Friday, April 30, 2010

Concord Considering Ordinance to Ban Smoking Completely in Downtown Area

The city council in Concord, California is considering an ordinance which would effectively ban smoking in the entire downtown area. The proposed ban would effectively prohibit smoking not only adjacent to building entrances, but on any sidewalks and streets in the downtown area.

The impetus for the proposed ban is that downtown businesses were upset that smokers were congregating outside of their stores: "Last year, downtown property owners asked the City Council to ban smoking in the area around Todos Santos, too, saying that smokers who had been pushed out of the park were congregating around their buildings. ... On the downtown ban, the city's staff had proposed banning smoking within 20 feet of doorways, as other cities have done. But the property owners who spoke to the subcommittee asked them to totally outlaw smoking for the blocks around the park, so as not to have pockets of smokers."

The Rest of the Story

The problem with these broad outdoor smoking bans is that they go beyond the issue of health protection. They go beyond the need to protect nonsmokers from significant exposure to secondhand smoke and instead, what they are protecting the public against is having to see smokers.

The business owners did not express concern about the health effects of secondhand smoke, but instead, their concern was that they didn't like the idea of having groups of smokers seen in the vicinity of their stores.

Once again, this demonstrates how the public health practice of tobacco control has shifted from a battle against cigarette smoke to a battle against cigarette smokers.

Public health advocates should remember that outdoors is exactly where we want smokers to be smoking. That is actually the way to minimize exposure of nonsmokers to secondhand smoke. Eventually, what these policies are going to do is make it impossible for smokers to smoke anywhere except in their own homes. And that would be detrimental to the public's health because it would expose their families - and their children - to the tobacco smoke.

Is it tobacco smoke exposure that we are fighting or is it the smoker?

Thursday, April 29, 2010

Authors of Study on Effects of Toronto Smoking Ban on Heart Attacks Respond to My Refutation of Study Conclusions

The authors of the study on the effect of Toronto's smoking ban on heart attacks have responded to my letter refuting the study's conclusions.

The background: The study examined trends in hospital admissions for cardiovascular and respiratory disease in Toronto from 1996 to 2006. A smoking ban in restaurants (excluding designated rooms) was implemented in 2001 and a smoking ban in bars (excluding designated rooms) was implemented in 2004. Two comparison cities - Durham Region and Thunder Bay - were used to control for secular trends in cardiovascular and respiratory disease.

The study findings were reported as follows: "Crude rates of admission to hospital because of cardiovascular conditions decreased by 39% (95% CI 38%–40%) and admissions because of respiratory conditions decreased by 33% (95% CI 32%–34%) during the ban period affecting restaurant settings. No consistent reductions in these rates were evident after smoking bans affecting other settings."

The study concludes that the observed declines in cardiovascular and respiratory hospital admissions were attributable to the smoking ban.

I published a rapid response (e-letter) to the study in which I presented the actual data, conducting the central analysis that is necessary to answer the research question. This analysis was not conducted in the published study. The results indicated that there was a decline in cardiovascular disease of equal magnitude in the comparison cities, thus negating the conclusion that the observed changes in heart disease in Toronto were attributable to the smoking ban.

In my commentary on April 17, I concluded: "It will be interesting to see how the authors of the study respond."

Well, we now know how the authors of the study responded.

Here is their response:




No, you didn't miss anything. That was their response: complete silence. Apparently, they have no interest in responding to this serious refutation of their study conclusion.

The Rest of the Story

It is highly unusual, as well as improper etiquette, in the academic world for authors to fail to respond to serious, evidence-based criticism of their study conclusions, especially when that criticism is published in a journal, and most especially when that criticism results in a complete refutation of their study conclusions.

I have certainly faced my share of criticism of my published work through the years, but I have never failed to respond sincerely and promptly to published criticism of my study conclusions.

I take the failure of the authors to respond to my criticism as an admission that my critique is correct and that an actual analysis of the data indeed shows that the degree of decline in cardiovascular disease in the comparison cities was similar to that observed in Toronto during the same time period, thus refuting the study's conclusion that the observed decline in heart disease admissions in Toronto was attributable to the smoking ban.

Good science depends upon a two-way, not a one-way communication from researchers. If scientists are not willing to defend their methods and conclusions, then there can be no advancement of scientific methods. There can also be no challenges to existing thinking because if scientists are not willing to re-think their conclusions, the existing thinking becomes gospel and is not subject to challenge, even if it is wrong. Perhaps more than anything, the unwillingness of tobacco control researchers to enter into any meaningful discussion with those who challenge their conclusions is the greatest threat to the integrity of tobacco control science.

Wednesday, April 28, 2010

GlaxoSmithKline to Market Nicotine Mini-Lozenges in Cherry and Mint Flavors; Is This Also a Ploy to Lure Kids?

Last week, I revealed that the Food and Drug Administration expressed concerns about dissolvable tobacco products, arguing that these products are small and candy-like with added flavors, and therefore may be appealing to children and adolescents. The FDA is considering whether to ban these products. In addition, anti-smoking researchers warned that R.J. Reynolds is trying to lure kids to use these products by adding candy flavorings.

As I wrote: "In a commentary in Pediatrics, Dr. Laurence R. Deyton, director of the newly formed Center for Tobacco Products at the Food and Drug Administration, and Dr. Marisa L. Cruz, also from the center, wrote about the “unique concerns” of dissolvable tobacco. ... "The candy-like appearance, added flavors, and easily concealable size of many of these products may be particularly appealing to children and adolescents," they wrote."

Yesterday, GlaxoSmithKline announced that it was going to take candy-like nicotine delivery products to a new level by marketing a new mini-lozenge which is smaller than lozenges currently on the market and dissolves three times faster. These lozenges come in a variety of flavors, including cherry (marketed as having a "refreshing" cherry flavor) and mint.

According to an article in Drug Store News: "GlaxoSmithKline announced Tuesday the launch of its new Nicorette Mini Lozenge, a smaller smoking-cessation lozenge that dissolves three times faster than stop-smoking lozenges currently on the market. The lozenges will be lined-priced with existing smoking-cessation products and will be sold at U.S. retail healthcare centers as three small vials, each containing 27 lozenges. The new mini lozenge is expected to drive incremental growth to the category, suggested Roger Scarlett-Smith, in an interview with Drug Store News, because the smaller lozenge size actually satisfies different usage scenarios. “It’s an opportunity for people to use it in a more situational way,” Scarlett-Smith said. For example, the small vials can be discreetly carried in a pocket for the person “on the go.”"

The Rest of the Story

The only thing missing from this story is the FDA's commentary in Pediatrics about how this product may appeal to children and adolescents.

The only thing missing is an FDA advisory committee to study whether the product may appeal to kids and to decide whether or not to pull the product off the market.

The only thing missing is an article by anti-smoking researchers warning that these small lozenges are easy to conceal and may therefore be appealing to kids, who can easily hide them in school.

The only thing missing is an article by anti-smoking researchers warning that these products represent a poisoning threat to children, who will observe there parents popping these candy-flavored lozenges and who may unintentionally leave them around the house, posing a risk of severe nicotine poisoning for young children.

The only thing missing is an article by anti-smoking researchers claiming that GlaxoSmithKline is trying to lure kids into using its candy-like nicotine lozenges in order to get them addicted to its products.

Why are these things missing? Quite simply, because the tobacco control movement is no longer science-based. It is guided more by ideology than science. And that ideology, combined with a heavy dose of money (or consultants) from pharmaceutical companies, works to protect Big Pharma profits, even when it comes at the expense of protection of the public's health. That ideology, combined with the financial influence of Big Pharma money, leads to a non-science based, inconsistent position with regard to nicotine-containing products.

To be clear, I am not arguing that Glaxo is marketing nicotine lozenges to kids or that kids are going to start popping these lozenges as a new fad that is going to spread like wildfire throughout the country. I am not arguing that the product should be taken off the market to prevent accidental poisoning of young children. However, I am pointing out that the exact same reasoning being used by the FDA and anti-smoking groups to condemn Camel orbs and electronic cigarettes would also lead to the condemnation of GlaxoSmithKline for marketing this new mini-lozenge product, in its appealing cherry and mint flavors.

The rest of the story is that the FDA, in its actions to date under its newly-found authority to regulate tobacco products, has been terribly inconsistent. Its actions have been guided more by ideology and a healthy dose of biased speculation than by science and evidence. The same is true of the anti-smoking groups and researchers who have completely lost sight of the fact that kids are not smoking candy-flavored orbs or electronic cigarettes; they're smoking the real ones.

