Wednesday, August 31, 2011

Tobacco Companies Aren't the Only Ones Who Tried to Block Graphic Cigarette Warning Labels

The cigarette companies which recently filed a First Amendment lawsuit are not the only ones to have tried to block the requirement for graphic warning labels on cigarette packs. In 2007, they got help from perhaps the least likely of sources.

The Campaign for Tobacco-Free Kids describes the history of the graphic warning label requirement: "Congress approved the 2009 law with broad, bipartisan support. Its sponsors included U.S. Reps. Henry Waxman (D-CA) and Todd Platts (R-PA), and former U.S. Sen. Christopher Dodd (D-CT). U.S. Sen. Mike Enzi (R-WY) championed the requirement for large, graphic cigarette warnings."

What the Campaign for Tobacco-Free Kids does not tell the public is that while Senator Enzi championed the requirement for large, graphic warning labels, the Campaign for Tobacco-Free Kids opposed his amendment.

Its press release is entitled "Tobacco Companies Seek to Avoid Telling the Deadly Truth," but the Campaign for Tobacco-Free Kids is itself avoiding telling its constituents the deadly truth by omitting a critical part of the story: the Campaign for Tobacco-Free Kids, along with the American Heart Association, American Lung Association, and American Cancer Society, opposed Senator Enzi's amendment.

I described Enzi's amendment in my July 2007 post: "Enzi Amendment #4: This amendment strengthens the required warning labels on cigarettes by increasing the size of warning labels from 30% to 50% of the pack and adding color graphics that depict the negative health consequences of smoking. This is similar to warning labels that have been used with some success in Canada. Again, there is absolutely no reason for health groups to oppose this amendment since it merely improves the warning labels."

But as I also described, the Campaign for Tobacco-Free Kids actively opposed Enzi Amendment #4: "Despite claiming to be overwhelmingly interested in saving lives, fighting Big Tobacco, protecting kids from addiction to cigarettes, and ending special protections for the tobacco industry, the Campaign for Tobacco-Free Kids (TFK) and three other health groups - the American Lung Association (ALA), American Cancer Society (ACS), and American Heart Association (AHA) - are opposing amendments to the proposed FDA legislation that would greatly strengthen it by allowing the Food and Drug Administration (FDA) to remove the nicotine from cigarettes, prohibiting the use of menthol and clove as primary flavorings in cigarettes, and increasing the size and strength of cigarette warning labels."

The Rest of the Story

While the Campaign for Tobacco-Free Kids is now blasting the tobacco companies for issuing a First Amendment challenge that the Campaign argues is solely intended "to fight all efforts to reduce the death and disease caused by tobacco," the rest of the story is that the Campaign itself fought to block this very effort "to reduce the death and disease caused by tobacco" and is now hiding the fact that it opposed, rather than supported Enzi Amendment #4.

The Campaign may be able to fool most of its constituents, but one thing it can't do is successfully re-write history. The truth shines through all of its charades and propaganda. And that truth is an ugly one: the national health organizations (TFK, ACS, AHA, and ALA) opposed the amendment which was ultimately responsible for the current requirement for the graphic warning labels. Instead of being a leader in promoting the public's health, the Campaign for Tobacco-Free Kids stood instead with Big Tobacco.

Tuesday, August 30, 2011

FDA Analysis Shows that Graphic Cigarette Warning Labels Increased Cigarette Smoking in Canada from 2001-2008

Using the exact data produced by the FDA in its Regulatory Impact Analysis of its new rule that will require graphic warning labels on cigarette packages, I analyzed the likely impact of these warning labels on cigarette smoking prevalence in the United States based on the Canadian experience from 2001-2008. My analysis, like that of the FDA, is based on the differences in smoking prevalence between Canada and the U.S. before and after the implementation of Canada's graphic warning labels (in 2001), after accounting for the differences in cigarette prices. The analysis is identical to that conducted by the FDA, expect that I used the period 2001-2008 to assess the impact of the graphic warning labels, rather than the period 2001-2009.

This analysis yields an estimate that the graphic warning labels in Canada increased smoking prevalence by 0.066 percentage points between 2001 and 2008.

Next, I conducted the same analysis as the FDA, except I excluded data from 1998, the year in which the Master Settlement Agreement was implemented in the U.S. and in which cigarette prices increased sharply, which is likely to be an outlying year for this reason. The results of the analysis were as follows:

The analysis yields an estimate that the graphic warning labels in Canada increased smoking prevalence by 0.256 percentage points between 2001 and 2009.

Finally, I conducted the same analysis as above, except restricting the follow-up time period to 2001-2008.

This analysis yields an estimate that the graphic warning labels in Canada increased smoking prevalence by 0.410 percentage points between 2001 and 2008.

The Rest of the Story

The rest of the story is that the FDA's analysis purporting to show that graphic warning labels will reduce smoking prevalence in the U.S. by 0.088 percentage points is extremely flimsy. It is sensitive to two outlying points in the data: the estimates for 1998 and those for 2009. If either year is omitted, the conclusion of the analysis is the opposite of what the FDA reported. If both are omitted, the analysis shows a substantial positive effect of the graphic warning labels on cigarette smoking.

To be sure, if an analysis of the data from 1994-2008 reveals a positive effect of the warning labels on cigarette smoking, then the analysis certainly cannot be trusted to infer that there was actually a negative effect of the warning labels. Inclusion of the 2009 data turns the entire analysis around. This is not the sign of a robust analysis whose conclusion can be trusted.

The only scientifically reasonable conclusion that one can draw from the FDA's own analysis is that the graphic warning labels had no substantial effect on cigarette smoking in Canada. Thus, one would not expect the warning labels to have any substantial effect on smoking in the United States.

Why is this analysis important?

First, the analysis is important because it has implications for the tobacco companies' lawsuit which attempts to overturn the regulation on First Amendment grounds. The FDA must convince the court that the regulation will advance a substantial government interest, meaning that it must provide evidence that the warning labels will significantly reduce cigarette consumption. However, the primary analysis upon which the FDA bases its conclusion actually demonstrates no significant effect of the regulation. This could be problematic for the defense of the regulation.

Second, the analysis is important because it suggests a further deterioration in the science being used by anti-smoking groups and even federal agencies involved in tobacco control. In order to conclude that graphic warning labels have a negative effect on cigarette consumption, the regulatory impact analysis had to ignore the lack of robustness in the analysis. Had the agency repeated the analysis omitting data from 2009, it would have seen how flimsy its conclusion is and realized that its ultimate conclusion is not supported by these data.

Third, the analysis is important because it adds to the evidence that the anti-smoking groups are grossly exaggerating the likely effects of the cigarette warning labels. Moreover, by dwelling on FDA regulation of cigarette constituents, disclosure of ingredients, and warning labels, anti-smoking groups are distracting attention from the evidence-based interventions which have been shown to actually decrease cigarette use. Thus, the obsession with these ineffective approaches is actually halting the nation's progress in confronting the cigarette smoking epidemic.

Finally, the analysis is important because it demonstrates that once again, the cigarette companies - in this case, Philip Morris - has outsmarted the public health community (i.e., the Campaign for Tobacco-Free Kids) by enticing it to agree to legislation which has very little public health benefit but which substantially protects the profits of the nation's leading tobacco company and insulates it from the major initiatives which could otherwise put a significant dent in its business.

Monday, August 29, 2011

Even the FDA Itself Concludes that Graphic Warning Labels Will Have Minimal Impact, and Perhaps No Impact, on Cigarette Smoking

In a little-known and little-publicized analysis, the FDA itself has concluded (in its Regulatory Impact Analysis) that the graphic warning labels will have very little impact, and perhaps no impact at all, on cigarette smoking. The analysis, to which the tobacco companies refer in their legal brief seeking an injunction against the warning label requirement, predicts that the graphic warning labels will only reduce smoking prevalence by 0.088 percentage points (less than 0.1 percentage points). Importantly, the 95% confidence interval for the effect includes zero, meaning that it is not statistically different from zero (see: Federal Register /Vol. 76, No. 120 /Wednesday, June 22, 2011).

