The Baylor Health Care System has announced that it will no longer hire smokers. But the policy goes far beyond that. The hospital system will not consider for employment smokers who are trying to quit using nicotine replacement therapy or electronic cigarettes. Nor will it hire ex-smokers who are successfully keeping themselves off of cigarettes by using NRT products or electronic cigarettes.
The policy is not simply an anti-smoker policy. It is an anti-nicotine policy. It forbids the employment of anyone who uses nicotine in any form, even if the person is using a product like electronic cigarettes in order to successfully keep away from cigarette smoking.
The Rest of the Story
This policy is making a moral statement, not a public health statement. In fact, in some ways the policy deters the improvement of the public's health by casting a dark cloud on the millions of smokers who are making or have successfully made quit attempts using nicotine replacement therapy, whether in the form of nicotine patches, gum, inhalers, or electronic cigarettes.
Why would a health care system want to discourage people from quitting smoking using nicotine-containing products?
The Baylor Health Care System appears to have joined the abstinence-only movement which has proven so counterproductive in public health.
Thursday, September 29, 2011
Tuesday, September 27, 2011
Hearing on Cigarette Warnings Reveals Key Issue: Are Proposed Labels Warnings or Advocacy Statements?
I have been writing for the past several weeks about what I see as a key issue in the lawsuit regarding the FDA's proposed cigarette warning labels: whether the proposed labels represent merely warnings about the health effects of smoking or whether they are really anti-smoking advertisements designed primarily to promote smoking cessation. According to an Associated Press article regarding last week's hearing before the District Court judge, this does appear to be a key issue in the case and Judge Richard Leon directly questioned the government attorney about this.
According to the article: "A federal judge peppered a government lawyer with questions Wednesday expressing doubts about whether the Food and Drug Administration can force tobacco companies to post graphic images on their cigarette packages showing the health effects of smoking. In a two-hour hearing, U.S. District Judge Richard Leon closely questioned Justice Department lawyer Mark Stern on whether the nine graphic images proposed by the FDA convey just the facts about the health risks of smoking or go beyond that into advocacy — a critical distinction in a case over free speech. ... Lawyers for the tobacco companies argued that the government is free to tell people how to live — through steps such as enacting smoking bans on teenagers and by requiring written, factual warnings on the sides of cigarette packages from the surgeon general about the effects of smoking. But what the government cannot do is "conscript" the companies "into an anti-smoking brigade," noted First Amendment lawyer Floyd Abrams told the judge. The judge questioned Stern about why the images did not amount to advocacy. "What do you say is the line" between advocacy and fact? he asked Stern. "This is not an ordinary product" and the images coupled with written warnings are designed to communicate the dangers to the public — including youngsters as well as adults, Stern replied."
The Rest of the Story
You can see why I argued yesterday that the amicus brief submitted by the Campaign for Tobacco-Free Kids and other anti-smoking groups hurts the government's case. In the hearing, government lawyer Mark Stern was very careful to insist that the purpose of the graphic warning labels is to "communicate the dangers to the public." He apparently argued that the graphic nature of the warnings is necessary in order to effectively communicate the dangers, as evidence shows that the current warnings are not effectively doing so.
In contrast, the amicus brief argues that the purpose of the graphic warnings is to send an anti-smoking message, encouraging smokers to quit by referring them to a telephonic counseling service, which the groups assert has proven effective in promoting smoking cessation.
Now, the FDA is in the awkward position of having to counter the amicus brief and convince the judge that the reasons for the graphic warning labels set forward in the brief by the anti-smoking groups are not the real reasons that the FDA has proposed these warnings.
While it is true that tobacco is not an ordinary product and that the type of warning that might be sufficient for a typical consumer product may not be effective for cigarettes, this would still not seem to explain why the 1-800-QUIT-NOW message needs to be included on the label. To me, the inclusion of that requirement is the chief legal problem with the proposed labels, as it appears difficult to assert that the inclusion of the smoking cessation number is intended and necessary to effectively convey a health warning, rather than intended to promote smoking cessation and help smokers quit by referring them for telephonic counseling.
According to the AP, Judge Leon indicated that he hopes to issue a ruling by the end of October.
According to the article: "A federal judge peppered a government lawyer with questions Wednesday expressing doubts about whether the Food and Drug Administration can force tobacco companies to post graphic images on their cigarette packages showing the health effects of smoking. In a two-hour hearing, U.S. District Judge Richard Leon closely questioned Justice Department lawyer Mark Stern on whether the nine graphic images proposed by the FDA convey just the facts about the health risks of smoking or go beyond that into advocacy — a critical distinction in a case over free speech. ... Lawyers for the tobacco companies argued that the government is free to tell people how to live — through steps such as enacting smoking bans on teenagers and by requiring written, factual warnings on the sides of cigarette packages from the surgeon general about the effects of smoking. But what the government cannot do is "conscript" the companies "into an anti-smoking brigade," noted First Amendment lawyer Floyd Abrams told the judge. The judge questioned Stern about why the images did not amount to advocacy. "What do you say is the line" between advocacy and fact? he asked Stern. "This is not an ordinary product" and the images coupled with written warnings are designed to communicate the dangers to the public — including youngsters as well as adults, Stern replied."
The Rest of the Story
You can see why I argued yesterday that the amicus brief submitted by the Campaign for Tobacco-Free Kids and other anti-smoking groups hurts the government's case. In the hearing, government lawyer Mark Stern was very careful to insist that the purpose of the graphic warning labels is to "communicate the dangers to the public." He apparently argued that the graphic nature of the warnings is necessary in order to effectively communicate the dangers, as evidence shows that the current warnings are not effectively doing so.
In contrast, the amicus brief argues that the purpose of the graphic warnings is to send an anti-smoking message, encouraging smokers to quit by referring them to a telephonic counseling service, which the groups assert has proven effective in promoting smoking cessation.
Now, the FDA is in the awkward position of having to counter the amicus brief and convince the judge that the reasons for the graphic warning labels set forward in the brief by the anti-smoking groups are not the real reasons that the FDA has proposed these warnings.
While it is true that tobacco is not an ordinary product and that the type of warning that might be sufficient for a typical consumer product may not be effective for cigarettes, this would still not seem to explain why the 1-800-QUIT-NOW message needs to be included on the label. To me, the inclusion of that requirement is the chief legal problem with the proposed labels, as it appears difficult to assert that the inclusion of the smoking cessation number is intended and necessary to effectively convey a health warning, rather than intended to promote smoking cessation and help smokers quit by referring them for telephonic counseling.
According to the AP, Judge Leon indicated that he hopes to issue a ruling by the end of October.
Sunday, September 25, 2011
Amicus Brief Submitted by Anti-Smoking Groups Undermines Case for Graphic Cigarette Warning Labels
A consortium of anti-smoking and health groups - including the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society, American Lung Association, American Medical Association, and the American Academy of Pediatrics - has submitted an amicus brief with the D.C. District Court to support the FDA's proposed graphic cigarette warning labels, which have been challenged by R.J. Reynolds, Lorillard, and several smaller tobacco companies.
The brief begins by making several strong points. First, it establishes that warning consumers about the health effects of smoking is a legitimate government interest. Second, it establishes that the current warning labels are insufficient for this purpose (there is abundant evidence to support this contention). Third, it provides evidence that the revised, graphic warning labels represent an improvement and that consumers are more likely to pay attention to them.
The Rest of the Story
At this point, however, the brief makes a surprising blunder. Rather than sticking to the argument that the revised warning labels will be more effective by virtue of more effectively delivering information about the adverse health effects of cigarette smoking, the brief essentially shows its hand of cards: it puts forward the argument that including the national quitline number on the cigarette pack will encourage individuals to quit smoking and help them quit by offering them assistance to do so about which they would not otherwise have known.
The brief argues: "Finally, there is also strong scientific evidence demonstrating the value of including the national quitline number, 1-800-QUIT-NOW, in the graphic warnings to inform consumers about the availability of assistance if they want to quit. As the Institute of Medicine found, quitlines have proven “effective … in helping individuals to stop smoking”—increasing smoking abstinence by as much as 30 to 50 percent. Id. at 237. Based on a careful review of the evidence, the U.S. Public Health Service similarly concluded that smokers who use telephone quitlines are significantly more successful at quitting than those who get little or no counseling. U.S. Pub. Health Serv., Clinical Practice Guidelines, Treating Tobacco Use and Dependence: 2008 Update 91-92 (2008).14 The Public Health Service’s guidelines accordingly recommend that “clinicians and health care delivery systems should both ensure patient access to quitlines and promote quitline use.” Id. at vii. These conclusions are consistent with well-established evidence confirming that by providing a direct and immediate cue for action, quitlines significantly increase the likelihood of changes in behavior. See, e.g., David B. Abrams, et al., Boosting Population Quits Through Evidence-Based Cessation Treatment and Policy, 38 Am J. Prev. Med. Supp. S351-363 (2010)."
This argument goes beyond the need to improve the warning message to make it more effective. First, it speaks to a desire not only to warn people about the health effects of smoking, but to encourage then to quit (beyond any desire to quit that might be associated with knowledge of health effects). Second, it demonstrates that the purpose of the revised warning labels is not merely to communicate health information more effectively, but to serve as an anti-smoking advertisement that promotes smoking cessation. Third, the argument acknowledges that an additional purpose of the warning label, beyond informing consumers about the health effects of the product, is to make them aware of a particular smoking cessation quitline service: in essence, to refer them for telephonic smoking cessation counseling. The brief essentially admits that a major purpose of the new warning labels is to "ensure patient access to quitlines and promote quitline use." The warning label is intended to serve as a "direct and immediate cue for action."
These purposes go far beyond the legitimate government interest in effectively communicating to the public a warning about the health effects of cigarette smoking. In the exact words of the interveners, a major purpose of the revised warning labels is to provide an anti-smoking advertisement that will promote smoking cessation by referring potential customers to a smoking cessation hotline number that will provide telephonic counseling as a direct and immediate intervention to try to get the customer to quit smoking.
It is not difficult to see that forcing a tobacco company to put an advertisement on its cigarette package which goes so far as referring a potential customer for a telephonic counseling intervention as a direct intervention to get the customer to discontinue the use of that product goes far beyond the permissible actions of the government under the First Amendment, even as accepted in Commonwealth Brands, Inc. v. United States (678 F. Supp. 2d 512, 528-32 [2010]). The district court in that case merely upheld the legitimacy of the government's interest in improving warnings in order to "convey relevant information in an effective way" (678 F. Supp. 2d at 530-31). However, provision of a referral for telephonic counseling to encourage discontinuation of the use of the product seems far beyond the conveying of "relevant information" to improve the effectiveness of the health warning.