The combination of ideology and pharmaceutical company influence has become blinding, to the point that it is obscuring the evidence and science base for tobacco control policy.

Tuesday, April 27, 2010

New Study Finds Menthol Smokers More Likely to Believe that Menthol Cigarettes Have Medicinal Properties and are Less Harmful than Regular Cigarettes

A new study published in the current issue of the journal Nicotine and Tobacco Research reports that menthol smokers are more likely to believe that menthol cigarettes have medicinal properties and that they are less hazardous than regular cigarettes (see: Unger JB, Allen B, Leonard E, Wenten M, Cruz TB. Menthol and non-menthol cigarette use among Black smokers in Southern California. Nicotine and Tobacco Research 2010; 12[4]:398-407).

The study examined the attitudes and beliefs of 720 Black smokers living in Los Angeles County. According to the study: "Fifty-seven percent of respondents were menthol-only smokers, 15% were regular-only smokers, and 28% smoked both menthols and regular cigarettes (combined smokers). In bivariate models, menthol-only and combined smokers had stronger beliefs in the medicinal effects of menthols relative to regular-only smokers. Menthol-only smokers held stronger beliefs, relative to regular-only smokers, that menthols were less harmful than regular cigarettes. Menthol-only smokers preferred the menthol taste/sensation more than combined smokers, who preferred the menthol taste/sensation more than regular-only smokers."

The study concludes: "Health education efforts are needed to dispel the myth that menthol cigarettes are more medicinal and less harmful than regular cigarettes. Prevention and cessation efforts in Black communities can be tailored to reflect predictors of menthol smoking to reduce tobacco-related morbidity and mortality."

The Rest of the Story

While much of the discussion over menthol cigarettes has focused on the issues of whether or not menthol is harmful (i.e., has adverse health effects) or whether menthol adds to the addictiveness of cigarettes, this study adds a new dimension to the debate: whether the marketing of menthol leads to inaccurate perceptions of the relative safety of menthol cigarettes among consumers who smoke these brands. Perceptions that menthol cigarettes are less harmful could, in turn, lead to either increased cigarette consumption or a decreased motivation to quit smoking.

It is important to recognize that the FDA Tobacco Products Scientific Advisory Committee was not charged with looking specifically at the question of whether menthol adds health harm or addictive potential to cigarette smoking. The Committee was given a broad mandate to examine the impact of menthol cigarettes on the public's health. That impact would certainly include distorted perceptions of the relative safety of menthol cigarettes among smokers who choose menthol brands.

This research adds important evidence regarding the impact of the marketing of menthol cigarettes on the public's health. It needs to be considered by the FDA Tobacco Products Scientific Advisory Committee as part of its overall examination of the menthol issue.

Monday, April 26, 2010

Action on Smoking and Health Argues for Insurance Surcharges for Smokers, but Not Obese People, Because Smokers are a Lower Income, Marginalized Group


ASH's Position is an Example of Classism in the Anti-Smoking Movement


Action on Smoking and Health (ASH) has proposed that smokers be forced to pay surcharges on their health insurance premiums in order to provide needed revenue for health care reform. In attempting to make the case for why smokers should face this surcharge while obese individuals should not, ASH argues that such a proposal would elicit less outrage if applied to smokers than obese people, because smokers are a marginalized, lower social class group that has less political clout.

ASH argues as follows: "Fewer than 20% of adults are smokers, and only about 13% smoke daily, while about 33% of adults are obese, and another 33% are classified as overweight. Thus the number potentially affected by a smoker surcharge is far smaller, and, because smokers are concentrated largely in the lower socioeconomic classes, they are less likely to be able to effectively object. A surcharge on the obese would arouse objections from a much larger segment of the population, including many people with considerable influence."

The Rest of the Story

Believe it or not, I'm not making this up. This is ASH's real argument for applying the surcharge to smokers, but not obese individuals.

This demonstrates that to ASH, this truly is class warfare. It is not about health or reducing health care costs; instead, it is about declaring war on a particular social class that ASH apparently abhors.

In public health, economic, and public policy terms, the fact that there are more obese and overweight individuals than smokers would argue for promoting a surcharge based on overweight as a priority, since it would result in a greater overall improvement in health and a greater amount of revenue for health care reform. ASH has distorted public health logic by arguing that the policy should apply to a much smaller group because that group is of a lower social class and thus, easier to control.

While I have been arguing for some time that the modern-day anti-smoking movement operates as a form of class warfare, rather than as a pure endeavor to improve the public's health, this is perhaps the first time that the movement has explicitly admitted that it is engaged in class warfare, and that its intent is to control and punish marginalized populations.

ASH is explicitly arguing that the degree of marginalization of a population should be a consideration (a positive one) in whether or not to regulate the behavior of a group of people. The more marginalized the group, the more appropriate it is to regulate their behavior, according to ASH's argument here. Such an argument is inherently classist. Marginalization should not be a factor in public health regulation, and it certainly shouldn't increase our propensity to regulate. If anything, it should caution us against actions that may increasingly marginalize that population, leading to adverse effects on them and their families.

The argument that punitive-type laws should be targeted towards those who have the least political power is also a classist position. When society needs money to pay for needed services, that revenue should be extracted from the most politically marginalized subgroup, according to ASH's argument.

ASH's' support for isolated insurance surcharges on smokers is but one example of classism in the anti-smoking movement. Another example is the efforts of ASH and other groups to isolate exposing children to secondhand smoke as the sole risk-increasing parental health behavior that would be classified as child abuse. The apparent attempt by at least some anti-smoking groups and advocates to intervene in the home and coerce parents to adopt a certain health behavior (not smoking around their kids), in the absence of evidence that this behavior necessarily leads to severe and immediate harm, is not only troubling because of its implications for parental autonomy and individual privacy rights, but also because it represents prejudice and discrimination based on social class.

Essentially, what such a policy says is that we as the more privileged, better educated class of citizens (nonsmokers) are going to tell a less privileged and less educated class of citizens (smokers) how to live their lives and how to raise their children within the privacy of their own homes.

Education is the strongest predictor of smoking status. So intervening to regulate smoking in the home is essentially an intervention that is going to punish less educated and less well off people for engaging in an unhealthy behavior. But because this is an isolated call for intrusion into the home (we are not calling for regulation of other health behaviors on the part of parents that affect their children), it has the appearance of being a class issue, rather than a true public health issue.

I don't see anyone calling for fines on parents who feed their children steak four nights a week, even though this is arguably doing health damage and increasing their risk for a number of chronic diseases. I don't see a call for criminalization of parents who don't put enough sunscreen on their children when they send them out to the country club swimming pool for the afternoon.

If anti-smoking groups really want to do something to help children who are exposed to secondhand smoke in the home, then how about offering free smoking cessation services to parents who want to quit smoking? How about using cigarette taxes to help these smokers, to benefit them directly, rather than call for taxes on smokers to fund completely unrelated programs that do not benefit the people who need the resources the most?

Classifying smoking around kids as child abuse, criminalizing this behavior, or outlawing it does nothing to address the social class disparities inherent in the public health problem of smoking. In fact, it exacerbates the very problem that we should be aiming to solve.

The war on tobacco-related morbidity and mortality should be just that: a war against tobacco products and the health harm that they cause. It should not be a war against what anti-smoking activists apparently view as a lower social class.

As a start, the increased degree of marginalization of a social group should never be used as a criterion to argue for the appropriateness of a proposed discriminatory public policy.

Action on Smoking and Health Destroys Argument for Plaintiffs in Tobacco Litigation; Argues that Smoking is Not an Addiction, Only Nicotine Is

In a position paper defending its proposal for a health insurance surcharge on smokers in order to raise needed revenue for health care reform, Action on Smoking and Health (ASH) has argued that in contrast to the arguments being made by plaintiffs in thousands of tobacco lawsuits, including the Engle progeny cases, smoking is a personal choice which represents a behavior and not an addiction.

According to ASH, smoking is a choice and not an addiction. Smokers make a free and conscious choice to smoke and their behavior should not be viewed as addictive. The only aspect of their addiction - says ASH - is the addiction to nicotine, and smokers who continue to smoke are making a deliberate and free choice to obtain nicotine from cigarettes rather than from nicotine replacement products that are available on the market.

