Thursday, September 29, 2011

Baylor Health Care System Will Not Hire Smokers Trying to Quit or Ex-Smokers Who Remain Off Cigarettes Using Nicotine Replacement Therapy

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.

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.

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.

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.

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.

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'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."

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.

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.

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.

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.

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.

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.

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.