This seems to be a rather strange situation where an intervener's amicus brief actually appears to help the other side. In this case, the anti-smoking groups' brief aids the plaintiffs by helping to establish that the purpose of the revised warning labels goes far beyond the desire to simply improve the effectiveness of the conveying of relevant health information to the consumer. If anything, the brief helps establish that the true underlying motive behind the revised warning labels is to achieve a large-scale, telephonic counseling intervention on cigarette purchasers by using the cigarette pack as a billboard to advertise, promote cessation, and refer the smoker for a telephonic counseling intervention.
To be clear, I am not in any way criticizing the intervention itself or the desire of these anti-smoking groups to aim to reduce smoking prevalence by using the cigarette pack as a form of an anti-smoking advertisement with a direct referral to the smoking cessation hotline. In fact, I applaud them for suggesting such an intervention. The problem, however, is that the intervention is almost certainly not constitutional, as it appears to violate the tobacco companies' free speech rights by compelling them to use their own cigarette packages as a referral system to initiate a process with each customer that is designed to ultimately lead to discontinuation of product use.
That is going to be a tall order for the FDA to defend. And ironically, I think this amicus brief actually makes it more likely that the judge will grant the plaintiff's request for a preliminary injunction.
The brief begins by making several strong points. First, it establishes that warning consumers about the health effects of smoking is a legitimate government interest. Second, it establishes that the current warning labels are insufficient for this purpose (there is abundant evidence to support this contention). Third, it provides evidence that the revised, graphic warning labels represent an improvement and that consumers are more likely to pay attention to them.
The Rest of the Story
At this point, however, the brief makes a surprising blunder. Rather than sticking to the argument that the revised warning labels will be more effective by virtue of more effectively delivering information about the adverse health effects of cigarette smoking, the brief essentially shows its hand of cards: it puts forward the argument that including the national quitline number on the cigarette pack will encourage individuals to quit smoking and help them quit by offering them assistance to do so about which they would not otherwise have known.
The brief argues: "Finally, there is also strong scientific evidence demonstrating the value of including the national quitline number, 1-800-QUIT-NOW, in the graphic warnings to inform consumers about the availability of assistance if they want to quit. As the Institute of Medicine found, quitlines have proven “effective … in helping individuals to stop smoking”—increasing smoking abstinence by as much as 30 to 50 percent. Id. at 237. Based on a careful review of the evidence, the U.S. Public Health Service similarly concluded that smokers who use telephone quitlines are significantly more successful at quitting than those who get little or no counseling. U.S. Pub. Health Serv., Clinical Practice Guidelines, Treating Tobacco Use and Dependence: 2008 Update 91-92 (2008).14 The Public Health Service’s guidelines accordingly recommend that “clinicians and health care delivery systems should both ensure patient access to quitlines and promote quitline use.” Id. at vii. These conclusions are consistent with well-established evidence confirming that by providing a direct and immediate cue for action, quitlines significantly increase the likelihood of changes in behavior. See, e.g., David B. Abrams, et al., Boosting Population Quits Through Evidence-Based Cessation Treatment and Policy, 38 Am J. Prev. Med. Supp. S351-363 (2010)."
This argument goes beyond the need to improve the warning message to make it more effective. First, it speaks to a desire not only to warn people about the health effects of smoking, but to encourage then to quit (beyond any desire to quit that might be associated with knowledge of health effects). Second, it demonstrates that the purpose of the revised warning labels is not merely to communicate health information more effectively, but to serve as an anti-smoking advertisement that promotes smoking cessation. Third, the argument acknowledges that an additional purpose of the warning label, beyond informing consumers about the health effects of the product, is to make them aware of a particular smoking cessation quitline service: in essence, to refer them for telephonic smoking cessation counseling. The brief essentially admits that a major purpose of the new warning labels is to "ensure patient access to quitlines and promote quitline use." The warning label is intended to serve as a "direct and immediate cue for action."
These purposes go far beyond the legitimate government interest in effectively communicating to the public a warning about the health effects of cigarette smoking. In the exact words of the interveners, a major purpose of the revised warning labels is to provide an anti-smoking advertisement that will promote smoking cessation by referring potential customers to a smoking cessation hotline number that will provide telephonic counseling as a direct and immediate intervention to try to get the customer to quit smoking.
It is not difficult to see that forcing a tobacco company to put an advertisement on its cigarette package which goes so far as referring a potential customer for a telephonic counseling intervention as a direct intervention to get the customer to discontinue the use of that product goes far beyond the permissible actions of the government under the First Amendment, even as accepted in Commonwealth Brands, Inc. v. United States (678 F. Supp. 2d 512, 528-32 [2010]). The district court in that case merely upheld the legitimacy of the government's interest in improving warnings in order to "convey relevant information in an effective way" (678 F. Supp. 2d at 530-31). However, provision of a referral for telephonic counseling to encourage discontinuation of the use of the product seems far beyond the conveying of "relevant information" to improve the effectiveness of the health warning.
This seems to be a rather strange situation where an intervener's amicus brief actually appears to help the other side. In this case, the anti-smoking groups' brief aids the plaintiffs by helping to establish that the purpose of the revised warning labels goes far beyond the desire to simply improve the effectiveness of the conveying of relevant health information to the consumer. If anything, the brief helps establish that the true underlying motive behind the revised warning labels is to achieve a large-scale, telephonic counseling intervention on cigarette purchasers by using the cigarette pack as a billboard to advertise, promote cessation, and refer the smoker for a telephonic counseling intervention.
To be clear, I am not in any way criticizing the intervention itself or the desire of these anti-smoking groups to aim to reduce smoking prevalence by using the cigarette pack as a form of an anti-smoking advertisement with a direct referral to the smoking cessation hotline. In fact, I applaud them for suggesting such an intervention. The problem, however, is that the intervention is almost certainly not constitutional, as it appears to violate the tobacco companies' free speech rights by compelling them to use their own cigarette packages as a referral system to initiate a process with each customer that is designed to ultimately lead to discontinuation of product use.
That is going to be a tall order for the FDA to defend. And ironically, I think this amicus brief actually makes it more likely that the judge will grant the plaintiff's request for a preliminary injunction.
Tuesday, September 20, 2011
Two Advertising Industry Groups Join Lawsuit Against FDA's Graphic Cigarette Warning Requirement
Two advertising industry groups have filed amicus briefs with the D.C. District Court, seeking to join the lawsuit by several tobacco companies, which seek an injunction against the FDA's proposal to require graphic warning labels on cigarette packages.
According to an article in the Richmond Times-Dispatch: "'The new cigarette warnings are expressly designed to be propagandistic rather than informative,' wrote the groups who represent hundreds of U.S. companies and thousands of advertising professionals. 'If the government can deputize tobacco companies through their product packaging and advertisements to deliver its message, there is no reason it could not do so for other things — and history shows it will not hesitate to do so.'"
The Rest of the Story
The advertising groups' comments mirror my own observations about the case. The central question is whether the "warning labels" are simply health warnings or whether they are actually advertisements that directly discourage product purchase. While the government has a legitimate interest in warning consumers about the health hazards of consumer products, it would be a violation of free speech rights to require those companies to go beyond warning labels and actively and directly discourage product purchase on the product labels.
The advertising groups raise this legitimate question: if the court rules that the FDA is justified in requiring anti-smoking advertisements on cigarette packages, then doesn't such a decision open the door to a floodgate of state actions to require all sorts of anti-product advertising on consumer product labels?
For example, could the New York City Health Department not then require that McDonalds display prominent anti-obesity posters at point of purchase of Big Macs, with gross pictures of fat-laden arteries and a message urging consumers not to consume this fat-laden product?
Could the Boston Public Health Commission not require that coffee containers include a graphic picture of a person suffering a cardiac arrhythmia, with a warning discouraging consumers from drinking coffee out of fear of suffering such an arrhythmia?
Clearly, the court must preserve the demarcation between a legitimate health warning message designed to inform consumers of non-controversial, factual information and persuasive advertising that goes beyond a mere warning message and directly discourages purchase of the product.
I think the FDA is going to have a difficult time convincing the court that graphic ads which display a stop-smoking quitline number are merely health warning messages, and that they do not cross the line into being persuasive advertisements intended to directly discourage the use of the product by consumers.
According to an article in the Richmond Times-Dispatch: "'The new cigarette warnings are expressly designed to be propagandistic rather than informative,' wrote the groups who represent hundreds of U.S. companies and thousands of advertising professionals. 'If the government can deputize tobacco companies through their product packaging and advertisements to deliver its message, there is no reason it could not do so for other things — and history shows it will not hesitate to do so.'"
The Rest of the Story
The advertising groups' comments mirror my own observations about the case. The central question is whether the "warning labels" are simply health warnings or whether they are actually advertisements that directly discourage product purchase. While the government has a legitimate interest in warning consumers about the health hazards of consumer products, it would be a violation of free speech rights to require those companies to go beyond warning labels and actively and directly discourage product purchase on the product labels.
The advertising groups raise this legitimate question: if the court rules that the FDA is justified in requiring anti-smoking advertisements on cigarette packages, then doesn't such a decision open the door to a floodgate of state actions to require all sorts of anti-product advertising on consumer product labels?
For example, could the New York City Health Department not then require that McDonalds display prominent anti-obesity posters at point of purchase of Big Macs, with gross pictures of fat-laden arteries and a message urging consumers not to consume this fat-laden product?
Could the Boston Public Health Commission not require that coffee containers include a graphic picture of a person suffering a cardiac arrhythmia, with a warning discouraging consumers from drinking coffee out of fear of suffering such an arrhythmia?
Clearly, the court must preserve the demarcation between a legitimate health warning message designed to inform consumers of non-controversial, factual information and persuasive advertising that goes beyond a mere warning message and directly discourages purchase of the product.
I think the FDA is going to have a difficult time convincing the court that graphic ads which display a stop-smoking quitline number are merely health warning messages, and that they do not cross the line into being persuasive advertisements intended to directly discourage the use of the product by consumers.
Thursday, September 15, 2011
Philadelphia Board of Health Considering Requiring Graphic Anti-Smoking Posters at Point of Tobacco Purchase
According to an article in the Philadelphia Inquirer, the Philadelphia Board of Health is considering an ordinance that would require retail tobacco stores to display graphic anti-smoking advertisements at the point of purchase.
