice is irresponsible and misguided. The best available evidence suggests that electronic cigarettes are much safer than regular cigarettes. The levels of carcinogens are orders of magnitude lower. There is no evidence that they cause lung disease. There are no specific safety concerns that anyone has pointed out, other than the nicotine, which is of course also present in nicotine replacement products.

It is even more irresponsible to tell the public: "We don't know what they are." What that is tantamount to saying is: "I didn't take the time to research electronic cigarettes and to review the twenty plus studies on the product."

We actually know exactly what electronic cigarettes are and what they contain. We have extensive reports from gas chromatographic mass spectrometric analyses which have determined the components in both the electronic cigarette cartridge liquid and in the produced vapor. So far, nothing has turned up which suggests that the product poses anything near as much risk as cigarette smoking. In fact, nothing has turned up yet which suggests that the product poses risks beyond that attributable to the nicotine in the product.

Do we need formal clinical trials to determine for certain the safety profile of electronic cigarettes? Yes. But that doesn't mean that we have no idea what is in them or what the safety profile is for the constituents in them.

The American Lung Association has the right to its own opinion about electronic cigarettes, but it is truly irresponsible to offer advice to smokers that is based on ignorance. It is irresponsible to offer advice to smokers when they haven't bothered to seek out and read all the available evidence that has been accumulated, including the twenty plus studies that have examined electronic cigarettes to determine the specific chemicals that they contain.

I believe it is also irresponsible of physicians to advise smokers to continue smoking rather than to quit by virtue of electronic cigarettes. That is almost tantamount to a death sentence for many smokers. Many smokers who have quit smoking with the use of e-cigarettes have testified to the immediate and perhaps life-saving improvement in their health which they have experienced. To deny these potential benefits to smokers is tantamount to malpractice.

Tuesday, November 02, 2010

ASH Cites Mississippi Study Despite Complete Lack of Statistical Significance of Starkville Results

Action on Smoking and Health (ASH) yesterday cited a new study from Mississippi State University in a press release claiming that there is new evidence that smoking bans immediately and significantly reduce heart attacks.

According to ASH: "If a new drug were discovered which could cut the rate of heart attacks by 10% or more, many communities would probably make it available to residents, especially if the cost savings from fewer heart attacks were greater than the cost of the program. Yet a new study of two different Mississippi communities has now found something even more effective which can be implemented at virtually no cost to prevent even more heart attacks and save millions of dollars in unnecessary medical costs in just two communities -- yet many leaders are reluctant to embrace it. The study found that a smoking ban in Starkville resulted in a 13.1% decline in hospital admissions for heart attacks, at an estimated savings of $288,270."

This is the same study I discussed yesterday. Although the study concludes that the smoking ban resulted in a 13.1% decline in hospital admissions for heart attacks, the confidence interval around that point estimate includes zero, meaning that the result is not statistically significant. Had there been just 3 fewer heart attacks among non-Starkville residents in the 1,000 days following the smoking ban, the decline in heart attacks among non-Starkville residents would have been greater than that among Starkville residents.

The Rest of the Story

This story demonstrates the lack of scientific scrutiny in the tobacco control movement these days. One would hope that these public health groups would read the studies before citing them to make sure that they are scientifically sound. Clearly, however, the intent is not to present solid science, but to present findings which are favorable to the cause. This is unfortunate, because by disseminating the results of shoddy scientific studies, these anti-smoking groups are actually hurting the cause by damaging the scientific credibility and reputation of the entire tobacco control movement.

Monday, November 01, 2010

Study Concludes that Starkville Smoking Ban Reduced Heart Attacks But Fails to Assess Statistical Significance of Results

A new study conducted by researchers at Mississippi State University concludes that smoking bans in Starkville and Hattiesburg resulted in a significant decline in heart attacks. The study was announced via a press release issued by the University.

The study methods were as follows: "These studies applied a controlled observational approach to objectively examine the hypothesized impact of smoke-free laws on hospital admissions for heart attacks in Starkville and in Hattiesburg. The Starkville Study examined the number of heart attack admissions between July 29, 2004 and April 7, 2009; while the Hattiesburg Study examined admissions between April 21, 2005 and June 30, 2009. Each study compared the number of heart attack admissions among people living within the city limits to those living in the local hospital catchment area, but outside of the city limits (and thus not protected by the
smoke-free ordinance)."

The results for Starkville were reported as follows: "During the 1,053 day period following the implementation of the smoke-free ordinance in Starkville, there were 38 heart attack admissions among Starkville residents, compared to the standardized rate of 52.57 admissions prior to the implementation. Outside of Starkville, there were 19 heart attack admissions, compared to the standardized rate of 22.30 admissions prior to the implementation. Thus, Starkville residents experienced a 27.7% reduction in heart attack admissions compared to the 14.8% reduction observed among those who did not live in Starkville."

For Hattiesburg, the reduction in heart attacks among residents was 13.4%, compared to a 3.8% reduction in heart attacks among non-residents.

Based on the finding that the decline in heart attacks among Starkville residents was greater than that among non-Starkville residents, the study concludes that the difference was due to the smoking ban and that during the study period, the ban resulted in a cost savings of $288,270. Using a similar calculation for Hattiesburg, the report claimed that the smoking ban resulted in a savings of $2.4 million.

The Rest of the Story

This study violates the most fundamental principal of epidemiology and biostatistics: you must evaluate any scientific hypothesis to see whether the results could be explained by chance. In other words, you must determine whether your results are statistically significant.