Specifically, ASH argues that "most people see buying and using cigarettes as a habit or a choice, thus fitting the criteria for a user fee. Although there is evidence that for many people smoking involves addiction, the addiction is to the drug nicotine, not to the act of smoking itself, which is a behavior. Because those who desire to can easily ingest nicotine from nicotine gum, nicotine patches, nicotine spray, and nicotine inhalers, their decision to ingest it by smoking rather than by using nicotine replacement products is a choice. Since it is a choice rather than an addiction, disease, or health status, it is fairer to impose personal responsibility for the choice by making smokers bear at least a small portion of the huge costs their choice imposes on the economy and the health care system."

The Rest of the Story

In one fell swoop, ASH has destroyed the argument necessary for plaintiffs to prevail in tobacco litigation. In order for juries to find tobacco companies partly responsible for the health damages suffered by smokers, those juries must be convinced that the decision to smoke was not a free and informed choice, but that instead, smoking is highly addictive and thus smokers, to some extent, were not free to simply decide not to smoke.

I find it ironic and very unfortunate that ASH - the group which helped pioneer these lawsuits against the tobacco companies in the first place - has now destroyed the very basis for this litigation by arguing that smoking is not an addiction, but instead, is a free and informed choice.

Specifically, ASH has argued that in making the decision to smoke, smokers have made an informed decision not to use nicotine replacement products to satisfy their nicotine addiction, but instead, to rely upon the continued use of cigarettes to satisfy their need for nicotine.

It is terribly ironic that ASH is now making precisely the same argument that the tobacco company defendants have been making in the courtroom: that smoking is a choice, not an addiction.

If I were representing the tobacco companies, I would introduce ASH's statement as evidence in every tobacco trial I was litigating to demonstrate to the jury that even among anti-smoking advocacy groups, smoking is viewed as a choice and not as an addiction. This would be extremely damaging to the plaintiffs in these cases, who need to convince the jury that they were addicted to smoking.

As an expert witness in many tobacco cases, including the Engle case, I can tell you that a key aspect of these trials - one which I addressed in great detail in my testimony - is the issue of whether or not the smokers in question were addicted, or whether they were merely smoking by choice. In fact, this is the central issue in these cases, and the way in which the juries view this issue is essentially dispositive of the outcome of the case.

Why has ASH given up this kind of ground to the tobacco companies? Because they boxed themselves into a corner by promoting such extreme policies - like calling smoking child abuse and arguing for isolated surcharges on smokers - that in order to defend these ridiculous proposals, they had to abandon their historical argument that smoking is addictive and switch over to the tobacco industry's position.

I find it quite unfortunate that ASH switched over to the tobacco industry position simply because it boxed itself into a corner by virtue of an untenable policy position. In doing this, ASH is - I believe - undoing much of the great work it has done in promoting justice for smokers fighting the tobacco companies.

Perhaps most unfortunate is the fact that ASH's argument that smoking is not an addiction is an untenable one from a scientific perspective. As I have been arguing for months on this blog (in the context of discussing why electronic cigarettes are so popular), the addictive nature of smoking is not due solely to the pharmacologic effects of nicotine. The behavior itself is part of the addiction.

Research shows that treating the pharmacologic aspect of the addiction is not enough to reduce the craving to smoke, and that replication of the behavioral aspect of smoking, even without any nicotine delivery, can be effective in suppressing the desire to smoke. Thus, ASH is simply wrong when it states that "the addiction is to the drug nicotine, not to the act of smoking itself, which is a behavior."

Despite the pharmacologically-laced and financially-influenced mentality of the anti-smoking movement these days, the act of smoking itself is part of the addiction, not just the pharmacologic and physiologic effects of the nicotine.

The rest of the story is that in its zeal to support oppressive and extreme policies that aim to punish and further marginalize smokers, ASH has backed itself into a corner and been forced to make a scientifically invalid argument that is not only false, but which does damage by destroying the plaintiff's position in thousands of lawsuits against the tobacco companies.

Friday, April 23, 2010

FDA Tobacco Control Score Card: Are FDA's Actions on Tobacco So Far Evidence-Based?

Today, I am issuing my first of a series of periodic FDA Tobacco Control Score Cards. The primary purpose of this score card is to monitor and evaluate how well the FDA is doing with its new-found authority to regulate tobacco products. Specifically, I will be evaluating the FDA on its actions by two criteria:

1. The degree to which the Agency's actions are evidence-based; and
2. The degree to which the Agency's actions will actually make a significant difference in either:
a. Reducing youth or adult smoking; or
b. Reducing disease by making cigarettes safer.

Today's evaluation includes the major actions that the FDA has taken so far in terms of regulating tobacco products. The information for the scorecard is summarized in the table below:

Scorecard #1: FDA Tobacco Control Actions as of April 2010

Issue

Evidence-Base

Action

Flavored cigarettes (non-menthol)

No youths are using any Big Tobacco flavored cigarette product

Banned

Electronic cigarettes

No documentation that any youths are using electronic cigarettes

Banned (though only enforced through interception of two shipments)

Dissolvable tobacco products

No documentation that more than an occasional youth is using these products

Considering ban

Regular cigarettes

Clear documentation that more than 3 million youths regularly use these products

None – no action taken yet that will significantly reduce the number of youth smokers or make cigarettes substantially safer to use


Grade: D

Explanation

The actions taken by the FDA to date have not been evidence-based. The ban on flavored cigarettes affected not a single Big Tobacco brand used by a youth in America and thus resulted in absolutely no reduction in youth smoking. The ban on electronic cigarettes, although not being enforced, has scared many vapers into returning to cigarette smoking, thus causing increased disease and adding to Big Tobacco profits. The Agency's pre-occupation with orbs, which are not a significant problem among youths, and its suggestion that these products are marketed to lure youths, are contradictory to the entire literature on tobacco and youth smoking. Most importantly, the Agency has not yet taken a single action that will significantly reduce either youth or adult smoking, and it has not yet taken a single action that will result in a reduction of disease by virtue of safer cigarettes. Thus, the Agency's grade at this first Rest of the Story score card is a D.

R.J. Reynolds Accused of Using Camel Orbs to Lure Kids

According to an article in the New York Times, a number of tobacco control researchers are accusing R.J. Reynolds of marketing Camel Orbs to youths to entice them to use tobacco and addict them to nicotine.

According to the article: "R. J. Reynolds Tobacco, the nation’s second-largest cigarette maker behind Philip Morris, is test marketing the product, Camel Orbs, along with other dissolvable tobacco products, in three cities. It is part of a broad industry trend to create smokeless products in response to declining cigarette use and the rise of smoke-free air laws. The study says Orbs, pellets made of finely ground tobacco with mint or cinnamon flavoring, are packed with nicotine and can poison children and lure young people to start using tobacco. The pellets dissolve in the mouth, like breath mints. “Nicotine is a highly addictive drug, and to make it look like a piece of candy is recklessly playing with the health of children,” the lead researcher, Gregory N. Connolly, a professor with the Harvard School of Public Health, said in an interview." ...

"Dr. Winickoff, who advised Professor Connolly on where to publish the study, contended that the tobacco industry was creating novel products partly to entice and addict a new generation of smokers to replace those who die." ...

"In a commentary in Pediatrics, Dr. Laurence R. Deyton, director of the newly formed Center for Tobacco Products at the Food and Drug Administration, and Dr. Marisa L. Cruz, also from the center, wrote about the “unique concerns” of dissolvable tobacco. New Reynolds products also include a thin strip similar to some breath mint products and a stick resembling a toothpick. "The candy-like appearance, added flavors, and easily concealable size of many of these products may be particularly appealing to children and adolescents," they wrote."

Dr. Connolly is a member of the FDA Tobacco Products Scientific Advisory Committee, which will be taking up the issue of Camel orbs as its second order of business (after dealing with menthol).

The Rest of the Story

This story demonstrates exactly why the FDA tobacco legislation is so detrimental to the public's health, and why it is such a victory for Philip Morris.

Anti-smoking researchers and federal regulators are apparently off their rockers thinking that R.J. Reynolds would be stupid enough to try to poison kids with their products so these products would then be taken off the market. The accusation that cigarette companies are marketing products to youth by making them look like candy demonstrates a complete misunderstanding of the reason why adolescents smoke in the first place.

Teenagers smoke because they want to look like and feel like adults, and separate themselves out from being kids. The whole point of smoking is that it is not candy. Candy is for kids. It's the cigarettes that are viewed as being for adults. Thus, smoking - not eating tobacco-infused candy - is the rite of passage into adulthood for adolescents.