According to the article, one aspect of the advertisements would be a smoking cessation hotline number.
The Rest of the Story
Quite simply, the rest of the story is that the proposed regulation is almost certainly unconstitutional because it violates the free speech rights of retail stores by compelling them to engage in speech with which they disagree and which is intended to directly harm their business by discouraging the purchase of the items in question.
Consider, for example, the requirement that McDonalds post, at the point of purchase, a graphic advertisement that shows a clogged artery with a message discouraging consumers from eating Big Macs. This would clearly be viewed as violating McDonalds' free speech rights.
Similarly, consider a requirement that a store selling light bulbs post an advertisement with a picture of environmental damage urging customers to purchase fluorescent bulbs in order to save energy and lessen the carbon blueprint. This, too, would clearly be unconstitutional.
The government does have a legitimate right to require health warning labels at point of purchase of products that may be hazardous. However, the proposed posters are not merely warning labels. They are advertisements that promote smoking cessation. In other words, they go beyond warning about health consequences and proceed to encourage smokers to quit. They discourage consumers from purchasing the very products that are being sold by the retail stores which are being required to display the posters.
A similar ordinance enacted by the New York City Council was struck down by a federal judge, although the ruling is under appeal.
According to the article, one aspect of the advertisements would be a smoking cessation hotline number.
The Rest of the Story
Quite simply, the rest of the story is that the proposed regulation is almost certainly unconstitutional because it violates the free speech rights of retail stores by compelling them to engage in speech with which they disagree and which is intended to directly harm their business by discouraging the purchase of the items in question.
Consider, for example, the requirement that McDonalds post, at the point of purchase, a graphic advertisement that shows a clogged artery with a message discouraging consumers from eating Big Macs. This would clearly be viewed as violating McDonalds' free speech rights.
Similarly, consider a requirement that a store selling light bulbs post an advertisement with a picture of environmental damage urging customers to purchase fluorescent bulbs in order to save energy and lessen the carbon blueprint. This, too, would clearly be unconstitutional.
The government does have a legitimate right to require health warning labels at point of purchase of products that may be hazardous. However, the proposed posters are not merely warning labels. They are advertisements that promote smoking cessation. In other words, they go beyond warning about health consequences and proceed to encourage smokers to quit. They discourage consumers from purchasing the very products that are being sold by the retail stores which are being required to display the posters.
A similar ordinance enacted by the New York City Council was struck down by a federal judge, although the ruling is under appeal.
Wednesday, September 14, 2011
New Study Finds No Significant Decline in Heart Attack Mortality Rates During the First Year in Six States with New Smoking Bans from 1995 to 2003
Jacob Sullum over at Reason.com's Hit & Run blog has alerted us to a new study, published online ahead of print late last month in the Journal of Community Health, which systematically examines changes in heart attack mortality trends within the first year of implementation of smoking bans in the six states which adopted such bans during the period 1995-2003.
(see: Rodu B, Peiper N, Cole P. Acute myocardial infarction mortality before and after state-wide smoking bans. J Community Health 2011; published online ahead of print on August 30, 2001. doi: 10.1007/s10900-011-9464-5)
The authors examined age-adjusted rates of heart attack mortality during the 3 years before implementation of the smoking ban and during the first year after the smoking ban was implemented. These trends were also compared with those in the 44 other states without smoking bans.
The results were that in four of the six states (California, Utah, Delaware, and South Dakota), the smoking bans were not associated with any significant short-term decline in heart attack mortality. In one of these states - South Dakota - there was an 8.9% increase in heart attack mortality during the first year of the smoking ban which was significantly different from the expected decline of 7.2%.
In two of the states - Florida and New York - there were declines in heart attack mortality during the first smoking ban year that were significantly greater than previous trends. However, these declines were not significantly different from the declines during the same year observed in the other 44 states. Specifically, the heart attack rate in Florida fell by 8.8% in 2004 and in New York it fell by 12% in 2004 (2004 was the year of the smoking ban implementation in both states). However, nationally, the heart attack mortality rate fell by 9.8% during 2004, a value not statistically different from what was observed in New York or Florida).
The paper concludes: "The major finding of this study is that state-wide smoke-free laws resulted in little or no measurable immediate effect on AMI [acute myocardial infarction] death rates."
"Smoke-free ordinances may serve public health objectives by providing non-smokers with indoor environments that are free from irritating and potentially harmful pollutants. However, this study does not provide evidence that these ordinances result in a measurable immediate reduction in AMI mortality of the magnitude claimed by reports based on very small incident numbers."
The Rest of the Story
This study adds to the growing body of literature suggesting that in large, systematic studies of multiple states or large population groups, no significant immediate effects of smoking bans on heart attacks can be detected. Jacob Sullum astutely points out that the studies which have reported dramatic effects of smoking bans on heart attacks have been in small communities, with small sample sizes. The larger studies - conducted on entire states or nations - and the systematic studies which have examined multiple communities or states - have generally failed to find any significant effect.
This phenomenon is a class demonstration of publication bias. When small studies are the ones which tend to report an effect and larger studies do not, one must be very suspicious of publication bias. The reason for this is that small studies which find a negative effect tend not to be published (or communities in which no dramatic decline in heart attacks is observed anecdotally tend not to be chosen for study).
I have argued that there is more than just publication bias occurring here, because even with the small positive studies, many have used inappropriate analyses or incorrectly analyzed or reported their findings. A great case in point is the Ohio Department of Health study released just last week, in which the actual data presented showed no evidence of an effect of the smoking ban on heart attacks, but the report concluded that there was a substantial effect. The discrepancy arose because the report essentially ignored the first six months of baseline data, in which there was a dramatic decline in heart attacks. Thus, the report gives the false impression that the baseline rate of change in heart attacks in Ohio was stable. In this light, the decline in heart attacks after the smoking ban is interpreted as demonstrating a huge effect of the ban. Instead, the truth is that the decline in heart attacks before the ban was actually greater than the decline after the ban.
Jacob Sullum nicely summarizes the phenomenon described above and also calls for a re-examination by the Institute of Medicine of the evidence on this issue: "While a few small jurisdictions, such as Helena, Montana, and Pueblo, Colorado, have seen big drops in AMI rates after implementing their smoking bans, studies that look at multiple jurisdictions and bigger populations (including analyses of nationwide data) find no such effect. Ban boosters focus on the few places that fit the story they want to tell, ignoring the broader picture. This blatant cherry picking has been blessed by the National Academy of Sciences, whose Institute of Medicine issued a 2009 report endorsing the biologically implausible notion that smoking bans have a noticeable impact on heart attack rates within a year or two. In light of the accumulating evidence to the contrary (much of which was available when the report was written), that embarrassing conclusion should be revisited."
(see: Rodu B, Peiper N, Cole P. Acute myocardial infarction mortality before and after state-wide smoking bans. J Community Health 2011; published online ahead of print on August 30, 2001. doi: 10.1007/s10900-011-9464-5)
The authors examined age-adjusted rates of heart attack mortality during the 3 years before implementation of the smoking ban and during the first year after the smoking ban was implemented. These trends were also compared with those in the 44 other states without smoking bans.
The results were that in four of the six states (California, Utah, Delaware, and South Dakota), the smoking bans were not associated with any significant short-term decline in heart attack mortality. In one of these states - South Dakota - there was an 8.9% increase in heart attack mortality during the first year of the smoking ban which was significantly different from the expected decline of 7.2%.
In two of the states - Florida and New York - there were declines in heart attack mortality during the first smoking ban year that were significantly greater than previous trends. However, these declines were not significantly different from the declines during the same year observed in the other 44 states. Specifically, the heart attack rate in Florida fell by 8.8% in 2004 and in New York it fell by 12% in 2004 (2004 was the year of the smoking ban implementation in both states). However, nationally, the heart attack mortality rate fell by 9.8% during 2004, a value not statistically different from what was observed in New York or Florida).
The paper concludes: "The major finding of this study is that state-wide smoke-free laws resulted in little or no measurable immediate effect on AMI [acute myocardial infarction] death rates."
"Smoke-free ordinances may serve public health objectives by providing non-smokers with indoor environments that are free from irritating and potentially harmful pollutants. However, this study does not provide evidence that these ordinances result in a measurable immediate reduction in AMI mortality of the magnitude claimed by reports based on very small incident numbers."
The Rest of the Story
This study adds to the growing body of literature suggesting that in large, systematic studies of multiple states or large population groups, no significant immediate effects of smoking bans on heart attacks can be detected. Jacob Sullum astutely points out that the studies which have reported dramatic effects of smoking bans on heart attacks have been in small communities, with small sample sizes. The larger studies - conducted on entire states or nations - and the systematic studies which have examined multiple communities or states - have generally failed to find any significant effect.
This phenomenon is a class demonstration of publication bias. When small studies are the ones which tend to report an effect and larger studies do not, one must be very suspicious of publication bias. The reason for this is that small studies which find a negative effect tend not to be published (or communities in which no dramatic decline in heart attacks is observed anecdotally tend not to be chosen for study).
I have argued that there is more than just publication bias occurring here, because even with the small positive studies, many have used inappropriate analyses or incorrectly analyzed or reported their findings. A great case in point is the Ohio Department of Health study released just last week, in which the actual data presented showed no evidence of an effect of the smoking ban on heart attacks, but the report concluded that there was a substantial effect. The discrepancy arose because the report essentially ignored the first six months of baseline data, in which there was a dramatic decline in heart attacks. Thus, the report gives the false impression that the baseline rate of change in heart attacks in Ohio was stable. In this light, the decline in heart attacks after the smoking ban is interpreted as demonstrating a huge effect of the ban. Instead, the truth is that the decline in heart attacks before the ban was actually greater than the decline after the ban.
Jacob Sullum nicely summarizes the phenomenon described above and also calls for a re-examination by the Institute of Medicine of the evidence on this issue: "While a few small jurisdictions, such as Helena, Montana, and Pueblo, Colorado, have seen big drops in AMI rates after implementing their smoking bans, studies that look at multiple jurisdictions and bigger populations (including analyses of nationwide data) find no such effect. Ban boosters focus on the few places that fit the story they want to tell, ignoring the broader picture. This blatant cherry picking has been blessed by the National Academy of Sciences, whose Institute of Medicine issued a 2009 report endorsing the biologically implausible notion that smoking bans have a noticeable impact on heart attack rates within a year or two. In light of the accumulating evidence to the contrary (much of which was available when the report was written), that embarrassing conclusion should be revisited."