No scientific journal will publish findings such as these without some test to see if the difference in the reduction in heart attacks between Starkville and non-Starkville residents is statistically significant. Nor should they. Without such a statistical test, we cannot determine whether the observed difference in the decline in heart attacks reflects a true difference, or whether it is merely due to chance.

I will focus on the Starkville findings, but the same arguments apply to the Hattiesburg results as well.

The study reports that heart attacks in the Starkville hospital declined by 27.7% after the smoking ban among Starkville residents, but by only 14.8% among non-Starkville residents. Based on the fact that the decline among Starkville residents was greater, the study concludes that the smoking ban was the cause of the difference.

Now suppose that instead of a 14.8% decline among non-Starkville residents, the decline had been 26.8%. Would the paper still conclude that there was a significant difference between the degree of decline among Starkville and non-Starkville residents? Presumably not. With such small sample sizes (there were only a total of 104 heart attacks among the entire study population during the entire study period), it is not possible to conclude that a decline of 27.7% and a decline of 26.8% are statistically different.

What if the decline among non-Starkville residents was 25.4%? Would that be statistically different from a decline of 27.7%? Most people looking at the small sample size would think: "probably not."

OK, then. At what level of decline would the difference become statistically significant?

The answer is: you can't tell just by looking at the data. You have to analyze the data using some statistical test to assess the significance of the difference in the change in heart attacks. This is a most basic principal of scientific analysis.

The rest of the story is that, shockingly, this study presents absolutely no statistical analysis. There is no test conducted to determine whether the observed decline in heart attacks of 27.7% among Starkville residents is indeed statistically different than the observed decline in heart attacks of 14.8% among non-Starkville residents.

This would be equivalent to a pollster conducting a poll with a sample size of 300 showing that 50.1% of likely voters indicate that they intend to vote for Harry Reid and 49.9% indicating a preference for Sharron Angle, and then the pollster concluding that Harry Reid can be penciled in as the winner. You have to know the margin of error. With a sample size of just 300, the margin of error is probably about +/- 8 percentage points. Clearly, Reid and Angle would be in a statistical dead heat and you'd have to be devoid of any scientific integrity to claim that your poll showed a significant difference in preference for these two candidates.

It is therefore shocking that this study makes no attempt to assess the significance of the difference between a 27.7% decline in heart attacks and a 14.8% decline in heart attacks. Even more shocking is the fact that the study is willing not only to draw a causal conclusion in the absence of any such statistical comparison, but that it goes so far as to calculate the exact number of dollars saved as a result of the smoking ban without having first determined whether there is any real statistical difference between a 27.7% and a 14.8% decline based on only 57 post-ban heart attacks.

There are various ways one can statistically compare the difference in the declines of 27.7% and 14.8%. However, in this study, no method was used at all.

I did my own calculations based on the results reported in the study and based on a conservative estimate which maximizes the likelihood of finding a statistically significant difference, I found that the difference between the two rates of decline was not even close to being statistically significant.

This is not surprising when you look at the actual numbers. Among Starkville residents, there were 33 heart attacks during the 660 days prior to the smoking ban and 38 heart attacks during the 1053 days post-ban. Among non-Starkville residents, there were 14 heart attacks during the 660 days pre-ban, and 19 heart attacks during the 1053 days post-ban.

Suppose that instead of 19 post-ban heart attacks among non-Starkville residents, there had been just 16 post-ban heart attacks. That's a difference of just 3 heart attacks!

Had that been the case, then there would have been a greater decline in heart attacks among non-Starkville residents than among Starkville residents!

This demonstrates how these findings have no statistical significance. A difference of just 3 heart attacks would have completely negated the study findings.

The same thing is true if there had been 3 more pre-ban heart attacks among Starkville residents. Had that occurred, the decline for non-Starkville residents would have been 30.0%, compared to 27.7% for Starkville residents.

In fact, had there been just 1 fewer pre-ban heart attack for Starkville residents, 1 more pre-ban heart attack for non-Starkville residents, 1 more post-ban heart attack for Starkville residents, and 1 fewer pre-ban heart attack for non-Starkville residents, the results would have completely reversed, and by its own logic, the study would have had to conclude that the smoking ban resulted in an increase in heart attacks (the decline in heart attacks among Starkville residents would have been only 24%, compared to 25% among non-Starkville residents).

For these findings, which are exquisitely sensitive to a simple shift in one heart attack here and one heart attack there, one must not put any confidence in their statistical meaning. Clearly, the role that these are just chance differences cannot be ruled out given the small sample size. Nevertheless, the study goes as far as telling us the exact cost savings from the heart attacks averted due to the smoking ban.

Had the study provided a simple additional piece of information - the confidence intervals around the key estimates in the study (i.e., the decline in heart attacks for Starkville and non-Starkville residents) - it would have been readily apparent that the study findings are not statistically significant. By my calculations, the confidence intervals around the 27.7% and 14.8% point estimates overlap, meaning that one cannot conclude that the 27.7% and 14.8% figures are statistically different from one another.

For the life of me, I cannot understand why studies of the relationship between smoking bans and heart attacks seem to bring out the weakest science. I can't think of another field of inquiry where I've seen conclusions like this which are being made without any statistical analysis whatsoever.

It certainly appears that we are dealing with a pre-determined conclusion and that the research is being done solely for the purpose of proving that pre-determined conclusion. The interest in addressing the research question as a legitimate scientific one is simply not there. What is the point of doing the research, however, if we are not going to actually objectively analyze the data?

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