R.J. Reynolds is not going to risk its entire Camel orb smokeless tobacco market by trying to lure lots of kids into using the product so that federal regulators take notice and ban the product from the market. The whole point of Camel orbs is to capture a unique niche caused by smoking regulations and policies - the market opportunity to gain profits by encouraging the use of a non-combusted tobacco product that can be used at any time when smoking is not allowed. It's not kids who R.J. Reynolds is after with Camel orbs. It's smokers. Especially smokers who work in places where smoking is not allowed or who dine in restaurants or bars where smoking is not allowed. There is a large potential market in encouraging smokers to use non-combusted products at these places and at these times.

Remember, every cigarette not smoked while a person is at a place where smoking is not permitted is a lost sale for the industry. If the industry can get someone to use an alternative tobacco product at such times, it is filling a market niche that would otherwise have remained empty.

The last thing in the world that R.J. Reynolds wants is for kids to start popping Camel orbs. The product would quickly be taken off the market, and then its sales can be no higher than zero. If R.J. Reynolds is marketing this product to kids, it is making a stupid marketing decision. And although I have taken issue with many of the companies' actions historically, the one thing I have never accused the company of doing is making a stupid marketing decision - one that is against its own interests.

The irony, of course, is that with all of this attention to Camel orbs, which very few adolescents are using, the FDA's attention is completely off of the product that actually is being used by hundreds of thousands of youths: Camel cigarettes.

Just as the initial action under the FDA legislation - banning flavored products - resulted in absolutely no cigarette brands produced by Big Tobacco being taken off the market, all of this brouhaha about Camel orbs is misdirected and is taking attention away from the actual problem: cigarette smoking. That's what kids are doing - they're smoking the damn real cigarettes. They don't care about the stupid candy!

But don't you see - that was the precise point of the FDA legislation: to create a regulatory scheme that would insulate cigarettes from any meaningful regulation, but would get the anti-smoking groups excited by enticing them with the regulation of all these alternative products: the flavored cigarettes (not menthol, of course), the orbs, the electronic cigarettes. Philip Morris brilliantly cemented its dominant market share by insulating its leading cigarette brands from meaningful regulation, and by putting up an obstacle to the introduction of potentially safer, but competitive products, including smokeless ones.

While the FDA is completely pre-occupied with deciding what to do about electronic cigarettes and Camel orbs (for which there is no documentation of any substantial use by youths), what has all but escaped notice is the fact that the FDA now approves the sale and marketing of deadly regular cigarettes, which are used by millions of youths and which will kill half of those who become addicted and end up using them long-term.

The entire agenda is misguided. And this preoccupation with Camel orbs - including the assertion that the purpose of these orbs is to lure kids - is exactly what Philip Morris had planned. In the mean time, kids go on smoking their Marlboros, Camels, and Newports, and there ain't a damn thing that the FDA is going to do about it.

Thursday, April 22, 2010

Anti-Smoking Group Claims that 30 Minutes of Secondhand Smoke Causes Heart Attacks in Healthy Adults

According to an article on FortBendNow.com, an anti-smoking group pushing for a restaurant smoking ban in Missouri City (Texas) has claimed that 30 minutes of exposure to secondhand smoke can cause heart attacks among healthy adults. The claim comes from the Tobacco Free Fort Bend Coalition:

"'The medical evidence is overwhelming. A study of acute effects of passive smoking in healthy young adults shows that 30 minutes in a smoke-filled area can cause a heart attack,'” said Mary Ann Dolezal, Tobacco Free Fort Bend Coalition chairman."

The Tobacco Free Fort Bend Coalition is heavily funded by the Texas Department of Health and Human Services, through a grant whose initial value was $94,000 in 2008.

The same article appeared in the Fort Bend Sun. Missouri City residents will vote on the proposed smoking ban (Proposition 1) on May 8.

The Rest of the Story

Assuming that the newspaper got the quote from the Tobacco Free Fort Bend coalition correctly, this piece of "medical evidence" was simply made up. It does not exist. There is no such study.

There is no medical evidence that 30 minutes of exposure to secondhand smoke can cause a heart attack in a healthy adult. In fact, such an effect is biologically implausible. You cannot develop coronary artery disease in 30 minutes. Even smokers who chain smoke heavily do not develop heart attacks until at least about 20 years of smoking. It simply doesn't happen in 30 minutes.

While my readers know that I strongly support smoking bans, I do not support the use of false scientific evidence to support these policies. I do not believe it is appropriate to spread lies and misinformation to the public in order to promote a public policy, even one which I strongly support.

This is not an isolated incident, but part of a recurrent pattern of misinformation being spread by anti-smoking groups about the acute cardiovascular effects of secondhand smoke. See my published article in the journal Epidemiologic Perspectives and Innovations for a detailed accounting of these claims.


(Thanks to Michael McFadden for the tip.)

Wednesday, April 21, 2010

New Study Finds No Effect of Bupropion (Zyban) on Craving to Smoke; Will Anti-Smoking Groups Call for Zyban to Be Pulled Off Market?

A new study published in the current issue of the journal Nicotine and Tobacco Research finds that the drug bupropion (Zyban), which is approved by the FDA for the treatment of smoking cessation and whose use is widely promoted by anti-smoking groups, had no effect on suppressing the craving to smoke among smokers in a randomized, double-blind, placebo-controlled clinical trial (see: Madden GJ, Kalman D. Effects of bupropion on simulated demand for cigarettes and the subjective effects of smoking. Nicotine and Tobacco Research 2010; 12(4):416-42).

According to the paper: "The effects of bupropion on simulated demand for cigarettes were investigated in a placebo-controlled double-blind clinical trial. Participants reported the number of cigarettes they would purchase and consume in a single day at a range of prices. The effects of medication on the subjective effects of smoking were also explored. ... Demand for cigarettes was well described by an exponential demand equation. Bupropion did not significantly decrease the maximum number of cigarettes that participants said they would smoke in a single day nor did it significantly alter the relation between price per cigarette and demand. ... Medication group had no effect on any subjective effects of smoking."

The paper concludes: "Bupropion had no significant effects on demand for cigarettes."

The Rest of the Story

The results of this study stand in stark contrast to those of a recent study which found that electronic cigarettes significantly suppress the desire to smoke.

That study, published in the April issue of Tobacco Control, demonstrated that electronic cigarettes are effective in suppressing the desire to smoke, have similar efficacy to nicotine inhalers, and are more pleasant to use than the nicotine inhaler (see: Bullen C, McRobbie H, Thornley S, Glover M, Lin R, Laugesen M. Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tobacco Control 2010; 19:98-103).

While I am not arguing here that Zyban should be taken off the market or that it has no effect in treating smoking cessation, I am pointing out that there is credible scientific evidence that electronic cigarettes are more effective than Zyban in suppressing the desire to smoke. Anti-smoking groups continue to argue that electronic cigarettes must be taken off the market because there is no evidence that they are effective in treating smoking cessation. However, the evidence right before their eyes suggests that these products are more effective than those approved by the FDA to treat smoking cessation.

In other words, I do not truly believe that it is the scientific evidence that these anti-smoking groups are concerned about. They continue to claim that we have no idea what is in electronic cigarettes when in fact, the constituents of these products have been studied extensively. In fact, we know far more about the constituents of electronic cigarettes than we do about the constituents of regular cigarettes. The evidence is not what these groups are concerned about. What I believe they are concerned about is the idea that it could be beneficial to someone's health to go through the motions of what looks like smoking. I believe the battle is a purely ideological one, not a scientific one.

In addition, I think the battle is a financial one, as the groups calling for a ban on electronic cigarettes have received funding from pharmaceutical companies which stand to lose severely if electronic cigarettes are shown to be more effective than pharmacotherapy in facilitating smoking cessation.

Zyban is manufactured by GlaxoSmithKline, and in fact, several of the anti-smoking groups supporting a ban on electronic cigarettes have a financial interest in Glaxo by virtue of having received significant funding from this company. For example, the American Academy of Pediatrics, which called for a ban on electronic cigarettes, has received sponsorship support from GlaxoSmithKline for its annual conference at the "gold" level. Other groups which have called for a ban on electronic cigarettes - the American Lung Association, American Cancer Society, and Campaign for Tobacco-Free Kids - have also received financial support for their activities from Glaxo.

This story also explains why it is so inappropriate for the FDA Tobacco Products Scientific Advisory Panel to contain members who have financial conflicts of interest with Big Pharma. They cannot objectively review data on the effectiveness of electronic cigarettes and pharmacotherapy for smoking cessation, a key issue which the FDA will need to consider. The chair of the Committee - Dr. Jonathan Samet - has received grant support from GlaxoSmithKline. In addition, the organization that he directed - the Institute for Global Tobacco Control - is funded by GlaxoSmithKline and Pfizer. A second panel member - Dr. Neal Benowitz - has also consulted for GlaxoSmithKline. And worst of all, a GlaxoSmithKline consultant - Dr. Jack Henningfield of Pinney Associates - was appointed to the panel.