In very clear terms, the Regulatory Impact Analysis emphasizes that its scientific evaluation concludes that the predicted effect of the graphic warning labels is not statistically different from zero: "FDA has had access to very small data sets, so our effectiveness estimates are in general not statistically distinguishable from zero; we therefore cannot reject, in a statistical sense, the possibility that the rule will not change the U.S. smoking rate. Therefore, the appropriate lower
bound on benefits is zero." (Federal Register 76 at 36776)

The Rest of the Story

What is even more striking than the fact that FDA has itself predicted a minimal impact of the graphic warning labels is the fact that its own analysis provides very flimsy evidence that the warning labels will have any impact. The analysis is based on a comparison of smoking rates in the U.S. and Canada before and after the implementation of graphic warning labels in Canada. The analysis compares smoking rates after accounting for the effect of cigarette tax changes, and attributes all unaccounted for differences to the Canadian warning labels. Given the huge variability in the data, examining the confidence intervals around the point estimate of the warning label effect is essential.

In this case, there was no observed significant effect of the graphic warning labels on smoking prevalence in Canada, once the tax increase was accounted for. Were this a scientific paper instead of a regulatory impact analysis, the paper would be forced to conclude that there was no significant effect of the graphic warning labels in Canada on cigarette smoking prevalence over an 8-year follow-up period.

Even more striking is the tremendous variability in the data. The analysis is sensitive to single outlying points, most importantly, the observed smoking prevalence change in Canada during the first year after the warning labels. This suggests that any minimal impact that was observed occurred immediately after the warning labels were introduced, due to their shock value, and that there was no effect whatsoever following that initial shock.

In fact, if you delete the year 2001 from the analysis, the observed difference in unexplained smoking rates between the U.S. and Canada is -0.23 percentage points, indicating that after the initial year of the warning labels, this intervention actually increased smoking prevalence in Canada by 0.23 percentage points.

Of course, an alternative explanation is that the widely fluctuating data are due simply to the large amount of random variation in the data, and that the overall analysis finds no statistically significant effect of the graphic warning labels on smoking prevalence.

Most significant, but shocking, of all, if the analysis is restricted to the period 1994-2008 (not including 2009), then the results show that the graphic warning labels in Canada increased smoking prevalence by 0.066 percentage points.

Thus, had the same analysis been conducted one year ago, before 2009 prevalence data were available, the very same report would have been forced to conclude that the proposed regulation is predicted to increase smoking rates and cost the U.S. billions of dollars.

This shows how flimsy the FDA's analysis is, and how scientifically shaky is its conclusion that the graphic warning labels will have a substantial negative effect on cigarette consumption.

The rest of the story is that the FDA's own analysis demonstrates no statistically significant impact of the graphic cigarette warning labels on smoking prevalence in Canada. This evidence - presented by the FDA itself - supports my earlier conclusion that the proposed graphic warning labels in the U.S. will likely have a minimal impact on cigarette smoking, and that this miminal effect will occur due to the immediate shock value of the warning change, not to any sustained effect of the warnings.

This analysis could also have implications for the FDA's ability to defend the graphic warning labels in court, since the FDA must show that the intervention will advance a substantial government interest, and if the FDA cannot provide evidence of a statistically significant effect of similar warnings in other countries on cigarette smoking, it makes it difficult to convince a court that the proposed regulation will advance the government's interest in reducing cigarette smoking rates.

As with so many other aspects of science that involve "unfavorable findings" for tobacco control, this is yet another one that you are not going to see disseminated by anti-smoking groups. Instead, you'll hear the rhetoric about how these new warning labels are going to "save countless lives." Unfortunately, the scientific evidence indicates otherwise: they will have a minimal effect and will not substantially lower cigarette company sales or profits.

Friday, August 26, 2011

Tobacco Companies Argue that Requiring Smoking Cessation Hotline Number on Cigarette Packs Makes Warnings Anti-Smoking Billboards

In the legal brief submitted by several tobacco companies (Reynolds American, Lorillard, Commonwealth Brands, Liggett, and Santa Fe Natural Tobacco Company) seeking an injunction against the FDA's soon to be implemented graphic warning labels, the companies argue that the required labels infringe on their free speech rights because they are more than merely factual health information. The companies contend that the warning labels are essentially anti-smoking promotions. A key element of the argument is that the FDA is requiring tobacco companies to place the national quit line number (1-800-QUIT-NOW) on their cigarette packs.

The companies therefore argue that: "Each warning also includes the “1-800-QUIT-NOW” hotline, thus requiring that Plaintiffs literally urge adult consumers of their lawful products to “QUIT-NOW.” ... Indeed, through the inclusion of the smoking cessation hotline, Plaintiffs are literally required to exhort their consumers to “QUIT-NOW.” This is hardly content-neutral speech. The Rule therefore falls outside the exception to strict scrutiny for purely factual and uncontroversial disclosure requirements."

In essence, the mandatory inclusion of the quit smoking hot line promotion requires the tobacco companies to urge their own customers to stop using the product. Thus, the companies have to express a viewpoint which is not their own. This, the brief argues, is the most odious violation of free speech rights:

"As the Court recently held in Sorrell, “[t]he State can express [its] view through its own speech. But a State’s failure to persuade does not allow it to hamstring the opposition. The State may not burden the speech of others in order to tilt public debate in a preferred direction.” 2011 WL 2472796, at *17. The application of strict scrutiny in this context reflects the First Amendment’s intolerance of laws that target speech according to its viewpoint. Like other forms of viewpoint discrimination, a requirement that a speaker promote a particular point of view in lieu of his or her own is “censorship in a most odious form.” Police Dept. of Chi. v. Mosley, 408 U.S. 92, 98 (1972) (quoting Cox v. Louisiana, 379 U.S. 536, 581 (1965) (Black, J., concurring); see also Blagojevich, 469 F.3d at 651 (“The Court has stated that where a statute ‘mandates speech that a speaker would not otherwise make,’ that statute ‘necessarily alters the content of the speech.’” (quoting Riley v. Nat’l Fed’n of the Blind of N.C., Inc., 487 U.S. 781, 795 (1988))). As such, compelled speech is, like other forms of viewpoint discrimination, “presumptively unconstitutional.” Rosenberger v. Rector & Visitors of Univ. of Va., 515 U.S. 819, 830 (1995)."

The Rest of the Story

There are two problems with the required graphic warning labels that I believe renders them subject to potential violation of the First Amendment. First, as the tobacco companies argue, it is going to be difficult for the FDA to assert that requiring tobacco companies to put the smoking cessation hot line number on their packs is merely a health warning, rather than a smoking cessation message.

Second, it is going to be difficult for the FDA to argue that the required warnings are the least restrictive interference with free speech that could accomplish the government's intended purpose in requiring that tobacco companies warn their consumers of the health hazards of smoking.

Wednesday, August 24, 2011

Tobacco Companies Seek Injunction Against Implementation of Graphic Cigarette Warning Labels

Several major tobacco companies - including Reynolds American, Lorillard, Liggett, and Commonwealth Brands (but not including Altria) - filed a lawsuit in the D.C. District Court seeking to overturn the FDA's new graphic cigarette warning labels, which are scheduled to take effect next year.

According to a Reuters article: "The lawsuit ... said the warnings required no later than September 22, 2012 would force cigarette makers to "engage in anti-smoking advocacy" on the government's behalf. They said this violates their free speech rights under the First Amendment, according to a complaint filed Tuesday with the U.S. District Court in Washington, D.C. 'The notion that the government can require those who manufacture a lawful product to emblazon half of its package with pictures and words admittedly drafted to persuade the public not to purchase that product cannot withstand constitutional scrutiny,' said Floyd Abrams, a prominent First Amendment specialist representing the cigarette makers, in a statement."

The Rest of the Story

The central question is whether these required warning labels represent bona fide health warnings - which are clearly allowable - or whether they cross the line into being anti-smoking commercials, which seems to be a violation of the tobacco companies' First Amendment rights.

The proposed New York City law that would have required stores to display anti-smoking posters at the point of sale of tobacco products seems to me to be a good example of the latter: anti-smoking messages that are intended to discourage use of the product, rather than simply to warn consumers of the health risks. The law was struck down because regulation of the promotion of cigarettes is preempted by the Federal Cigarette Labeling and Advertising Act. Whether the law would have been upheld on First Amendment concerns is not clear.

Since the graphic pictures proposed for the cigarette warning labels are directly tied to the warnings regarding the health effects, it is not as clear that these warning labels represent anti-smoking messages as opposed to bona fide health warnings.

Judge Richard Leon has scheduled a September 21 hearing in the case and plans to rule on the proposed injunction in October.