Tuesday, September 13, 2011
Pasco County Considering Not Hiring Teachers Who Smoke
According to an article in the St. Petersburg Times, the Pasco County (Florida) school board is considering not hiring teachers who smoke. At present, the county refuses to hire school food service workers who smoke. The policy being discussed would extend that restriction to all school district employees.
According to the article, a major reason for the proposed policy is to prevent sending a mixed message about smoking to students. The article quotes a school board member as stating: "We are sending a mixed message when we tell students not to smoke then we allow smoking for teachers."
The policy would apply only to new hires, not to existing employees.
The Rest of the Story
If the school board member really believes that her argument justifies a ban on hiring smokers in the school system, then would she not also have to support a new policy that precludes the hiring of people who drink alcohol, use swear words, or have sex?
After all, students are sent a message that they should not smoke, use alcohol, or swear, and younger students are sent a message that they should not have sex. So to avoid sending a mixed message to students, would it not be important to preclude teachers who smoke, drink, swear, or have sex? You might as well convert the Pasco County public school system into a convent.
I would also point out that if the justification for this proposed policy is to prevent sending a mixed message, then shouldn't the policy apply both to current and new employees? How does a new employee smoking send a mixed message to students, while a current employee smoking does not?
It must be recognized that this policy would result in a substantial problem for many teachers in the County to find employment. It would affect a large number of individuals, as the school system is quite large. There are about 65,000 students, 13 high schools, 15 middle schools, and 45 elementary schools.
It is also important to point out that the policy would result in a decrease in the quality of the teaching staff at these schools. According to the article, 27% of district employees smoke. To reduce the pool of applicants by throwing out 27% of them right from the start is certainly going to result in the inability to hire the best candidates for the job.
Fortunately (and surprisingly), the tobacco prevention program at the Pasco County Health Department appears to have an enlightened and appropriate attitude about the proposed policy: "Lisa Sloan, a tobacco prevention specialist with the Pasco County Health Department, told the board that targeting the workplace rather than employee hiring would likely have more widespread results. It's also easier to regulate what people do at district locations rather than worry about what they do elsewhere, she added. She said that about 27 percent of district employees smoke, and that a new policy supported with health services could help reduce those numbers. Sloan recommended a go-slow approach, to win the widest backing possible.'Smokers are addicted. This is very uncomfortable,' she said. 'They don't like restrictions and they certainly don't like surprises.'"
I agree, and congratulate the Pasco County Health Department for dealing with the issue of employee smoking in the appropriate way. Employment discrimination is not justified, even if it would reduce health insurance costs or improve employee health.
According to the article, a major reason for the proposed policy is to prevent sending a mixed message about smoking to students. The article quotes a school board member as stating: "We are sending a mixed message when we tell students not to smoke then we allow smoking for teachers."
The policy would apply only to new hires, not to existing employees.
The Rest of the Story
If the school board member really believes that her argument justifies a ban on hiring smokers in the school system, then would she not also have to support a new policy that precludes the hiring of people who drink alcohol, use swear words, or have sex?
After all, students are sent a message that they should not smoke, use alcohol, or swear, and younger students are sent a message that they should not have sex. So to avoid sending a mixed message to students, would it not be important to preclude teachers who smoke, drink, swear, or have sex? You might as well convert the Pasco County public school system into a convent.
I would also point out that if the justification for this proposed policy is to prevent sending a mixed message, then shouldn't the policy apply both to current and new employees? How does a new employee smoking send a mixed message to students, while a current employee smoking does not?
It must be recognized that this policy would result in a substantial problem for many teachers in the County to find employment. It would affect a large number of individuals, as the school system is quite large. There are about 65,000 students, 13 high schools, 15 middle schools, and 45 elementary schools.
It is also important to point out that the policy would result in a decrease in the quality of the teaching staff at these schools. According to the article, 27% of district employees smoke. To reduce the pool of applicants by throwing out 27% of them right from the start is certainly going to result in the inability to hire the best candidates for the job.
Fortunately (and surprisingly), the tobacco prevention program at the Pasco County Health Department appears to have an enlightened and appropriate attitude about the proposed policy: "Lisa Sloan, a tobacco prevention specialist with the Pasco County Health Department, told the board that targeting the workplace rather than employee hiring would likely have more widespread results. It's also easier to regulate what people do at district locations rather than worry about what they do elsewhere, she added. She said that about 27 percent of district employees smoke, and that a new policy supported with health services could help reduce those numbers. Sloan recommended a go-slow approach, to win the widest backing possible.'Smokers are addicted. This is very uncomfortable,' she said. 'They don't like restrictions and they certainly don't like surprises.'"
I agree, and congratulate the Pasco County Health Department for dealing with the issue of employee smoking in the appropriate way. Employment discrimination is not justified, even if it would reduce health insurance costs or improve employee health.
Monday, September 12, 2011
The FDA's Harmful Constituents in Cigarettes List: A Bureaucratic Waste of Time
The FDA's Center for Tobacco Products, as part of its new authority under the Family Smoking Prevention and Tobacco Control Act, has decided to try to protect the public's health by compiling a list of harmful and potentially harmful constituents in cigarettes and cigarette smoke (as well as other tobacco products). The Agency is seeking public comment to help prepare this list of constituents which are inhaled and which cause direct or indirect harm to cigarette users.
The Rest of the Story
In my opinion, this exercise is a pointless waste of time and resources. It would be useful only if the FDA could do something meaningful with the list. But there really is nothing that the Agency can do with the list that is permissible under the law and that would protect the public's health by making cigarettes safer.
The public needs to understand that there are between 10,000 and 100,000 chemicals in cigarette smoke, and that only about 4,000 to 6,000 of these chemical constituents are known. The majority of the constituents in tobacco smoke are a mystery. Moreover, we do not know exactly which constituents, at what levels, and in what combination, are responsible for each of the disease caused by tobacco smoke exposure. Thus, the reduction or removal of specific constituents in tobacco smoke is essentially pointless, as it will not ensure any reduction in risk.
A great example of this is the Winston cigarette, which has removed all additives and consists only of "pure" tobacco. Given the elimination of all additives, one would think that the anti-smoking groups would have congratulated R.J. Reynolds for having produced a safer cigarette. Instead, the anti-smoking groups attacked Reynolds for advertising that Winston cigarettes are additive-free, and forced the company to put a disclaimer on its packages and advertisements for Winston declaring that "no additives does not mean a safer cigarette."
Clearly, the anti-smoking groups understand that even the removal of all additives from cigarettes does not in any way imply that the resulting product is safer.
Nevertheless, the anti-smoking groups, and apparently the FDA as well, would have us believe that by limiting certain constituents - like nitrosamines - in cigarettes, the product will be made safer. Some - like the Campaign for Tobacco-Free Kids - have stated to the public that cigarettes with lower nitrosamines would be safer.
To my mind, this is fraudulent deception. It's no different from what the tobacco companies did regarding low-tar cigarettes or no-additive cigarettes, and it is precisely what they were found guilty of in federal court when Judge Kessler issued her scathing opinion.
But in 2011, it is the anti-smoking groups and the government which are perpetuating the very myths that the DOJ lawsuit aimed to dispel. And most ironically, it is Philip Morris - a defendant in the DOJ lawsuit - which is the only group to tell it like it is and provide appropriate advice to the public: If you are concerned about your health, says Philip Morris, then quit smoking.
Not so, according to the anti-smoking groups. The implication of the Campaign for Tobacco-Free Kids' public statements is that it is only a matter of time before the FDA issues regulations that will mandate changes in cigarettes to make them safer. The Campaign's de facto advice to smokers: don't quit now, because if you wait a little bit, the FDA will be mandating a safer cigarette.
The rest of the story is that nitrosamines are only one of more than 40 recognized carcinogens in tobacco smoke. Thus, lowering levels of nitrosamines is not necessarily going to lower cancer risk. It also depends on what happens to the other 39. And it turns out that the most common methods used to reduce nitrosamines in cigarettes result in an increase in at least some of the other carcinogens in the cigarette. Moreover, we simply don't know which carcinogens, at what amounts, and in what combination, are responsible for the carcinogenic effects of cigarettes. Nor do we have biomarkers that accurately predict human risk. It would take a long-term epidemiologic study to determine whether mandating reduced TSNA levels in cigarettes would result in a safer product.
There is actually scientific plausibility behind the notion that mandating lower TSNA cigarettes could result in a more hazardous, not a less hazardous product. Such a mandate would almost certainly result in higher use of flue-cured, rather than burley tobacco in cigarettes because burley tobacco produces higher TSNA levels. Thus, such a mandate by the FDA would cause tobacco manufacturers to shift towards higher amounts of flue-cured tobacco.
However, there is scientific evidence that flue-cured tobacco yields higher levels of benzo[a]pyrene and tar than burley tobacco. Since tar and benzo[a]pyrene are associated with cancer risk, it is at least plausible that an FDA directive to reduce TSNA levels would increase the national burden of cancer.
For these reasons, compiling a list of the hazardous components in cigarette smoke is not only an exercise in futility that wastes time and resources, but it may also be providing a false sense of "security" to the public. Even if a large number of the known toxins in cigarette smoke were removed, there would be no guarantee that the resulting product would be any safer. But the FDA's regulation of cigarettes, and its emphasis on the "hazardous ingredient list" undermines the public's appreciation of the dangers of cigarette smoking and the complete lack of understanding of what is contained in cigarette smoke and how each of the tens of thousands of constituents relates to human health. It presents a false sense to the public that by virtue of FDA regulation, cigarettes are somehow going to be safer. This undermines decades of education about the harmful nature of cigarette smoking, and in my opinion, does more damage than good.
The Rest of the Story
In my opinion, this exercise is a pointless waste of time and resources. It would be useful only if the FDA could do something meaningful with the list. But there really is nothing that the Agency can do with the list that is permissible under the law and that would protect the public's health by making cigarettes safer.
The public needs to understand that there are between 10,000 and 100,000 chemicals in cigarette smoke, and that only about 4,000 to 6,000 of these chemical constituents are known. The majority of the constituents in tobacco smoke are a mystery. Moreover, we do not know exactly which constituents, at what levels, and in what combination, are responsible for each of the disease caused by tobacco smoke exposure. Thus, the reduction or removal of specific constituents in tobacco smoke is essentially pointless, as it will not ensure any reduction in risk.