The rest of the story is that despite the claims of anti-smoking groups that nothing is known about the safety or effectiveness of electronic cigarettes, there is in fact evidence that these devices may actually be as effective or even more effective than approved pharmaceutical therapies for decreasing the desire to smoke, probably because they address the behavioral and not just pharmacologic aspects of the addiction. But anti-smoking groups, I am convinced, are not interested in the actual scientific evidence. Like the data on smoking bans and heart disease, these groups will simply ignore data that does not conform to their pre-conceived ideas.

Tuesday, April 20, 2010

Anti-Smoking Argument in Support of Workplace Smoker Bans Destroys Argument for Workplace Smoking Bans

An article in the Pocono Record highlights a central argument in the anti-smoking movement's support for workplace smoker bans: that individuals do not have a right to employment in any particular workplace, so it is acceptable for an employer to discriminate against them.

The article discusses the new policy announced by St. Luke's Hospital and Health System in Pennsylvania, which will no longer hire smokers as of this May. According to the article, the justification for the new policy is that it is intended to promote a healthier workplace.

"The hospital's news release also says Pennsylvania is one of 20 states where anti-nicotine hiring policies are legal, but there may be a case to be made with regard to privacy laws, a Bethlehem attorney said Tuesday. John Harrison, a labor law specialist with Broughal & DeVito, said, "I would not be surprised if you see someone challenging this statute who is a smoker and doesn't get a job and says this is an invasion of his privacy," Harrison said. "That what somebody does on their own time at home is considered your own time."

"But Gary Asteak, an Easton lawyer, said he doesn't believe there's a right-to-privacy case to be made about St. Luke's new policy. "Not any more than drugs. They can drug test people," he said. "I think they have every bit the right to decide who they want to employ, and I don't believe an individual has the right to a job at that hospital. They have the right to work, but not necessarily at that hospital."

The Rest of the Story

As this article makes clear, a central argument necessary to defend smoker-free workplace policies is that there is no right of an individual to pursue employment at a particular workplace. While smokers have a right to work, they don't have a right to seek employment at any specific workplace. Thus, it is acceptable for employers to discriminate against smokers.

Without this argument, the justification for smoker-free workplaces disappears. Because if individuals have a right to seek employment at any workplace when they are qualified for such employment, then it violates individual rights to deny employment to someone on categorical grounds that have nothing to do with their job qualifications.

Here is the problem, and the rest of the story: If one accepts the argument that an individual has no right to seek employment at any particular workplace, then it becomes acceptable to allow employers to hire only smokers and thus to obviate the need for workplace smoking bans if cases in which the employer agrees not to hire nonsmokers (or to only hire nonsmokers who agree to be exposed to tobacco smoke).

In other words, the justification for banning smokers in the workplace completely invalidates the argument for banning smoking in all workplaces.

If it is true that no individual has a right to pursue employment at a particular workplace at which they are qualified for employment, then it is also true that there is no violation of individual rights if you tell nonsmokers that their services are not wanted at restaurants that allow smoking.

Let me put it this way to illustrate what I'm saying: Suppose I approached an anti-smoking group and made the following argument. There is no need to ban smoking in all restaurants. We simply need to ban smoking in some restaurants. We can allow restaurants to permit smoking as long as no one who works there is a nonsmoker. Why not simply amend smoke-free laws to allow certain establishments to allow smoking, under the condition that they hire only smokers or nonsmokers who agree to be exposed to secondhand smoke at work?

I can argue against such a proposal, because I believe that all individuals have the right to seek employment at any workplace for which they are qualified to do the work. Thus, it would violate individual rights to tell nonsmokers that they are ineligible to apply for employment at a particular restaurant, or that they are only eligible for employment if they agree to be exposed to secondhand smoke. I believe that either of those policies would violate individual rights, and is therefore unacceptable and inappropriate.

However, anti-smoking groups and advocates who are defending smoker-free workplaces cannot make the same argument. Their support for such policies relies upon the contention that there is no individual right to work in a particular workplace if one is otherwise qualified for employment. To paraphrase Asteak above, one would have to argue that individuals have the right to work, but not at any particular restaurant. It's fine to make that argument, but if you do so, you have just conceded that there is no need for 100% smoke-free workplace laws.

Thus, the rest of the story is that in their zeal to support the non-hiring or even firing of smokers on categorical grounds, I believe anti-smoking groups have undermined and perhaps destroyed their own arguments in support of workplace smoking bans.

Monday, April 19, 2010

Florida City to Consider Ordinance to Fire City Employees Who Smoke

Tonight, the Brooksville City Council (near Tampa, Florida) will consider an ordinance which would prohibit smoking by city employees and fire those employees who continue to smoke.

To make it clear, we are not talking about prohibiting smoking at work or continuing to smoke in the workplace. We are talking about smoking in one's private home, off-the-job.

According to the proposed policy, city workers who smoke or use smokeless tobacco would be given one year to quit or face disciplinary action, including termination.

According to an article in Hernando Today: "Mayor Lara Bradburn said she supports the creation of a tobacco-free workplace and any program that encourages employees to quit smoking. She also agrees with the practice of not hiring people who smoke. "There's no reason people should smoke," Bradburn said. "Nothing good ever came from smoking." Referring to smoking as the root of all evil — particularly following her mother's troubles with the habit — Bradburn said that eliminating tobacco use would help decrease city insurance rates — at cost savings to taxpayers — while helping employees be healthier."

The article suggests that the policy would allow employees to avoid termination by enrolling in a smoking cessation program.

According to the agenda for tonight's meeting, the City Council will meet at 7:00 p.m. and take up the smoking issue as the third item on its regular agenda.

The Rest of the Story

Enough is enough already.

This movement to ban smokers from employment has gotten out of control. Now, not only does the Brooksville mayor want to ban smokers from seeking employment with the city, but she apparently wants to fire the existing smokers if they don't quit.

The exact same reasoning being used to support this policy could also be used to support firing obese or overweight employees. The health care costs associated with obesity and overweight are enormous (rivaling if not surpassing those associated with smoking). Why isn't the Brooksville City Council also considering an ordinance to fire all overweight or obese employees if they do not get their weight under control in one year?

What about employees who drink alcohol excessively? Those who do not get enough exercise? Those who don't use sunscreen? Those who go to tanning salons? Those who fail to wear seat belts? Those who do not get annual mammograms? Those who do not get regular colonoscopies? Those who eat high-fat diets? Those who do not get their cholesterol under control?

The fact that the city is apparently going to allow smokers to continue to be employed as long as they enroll in a smoking cessation program suggests that the policy has nothing to do with health, a healthy workforce, a healthy environment, or controlling health costs. If that were the case, then it wouldn't matter whether an employee enrolled in a smoking cessation program. All that would matter is if the employee quit smoking or not.

The fact that enrolling in a smoking cessation program is enough to appease the powers in Brooksville suggests that this policy is not about health at all, but is actually about lifestyle control. The city council doesn't like the idea that people smoke, so it is going to coerce them to quit, or at least to enter a smoking cessation program. Other unhealthy behaviors are fine, but smoking - not acceptable.

In addition to being blatant employment discrimination, this policy is a clear and unwarranted intrusion into employee privacy. The Council should reject it outright.

If any readers in the Tampa area are able to attend the meeting tonight, I would appreciate a report on the discussion and outcome of tonight's meeting.

Saturday, April 17, 2010

My Rapid Response (E-Letter) Published in Candian Medical Association Journal

My rapid response (e-letter) to the study purporting to show that a decline in cardiovascular disease in Toronto was attributable to the smoking ban was published in the Canadian Medical Association Journal. In this response, I present the actual data, conducting the central analysis that is necessary to answer the research question. This analysis was not conducted in the published study. The results indicate that there was a decline in cardiovascular disease of equal magnitude in the comparison cities, thus negating the conclusion that the observed changes in heart disease in Toronto were attributable to the smoking ban. It will be interesting to see how the authors of the study respond.