Tuesday, August 23, 2011

Experimental Study Demonstrates that Graphic Cigarette Warning Messages Invoke Defense Response; May Explain Observed Lack of Effect of Warning Labels

A new study published in the current issue of the Journal of Media Psychology finds that graphic cigarette health warning messages invoke a defensive response and therefore may not be effective.

See: Glenn Leshner, Paul Bolls, and Kevin Wise. Motivated Processing of Fear Appeal and Disgust Images in Televised Anti-Tobacco Ads. Journal of Media Psychology 2011; 23(2):77-89.

The research involves an experiment in which subjects were shown anti-smoking television commercials with combinations of graphic or non-graphic ads with threatening or non-threatening messages. The major finding was that the combination of graphic ads with threatening messages led to a defensive reaction among subjects, rendering them less able to process and attend to the message, which in turn reduces the likely effectiveness of the communication.

According to the researchers: "Health communicators have long searched for the most effective ways to convince smokers to quit. Now, University of Missouri researchers have found that using a combination of disturbing images and threatening messages to prevent smoking is not effective and could potentially cause an unexpected reaction." ... "showing viewers a combination of threatening and disgusting television public service announcements (PSAs) caused viewers to experience the beginnings of strong defensive reactions. The researchers found that when viewers saw the PSAs with both threatening and disgusting material, they tended to withdraw mental resources from processing the messages while simultaneously reducing the intensity of their emotional responses. Leshner says that these types of images could possibly have a “boomerang effect,” meaning the defensive reactions could be so strong that they cause viewers to stop processing the messages in the PSAs."

"PSAs that included both threatening and disgusting images caused participants to have defensive responses, where defensive reactions were so strong that the participants unconsciously limited the mental resources they allocated to processing the messages. They also had worse memories and a lower emotional responses when the threatening PSAs included disgusting images. Leshner says that when a disgusting image is included in a threatening PSA, the ad becomes too noxious for the viewer." ...

"“We noticed in our collection of anti-tobacco public service announcements a number of ads that contained very disturbing images, such as cholesterol being squeezed from a human artery, a diseased lung, or a cancer-riddled tongue,” Leshner said. “Presumably, these messages are designed to scare people so that they don’t smoke. It appears that this strategy may backfire.” Bolls says that the recent MU study shows that new FDA regulations requiring cigarette companies to include potentially threatening and disgusting images on cigarette packages may be ineffective at communicating the desired message that smoking is unhealthy. “Simply trying to encourage smokers to quit by exposing them to combined threatening and disgusting visual images is not an effective way to change attitudes and behaviors,” Bolls said. “Effective communication is more complicated than simply showing a disgusting picture. That kind of communication will usually result in a defensive avoidance response where the smoker will try to avoid the disgusting images, not the cigarettes.”"

The Rest of the Story

These findings may help explain the observed lack of effectiveness of graphic warning labels in reducing smoking prevalence or cigarette consumption in England, as I reported here yesterday.

The current research suggests that the combination of a disgusting image with a threatening warning may lead to a defensive reaction among recipients of the message, leading to avoidance of the message rather than attendance to it. As Leshner explains, these warning labels become "too noxious" for the viewer, who has a defensive reaction, and the strategy backfires.

The key problem with a defensive reaction is that the viewer no longer attends to the message and processing of the message ends abruptly. In addition, the message likely induces psychological reactance, a feeling of threatened loss of freedom and control which is best relieved by ignoring or dismissing the warning and smoking a cigarette.

There are now multiple lines of evidence accumulating to suggest that the graphic warning labels which will appear on cigarettes in the U.S. next year will not have any substantial effect on cigarette consumption.

Monday, August 22, 2011

New Study Shows No Effect of Graphic Warning Labels in England on Smoking Behavior

A new study from the National Centre for Social Research (London) and the Institute for Social Marketing, University of Sterling shows no effect of England's graphic warning labels on cigarette smoking. The study consisted of two waves of surveys, one conducted before the implementation of the graphic warning labels and one conducted afterwards. The graphic warning labels were introduced in October 2008. The second wave of interviews was conducted in the summer of 2010. Thus, the warning labels had been in effect for nearly 2 years at the time of the second wave survey.

The following were the major findings of the study regarding the effects of the graphic warning labels on smoking behavior:

1. There was no observed effect of the graphic warning labels on cigarette smoking prevalence.

2. There was no observed effect of the warning labels on cigarette consumption.

3. There was no observed effect of the warning labels on smoking reduction (measured as forgoing cigarettes due to the warning labels).

Thus, there was no observed effect of the new warning labels on any aspect of smoking behavior.

The report concludes: "Smokers were more likely to report that the warnings messages made them think about their smoking behaviour and thought about quitting smoking after the pictures warnings were introduced. However, as yet, these ‘emotional’ responses have not been translated into behavioural change. It remains to be seen whether such transitions are observed once the picture health warnings have been in circulation for a longer period of time."

The report also concludes: "Forgoing a cigarette when about to smoke one; stubbing out a cigarette or using a variety of techniques to avoid viewing the health warnings messages are important behavioural responses to the health warnings. Among both adults and young people, the prevalence of forgoing a cigarette or stubbing a cigarette out did not change post implementation of the pictures. However, using techniques to avoid viewing the health warnings messages (such as covering up the messages or using a case or container) increased significantly post 1st October 2008."

The report summarizes its findings as follows: "The only significant change in behaviour was that more adult smokers reported using a technique to avoid seeing the messages. It therefore remains to be seen whether these emotional responses are translated into behavioural change in the future. Among young people, the impact of picture health warnings was negligible."

The Rest of the Story

Although there was high recall for the graphic cigarette warning labels, these report finds no evidence that these labels had any impact on smoking behavior of either youths or adults. In fact, the only change in smoking behavior observed in this study was that smokers were more likely to cover up the warning labels to avoid having to see them.

This study provides significant evidence that graphic warning labels did not have any profound effect on cigarette smoking behavior after their introduction in England. While the authors of the report suggest that with time, the warnings could have an effect, I believe the opposite is the case. The impact of the warning labels is likely to be greatest when initially introduced because of the shock value of the images. This immediate effect is likely to wane over time. In fact, I think it is likely that the warning labels could have had a small, but immediate effect on smoking behavior that was missed by the study because the follow-up survey was conducted so long after the warning labels were introduced. Nevertheless, any such immediate effect does not appear to have had any substantial sustained effect on smoking behavior.

While this is just one country's experience, the results of the study do support my prediction that the graphic warning labels soon to be introduced in the United States will have no substantial effect on cigarette consumption. The only piece of the Family Smoking Prevention and Tobacco Control Act which I believe had any chance of having a significant positive effect on the public's health looks like even it will not produce any tangible results. Thus, I continue to believe that the Tobacco Act was an unmitigated disaster for the public's health, and a great victory for the tobacco companies, especially for Philip Morris.

I contend that you are not going to out-negotiate the tobacco companies at the bargaining table. The Campaign for Tobacco-Free Kids thought they could, but they failed miserably. They should have learned their lesson from the failed 1997 global tobacco bailout and the successful (from the point of the tobacco companies) 1998 global tobacco settlement: you cannot outsmart the tobacco companies in the negotiating room. They will take public health groups to the cleaner any day.

Thursday, August 18, 2011

Pendleton to Consider Ban on Sitting or Standing While Smoking in Certain Outdoor Areas

According to an article on the WSPA web site, the town of Pendleton (South Carolina) is considering an ordinance which would make it illegal to stand or sit while smoking in certain outdoor areas: those within 10 feet of a restaurant or public event.

According to the article: "If some town leaders in Pendleton have their way, sitting outside and smoking in certain areas will be against the law. Pendleton Mayor Randy Hayes says, “This is about public health, no matter how you look at it.” The town is also considering an indoor smoking ban to include bars and restaurants. But Hayes says the major sticking point is what to include outdoors. Hayes says, “We're not trying to tell anyone you can't smoke in the town of Pendleton. We're trying to be very selective on where these things can take place.” Under the town's proposed ordinance, if you're within ten feet of a restaurant or ten feet of a public event at a stadium, ampitheater or ball park, you have to keep walking and smoking, and you cannot not stop, stand, sit or linger."

The Rest of the Story

This proposal raises a number of serious questions.

First, what if a smoker is walking back and forth (pacing), in and out of the 10 foot buffer zone? Does that satisfy the ordinance's requirements? After all, the smoker would be walking at all times. Does it matter if you keep walking within the 10-foot buffer zone versus walking in and out of the zone?