A great example of this is the Winston cigarette, which has removed all additives and consists only of "pure" tobacco. Given the elimination of all additives, one would think that the anti-smoking groups would have congratulated R.J. Reynolds for having produced a safer cigarette. Instead, the anti-smoking groups attacked Reynolds for advertising that Winston cigarettes are additive-free, and forced the company to put a disclaimer on its packages and advertisements for Winston declaring that "no additives does not mean a safer cigarette."
Clearly, the anti-smoking groups understand that even the removal of all additives from cigarettes does not in any way imply that the resulting product is safer.
Nevertheless, the anti-smoking groups, and apparently the FDA as well, would have us believe that by limiting certain constituents - like nitrosamines - in cigarettes, the product will be made safer. Some - like the Campaign for Tobacco-Free Kids - have stated to the public that cigarettes with lower nitrosamines would be safer.
To my mind, this is fraudulent deception. It's no different from what the tobacco companies did regarding low-tar cigarettes or no-additive cigarettes, and it is precisely what they were found guilty of in federal court when Judge Kessler issued her scathing opinion.
But in 2011, it is the anti-smoking groups and the government which are perpetuating the very myths that the DOJ lawsuit aimed to dispel. And most ironically, it is Philip Morris - a defendant in the DOJ lawsuit - which is the only group to tell it like it is and provide appropriate advice to the public: If you are concerned about your health, says Philip Morris, then quit smoking.
Not so, according to the anti-smoking groups. The implication of the Campaign for Tobacco-Free Kids' public statements is that it is only a matter of time before the FDA issues regulations that will mandate changes in cigarettes to make them safer. The Campaign's de facto advice to smokers: don't quit now, because if you wait a little bit, the FDA will be mandating a safer cigarette.
The rest of the story is that nitrosamines are only one of more than 40 recognized carcinogens in tobacco smoke. Thus, lowering levels of nitrosamines is not necessarily going to lower cancer risk. It also depends on what happens to the other 39. And it turns out that the most common methods used to reduce nitrosamines in cigarettes result in an increase in at least some of the other carcinogens in the cigarette. Moreover, we simply don't know which carcinogens, at what amounts, and in what combination, are responsible for the carcinogenic effects of cigarettes. Nor do we have biomarkers that accurately predict human risk. It would take a long-term epidemiologic study to determine whether mandating reduced TSNA levels in cigarettes would result in a safer product.
There is actually scientific plausibility behind the notion that mandating lower TSNA cigarettes could result in a more hazardous, not a less hazardous product. Such a mandate would almost certainly result in higher use of flue-cured, rather than burley tobacco in cigarettes because burley tobacco produces higher TSNA levels. Thus, such a mandate by the FDA would cause tobacco manufacturers to shift towards higher amounts of flue-cured tobacco.
However, there is scientific evidence that flue-cured tobacco yields higher levels of benzo[a]pyrene and tar than burley tobacco. Since tar and benzo[a]pyrene are associated with cancer risk, it is at least plausible that an FDA directive to reduce TSNA levels would increase the national burden of cancer.
For these reasons, compiling a list of the hazardous components in cigarette smoke is not only an exercise in futility that wastes time and resources, but it may also be providing a false sense of "security" to the public. Even if a large number of the known toxins in cigarette smoke were removed, there would be no guarantee that the resulting product would be any safer. But the FDA's regulation of cigarettes, and its emphasis on the "hazardous ingredient list" undermines the public's appreciation of the dangers of cigarette smoking and the complete lack of understanding of what is contained in cigarette smoke and how each of the tens of thousands of constituents relates to human health. It presents a false sense to the public that by virtue of FDA regulation, cigarettes are somehow going to be safer. This undermines decades of education about the harmful nature of cigarette smoking, and in my opinion, does more damage than good.
Friday, September 09, 2011
Canadian National Conference on Tobacco or Health Throws Scientific Integrity Out the Window; Accepts Major Sponsorship from Pfizer
The 7th annual National Conference on Tobacco or Health will be held this November in Toronto.
A leading sponsor of the conference is Pfizer, manufacturer of Chantix, a smoking cessation drug which has come under fire because of its association with suicide, violent behavior, and heart attacks.
One of the major topics of discussion at the conference will be methods for smoking cessation. For example, two of the sessions listed on the preliminary program are "Comprehensive Approaches to Tobacco Cessation and Support in Health Care and Community Settings" and "Cessation: Tried, Tested and Now."
The Rest of the Story
The National Conference on Tobacco or Health has sacrificed its scientific integrity for money. By accepting this sponsorship from Pfizer, the conference has assured that no objective and unconflicted discussion of the effective strategies for smoking cessation can take place.
For example, how can an objective discussion of the risks of Chantix use possibly occur at the conference? To be sure, the conference is not going to highlight or even accept any talks on the deaths caused by Chantix. Doing so would risk future sponsorship.
How can one expect that the conference would include in the program a talk on the hundreds of cases of violent and often fatal adverse effects that have been reported with Chantix when the drug's manufacturer is a major sponsor of the conference?
The pharmaceutical sponsorship creates, by its very existence, an unavoidable bias that precludes a truly objective consideration of any scientific issue that may have significant implications for the profitability of smoking cessation drugs, and therefore, for their manufacturers who are conference sponsors. This bias does not necessarily have to be conscious. In fact, the most concerning bias is that which could arise subconsciously by virtue of the sponsorship of the conference by Big Pharma.
The rest of the story is that the funding by Pfizer creates a substantial conflict of interest that precludes the objective consideration of many important scientific issues; in particular, the role of smoking cessation drugs as part of national tobacco control strategies.
The International Society for the Prevention of Tobacco Induced Diseases (ISPTID) is one of the few national or international organizations that, despite past acceptance of sponsorships from Big Pharma, has changed and found other ways to support its annual meetings. I understand the difficulty of finding funding to support these large meetings. But it is possible to find alternative sources of funding. Failing to do so compromises the scientific integrity of these conferences.
A leading sponsor of the conference is Pfizer, manufacturer of Chantix, a smoking cessation drug which has come under fire because of its association with suicide, violent behavior, and heart attacks.
One of the major topics of discussion at the conference will be methods for smoking cessation. For example, two of the sessions listed on the preliminary program are "Comprehensive Approaches to Tobacco Cessation and Support in Health Care and Community Settings" and "Cessation: Tried, Tested and Now."
The Rest of the Story
The National Conference on Tobacco or Health has sacrificed its scientific integrity for money. By accepting this sponsorship from Pfizer, the conference has assured that no objective and unconflicted discussion of the effective strategies for smoking cessation can take place.
For example, how can an objective discussion of the risks of Chantix use possibly occur at the conference? To be sure, the conference is not going to highlight or even accept any talks on the deaths caused by Chantix. Doing so would risk future sponsorship.
How can one expect that the conference would include in the program a talk on the hundreds of cases of violent and often fatal adverse effects that have been reported with Chantix when the drug's manufacturer is a major sponsor of the conference?
The pharmaceutical sponsorship creates, by its very existence, an unavoidable bias that precludes a truly objective consideration of any scientific issue that may have significant implications for the profitability of smoking cessation drugs, and therefore, for their manufacturers who are conference sponsors. This bias does not necessarily have to be conscious. In fact, the most concerning bias is that which could arise subconsciously by virtue of the sponsorship of the conference by Big Pharma.
The rest of the story is that the funding by Pfizer creates a substantial conflict of interest that precludes the objective consideration of many important scientific issues; in particular, the role of smoking cessation drugs as part of national tobacco control strategies.
The International Society for the Prevention of Tobacco Induced Diseases (ISPTID) is one of the few national or international organizations that, despite past acceptance of sponsorships from Big Pharma, has changed and found other ways to support its annual meetings. I understand the difficulty of finding funding to support these large meetings. But it is possible to find alternative sources of funding. Failing to do so compromises the scientific integrity of these conferences.
Thursday, September 08, 2011
World Trade Organization Rules U.S. Cigarette Flavoring Ban Discriminatory; Finds U.S. in Violation of Trade Agreements
The World Trade Organization (WTO) has found that the Family Smoking Prevention and Tobacco Control Act's prohibition of flavored cigarettes with an exemption for menthol violates international trade agreements because it arbitrarily (without a health basis) discriminates against imported cigarettes. In particular, the WTO found that the ban on clove cigarettes ("kreteks") unfairly discriminates against imported flavored cigarettes (largely from Indonesia, which filed the complaint) while allowing domestic flavored cigarettes (menthol cigarettes) to remain on the market.
According to an article in the Jakarta Globe: "The Indonesian government has welcomed the World Trade Organization’s ruling against a US ban on the importation of clove cigarettes, calling for shipments to resume. The global trade body ruled on Friday that the United States was imposing discriminatory trade rules in banning the sale of kretek — Indonesian clove cigarettes. Gusmardi Bustami, the director general of international trade at Indonesia’s Trade Ministry, said on Sunday that the ruling made it clear that the US had engaged in trade discrimination. “With this ruling, the US must admit that they were wrong for their discriminatory trade rules. I don’t see any reasons why we can’t resume selling kretek cigarettes to the US,” Gusmardi said."
"The US Food and Drug Administration in September 2009 banned cigarettes with fruit, confectionery or clove flavors, arguing they encouraged young people to smoke. That resulted in a ban of imports of kretek the following year. But menthol cigarettes were not banned, and the Indonesian government said the US was protecting domestic sales of menthol cigarettes and that it intended to keep kretek out of the market. “Our study concludes that clove and menthol are equally harmful to health, therefore, the ban was discriminatory,” Gusmardi said. In its ruling, the WTO panel found that clove and menthol-flavored cigarettes are “like products.” Gusmardi said that kretek is used by fewer than 1 percent of young smokers and accounts for less than 1 percent of total cigarette sales in the US. Meanwhile, menthol was consumed by 43 percent of young smokers and made up almost 25 percent of total cigarettes sold in the country."
The World Trade Organization has asked the U.S. to revise its law so that it comports with international trade policy. If the U.S. does not wish to comply, it still has 60 days to appeal the ruling.
While clove cigarettes are produced almost entirely outside the U.S., essentially all menthol cigarettes are produced domestically.
The Rest of the Story
This ruling confirms my judgment, expressed in a July 22, 2010 post, that the Tobacco Act's flavored cigarette ban violates international trade policy by arbitrarily (without a health basis) treating like products differently -- favoring domestic cigarettes over imported ones. As I wrote at that time: "the Family Smoking Prevention and Tobacco Control Act's ban on flavored cigarettes - including clove cigarettes - but with an exemption for menthol cigarettes does appear to violate international trade agreements. Specifically, it appears to violate Articles 2.1 and 2.2 of the Technical Barriers to Trade Agreement, Article 3.4 of the General Agreement on Tariffs and Trade, and Articles 5.4 and 5.5 of the Agreement on the Application of Sanitary and Phytosanitary Measures."