Thursday, April 15, 2010

Actual Data from Study of Toronto Smoking Ban on Heart Disease Admissions Show No Effect; Declines in Control Cities Were Similar to Those in Toronto

Tuesday, I reported here that yet another study with severely faulty methods has concluded that an observed decline in cardiovascular disease admissions is attributable to a smoking ban. The study, which was published online ahead of print in the Canadian Medical Association Journal, purported to show that the smoking ban resulted in a decrease in cardiovascular disease admissions by reporting a large decline in admissions in Toronto, which the study said did not occur in the comparison cities (Durham Region and Thunder Bay).

The study has received widespread media attention, with a typical headline reading something like that in the Toronto Globe and Mail (Toronto Smoking Ban Leads to Decline in Hospitalizations) and text reading something like: "A ban on smoking in restaurants is being credited for a precipitous drop in hospital admissions for cardiovascular and respiratory problems."

Today, I report an analysis of the actual data. The data on cardiovascular disease admission rates for Toronto are reported in the study and the data for the two comparison cities are reported in an online appendix.

The Rest of the Story

The truth is that the data show that while there was indeed a huge decline in cardiovascular disease admissions in Toronto, there were also huge declines in cardiovascular disease admission rates in both of the comparison cities during the same time period. If one actually examines and analyzes the data, one sees that the magnitude of the decline in cardiovascular disease admission rates in Toronto is similar to that observed in the comparison cities. Therefore, this paper does not provide any evidence that the smoking ban led to a decline in cardiovascular disease hospitalizations.

To see why the study conclusions are invalid, consider the following data.

1. Decline in angina hospital admission rates, 2001-2006

Toronto: 60%
Durham Region: 59%

Conclusion: There was no difference in the rate of decline in hospital admissions for angina in Toronto compared to Durham Region from 2001-2006.

2. Decline in heart attack hospital admission rates, 2001-2006

Toronto: 28%
Thunder Bay: 28%

Conclusion: There was no difference in the rate of decline in hospital admissions for heart attacks in Toronto compared to Thunder Bay from 2001-2006.

3. Decline in stroke hospital admission rates, 2001-2006

Toronto: 35%
Durham Region: 35%

Conclusion: There was no difference in the rate of decline in hospital admissions for stroke in Toronto compared to Durham Region from 2001-2006.

4. Decline in overall cardiovascular disease hospital admission rates, 2001-2006

Toronto: 42%
Durham Region: 38%

Conclusion: There was almost no difference in the rate of decline in hospital admissions for cardiovascular disease in Toronto compared to Durham Region from 2001-2006.

Even if you just examine the period from 2001-2004, when the smoking ban in restaurants was in effect (but before the bar smoking ban took effect), the results are similar:

5. Decline in overall cardiovascular disease hospital admission rates, 2001-2004

Toronto: 29%
Durham Region: 31%

Conclusion: There was no difference in the rate of decline in hospital admissions for cardiovascular disease in Toronto compared to Durham Region from 2001-2006.

What This All Means

What this all means is that the study was correct in reporting a large decline in cardiovascular disease admissions in Toronto that occurred shortly after the smoking ban. However, where the study went awry was in simply telling the reader that there was no similar decline in the comparison cities, when in fact these cities experienced very similar declines in cardiovascular disease rates to those observed in Toronto.

The most important point I want to emphasize is that these trends are readily evident simply from looking at the actual data. And although the paper claims to have compared hospitalization trends in Toronto with those in the comparison cities, it actually does not analyze the data from Durham Region or Thunder Bay. These data are summarily dismissed, without any question asked. The paper justifies this by arguing that there is not a consistent trend.

Well it looks pretty consistent to me. Nevertheless, consistent or not, a study should actually analyze the data it collects. That's a most basic concept in data analysis. You collect data and then you analyze it.

Strikingly, while this paper presents and analyzes the data for trends in cholecystitis, appendicitis, and bowel obstruction in the comparison cities, it does not do the same for cardiovascular disease. But that is the most important part of the analysis, which is central to the study's ability to determine whether the observed changes in heart disease in Toronto were attributable to the smoking ban or due to a secular decline that was occurring anyway.

In other words, this paper does not actually perform the critical analysis that is central to the research question it poses. I have no idea how the paper got past the peer review process without having carried out the central analysis required to answer its basic research question. Nor do I understand how the paper could just leave the data for the control cities sitting there and not analyze them.

I can't answer those questions, but I can tell you that the actual data collected in this study demonstrate that the declines in cardiovascular disease associated with the smoking ban in Toronto were roughly identical to those observed in the comparison cities during the same time period. Thus, the study does not support the conclusion that the smoking ban resulted in a decline in cardiovascular disease hospitalizations.

Wednesday, April 14, 2010

IN MY VIEW: American Lung Association is Full of Hypocrisy in Issuing Report Calling for Reduction in Burden of Lung Cancer on African Americans

On Monday, the American Lung Association issued a press release announcing its new report on the toll of lung cancer among African Americans, entitled "Too Many Cases, Too Many Deaths: Lung Cancer in African Americans."

The report highlights the role of menthol cigarettes in the epidemic of lung cancer among African Americans. According to the report: "The tobacco industry’s [marketing] efforts have been wildly successful. According to a November 2009 report from the Substance Abuse and Mental Health Services Administration, nearly 83 percent of African American smokers aged 12 and older choose menthol cigarettes. This compares to 32 percent of Hispanic smokers, and only 24 percent of white smokers. It has been suggested that this difference in the use of menthol cigarettes may contribute to the health disparity between black and white smokers." ...

"Research suggests that:
• Menthol smokers have higher levels of cotinine, a byproduct of nicotine, in their blood than nonmenthol smokers. These increased levels of cotinine have been related to higher nicotine exposure and may be associated with more severe levels of addiction.
• Menthol smokers are less likely than non-menthol smokers to feel confident in their ability to
quit smoking.
• Menthol smokers are less likely to attempt cessation, more likely to relapse after successfully
quitting and less likely to report sustained smoking cessation than non-menthol smokers."

According to the press release, Charles D. Connor, the American Lung Association President and CEO, stated: "As an organization dedicated to public health, we have an important role to play in raising awareness and reducing the toll of lung cancer as the number one cancer killer among African Americans. While some progress has been made, especially in reducing smoking rates and exposure to secondhand smoke, much remains to be done. Reducing lung cancer needs a focused effort. The Lung Association stands ready to work with the healthcare industry as well as governments, community leaders and individuals, to eliminate the disparity of lung cancer in African Americans."

The Rest of the Story

The American Lung Association stands ready to work with the healthcare industry as well as governments...to eliminate the disparity of lung cancer in African Americans?

Well....not exactly.

Quite on the contrary, the American Lung Association stood ready to work with Philip Morris to help maintain the disparity of lung cancer among African Americans by supporting legislation that banned cigarette flavorings but exempted menthol. Even worse, the American Lung Association was part of a coalition which actually opposed an amendment to the legislation that would have eliminated the menthol exemption.

In other words, the American Lung Association effectively lobbied to kill legislation that would have addressed the very problem it bemoans at length in its report: the role that menthol cigarettes play in addicting and killing African Americans.

I'm sorry, but we know where the American Lung Association stands when it comes to the issue of addressing the problem of menthol cigarettes. The ALA had its opportunity, and it used it to eviscerate legislation that would have eliminated the problem and gone a long way to help actually reduce disparities in lung cancer among African Americans. The American Lung Association puts on a good show - they can certainly talk the talk, but they are clearly not willing to walk the walk.

When it really counted, the American Lung Association was simply not there for the African American community. Instead, the ALA sided with the nation's largest cigarette company - Philip Morris - in making sure that the FDA tobacco legislation did not affect the sales of menthol cigarettes, by far the leading brand of cigarettes used by African American smokers, adults and youths alike.

Sadly, the American Lung Association itself has cited, in this report, all of the evidence necessary to understand the role that menthol plays in addicting African American smokers. The ALA itself has acknowledged that menthol is related to higher levels of addiction and that "Menthol smokers are less likely to attempt cessation, more likely to relapse after successfully
quitting and less likely to report sustained smoking cessation than non-menthol smokers."

What is most troublesome here is the hypocrisy of the American Lung Association, not simply its position. If it had not gone to great lengths to bemoan the problem of menthol, then one might excuse its failure to support a ban on menthol flavorings. But you can't have it both ways. You can't argue how terrible it is that cigarette companies are marketing menthol cigarettes to African Americans and how it makes it much more difficult for them to quit smoking, then talk about how committed you are to reducing disparities in lung cancer among African Americans, and all at the same time, hide the fact that your organization stood shoulder-to-shoulder with Philip Morris in ensuring that the sales of menthol cigarettes would be specially protected by the legislation.