Second, what precisely defines "lingering." What if the smoker is waiting for a ride, and the ride doesn't show up? Is that lingering? Is it lingering if the smoker honestly believes that the person is going to show up? How long can you stay in the vicinity of the public event before it is considered lingering?

Third, what if you stop momentarily, but not permanently? How long can you stop before you are breaking the law? Is a five-second break allowable? What if you are tired and need to catch your breath?

Fourth, how fast do you have to be going to be deemed walking? What if you are moving really slowly, taking one step every 10-15 seconds. Is that walking or standing still? Perhaps you are a really slow walker. At what rate of speed must you be going in order to be considered as a walker rather than as a lingerer?

Fifth, are you allowed to sit at a distance of 11 feet from the public event and blow smoke into the 10-feet buffer zone? Does it matter what direction the wind is blowing? What if you are sitting 9 feet away from the public event but the wind is blowing away from the buffer zone? Does that matter?

This is just the tip of the iceberg. Many more intriguing questions remain.

What about hopping? You're neither sitting nor standing, so is that allowed? What if you are on a pogo stick?

Can you leave the area and come back? Is that considered lingering, wandering, or meandering under the law? Is loitering acceptable? Is loitering the same as lingering, or is it defined differently? How is dilly dallying handled under the ordinance? Is it halfway between lingering and loitering, or is it more towards one or the other? And most importantly, what about traipsing? Is smoking while traipsing an offense or not?

Wednesday, August 17, 2011

Why is the American Lung Association Deceiving the Public About the Facts? Why are They Hiding the Fact that NRT Contains Cancer-Causing Agents?

In a statement of advice to the public issued on Monday, the American Lung Association (ALA) warns the public against using electronic cigarettes to quit smoking because they have been found to contain "cancer-causing agents." Instead, the ALA advises people to use "FDA-approved" drugs, such as nicotine replacement therapy (NRT).

According to the American Lung Association statement: "There is no scientific evidence establishing the safety of e-cigarettes. The FDA has found that these products contain cancer-causing agents and toxic chemicals, including the ingredients found in anti-freeze."

The Rest of the Story

The rest of the story is that the American Lung Association is deceiving the public. The truth is that the level of "cancer-causing agents" (i.e., tobacco-specific nitrosamines) found in electronic cigarettes was miniscule. It was so low that it is in fact comparable to the level found in ...

... you guessed it: the nicotine patch!

According to the FDA laboratory study, the level of tobacco-specific nitrosamines in electronic cigarettes was so low that it could not be quantified. It was below the level of quantification for the laboratory method.

Laugesen reported that the level of NNK in electronic cigarette cartridges is 1.5 ng per gram.

Stepanov et al. have reported that the nicotine patch (Nicoderm CQ) contains 8 ng of NNK per gram.

Thus, the level of NNK in electronic cigarettes is actually less than that of the nicotine patch. The level of total tobacco-specific nitrosamines in electronic cigarette cartridges is about the same as in the nicotine patch.

However, the American Lung Association is not informing the public that the nicotine patch - which it recommends as being safe - contains cancer-causing agents. The ALA is only telling the public that electronic cigarettes contain cancer-causing agents, even though the levels of cancer-causing agents in the two products are identical.

This is a biased reporting of the science and I believe it is deceptive.

Why does a public health group like the ALA need to deceive the public? What happened to the scientific integrity of tobacco control organizations like ALA? And why is there no apparent concern for the ethical principle of telling the truth to the public?

I believe the answer, sadly, is that anti-smoking groups are committed to a pre-determined agenda and rather than objectively reporting the science, they only report the information that supports this agenda. This, I believe, is why you don't see the ALA informing the public that the nicotine patch also contains cancer-causing agents or that it was only trace levels of these agents that the FDA detected in electronic cigarettes.

Unfortunately, anti-smoking organizations are largely failing to report to the public the whole truth. This is why there is a need for someone to report the rest of the story.

Tuesday, August 16, 2011

Does Decrying the Comparison of Tobacco Companies to Hitler Make One a Tobacco Industry Shill?

In an interesting commentary at The Exiled, Yasha Levine presents his case that Malcolm Gladwell -- author of the popular books The Tipping Point, Outliers, and Blink -- is a tobacco industry shill who has spouted tobacco industry propaganda and has a relationship with Big Tobacco.

One of the major arguments Levine puts forward to support his argument that Gladwell is a Big Tobacco shill is that Gladwell criticized journalist Philip Hilts for comparing tobacco industry executives to Nazis.

Levine writes: "What the hell is Gladwell doing on a list of tobacco-industry defenders? Well, at least one thing is clear: It’s not because of some freakish clerical error. He carried big tobacco’s water when they needed it most.

And he continued doing it even after being hired by New Yorker in the mid-90′s. For example: In a 1996 book review published in the New Republic, Gladwell slammed journalist Philip J. Hilts for comparing tobacco industry execs to Nazis, and then used the occasion to smear all tobacco critics in general:

What is grotesque about this passage is not just the casualness with which Hilts enlists the Holocaust in his campaign against the Marlboro Man; Auschwitz, after all, has been cheapened before. It is also the incredible moral and analytical simplification, the obliteration of notions of responsibility, that is required to compare the act of selling people cigarettes to the act of herding people into a gas chamber. At the moment of its greatest victory, the anti-tobacco movement has begun to acquire a noxious odor of its own.

Big tobacco was clearly pleased with his efforts."

Levine concludes by suggesting that Gladwell not only spouts tobacco industry propaganda but has a relationship, presumably financial, with Big Tobacco: "The New Yorker might want to ask Gladwell about the kind of relationship he had/still has with big tobacco. Readers would probably want to know."

The Rest of the Story

Whether Malcolm Gladwell is or is not a tobacco industry shill, I find it troubling that his criticism of the comparison of tobacco executives to Nazis is used as evidence to support that contention. I find the comparison distasteful, inaccurate, and insensitive to the victims of the Holocaust. To say that the Nazis were only as "evil" as the executives who sell a legal product which is in demand by millions of Americans is inappropriate and minimizes the tragedy of the Holocaust. Thus, to criticize such a comparison seems perfectly reasonable. It hardly characterizes one as a tobacco industry shill.

By Levine's argument, I am a tobacco industry shill because I criticized a former American Cancer Society president for comparing tobacco executives to terrorists. I wrote: "I completely reject any reference to tobacco manufacturers and marketers as "terrorists," and if Dr. Seffrin made this remark (and there is no reason to believe that the Post is not being accurate in its reporting), I think it is inappropriate, irresponsible, and plainly wrong."

Does this mean that I am a tobacco industry shill or that I must have a financial relationship with Big Tobacco?

One other aspect of the commentary which I find troubling is the accusation thrown at Gladwell that he has a relationship - presumably financial - with Big Tobacco. While the article provides evidence that Gladwell has taken positions that support the tobacco industry, it provides no evidence that he has ever received tobacco industry funding or that he had any type of relationship with the tobacco companies. I do not believe it is right to make such an accusation without having at least some evidence.

Monday, August 15, 2011

Anti-Smoking Researchers Argue that Mathews Study Shows Significant Effect of Smoking Bans on Acute MI; Lack of Scientific Rigor Apparent

Last week, I reported on a study, by Dr. Robin Mathews of the Duke Clinical Research Institute, that examined rates of heart attacks among persons ages 65 and older in 74 cities across the U.S. which adopted strong smoking bans during the period 2000-2008. The researchers compared the heart attack rate in each city during the year before and after the smoking ban was implemented.

When Mathews included all 74 cities that enacted smoking bans during the study period (regardless of strength of the ordinance), he found an overall decline in heart attack rates of just 3%. However, when the analysis was restricted to the 43 cities whose newly enacted ordinances represented a significant increase in protection from secondhand smoke, Mathews reports that there was absolutely no change in the heart attack rates across the sample of cities. A figure shows that heart attacks decreased in some cities and increased in others. All told, heart attack rates decreased by an insignificant 1% among these 43 cities.

Based on these findings, I pointed out that the study fails to support the conclusion - being widely disseminated by anti-smoking groups - that smoking bans result in dramatic, immediate reductions in hospital admissions for acute myocardial infarction. The Institute of Medicine report, for example, cites a reduction of 17% in heart attacks across the studies that it evaluated.

Now, a number of anti-smoking researchers, presumably in response to my blog post, have argued that the Mathews study actually supports the prior research, demonstrating that while small (3%), there is a "significant effect" of smoking bans on heart attacks within one year of implementation of these laws.