I summarized the basis for my opinion as follows: "As I have argued extensively, there is no public health or scientific justification for the menthol exemption. It was clearly a political compromise that served purely political purposes. In fact, a number of health groups and policy makers have readily acknowledged that the menthol exemption was inserted for political reasons. I have yet to hear any credible scientific or public health justification for such an exemption (which is perhaps the reason why the U.S. has failed to provide any justification to Indonesia)."
The WTO decision follows the reasoning that I outlined. Clove cigarettes and menthol cigarettes are "like products." They are both flavored cigarettes. However, there is no public health justification for banning clove cigarettes while exempting menthol cigarettes. Since clove cigarettes are almost exclusively imported and menthol cigarettes are almost exclusively produced domestically, the policy represents discrimination which maximizes trade effects.
This ruling exposes the hypocrisy of the national anti-smoking groups and politicians who crafted the Tobacco Act. It also exposes the fact that the Tobacco Act is largely a political show-piece, designed to make it look like anti-smoking groups and politicians are taking on Big Tobacco, when in fact they are protecting the domestic cigarette market.
According to an article in the Jakarta Globe: "The Indonesian government has welcomed the World Trade Organization’s ruling against a US ban on the importation of clove cigarettes, calling for shipments to resume. The global trade body ruled on Friday that the United States was imposing discriminatory trade rules in banning the sale of kretek — Indonesian clove cigarettes. Gusmardi Bustami, the director general of international trade at Indonesia’s Trade Ministry, said on Sunday that the ruling made it clear that the US had engaged in trade discrimination. “With this ruling, the US must admit that they were wrong for their discriminatory trade rules. I don’t see any reasons why we can’t resume selling kretek cigarettes to the US,” Gusmardi said."
"The US Food and Drug Administration in September 2009 banned cigarettes with fruit, confectionery or clove flavors, arguing they encouraged young people to smoke. That resulted in a ban of imports of kretek the following year. But menthol cigarettes were not banned, and the Indonesian government said the US was protecting domestic sales of menthol cigarettes and that it intended to keep kretek out of the market. “Our study concludes that clove and menthol are equally harmful to health, therefore, the ban was discriminatory,” Gusmardi said. In its ruling, the WTO panel found that clove and menthol-flavored cigarettes are “like products.” Gusmardi said that kretek is used by fewer than 1 percent of young smokers and accounts for less than 1 percent of total cigarette sales in the US. Meanwhile, menthol was consumed by 43 percent of young smokers and made up almost 25 percent of total cigarettes sold in the country."
The World Trade Organization has asked the U.S. to revise its law so that it comports with international trade policy. If the U.S. does not wish to comply, it still has 60 days to appeal the ruling.
While clove cigarettes are produced almost entirely outside the U.S., essentially all menthol cigarettes are produced domestically.
The Rest of the Story
This ruling confirms my judgment, expressed in a July 22, 2010 post, that the Tobacco Act's flavored cigarette ban violates international trade policy by arbitrarily (without a health basis) treating like products differently -- favoring domestic cigarettes over imported ones. As I wrote at that time: "the Family Smoking Prevention and Tobacco Control Act's ban on flavored cigarettes - including clove cigarettes - but with an exemption for menthol cigarettes does appear to violate international trade agreements. Specifically, it appears to violate Articles 2.1 and 2.2 of the Technical Barriers to Trade Agreement, Article 3.4 of the General Agreement on Tariffs and Trade, and Articles 5.4 and 5.5 of the Agreement on the Application of Sanitary and Phytosanitary Measures."
I summarized the basis for my opinion as follows: "As I have argued extensively, there is no public health or scientific justification for the menthol exemption. It was clearly a political compromise that served purely political purposes. In fact, a number of health groups and policy makers have readily acknowledged that the menthol exemption was inserted for political reasons. I have yet to hear any credible scientific or public health justification for such an exemption (which is perhaps the reason why the U.S. has failed to provide any justification to Indonesia)."
The WTO decision follows the reasoning that I outlined. Clove cigarettes and menthol cigarettes are "like products." They are both flavored cigarettes. However, there is no public health justification for banning clove cigarettes while exempting menthol cigarettes. Since clove cigarettes are almost exclusively imported and menthol cigarettes are almost exclusively produced domestically, the policy represents discrimination which maximizes trade effects.
This ruling exposes the hypocrisy of the national anti-smoking groups and politicians who crafted the Tobacco Act. It also exposes the fact that the Tobacco Act is largely a political show-piece, designed to make it look like anti-smoking groups and politicians are taking on Big Tobacco, when in fact they are protecting the domestic cigarette market.
Wednesday, September 07, 2011
The Ohio Miracle: How Statistics Can Be Used to Create an Effect that Isn't There
Yesterday, I commented on a new report out of the Ohio Department of Health which concludes that the statewide smoking ban implemented in May 2007 caused a significant decline in heart attacks during the period 2007-2009, based on an analysis of hospital discharge data for the diagnosis of myocardial infarction (heart attack). However, I explained that the actual data do not demonstrate any effect of the smoking ban on heart attacks: the baseline annual rate of decline in heart attacks in Ohio was 4.7%, and the average post-implementation annual rate of decline in heart attacks was 3.6%.
How, then, did the report manage to find "a significant change in age‐adjusted rates of AMI discharges within one month after the enactment of the Smoke‐Free Workplace Act"?
The Rest of the Story
The key to understanding this story is to appreciate the difference between an a priori hypothesis and a post-analysis hypothesis. An a priori hypothesis is a logic-based theory that is developed prior to the analysis and guides the analytic method based on a conceptual model of the expected pattern of the outcome variable over time, and in relation to the intervention being tested. A post-analysis hypothesis is one that develops after the data analysis has been initiated.
In the Ohio report, the study puts forward a clear a priori hypothesis: that the rate of decline in heart attacks accelerated after implementation of the smoking ban. Thus, a linear trend in heart attacks is assumed, which changes after the smoking ban. This is most directly modeled as two lines: one before the ban and one after the ban, with the inflection point (or change in slope) at the point of implementation.
Nowhere does the report hypothesize, based on a conceptual model, that the pattern of heart attacks would follow a polynomial curve, with a huge decline in heart attacks that levels off completely for a period of time and then resumes with another huge decline in heart attacks. There is absolutely no a priori reason to believe that this is the pattern that heart attack trends in Ohio would follow. None of the prior studies on smoking bans on heart attacks has used such a model or detected such a pattern.
Nevertheless, this is the structure that this study imposes on the data.
Now, if one were to simply model the changes in heart attacks in Ohio as two lines, one before and one after the intervention, one would find that the slope of the pre-intervention line exceeds that of the post-intervention line. In other words, heart attacks were declining slightly more rapidly prior to the smoking ban than after the smoking ban, at least during the study period 2005-2009, which are the years used in the Ohio analysis. There is no way to avoid this conclusion if one uses a linear model.
Now consider what happens if you model these same data by forcing a polynomial curve. Because of the shape of the curve, it is going to markedly exaggerate the slope of the declining heart attack trend before the inflection point because there is only one year's worth of data. Thus, the actual data points prior to the intervention are going to be too high and to correct for that, the dummy variable "finds" that the heart attack rates were higher in this pre-intervention period than after the intervention.
One can see this in Figure 1. There is no reason to believe, for example, that the decline in heart attacks from January 1, 2005 to January 1, 2006 was extremely sharp for the first half of the year and decelerated rapidly in the latter half of the year. There is no reason why a linear trend could not be hypothesized to have occurred, especially over such a short period of time when there is seasonal variation in rates. In order to correct for this, the cubic model needs to "artificially" increase the pre-intervention heart attack rate estimates.
This is best seen in Figure 2, where one can see that the observed heart attack rates from January 1, 2005 to June 1, 2005 are completely inconsistent with the model used. In fact, for some reason, the figure does now show the predicted heart attack values for January 1, 2005 to June 1, 2005.
By ignoring the actual sharp decline in heart attacks that occurred from January 1, 2005 to June 1, 2005, the model is able to make it appear that there wasn't much change in the heart attack rate just prior to the smoking ban. Obviously, this is nonsense. In fact, if one believes this modeling of the data, then there was a drastic decline in heart attacks in the early part of 2005 which leveled off in association with the smoking ban implementation.
Despite the precarious nature of the analysis, it doesn't stop the report from going on to estimate the actual number of heart attacks averted and to calculate the dollar savings from those averted heart attacks. This should certainly give the reader pause as to the true intentions and purpose of the report. Is it to find out the truth, or to provide post-hoc justification for the smoking ban?
The rest of the story is that the data tell one story and the report tells quite another. When a linear model doesn't provide the answer one wants, it is just too easy to use more complicated models, for which there is no conceptual basis. If you try enough manipulations, you are always going to be able to show the effect that you want. However, it is the truth that we should be after, not "favorable" evidence.
How, then, did the report manage to find "a significant change in age‐adjusted rates of AMI discharges within one month after the enactment of the Smoke‐Free Workplace Act"?
The Rest of the Story
The key to understanding this story is to appreciate the difference between an a priori hypothesis and a post-analysis hypothesis. An a priori hypothesis is a logic-based theory that is developed prior to the analysis and guides the analytic method based on a conceptual model of the expected pattern of the outcome variable over time, and in relation to the intervention being tested. A post-analysis hypothesis is one that develops after the data analysis has been initiated.
In the Ohio report, the study puts forward a clear a priori hypothesis: that the rate of decline in heart attacks accelerated after implementation of the smoking ban. Thus, a linear trend in heart attacks is assumed, which changes after the smoking ban. This is most directly modeled as two lines: one before the ban and one after the ban, with the inflection point (or change in slope) at the point of implementation.
Nowhere does the report hypothesize, based on a conceptual model, that the pattern of heart attacks would follow a polynomial curve, with a huge decline in heart attacks that levels off completely for a period of time and then resumes with another huge decline in heart attacks. There is absolutely no a priori reason to believe that this is the pattern that heart attack trends in Ohio would follow. None of the prior studies on smoking bans on heart attacks has used such a model or detected such a pattern.
Nevertheless, this is the structure that this study imposes on the data.