Last Thursday, in my Social and Behavioral Sciences class, I explained to 120 public health students how the American Lung Association's actions are an example of institutional racism: a systematic (though unintentional) bias in health protection on the basis of race which serves to increase racial health disparities. The American Lung Association's role in supporting this form of institutionalized racism is bad enough. But to then come out and boast about how concerned you are about reducing racial health disparities is nearly unconscionable.

Now let me say that I can handle the fact that the American Lung Association may have decided to make a political compromise with Philip Morris in order to appease the company and ensure the passage of the legislation. There's nothing wrong with the ALA playing politics. However, if you are going to do that, then you sacrifice your ability to then boast to the American people how tough you are in standing up to reduce racial health disparities.

The fact is: the American Lung Association sold out the health interests of the African American community as part of a purely political compromise to secure passage of the legislation. That may be a good decision or a bad one, but it is certainly not an example of standing up to the tobacco companies in order to reduce racial disparities. It goes a very long way towards maintaining the racial disparity in lung cancer.

In fact, it is precisely actions like those of the American Lung Association which I believe are largely responsible for the maintenance of racial health disparities like the one that the ALA is bemoaning. It is the failure to stand up against economic and corporate interests and to accept the status quo -- supporting legislation and policies that may look good on paper but which don't actually make the changes necessary to reduce disparities -- that contributes to the maintenance of racial health disparities in the first place.

You see, many organizations in tobacco control talk the talk - they include African Americans on boards and they design programs which they claim are targeted to African Americans. But when you look at the actual allocation of resources, when you look at the actual participation of African Americans in the decision-making processes, you'll find that there is more talk than action.

For all of their talk about reducing racial health disparities, the American Lung Association and its coalition supporting the FDA tobacco legislation did not include the African American community and its leaders in discussions about the menthol issue when this bill was being negotiated with Philip Morris.

It's all very nice for the American Lung Association to secure an African American physician to highlight its report about how terrible a scourge menthol is to the African American community, but where was the American Lung Association's interest in consulting with the African American community when its health was on the trading block during the Congressionally-mediated negotiations with Philip Morris? Why did the American Lung Association not consult with Dr. Hicks and other leaders in the African American community when it decided to lend its support to the amendment that protected menthol sales to the African American community?

It's sure nice to include an African American in your quotes about your new report, but it would have really meant something to include the African American community in the organization's decision-making around whether or not to sell out the health of African Americans to secure passage of the legislation.

In light of its own statements about the role of menthol cigarettes in addicting and killing African Americans and in light of its widely disseminated promise to reduce the disparate burden of lung cancer among African Americans, might I suggest that "It is obvious today that (the American Lung Association) has defaulted on this promissory note insofar as (our) citizens of color are concerned. Instead of honoring this sacred obligation, (the American Lung Association) has given the (African American) people a bad check; a check which has come back marked 'insufficient funds.'"

The rest of the story is that despite its promises, the American Lung Association has sold out the health interests of the African American community by using menthol as a bargaining chip to secure passage of a deal negotiated with the tobacco industry, thus leaving African Americans holding a promissory note that is not worth the paper upon which it is written. In this case, the check might not come back saying "insufficient funds," but "insufficient fortitude."

Tuesday, April 13, 2010

Study Attributes Fall in Cardiovascular Admissions in Toronto to Smoking Ban and Decrease in Secondhand Smoke Exposure, But Methods are Faulty

Yet another study with severely faulty methods has concluded that an observed decline in cardiovascular disease admissions is attributable to a smoking ban. This time, the place is Toronto and the study was published yesterday online ahead of print in the Canadian Medical Association Journal.

The study examined trends in hospital admissions for cardiovascular and respiratory disease in Toronto from 1996 to 2006. A smoking ban in restaurants (excluding designated rooms) was implemented in 2001 and a smoking ban in bars (excluding designated rooms) was implemented in 2004. Two comparison cities - Durham Region and Thunder Bay - were used to control for secular trends in cardiovascular and respiratory disease.

The study findings were reported as follows: "Crude rates of admission to hospital because of cardiovascular conditions decreased by 39% (95% CI 38%–40%) and admissions because of respiratory conditions decreased by 33% (95% CI 32%–34%) during the ban period affecting restaurant settings. No consistent reductions in these rates were evident after smoking bans affecting other settings."

The study concludes that the observed declines in cardiovascular and respiratory hospital admissions were attributable to the smoking ban.

The paper notes that "the ecological design of this study prevents the delineation of individual smoking status and other individual-level information, such as actual exposure to second-hand smoke and other risk factors (e.g., prior acute myocardial infarction and other comorbidities).
This methodological limitation makes it possible that our observed decreases in both cardiovascular- and respiratory related admissions to hospital were the result of active
smokers smoking less or quitting."

Nevertheless, this limitation does not stop the authors from concluding: "that the reduction in hospital admissions observed in our study is unlikely to have resulted from decreased rates of smoking." In other words, they are attributing the declines in cardiovascular admissions to decreased secondhand smoke exposure due to the smoking ban in restaurants and bars.

The Rest of the Story

There are huge problems with this study. While it is plausible that a smoking ban would result in an immediate decline in respiratory disease admissions, the observed declines in cardiovascular disease admissions are not plausibly related to decreased secondhand smoke exposure associated with a bar and/or restaurant smoking ban. This commentary will focus on the study's conclusions regarding the reduction in cardiovascular disease admissions.

The first problem is that an examination of the trend in cardiovascular disease admissions in the control communities demonstrates that there was a dramatic decline during the study period, completely negating the study's primary conclusion.

While the data for the comparison cities is not presented in the paper, it is provided in an online appendix. If you look at the data on angina admissions in Durham Region, you'll notice that between 2001 and 2004, there was a whopping 53% decline in angina admission rates. The paper discounts any declines in cardiovascular disease in the control cities by stating that there were "no consistent reductions." However, this is a highly biased presentation of the data. There is a very striking 53% decline in angina admissions in Durham Region, and such a finding completely negates the study conclusion, because it demonstrates that declines in cardiovascular disease admissions of an even greater magnitude than observed in Toronto occurred in this comparison city during the study period.

To see why I would argue that the paper's presentation of the findings and its conclusions are highly biased, note that the paper does not even mention this whopping 53% decline in angina admission rates. It is literally buried. Ignored. The same reasoning used by this paper to conclude that the smoking ban led to the observed decline in angina in Toronto would also argue that the 53% decline in angina admissions in Durham Region was attributable to the absence of a smoking ban. Clearly, the paper's conclusion is simply not supported by the actual data.

Also ignored is the fact that heart attack rates in Durham Region were on the rise during the baseline period, thus making it inappropriate to compare changes in rates of heart attacks in this city with those in Toronto.

Also ignored: stroke admissions in Durham Region declined by a whopping 47% from 2000-2006.

And if this were not enough to invalidate the study conclusions, look at the trends in cardiovascular disease admissions in Thunder Bay. From 2000 to 2006, there was a whopping 43% decline in angina admissions. Furthermore, there was a 28% decline in heart attack admissions in Thunder Bay from 2003 to 2006.

Frankly, in the midst of these huge declines in cardiovascular disease admissions in both of the comparison cities, I simply cannot see how the paper can possibly mislead readers into thinking that there were no declines in cardiovascular disease in these control areas. An examination of the actual data reveals that the paper is hiding the key fact that huge secular declines in cardiovascular disease admissions were occurring anyway in the control cities, even in the absence of a smoking ban. This completely negates the study's conclusion that the observed decline in Toronto's admissions for cardiovascular disease are attributable to its smoking ban.

While the finding that there were also striking declines in cardiovascular disease admissions in these control communities does not prove that the changes in Toronto were independent of the smoking ban, it does prevent any reasonable conclusion that the decrease in cardiovascular disease admissions is attributable to the smoking ban. Again, I can't understand how one could obscure the clearly evident and quite massive declines in both of these comparison cities by stating that there are no "consistent declines." That is obviously a very subjective term as we don't know exactly what consistent is. But what it appears to mean is that the study authors didn't like what they saw when they examined the control city trends because it didn't lend itself to a clean conclusion, so they appeared to have obfuscated the findings by simply casting them aside under the presumption that the pattern was not consistent.

Perhaps the pattern is not entirely consistent, but it certainly is evident.