The Rest of the Story

There are two reasons why the argument disseminated by these anti-smoking advocates is scientifically flawed.

1. The argument ignores the relevant analysis, relying on the result of an essentially meaningless analysis.

First, it ignores a major result of the study, choosing instead the one result which found a significant effect but ignoring what is actually the most relevant analysis, which failed to find an effect.

The analysis of all 74 cities, which did find a significant decline in heart attacks of 3%, included cities that had enacted ordinances that failed to "meaningfully" increase protection from secondhand smoke. Thus, these cities were misclassified. Rather than being in the intervention group, they should have been considered to be communities that did not increase their secondhand smoke protection.

The relevant analysis is the analysis of the 43 cities in which the level of protection from secondhand smoke meaningfully increased after implementation of the smoking ordinance. It was that analysis which found only a 1% (non-significant) decline in heart attacks.

If an ordinance provides no meaningful increase in protection from secondhand smoke, then why would one classify it as an intervention community?

2. The study lacks a control or comparison group.

Second, because the study lacks a control group, all one can conclude from it is the change in heart attacks from before to after the ordinances. One cannot infer that this change was due to the ordinance because there is no evidence that these declines exceed those that were occurring simultaneously in communities without smoking bans.

Even if we accept the results of the full analysis of 74 cities (a 3% decline in heart attacks overall in these cities), the only way one could credibly conclude that this 3% decline was due to the smoking bans is to compare this decline to that in communities without smoking bans and show that the heart attack decline in the intervention (i.e., smoking ban) communities was significantly greater.

The rest of the story is that heart attack rates during the study period declined substantially throughout the United States, even in communities without smoking bans, and the average annual rate of decline in heart attack admissions among 65+ year olds during the study period appears to be in the approximate range of 3% per year.

Based on data from the Health Care Utilization Project, I calculated the year-to-year declines in heart attack admissions among persons ages 65 and up nationally for the years 2000 to 2006 (more recent data are not yet available on admissions). The average annual decline in admissions was 3.4%.

Thus, the observed decline in heart attacks in the 74 communities that enacted smoking bans during the study period appears to be a little lower than the decline in heart attacks that occurred nationally, with or without smoking bans in place.

To demonstrate how "meaningless" the observed 3% decline in heart attacks is in the context of a control group (the United States as a whole), the annual decline in heart attack admissions among 65+ year-olds during the more recent years was as follows:

2002-2003: -4.5%
2003-2004: -8.0%
2004-2005: -7.0%
2005-2006: -4.5%

Without even seeing these data, the anti-smoking researchers have nevertheless concluded that a mere 3% reduction in heart attacks in a one-year period is a significantly greater decline than what was occurring nationally anyway based on secular trends, in the absence of a smoking ordinance.

Of course, what we really need as a comparison group are cities that are similar to those which enacted smoking bans in other ways, but did not themselves enact smoking bans. The national data include cities with and without smoking bans.

My point is simply that without the comparison data from communities that did not enact smoking bans, one cannot possibly conclude that the observed 3% decline in heart attacks in the cities that enacted smoking bans was greater than what would have occurred in the absence of these bans.

The Mathews study certainly cannot be used to support the contention that smoking bans result in a significant short-term decline in heart attacks. At best, all it can support is the conclusion that in the cities which enacted smoking bans, there was an overall average decline of 3% in heart attacks during the first year of implementation. This 3% decline could be more than, less than, or the same as what would have occurred in the absence of the smoking bans (i.e., the observed change in heart attacks during the same period of time in comparison cities without smoking bans).

While I am a passionate supporter and promoter of smoking bans, I do my best to try not to let that interfere with my interpretation of the scientific evidence. As is hopefully apparent to regular readers, I will report findings to the public, even if they are "unfavorable" to us in tobacco control.

I want to close by emphasizing that in the long-term, smoking bans will almost certainly reduce heart disease (and therefore heart attacks). The question is whether this effect can and will happen immediately (within one year). Even if we fail to see an effect on heart attacks within one year, this does not argue against the enactment of smoking bans. In fact, even if smoking bans had no long-term effect on heart disease, the respiratory effects of secondhand smoke alone would be enough to support protecting the public from secondhand smoke exposure.

I do hope, however, that we in tobacco control will base our support of smoke-free policies on credible scientific evidence, rather than on a study like the Mathews one which lacks a control group and makes the conclusion being disseminated by these researchers an unsupportable one.

Sunday, August 14, 2011

Data from Other Countries Show No Effect of Graphic Warning Labels on Cigarette Consumption

A report issued last week by UBS Investment Research analyzes trends in cigarette consumption in five major economies that recently mandated warning labels similar to those that the FDA will require starting next year (Canada, Australia, Brazil, the U.K., and India). The report compares cigarette sales during the three years before and three years after implementation of the graphic warning labels.

The rate of decline in cigarette sales following the graphic warning labels increased in two countries, and decreased in three of the countries. Overall, the analysis fails to provide any significant evidence that graphic warning labels have a substantial effect on cigarette consumption.

The Rest of the Story

This analysis supports my general conclusion regarding the overall scientific evidence about the likely impact of the soon to be implemented graphic warning labels. While I believe that a small short-term effect on cigarette smoking among existing smokers is likely, I do not think the effect will be substantial, nor will it be sustained over the long-term. The experience of several other countries seems to bear this out.

The warning labels do not appear to represent any significant threat to cigarette company profits. Sadly, that is the strongest aspect of the Family Smoking Prevention and Tobacco Control Act.

From now on, I must use parentheses when citing the act, as it is more appropriately the Family Smoking "Prevention" and Tobacco "Control" Act. The only thing being prevented is the deterioration of the profitability of the tobacco companies. And the only thing being controlled is the ability of smaller companies to compete with the big guys, especially Philip Morris, which dominates current domestic market share.

Friday, August 12, 2011

Physician's Argument for Banning Tobacco Sales in Pharmacies Fails: How Will this Policy Reduce Smoking Rates?

A physician in Taunton (Massachusetts), in a letter to the editor in the Taunton Daily Gazette, presents an argument in favor of banning tobacco sales in pharmacies that is typical of many I hear in support of these policies. He argues that this policy will help reduce health care costs and premiums, secondhand smoke exposure, and cigarette butts in parking lots, as well as promote the public's health and safety and protect the city's youth.

The pediatrician writes: "I want to compliment David Riley and Gerry Tuoti on their excellent coverage and well-researched article, “Up in Ash” (Aug. 7) on the smoking incidence in Massachusetts and the alarming higher percentages of smoking in Taunton. One paragraph discusses a ban on the sale of tobacco products in pharmacies. There is momentum for this in the state; Boston has been doing it for two years. How can we, in good conscience, allow a patient to buy medication for asthma, bronchitis, or pneumonia and have tobacco products at the check-out counter? The Taunton Board of Health has an opportunity to “promote the health, safety, and welfare” and protect the innocent and uneducated. Director Heather Gallant called the data “concerning.” I urge citizens who deplore increased health care costs and premiums, second-hand smoke, and cigarette butts in parking lots to contact our Board members, Drs. Burden, Nates and Bodner at 508-821-1400 to pass this measure."

The Rest of the Story

How is this policy - banning the sale of tobacco in Taunton pharmacies - going to reduce health care costs and premiums, decrease secondhand smoke, lower the number of cigarette butts, protect the public's health, and protect youth? The policy will almost certainly have no impact on tobacco sales or tobacco use, among adults or youth. Both youth and adults will easily be able to buy their cigarettes elsewhere.

There are plenty of places, besides pharmacies, where I imagine you can buy cigarettes in Taunton, including:
  • Taunton Xtra Mart
  • Cumberland Farms
  • Girlies Variety Store
  • Stop N Save Lower Price Tobacco Store
  • Broadway Mart
  • Star Food Mart
  • Pete's Mart
  • Pop's Texaco Services Station
  • Super Petroleum
  • City Citgo
  • Planet Petroleum
  • Silver City Gas
  • Taunton Mobil Mart
You can't tell me that by banning the sale of tobacco in pharmacies, you are in any way going to decrease the sale of tobacco. The policy will therefore not have any effect whatsoever on youth smoking, adult smoking, secondhand smoke exposure, cigarette butts, protecting the public's health, or protecting youth.

The only effect this policy will have is to shift tobacco sales from Taunton pharmacies over to these other tobacco outlets. Thus, the policy is not a public health policy. It is more of a "revenue redistribution" policy.