Now, if one were to simply model the changes in heart attacks in Ohio as two lines, one before and one after the intervention, one would find that the slope of the pre-intervention line exceeds that of the post-intervention line. In other words, heart attacks were declining slightly more rapidly prior to the smoking ban than after the smoking ban, at least during the study period 2005-2009, which are the years used in the Ohio analysis. There is no way to avoid this conclusion if one uses a linear model.
Now consider what happens if you model these same data by forcing a polynomial curve. Because of the shape of the curve, it is going to markedly exaggerate the slope of the declining heart attack trend before the inflection point because there is only one year's worth of data. Thus, the actual data points prior to the intervention are going to be too high and to correct for that, the dummy variable "finds" that the heart attack rates were higher in this pre-intervention period than after the intervention.
One can see this in Figure 1. There is no reason to believe, for example, that the decline in heart attacks from January 1, 2005 to January 1, 2006 was extremely sharp for the first half of the year and decelerated rapidly in the latter half of the year. There is no reason why a linear trend could not be hypothesized to have occurred, especially over such a short period of time when there is seasonal variation in rates. In order to correct for this, the cubic model needs to "artificially" increase the pre-intervention heart attack rate estimates.
This is best seen in Figure 2, where one can see that the observed heart attack rates from January 1, 2005 to June 1, 2005 are completely inconsistent with the model used. In fact, for some reason, the figure does now show the predicted heart attack values for January 1, 2005 to June 1, 2005.
By ignoring the actual sharp decline in heart attacks that occurred from January 1, 2005 to June 1, 2005, the model is able to make it appear that there wasn't much change in the heart attack rate just prior to the smoking ban. Obviously, this is nonsense. In fact, if one believes this modeling of the data, then there was a drastic decline in heart attacks in the early part of 2005 which leveled off in association with the smoking ban implementation.
Despite the precarious nature of the analysis, it doesn't stop the report from going on to estimate the actual number of heart attacks averted and to calculate the dollar savings from those averted heart attacks. This should certainly give the reader pause as to the true intentions and purpose of the report. Is it to find out the truth, or to provide post-hoc justification for the smoking ban?
The rest of the story is that the data tell one story and the report tells quite another. When a linear model doesn't provide the answer one wants, it is just too easy to use more complicated models, for which there is no conceptual basis. If you try enough manipulations, you are always going to be able to show the effect that you want. However, it is the truth that we should be after, not "favorable" evidence.
Tuesday, September 06, 2011
New Report from Ohio Health Department Concludes that Smoking Ban Reduced Heart Attack Admissions; However, Actual Data Show No Apparent Efffect
A new report out of the Ohio state Department of Health concludes that the statewide smoking ban implemented in May 2007 caused a significant decline in heart attacks during the period 2007-2009, based on an analysis of hospital discharge data for the diagnosis of myocardial infarction (heart attack).
The study compared hospital discharge data on patients with a primary diagnosis of acute myocardial infarction from before to after the state Smoke-Free Workplace Act went into effect. Data were obtained from all hospitals in Ohio for the years 2005 through 2009. Thus, the rate of change in heart attacks could be estimated for the year before the Act and for the first three years following implementation of the Act.
The report concludes: "The analysis determined a significant change in age‐adjusted rates of AMI discharges within one month after the enactment of the Smoke‐Free Workplace Act."
A press release accompanying the report also boasted that: "The analysis of discharge data from Ohio hospitals ... revealed a sharp decline in heart attack rates immediately following implementation of the law."
The conclusion that the smoking ban led to a significant decline in heart attacks was widely disseminated by the media (example 1; example 2; example 3).
The Rest of the Story
Unfortunately, the actual data presented by the report does not support the conclusion that the smoking ban led to an immediate and significant decline in heart attacks in Ohio.
The smoking ban went into effect in December 2006, although rules for implementation were not issued until May 2007. Thus, the ban was implemented starting in December 2006 but was in full effect by May 2007. Therefore, 2007 was the first year in which the ban was in effect. Any change in heart attacks from 2006 to 2007 could potentially be attributed to the smoking ban. The change in heart attacks from 2005 to 2006 represents the baseline trend in heart attacks in Ohio, prior to the smoking ban. The change in heart attacks from 2007 to 2008 and from 2008 to 2009 represents the 2nd and 3rd years of implementation of the ban.
So if the report's conclusion is correct, then the rate of decline in heart attack discharges in Ohio for the years 2006 to 2007, 2007 to 2008, and 2008-2009 should be substantially greater than the rate of decline in heart attacks from 2005 to 2006, prior to the ban. Let's look at the actual data:
The annual declines in the age-adjusted hospital discharge rates for acute myocardial infarction across hospitals in Ohio were as follows:
2006-2007 (baseline): -4.7%
2006-2007 (first year of implementation): -2.7%
2007-2008 (second year of implementation): -2.2%
2008-2009 (third year of implementation): -6.3%
Average annual decline post-implementation: -3.6%
Thus, what the data show is that the baseline annual rate of decline in heart attacks in Ohio was 4.7%, and the average post-implementation annual rate of decline in heart attacks was 3.6%.
In other words, the rate of decline in heart attack discharges in Ohio was greater prior to the smoking ban than it was in the first three years after the smoking ban.
This clearly does not support the conclusion that the smoking ban resulted in a large and immediate decline in heart attack discharges.
If one looks at the data graphically, one can see that there was little change in the heart attack trend in Ohio after the smoking ban. There was a gradual decline that clearly was present prior to the smoking ban went into effect. The rate of decline decreased slightly during the first two years of the ban and then accelerated slightly during the third year of the ban.
How, then, is the report able to come up with a conclusion that the smoking ban led to an immediate and significant decline in heart attacks?
The answer is simple: by using a cubic spline model rather than a simple linear model, which is what the report hypothesizes in its introduction section. The cubic model negates the large decline in heart attacks that was observed during 2005 (see Figure 1 of the report). It essentially "erases" the baseline trend of a substantial decline in heart attacks, zeroing it out so that any decline in heart attacks observed after the intervention will appear greater than prior to the intervention.
Had the report simply drawn two lines, one before and one after the intervention, it would have been forced to conclude that there was no significant change in the rate of decline in heart attacks (or if anything, the rate of decline decreased following the smoking ban).
The most accurate description of the trend in heart attacks in Ohio is that the rate was dropping rapidly prior to the smoking ban and that the rate of decline decelerated slightly during the first two years of smoking ban implementation and then accelerated during the third year. The presence or absence of the smoking ban appears to have nothing to do with the heart attack trend.
Another way in which the report makes it appear that the effect of the smoking ban is greater than actually observed is by plotting the data on a graph that fails to use 0 as the lower end of the y-axis (again, see Figure 1). This is a classic flaw in graph presentation that can deceive viewers into believing that an effect is present when it is not. Graphs should always have 0 as the lower end of the y-axis in order to avoid this problem.
Darrell Huff discusses this method of distorting data presentation in his classic book "How to Lie With Statistics." (see Chapter 5: The Gee-Whiz Graph)
Because the actual data show no significant increase in the rate of decline in heart attacks in Ohio after implementation of the smoking ban, I won't even get into the most important flaw of the analysis, which is the absence of any comparison or control group. Even if heart attacks did decline in Ohio during the past four years or so, one needs to know whether that is unique or whether heart attacks were also declining elsewhere during the past four years. Without any comparison group, it is impossible to make such a determination.
The rest of the story is that this report has manipulated the analysis in order to try to show an effect that is simply not present in the data. This doesn't do anti-smoking advocates any favors. While I agree with the ultimate conclusion of the health department director - that the smoking ban was a highly appropriate intervention that is having a positive health impact on Ohio residents - a large and immediate decline in heart attacks is not part of the reason. By placing such a large emphasis on the need to demonstrate an immediate decline in heart attacks (when it takes many years for secondhand smoke exposure to cause heart disease), and by distorting the science in order to try to show such effects, anti-smoking advocates are actually weakening, not strengthening the argument for workplace smoking bans.
The study compared hospital discharge data on patients with a primary diagnosis of acute myocardial infarction from before to after the state Smoke-Free Workplace Act went into effect. Data were obtained from all hospitals in Ohio for the years 2005 through 2009. Thus, the rate of change in heart attacks could be estimated for the year before the Act and for the first three years following implementation of the Act.
The report concludes: "The analysis determined a significant change in age‐adjusted rates of AMI discharges within one month after the enactment of the Smoke‐Free Workplace Act."
A press release accompanying the report also boasted that: "The analysis of discharge data from Ohio hospitals ... revealed a sharp decline in heart attack rates immediately following implementation of the law."
The conclusion that the smoking ban led to a significant decline in heart attacks was widely disseminated by the media (example 1; example 2; example 3).
The Rest of the Story
Unfortunately, the actual data presented by the report does not support the conclusion that the smoking ban led to an immediate and significant decline in heart attacks in Ohio.
The smoking ban went into effect in December 2006, although rules for implementation were not issued until May 2007. Thus, the ban was implemented starting in December 2006 but was in full effect by May 2007. Therefore, 2007 was the first year in which the ban was in effect. Any change in heart attacks from 2006 to 2007 could potentially be attributed to the smoking ban. The change in heart attacks from 2005 to 2006 represents the baseline trend in heart attacks in Ohio, prior to the smoking ban. The change in heart attacks from 2007 to 2008 and from 2008 to 2009 represents the 2nd and 3rd years of implementation of the ban.
So if the report's conclusion is correct, then the rate of decline in heart attack discharges in Ohio for the years 2006 to 2007, 2007 to 2008, and 2008-2009 should be substantially greater than the rate of decline in heart attacks from 2005 to 2006, prior to the ban. Let's look at the actual data:
The annual declines in the age-adjusted hospital discharge rates for acute myocardial infarction across hospitals in Ohio were as follows:
2006-2007 (baseline): -4.7%
2006-2007 (first year of implementation): -2.7%
2007-2008 (second year of implementation): -2.2%
2008-2009 (third year of implementation): -6.3%
Average annual decline post-implementation: -3.6%
Thus, what the data show is that the baseline annual rate of decline in heart attacks in Ohio was 4.7%, and the average post-implementation annual rate of decline in heart attacks was 3.6%.
In other words, the rate of decline in heart attack discharges in Ohio was greater prior to the smoking ban than it was in the first three years after the smoking ban.
This clearly does not support the conclusion that the smoking ban resulted in a large and immediate decline in heart attack discharges.