We hardly need to go further because this first problem completely negates the study findings and conclusion, but I will point out a second major problem with the study. The comparison cities are very different from Toronto and are not the least bit comparable. Most striking is the difference in smoking prevalence near the end of the study period (2005), which was only 18.1% in Toronto but 26.6% in Thunder Bay and 24.8% in Durham Region. This suggests that declines in smoking observed in Toronto did not occur in these other areas. It makes a decline in smoking in Toronto a likely explanation for any true differences in the cardiovascular disease trends. In the face of this difference in smoking prevalence, I don't see how one can conclude that reduction in secondhand smoke exposure is the most likely cause for the purported difference in cardiovascular disease trends.

The rest of the story is that we have yet another study purporting to show a dramatic and immediate effect of smoking bans on acute cardiovascular event admissions which turns out to be severely flawed. In this case, the data presented in the paper (or at least in the appendix) not only fail to support the study conclusion, but they actually refute that conclusion. They also refute the findings themselves as presented in the paper.

If anyone out there can look at the Appendix and tell me that they see no evident reduction in cardiovascular disease admissions in either of the comparison cities, I'd like to know how you came to such an impression. I believe the actual data is quite clear in showing that this study failed to accurately present the findings and therefore resulted in an unsupported and unjustified conclusion.

While I strongly support smoking bans (and would actually go further than Toronto did by arguing that it makes no sense to allow designated smoking rooms), I do not support the sloppy or biased interpretation of scientific data to try to support a particular conclusion. I would love nothing more than to see that smoking bans are reducing acute coronary events within a couple of years of their implementation. However, I will not disseminate such conclusions unless they are fully supported by the underlying scientific evidence.

New Study Demonstrates Effectiveness of Electronic Cigarettes in Suppressing Desire to Smoke; E-Cigs Performed as Well as Nicotine Inhalers

A new study, published in the April issue of Tobacco Control, demonstrates that electronic cigarettes are effective in suppressing the desire to smoke, have similar efficacy to nicotine inhalers, and are more pleasant to use than the nicotine inhaler (see: Bullen C, McRobbie H, Thornley S, Glover M, Lin R, Laugesen M. Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tobacco Control 2010; 19:98-103).

The study was conducted among 40 smokers who refrained from smoking overnight and then were given either cigarettes, a nicotine inhaler, or electronic cigarettes. The electronic cigarette produced a significant decline in the desire to smoke, an effect equivalent to that observed with the nicotine inhaler. However, the electronic cigarette was found to be more pleasurable and to have fewer side effects than the nicotine inhaler.

Of note, the 0 mg electronic cigarette also significantly reduced the desire to smoke after overnight abstinence, although its effects were shorter-lived than those of the 16 mg electronic cigarette.

The 16 mg electronic cigarette produced a modest increase in blood nicotine levels, similar to those observed with the nicotine inhaler.

The study concludes: "The 16 mg Ruyan V8 ENDD [electronic nicotine delivery device] alleviated desire to smoke after overnight abstinence, was well tolerated and had a pharmacokinetic profile more like the Nicorette inhalator than a tobacco cigarette. Evaluation of the ENDD for longer-term safety, potential for long-term use and efficacy as a cessation aid is needed."

The Rest of the Story

This study demonstrates that the electronic cigarette is effective in suppressing the desire to smoke and suppressing withdrawal symptoms among dependent smokers, even though they deliver only modest amounts of nicotine to the user. The efficacy and acute adverse effect profile of the product was found to be similar to that of the nicotine inhaler, but the electronic cigarette was generally preferred to the inhaler. Most interestingly, even use of the 0 mg product resulted in a significant suppression of the desire to smoke.

That even the 0 mg cartridge was effective in suppressing the desire to smoke suggests that a substantial reason for the electronic cigarette's effectiveness is its simulation of smoking behavior. It appears that the behavioral aspect of the addiction to smoking, and not just the pharmacologic aspect of the addiction, needs to be addressed for a smoking cessation product to be effective. This may help explain why the electronic cigarette has anecdotally been widely reported as being effective in helping smokers quit.

Anti-smoking groups and advocates can no longer argue that there is no published evidence that electronic cigarettes are effective in suppressing the desire to smoke. The results of this study suggest that these devices may have the potential to be an effective strategy for smoking cessation, making them a potentially life-saving innovation.

This research should lead to the FDA making the study of electronic cigarettes a priority. Rather than ban the product, as many anti-smoking groups are urging, the FDA should embrace the potential of this approach to smoking cessation, and should work with manufacturers and distributors to help craft a research agenda that will answer questions about effectiveness in smoking cessation and long-term safety.

Meanwhile, states considering legislation to ban the electronic cigarette should reject such legislation, because enacting these laws will certainly lead to thousands of ex-smokers returning to smoking, which would substantially harm the public's health.

Thursday, April 08, 2010

New Study Shows Huge Decline in Heart Attack Admissions; Demonstrates Why IOM Committee's Report on Effect of Smoking Bans is Such Poor Science

A study published in a recent issue of the journal Circulation reports that from 2002 to 2007, there was a 23.4% decline in heart attack admissions among the Medicare fee-for-service population (see: Chen J, Normand SL, Wang Y, Drye EE, Schreiner GC, Krumholz HM. Recent declines in hospitalizations for acute myocardial infarction for Medicare fee-for-service beneficiaries: progress and continuing challenges. Circulation. 2010 Mar 23;121:1322-8).

After controlling for age and other factors, the study estimates that the average decline in heart attack admissions in recent years has been 5.8% per year. According to the study authors, this secular decline in heart attack admissions is attributable to a number of factors, including improved medication for heart disease (especially the use of statins to lower cholesterol levels), improved surgical treatment for coronary artery stenosis, and decreased rates of smoking.

The Rest of the Story

This study demonstrates why the IOM committee which issued a report on the effect of smoking bans on heart attacks used such poor science in drawing its conclusion. Because of weaknesses in the underlying studies, the committee was unable to quantify the magnitude of the decrease in heart attacks associated with the implementation of smoking bans. But this new study shows that there was a large secular decline in heart attacks occurring anyway, on the order of about a 6% decline in heart attack admissions per year. If the IOM committee was unable to quantify the magnitude of the effect of smoking bans on heart attacks, then how does the committee know that the decline was significantly greater than 6%?

In fact, the IOM committee made no attempt to quantify the secular change in heart attacks that is occurring in the absence of smoking bans. And it made no attempt to quantify the degree to which heart attack declines associated with smoking bans exceed the secular declines that are occurring anyway, as documented in this new study.

In other words, the IOM committee's conclusions were based on very poor science: the absence of any control group and the failure to estimate a magnitude of effect and determine whether the confidence interval around that point estimate includes the secular rate of decline occurring in the absence of smoking bans.

This new study also demonstrates the invalidity of the conclusions of many of the individual smoking ban/heart attack studies.

For example, a study on the effect of smoking bans on heart attacks in New York State concluded that there was an 8% decline in heart attacks in the year following the statewide smoking ban. The study concludes that the smoking ban reduced heart attacks by 8%. But these new data show that in the same year (2004), heart attacks nationwide were declining by about 6%. This suggests, actually, that the New York State smoking ban had no immediate effect on heart attack rates. Certainly, in light of the 6% decline that would have been expected anyway, the finding that heart attacks declined in 8% does not support a conclusion that the smoking ban significantly reduced heart attacks (and obviously does not support the conclusion that the ban decreased heart attacks by 8%).

Nevertheless, these are data that the IOM committee relied upon to justify what now looks like a pre-determined conclusion that smoking bans result in immediate reductions in heart attacks.

As another example, consider the recent meta-analysis out of the Kansas University Medical Center which showed an 8% decline in heart attacks associated with smoking bans in 11 published studies. That 8% decline sounds impressive. Until you consider the fact that heart attacks are declining by about 6% per year anyway. I hate to have to say it, but this really amounts to junk science. The complete absence of any comparison group and the assumption that any change in heart attacks that occurs is attributable to the smoking ban. Any student in my program evaluation course who proposed a study like this without a control group would not pass the class.

The rest of the story is that there is now strong evidence that heart attacks are declining substantially due to improved medical and surgical treatment of heart disease and behavioral changes, including declines in smoking. The magnitude of the secular decline in heart attacks is roughly the same as the declines in heart attacks reported in the published studies which are being used to support the conclusions that smoking bans result in immediate, dramatic reductions in heart attacks. The chief failure of anti-smoking groups and researchers which are using these studies to support the conclusion that smoking bans were the cause of the decline in heart attacks is that they have failed to consider that heart attacks are declining substantially anyway. They have failed to compare the rates of decline associated with the implementation of smoking bans with the secular rates of decline in heart attacks. This has led to conclusions which are unsupported by scientific evidence and based on severely flawed science.