If the true goal were to significantly reduce youth smoking, then wouldn't the first object of one's action be the sale of cigarettes to youth at convenience stores and gas stations? After all, those are the locations at which youth are most likely to buy cigarettes, not pharmacies.

Not only does this policy fail to make sense and fail to have a legitimate public health justification, but it also fails to accomplish the very goals that the author of this letter claims to be trying to achieve.

Thursday, August 11, 2011

New Study Finds that Smoking Bans Have No Short-Term Effect on Heart Attack Admissions

A study presented at the American Heart Association annual meeting found that smoking bans have no effect on the incidence of heart attacks during the first year after implementation.

The study, by Dr. Robin Mathews of the Duke Clinical Research Institute, examined rates of heart attacks among persons ages 65 and older in 43 cities across the U.S. which adopted strong smoking bans during the period 2000-2008. The heart attack rates were compared from one year prior to the smoking ban to the year following implementation of the smoking ban. Mathews reports that there was absolutely no change in the heart attack rates across the sample of cities. A figure shows that heart attacks decreased in some cities and increased in others. All told, heart attack rates decreased by an insignificant 1%.

When Mathews included all 74 cities that enacted smoking bans during the study period (regardless of strength of the ordinance), he found an overall decline in heart attack rates of just 3%.

The study concludes that the actual effect of smoking bans on heart attacks is much lower than has been reported in the previous literature.

The Rest of the Story

While there have been individual studies that reported a significant, and sometimes very large, decline in heart attacks in communities following the implementation of a smoking ban, every study that has systematically examined the relationship between smoking bans and heart attacks across all communities that implemented smoking bans in a given time period has found no major effect.

It seems clear that the explanation for the discrepancy is publication bias. There are many factors operating which discourage researchers from reporting "negative" findings. It is also much more difficult to get negative findings published, especially on this topic. No researchers are running out to publish a study showing no decline in heart attacks following a smoking ban.

The studies which have systematically examined the effect of smoking bans on heart attacks in all cities across the country that have implemented such bans have found that while heart attacks have declined in many cities, they have increased in others. The overall effect is nil, or very close to it. However, the only studies being published are the ones which have found a positive effect. This is a classic presentation of publication bias.

The effect is compounded by the fact that the media are less interested in covering "negative" studies (and researchers are less excited about going to the media with "negative" results). For example, the current study is a case in point. I could find no newspaper articles that reported the results of this "negative" study. In contrast, when a study with "positive" findings is presented at a scientific conference, it tends to be widely publicized.

In addition, anti-smoking groups only report the results of the "positive" studies. To the best of my knowledge, no anti-smoking group has reported the results of the Mathews study. And they won't, because it is not scientific accuracy which is driving the movement these days. I won't even go through the motions of offering my usual $100 reward to the first anti-smoking group that reports these "negative" findings because it just isn't going to happen. The interest is not in reporting the science, but in reporting "favorable" results.

The shame is that there are no "favorable" or "unfavorable" results. The truth is the truth. The science is the science.

NOTE: Christopher Snowdon has a very nice summary and commentary of this research over at Velvet Glove Irong Fist. Tim Worstall writes about the issue here in Forbes magazine.

Wednesday, August 10, 2011

15 Days in Jail for Smoking in a Park?

According to an article in the Glens Falls Post Star, the Glens Falls (NY) Common Council has enacted an ordinance which bans smoking in all city parks and violators are subject to up to 15 days of jail time.

Apparently, the ordinance bans not only smoking, but also smokeless tobacco use and the use of any type of tobacco product.

The Rest of the Story

Sending someone to jail for 15 days for smoking in a part seems rather extreme. The idea that someone could be forced to live in the slammer for 2 weeks because he used smokeless tobacco in a park is simply ludicrous. Since smokeless tobacco produces no smoke, it is not causing harm to anyone else. Thus, it is nothing more than a "moral" offense. To be forced to serve jail time for an offense that harms no one else (and which could potentially be an effort on the part of the user to reduce harm to himself) is ridiculous.

I would argue that even smoking a cigarette in a park causes no harm to anyone else. Certainly it causes no harm that the other person is unable to easily avoid. There is no need to ban smoking in parks, but there is certainly no justification for making it a criminal offense carrying potential jail time.

On the heels of my post yesterday about King James I and his casting of smoking as sin - a moral offense - today's story reinforces my argument that the tobacco control movement has not progressed in its view of tobacco use in the past 400 years.

Tuesday, August 09, 2011

Name This Anti-Smoking Advocate

"Have you not reason then to be ashamed and to forbear this filthy novelty, so basely grounded, so foolishly received and so grossly mistaken in the right use thereof. In your abuse thereof sinning against God harming yourselves both in person and goods, and raking also thereby the marks and notes of vanity upon you by the custom thereof making yourselves to be wondered at by all foreign civil nations and by all strangers that come among you to be scorned and held in contempt; a custom loathsome to the eye, hateful to the nose, harmful to the brain, dangerous to the lungs, and in the black stinking fume thereof nearest resembling the horrible stygian smoke of the pit that is bottomless."

Today's question is: What anti-smoking advocate made the above statement? The choices are:

a. John Banzhaf
b. Stanton Glantz
c. James Repace
d. Michael Siegel
e. King James I

The answer, obviously, is King James I. But with slightly altered language, the quote could just as easily have been made by many of today's anti-smoking advocates. The quote is from the King James I treatise entitled "A Counter-Blaste to Tobacco," which was published in 1604.

This treatise is interesting for a number of reasons. First, it clearly recognizes the harmful effects of tobacco, including its adverse impact on the lungs.

Second, it also recognizes the addictive nature of tobacco use. King James writes: "And from this weakness it precedes that many in this kingdom have had such a continual use of taking this unsavory smoke, as now they are not able to forbear the same no more than an old drunkard can abide to be long sober without falling into an incurable weakness and evil constitution. For their continual custom hath made to them habitual alter am natural."

Third, it views tobacco use not merely as an unhealthy behavior, but as an immoral one that reflects sinful behavior and poor character. King James writes: "Thus having, as I trust, sufficiently answered the most principle arguments that are used in defense of this vile custom, it rests only to inform you what sins and vanities you commit in the filthy abuse thereof: First, are you not guilty of sinful and shameful lust (for lust may be as well in any of the senses as in feeling) that although you be troubled with no disease, but in perfect health, yet can you neither be merry at an ordinary, not lascivious in the stews, if you lack tobacco to provoke your appetite to any of those sorts of recreation lusting after it as the children of Israel did in the wilderness after quails. Secondly: it is as you use, or rather abuse, it a branch of the sin of drunkenness, which is the root of all sins; for as the only delight that drunkards take in wine is in the strength of the taste, and the force of the fume thereof that mounts up to the brain, for no drunkards love any weak or sweet drink."

The Rest of the Story

I find it unfortunate that our view of smokers as sinners who have poor character does not seem to have advanced in the past 400 years. The modern-day anti-smoking movement is essentially repeating the mantra of King James, albeit in somewhat toned down fashion. Smokers are essentially viewed as sinners who must be punished. A number of policies being promoted by anti-smoking groups in 2011 support this view. They include:
  1. policies to not only remove tobacco smoke from the workplace, but also to remove smokers;
  2. policies that deny medical care to smokers;
  3. policies that treat smoking around children as a form of child abuse, even allowing removal of children from homes with smokers under certain conditions;
  4. policies that make smokers ineligible to adopt or foster children; and
  5. policies that fine smokers to enter an entitlement program (e.g., Medicaid).

Monday, August 08, 2011

Gallup Poll Shows Increasing Lack of Respect for Smokers

A new Gallup poll reveals that the percentage of Americans who have less respect for smokers has increased markedly since 1994 and greatly exceeds the percentage of people who have less respect for persons who are obese.

In the 2011 poll, 25% of Americans reported that they have less respect for people who smoke, while 12% stated that they have less respect for people who are obese. In 1994, only 14% of Americans answered that they had less respect for smokers. That percentage has increased steadily since then, and increased from one in five to one in four over the past eight years.

When only lifetime nonsmokers are considered, the numbers are even more striking. One-third of people who have never smoked responded that they have less respect for smokers. Disrespect for smokers was associated with a person having higher levels of education and income.

The Rest of the Story

While the poll itself does not provide an evaluation of the reasons for the increasing lack of respect for smokers, I believe that changes in the anti-smoking movement have been a major contributor.