If one looks at the data graphically, one can see that there was little change in the heart attack trend in Ohio after the smoking ban. There was a gradual decline that clearly was present prior to the smoking ban went into effect. The rate of decline decreased slightly during the first two years of the ban and then accelerated slightly during the third year of the ban.
How, then, is the report able to come up with a conclusion that the smoking ban led to an immediate and significant decline in heart attacks?
The answer is simple: by using a cubic spline model rather than a simple linear model, which is what the report hypothesizes in its introduction section. The cubic model negates the large decline in heart attacks that was observed during 2005 (see Figure 1 of the report). It essentially "erases" the baseline trend of a substantial decline in heart attacks, zeroing it out so that any decline in heart attacks observed after the intervention will appear greater than prior to the intervention.
Had the report simply drawn two lines, one before and one after the intervention, it would have been forced to conclude that there was no significant change in the rate of decline in heart attacks (or if anything, the rate of decline decreased following the smoking ban).
The most accurate description of the trend in heart attacks in Ohio is that the rate was dropping rapidly prior to the smoking ban and that the rate of decline decelerated slightly during the first two years of smoking ban implementation and then accelerated during the third year. The presence or absence of the smoking ban appears to have nothing to do with the heart attack trend.
Another way in which the report makes it appear that the effect of the smoking ban is greater than actually observed is by plotting the data on a graph that fails to use 0 as the lower end of the y-axis (again, see Figure 1). This is a classic flaw in graph presentation that can deceive viewers into believing that an effect is present when it is not. Graphs should always have 0 as the lower end of the y-axis in order to avoid this problem.
Darrell Huff discusses this method of distorting data presentation in his classic book "How to Lie With Statistics." (see Chapter 5: The Gee-Whiz Graph)
Because the actual data show no significant increase in the rate of decline in heart attacks in Ohio after implementation of the smoking ban, I won't even get into the most important flaw of the analysis, which is the absence of any comparison or control group. Even if heart attacks did decline in Ohio during the past four years or so, one needs to know whether that is unique or whether heart attacks were also declining elsewhere during the past four years. Without any comparison group, it is impossible to make such a determination.
The rest of the story is that this report has manipulated the analysis in order to try to show an effect that is simply not present in the data. This doesn't do anti-smoking advocates any favors. While I agree with the ultimate conclusion of the health department director - that the smoking ban was a highly appropriate intervention that is having a positive health impact on Ohio residents - a large and immediate decline in heart attacks is not part of the reason. By placing such a large emphasis on the need to demonstrate an immediate decline in heart attacks (when it takes many years for secondhand smoke exposure to cause heart disease), and by distorting the science in order to try to show such effects, anti-smoking advocates are actually weakening, not strengthening the argument for workplace smoking bans.
Thursday, September 01, 2011
In Embarrassment for National Anti-Smoking Groups and Politicians, Tobacco Companies Instruct Them on How to Properly Conduct Their Business
In a major embarrassment for the national anti-smoking groups and members of Congress who have painted themselves as wanting to reduce smoking rates, several of the nation's tobacco companies have provided a scathing, yet correct critique of their efforts and insightful recommendations of what they should be doing if they were seriously interested in reducing tobacco use.
When even the tobacco companies criticize you for not doing the right things to reduce tobacco use, it should wake you up, or at least give you pause to consider your actions.
The critique of current anti-smoking efforts comes in the form of the legal brief submitted by Reynolds American, Lorillard, Commonwealth Brands, and Santa Fe Tobacco Company seeking to overturn the graphic warning label requirement.
One of the points made in the brief is that the requirement for large graphic warning labels is not narrowly tailored as it is not the least restrictive policy that would advance the government's interest in warning consumers about the hazards of smoking. Moreover, the tobacco companies argue that there are far more effective ways to reduce smoking than showing smokers gory pictures.
In particular, the tobacco companies put forward two alternative ideas which, unlike the warning labels, are evidence-based and have been shown to substantially reduce smoking rates.
1. The tobacco companies point out that the federal government could require states to spend a significant amount of their Master Settlement Agreement proceeds on tobacco control programs. This requirement could be in the form of tying federal funding to states having allocated a certain proportion of MSA revenue to anti-smoking programs.
The companies write: "The MSA annually provides the States with billions of dollars intended for tobacco control programs. The federal Centers for Disease Control and Prevention (“CDC”) has found that requiring the States to increase the allocation of MSA funds to youth tobacco prevention—from the meager 3.5% recently employed to the still-modest CDC-recommended 15%—would be effective in reducing tobacco use. ... The Government therefore could use its power under the Spending Clause ... to condition receipt of federal funds on States’ allocation of MSA funds in accordance with CDC recommendations."
2. The tobacco companies also point out that the federal government could increase the cigarette tax, which would lead to a reduction in cigarette consumption.
The companies write: "The Government could also consider whether increased cigarette taxes, which have been shown to reduce cigarette consumption, would be at least as effective as the Rule."
The Rest of the Story
I believe that if the national anti-smoking groups and members of Congress who supposedly want to reduce smoking rates had implemented the tobacco companies' recommendations, rather than become obsessed with the inane idea of asking the FDA to regulate the "safety" of tobacco products and relying upon warnings on the cigarette packs to discourage smoking, the field of tobacco control would be in a drastically better place than it is today.
While raising the federal cigarette excise tax would itself reduce smoking rates, allocating those revenues towards state-of-the-art anti-smoking programs in all 50 states, combined with requiring states to allocate a minimum proportion of their MSA payments to such programs, would represent the most effective national strategy for tobacco control in history.
Imagine if all 50 states implemented tobacco control programs similar to that in California, the only state with a sustained, comprehensive tobacco control program for the past two decades. Imagine if those programs included a focus on reaching disadvantaged communities, including communities of color. Imagine, for example, if the money were available to provide Pathways to Freedom to every African American smoker who desired to quit smoking. Imagine if all states implemented anti-smoking television commercials like those used in the "truth" campaign.
This is where the anti-smoking groups and Congress should have directed their efforts over the past five years, rather than creating an untenable system by which the agency charged with protecting the nation's food and drug supply is charged with somehow ensuring that cigarettes are "safe," which is an impossible task that wastes precious resources.
I think it is embarrassing that at the end of the day, the tobacco companies - and not the national anti-smoking groups (i.e, Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, etc.) - have put together an effective strategy for reducing tobacco use, while the national anti-smoking groups have instead created a purposeless federal bureaucracy that is going to spend millions of dollars but effect no substantial changes in either cigarette safety or cigarette smoking rates.
It is one thing for other tobacco control advocates to point out to these anti-smoking groups that perhaps the strategies they are pursuing are not the most effective. It is downright embarrassing, however, when the tobacco companies themselves point out that the strategies being promoted by those groups are the least effective ones available, and then they go ahead and lay out the strategies that would actually make a huge dent in cigarette sales.
When even the tobacco companies criticize you for not doing the right things to reduce tobacco use, it should wake you up, or at least give you pause to consider your actions.
The critique of current anti-smoking efforts comes in the form of the legal brief submitted by Reynolds American, Lorillard, Commonwealth Brands, and Santa Fe Tobacco Company seeking to overturn the graphic warning label requirement.
One of the points made in the brief is that the requirement for large graphic warning labels is not narrowly tailored as it is not the least restrictive policy that would advance the government's interest in warning consumers about the hazards of smoking. Moreover, the tobacco companies argue that there are far more effective ways to reduce smoking than showing smokers gory pictures.
In particular, the tobacco companies put forward two alternative ideas which, unlike the warning labels, are evidence-based and have been shown to substantially reduce smoking rates.
1. The tobacco companies point out that the federal government could require states to spend a significant amount of their Master Settlement Agreement proceeds on tobacco control programs. This requirement could be in the form of tying federal funding to states having allocated a certain proportion of MSA revenue to anti-smoking programs.
The companies write: "The MSA annually provides the States with billions of dollars intended for tobacco control programs. The federal Centers for Disease Control and Prevention (“CDC”) has found that requiring the States to increase the allocation of MSA funds to youth tobacco prevention—from the meager 3.5% recently employed to the still-modest CDC-recommended 15%—would be effective in reducing tobacco use. ... The Government therefore could use its power under the Spending Clause ... to condition receipt of federal funds on States’ allocation of MSA funds in accordance with CDC recommendations."
2. The tobacco companies also point out that the federal government could increase the cigarette tax, which would lead to a reduction in cigarette consumption.
The companies write: "The Government could also consider whether increased cigarette taxes, which have been shown to reduce cigarette consumption, would be at least as effective as the Rule."
The Rest of the Story
I believe that if the national anti-smoking groups and members of Congress who supposedly want to reduce smoking rates had implemented the tobacco companies' recommendations, rather than become obsessed with the inane idea of asking the FDA to regulate the "safety" of tobacco products and relying upon warnings on the cigarette packs to discourage smoking, the field of tobacco control would be in a drastically better place than it is today.
While raising the federal cigarette excise tax would itself reduce smoking rates, allocating those revenues towards state-of-the-art anti-smoking programs in all 50 states, combined with requiring states to allocate a minimum proportion of their MSA payments to such programs, would represent the most effective national strategy for tobacco control in history.
Imagine if all 50 states implemented tobacco control programs similar to that in California, the only state with a sustained, comprehensive tobacco control program for the past two decades. Imagine if those programs included a focus on reaching disadvantaged communities, including communities of color. Imagine, for example, if the money were available to provide Pathways to Freedom to every African American smoker who desired to quit smoking. Imagine if all states implemented anti-smoking television commercials like those used in the "truth" campaign.
This is where the anti-smoking groups and Congress should have directed their efforts over the past five years, rather than creating an untenable system by which the agency charged with protecting the nation's food and drug supply is charged with somehow ensuring that cigarettes are "safe," which is an impossible task that wastes precious resources.
I think it is embarrassing that at the end of the day, the tobacco companies - and not the national anti-smoking groups (i.e, Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, etc.) - have put together an effective strategy for reducing tobacco use, while the national anti-smoking groups have instead created a purposeless federal bureaucracy that is going to spend millions of dollars but effect no substantial changes in either cigarette safety or cigarette smoking rates.
It is one thing for other tobacco control advocates to point out to these anti-smoking groups that perhaps the strategies they are pursuing are not the most effective. It is downright embarrassing, however, when the tobacco companies themselves point out that the strategies being promoted by those groups are the least effective ones available, and then they go ahead and lay out the strategies that would actually make a huge dent in cigarette sales.
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.
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.
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.
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.
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.
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.
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.
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?
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.
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.
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