For example, there has been a change in the movement from a focus on attacking "smoke" to attacking the "smoker." Many anti-smoking groups are supporting policies to not only remove tobacco smoke from the workplace, but also to remove smokers. Hospitals in particular are leading the trend in refusing to allow smokers to enter the workforce. Some anti-smoking groups are promoting refusal of medical care to smokers, removal of children from homes with smokers under certain conditions, and ineligibility of smokers to adopt or foster children.

The key tenet to all of the above anti-smoking policies is that smoking is a stupid decision that is entirely under the control of the smoker and that no person with any degree of intelligence would make such a decision. This premise goes completely against the central theme of the anti-tobacco movement at the time I entered the movement, which was that smoking is an addiction and that smokers are in a sense victims of the tobacco industry's brilliant marketing and the addictive nature of the product and the behavior, rather than a result of stupid decision-making.

I entered the tobacco control movement largely because I wanted to help my many patients who were smokers and were suffering from chronic and often debilitating diseases. I witnessed the toll that smoking takes on health directly during my medical school years and also during my internship and residency. During that time, I decided to dedicate my career to try to prevent the suffering caused by smoking-related disease. Never would I have dreamed at that time that the movement would eventually become an attack on smokers, rather than a movement which sympathized with and was dedicated to helping smokers.

The tobacco control movement needs to re-think where it is and the direction in which it is going. In light of these new data from Gallup, we need to think carefully about whether this is really where we want to be. Are we really trying to engender a disrespect for smokers? Do we really want the public to view smoking as nothing more than a poor decision on the part of adults?

In many ways, the success of the tobacco control movement has been attributable, I think, to our success in framing smoking as an addiction, emphasizing that most smokers begin smoking as youth, explaining that youth are not making fully informed decisions, and recognizing that once addicted as a youth, it is very difficult to quit. It is not as simple as just blaming smokers for making a poor decision and not having the intelligence or will to change their behavior.

Nor should smoking be viewed as a moral issue or as one of character in the first place. Smoking should be viewed as a consumer behavior, much like the purchase of any other product which affects one's health, and the role of the tobacco corporations in marketing the product and designing it in a way to maximize its addictive power should be the focus of our educational, program, and policy actions.

The Gallup poll results should be viewed as a bad report card for the tobacco control movement. In lieu of requiring our parent to sign this bad report card, my hope is that the movement will reconsider the direction that the program is going and make immediate changes to alter our course.

Friday, August 05, 2011

New Research Article Confirms that Advising E-Cigarette Users to Switch to FDA-Approved Products Would Be a Grave Mistake

An article published online ahead of print in the International Journal of Clinical Practice finds that the overwhelming majority of dedicated electronic cigarette users have already tried to quit smoking many times and most have tried and failed with FDA-approved smoking cessation therapies. The critical implication of this finding is that advising e-cigarette users to switch to FDA-approved drugs, as was recommended by authors of a New England Journal of Medicine commentary article last week, would have devastating public health consequences, as most of these ex-smokers would return to smoking due to their previous lack of success with NRT, Chantix, and other approved smoking cessation drugs.

(See: Foulds, J., Veldheer, S. and Berg, A. (2011), Electronic cigarettes (e-cigs): views of aficionados and clinical/public health perspectives. International Journal of Clinical Practice. doi: 10.1111/j.1742-1241.2011.02751.x)

The research involved personal interviews with 104 experienced electronic cigarette users. The major findings were as follows:
  1. "Of all the e-cig users, 78% had not used any tobacco in the prior 30 days."
  2. "They had previously smoked an average of 25 cigarettes per day, and had tried to quit smoking an average of nine times before they started using e-cigs."
  3. "Two-thirds had previously tried to quit smoking using an FDA-approved smoking cessation medication."
  4. "Three quarters started using e-cigs with the intention of quitting smoking and almost all felt that the e-cig had helped them to succeed in quitting smoking."
The Rest of the Story

This study adds to a growing body of survey-based evidence that electronic cigarettes are being used successfully by thousands of smokers to quit smoking. The proportion of users who are successful in quitting is not clear because none of these surveys has obtained a representative sample of electronic cigarette users. However, despite this limitation, the combined evidence makes it untenable at this point to opine, as Abrams and Cobb did in their New England Journal of Medicine commentary, that electronic cigarettes are likely to be ineffective for smoking cessation because of their ineffective delivery of nicotine.

Abrams and Cobb's conclusion was based on a single study in which novice e-cigarette users were instructed to take 10 puffs. What this new study finds, however, is that experienced electronic cigarette users have found ways of enhancing the nicotine delivery from these devices and do not simply take 10 puffs. For example, some have found that priming the device prior to use enhances nicotine delivery. There are also varieties with stronger batteries that may be more effective in delivering nicotine. Moreover, there is some evidence that even with poor nicotine delivery, the physical stimuli and mimicking of the smoking experience are sufficient to suppress the craving to smoke, and thus smoking cessation can be achieved even without high nicotine delivery.

Perhaps more importantly, this study documents that the overwhelming majority of electronic cigarette users who have successfully quit smoking using these devices have already failed many times before trying to quit, most often with FDA-approved smoking cessation drugs. Thus, the recommendation that these ex-smokers discontinue the use of e-cigarettes and return to nicotine replacement therapy, Chantix, or other FDA-approved drugs will most likely result in their returning to cigarette smoking, as they have already failed many times in the past with the FDA-approved methods.

In fact, the primary stimulus for the use of the e-cigarette appears to be that a long-time smoker who has failed many previous quit attempts with standard approaches wants to try something new and different that may have better success.

The rest of the story is that based on this new evidence, the recommendation that e-cigarette users switch to FDA-approved smoking cessation drugs is irresponsible. If followed, it will almost certainly result in thousands of ex-smokers resuming cigarette smoking. Many of these ex-smokers have already experienced dramatic improvement in their health, especially in their lung function and respiratory symptoms. For medical advice from physicians to result in thousands of ex-smokers returning to cigarette smoking and negating (and reversing) the health gains they have made would be quite unfortunate. This is why I argue that the recommendation made by Abrams and Cobb is irresponsible and why following that advice would be a grave mistake on a population basis.

Foulds et al. deserve credit for having the insight and judgment to make a responsible, science-based recommendation: "if the patient perceives that the e-cig is helping them to stay off cigarettes and is not reporting any health problems likely attributable to the e-cig, then the focus should be on staying smoke-free rather than e-cig free. The health risks from smoking are large and are known with certainty. Comparatively, the health risks from e-cig use are likely much smaller (if any) and temporarily switching to e-cigs will likely yield a large health benefit."

Wednesday, August 03, 2011

I Will Answer Questions on Electronic Cigarettes at 8:00 ET Tonight on a Facebook Web Chat

I will answer questions about electronic cigarettes tonight at 8:00 p.m. ET at the Blu Cigs Facebook page.

Jupiter to Ban Flavored Tobacco Products, Except for Menthol Cigarettes; Policy Ensures There Will Be No Significant Decline in Youth Smoking

According to an article in the Palm Beach Post, the town of Jupiter (Florida) is considering passing a non-binding resolution that would ask stores in the town not to sell flavored tobacco products. Similarly, the city of Fort Myers is considering a resolution asking its stores to refrain from selling flavored tobacco products.

The justification for both resolutions: flavored tobacco products appeal to kids and secret tobacco industry documents reveal that the companies add flavors to their products to entice young people to use them.

The Rest of the Story

The rest of the story, of course, is that neither Jupiter nor Fort Myers truly has any sincere interest in curtailing youth smoking. If they did, then they would certainly choose menthol cigarettes as the first product to ban, rather than exempt the one flavored tobacco product that is actually used by an enormous percentage of Florida youths. Instead, policy makers in these two communities are taking a politically correct action: one that makes it look like they are doing something about the youth smoking problem, but which will actually accomplish close to nothing. The real problem - the use of the one flavored tobacco product that actually amounts to a substantial proportion of youth tobacco use - is left unaddressed.

Nearly half of Florida youths who start smoking use menthol cigarettes. Only a handful use other flavored tobacco products like snus or dissolvable tobacco. Banning flavored tobacco products with the exception of menthol cigarettes is not only a display of political cowardice, it is also highly hypocritical. It sends the message that it is not OK to try to entice youths with flavoring, unless you are eminently successful doing so and can get almost half of youths to use your products. If you can only get a smattering of kids to use your flavored tobacco product, then it must be banned. But if you can get close to a 50% market share with your flavored cigarette, then you're in business in the towns of Jupiter and Fort Myers.

Tuesday, August 02, 2011

New Study Documents that Thousands of E-Cigarette Users are Having Success Quitting; Claim that E-Cigs are Ineffective is No Longer Tenable

A new study published online ahead of print in the journal Addiction suggests that electronic cigarettes have been effective in helping literally thousands of smokers to cut down or quit smoking entirely, refuting a claim in last week's New England Journal of Medicine that these devices are likely to be ineffective because they deliver very little nicotine (a claim which was based entirely on a single study in which subjects were instructed to take 10 puffs on an e-cig, but no more).

(see: Etter J-F, Bullen C. Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy. Addiction 2011; doi:10.1111/j.1360-0443.2011.03505.x).

The study involved a survey of electronic cigarette usage patterns and results using two survey frames: one was subjects recruited through electronic cigarette-related web sites and forums. The other was subjects recruited though smoking or smoking cessation web sites having nothing to do with e-cigarettes. Although the first sampling frame would produce a biased sample (consisting of people with more successful experiences with e-cigarettes than in the population as a whole), the authors compared the results between the two samples to provide some indication of the extent to which the results were biased by the sampling scheme.

The most notable finding was that there were not marked differences between the experiences of e-cigarette users recruited via e-cigarette forums versus non-e-cigarette-related sites. Even among the subjects recruited from general smoking cessation sites or via Google, the overwhelming majority of ever users of electronic cigarettes (80.8%) reported that e-cigarettes helped them reduce smoking a lot (compared to 93.2% of subjects recruited via e-cigarette-related sites).

Among ex-smokers recruited at the general sites, 93.3% reported that e-cigarettes helped them quit smoking (compared to 96.1% of subjects recruited via e-cigarette sites).

Among all e-cigarette users, 92.2% stated that the device helped them to reduce smoking a lot. An overwhelming majority (88.6) reported that it is easy to abstain from smoking when using the e-cigarette.

Interestingly, the overwhelming majority (82.7%) of electronic cigarette users are worried that these devices might be banned and 79.2% of those who quit smoking using e-cigarettes are afraid that they would return to smoking if such a ban occurred. Of those who stopped smoking while on e-cigarettes, 96.0% reported that the electronic cigarette played a definitive role in helping them quit smoking.

The paper's major finding is as follows: "e-cigarettes were used largely by former smokers as an aid to quit smoking, to avoid relapse and to deal with withdrawal symptoms, much as people use nicotine replacement therapy (NRT). ... Our data suggest that e-cigarettes may help smokers to quit smoking, reduce their cigarette consumption and attenuate craving and tobacco withdrawal symptoms. Users of nicotine-containing e-cigarettes reported only slightly superior effects on withdrawal than users of non-nicotine cigarettes, suggesting that nicotine delivery explains only part of the effect of these devices on withdrawal, and that sensory and behavioural components of the e-cigarette are also important."

Another important finding is that smokers who used e-cigarettes (but did not quit entirely) still improved their health: "current smokers who used the e-cigarette had fewer respiratory symptoms than smokers who did not use it ... which we speculate might be a consequence of reduced smoking. This difference is substantial ... and very close to the difference ... reported previously between patients with moderate and severe COPD."

The paper concludes: "E-cigarettes were used mainly by former smokers as an aid to quit smoking and avoid relapse. These products were perceived as satisfactory, useful, and efficacious, and almost all users preferred nicotine-containing e-cigarettes."

The Rest of the Story

Despite the fact that the sample is non-representative and the true efficacy of electronic cigarettes is certainly lower than reported here, the findings of the study nevertheless provide strong evidence that electronic cigarettes are being used with success by many smokers to quit smoking or cut down substantially on the number of cigarettes they consume, and that e-cigarettes are being used with success by many ex-smokers to remain off cigarettes.

Based on this survey alone, there are more than 2,000 ex-smokers who are electronic cigarette users who claim that the device played an instrumental role in their success in quitting smoking. Nearly 80% of these ex-smokers fear they would return to smoking if they discontinued the use of electronic cigarettes, as recommended by Cobb and Abrams in their New England Journal of Medicine perspective article.

Given these findings, along with previous data from other surveys and anecdotal evidence from numerous other sources, the claim that electronic cigarettes are completely ineffective in smoking cessation because they do not deliver nicotine effectively is now untenable.

It is now clear that there are indeed thousands of ex-smokers who successfully quit smoking because of electronic cigarettes and who would likely return to smoking if persuaded to discontinue using electronic cigarettes in favor of an "approved" form of smoking cessation pharmacotherapy.

It is also clear that there are thousands of ex-smokers who successfully quit smoking because of electronic cigarettes and who would likely return to smoking if e-cigarettes were banned or taken off the market, as recommended by numerous anti-smoking groups, including the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society, American Lung Association, and the American Legacy Foundation.

While there is no question that more rigorous research is needed to study the effectiveness of electronic cigarettes for smoking cessation (e.g., clinical trials), there is also no question that these products can be effective and are effective among thousands of users. This may not mean that the proportion of users who are successful is high, but it does mean that the number of people who would be harmed by taking e-cigarettes off the market or by persuading people to discontinue their use is substantial.

Thus, promoting the removal of electronic cigarettes from the market pending further research and recommending that people refrain from using the product pending further research are both strategies that will almost invariably cause substantial health harm to the population. Therefore, I do not find either of these approaches to be responsible and appropriate ones.

Monday, August 01, 2011

E-Cigarette Opponents Recommend that Smokers Use a Drug With Known Deadly Effects, Rather than a Product With No Known Toxicity

Authors of a recent Perspective article in the New England Journal of Medicine - both physicians - recommended in that article that smokers trying to quit should use approved smoking cessation drugs rather than electronic cigarettes to help them get off of cigarettes. In particular, they advocate for the use of Chantix instead of electronic cigarettes as a pharmaceutical product for smoking cessation.

According to the article: "In reality, both smokers and e-cigarette users have many alternatives: multiple nicotine products, approved, regulated, and deemed to be safe and effective by the FDA, are already widely available (in addition to other effective cessation tools, such as varenicline, bupropion, telephone quit-lines, and Web-based services)."

Thus, the article recommends that smokers use varenicline (Chantix) instead of electronic cigarettes to help them quit smoking and it also recommends that ex-smokers who have quit using electronic cigarettes discontinue electronic cigarette use and instead use drugs like Chantix.

The Rest of the Story

The rest of the story is that this article is recommending that electronic cigarette users switch to a drug (Chantix) with known, severe potential toxicity, including the risk of death, rather than remain off cigarettes using a product with no known toxicity (beyond the risks of long-term nicotine use).

While Chantix has been linked to more than 200 deaths (from suicide) and thousands of other severe adverse side effects, electronic cigarettes have been linked to no deaths and no severe adverse side effects.

Why, then, would these physicians recommend that ex-smokers discontinue a product with no known toxicity and switch over to a product with well-documented, potentially fatal toxicity? In my view, this makes no sense at all.

The only possible explanation I can even begin to come up with is a financial one: one of the authors of the article has received funding in the past from Pfizer, the maker of Chantix. As I pointed out earlier, Dr. Abrams has received grant funding from multiple pharmaceutical companies that have investigated or manufactured smoking cessation drugs, including Eli Lilly, Dupont Merck, Glaxo-Wellcome, SmithKline Beecham, Sano Corporation, Bristol-Myers Squibb, Knoll Pharmaceuticals, and Pfizer.

Interestingly, the research funded by Pfizer was a pair of studies specifically designed to test the effectiveness of varenicline (Chantix) for smoking cessation. With this direct conflict of interest then, it may not be as difficult to imagine why there could be an appearance of bias in the recommendation that electronic cigarette users put down their devices with no known toxicity and switch over to a drug that appears to have killed hundreds of people.

My additional question is this: why bother studying the toxicity of electronic cigarettes if we have a drug we already know is killing hundreds, but these researchers are not calling for it to be removed from the market? How many deaths from electronic cigarettes would have to occur in such research before it would warrant removal from the market? Since Chantix is already killing hundreds but not being removed, what is the point of even studying electronic cigarette toxicity?

It appears to me that the recommendations being made are not science-based, but are ideological and/or influenced by financial conflicts of interest. The science base simply doesn't support recommending that people use a drug with known severe toxicity and over 200 associated deaths over a product that has so far not been associated with a single death or severe adverse event.

If readers can help me make sense out of this recommendation, please help. I am struggling to understand it.