Despite Loopholes, No Improvements in FDA Tobacco Legislation

An analysis conducted by Barron's Online has confirmed that the FDA tobacco legislation introduced in Congress this session is nearly identical to the bill that was defeated in Conference Committee last session. Economic analyst Bonnie Herzog wrote in a March 30 article that despite a broader array of initial support for the bill, chances for passage in 2005 remain low.

The Rest of the Story

These findings suggest that despite being aware of numerous flaws in the FDA tobacco legislation, the major organizations that supported this legislation last session did not insist upon any changes to strengthen it.

While there are problems in the bill's overall regulatory approach that I think render it inappropriate from a public health policy perspective (see previous posts: post 1 post 2 post 3), there are still a number of improvements that could have been made. These were outlined in a policy analysis that I prepared last year. They include the following:

• Section 906(d)(1) (General Provisions Respecting the Control of Tobacco Products): Delete the phrase "No such regulation may require that the sale or distribution of a tobacco product be limited to the written or oral authorization of a practitioner licensed by law to prescribe medical products." This is a scientific and regulatory policy matter and should not be politicized.
• Section 906(d)(3)(A): Delete ("No restrictions under paragraph (1) may--`(i) prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets; or `(ii) establish a minimum age of sale of tobacco products to any person older than 18 years of age.") This is a scientific and regulatory policy matter and should not be politicized.
• Section 907(a)(4)(b)(v): Delete ("provision requiring that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 906(d))." This is a scientific and regulatory policy matter and should not be politicized.
• Section 907(b)(3)(A): Delete ("Because of the importance of a decision of the Secretary to issue a regulation establishing a tobacco product standard--`(A) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll your own tobacco products; or `(B) requiring the reduction of nicotine yields of a tobacco product to zero, Congress expressly reserves to itself such power.") This is a scientific and regulatory policy matter and should not be politicized.
• Section 915: Delete and replace with the following: "Section 801 of Title V of the United States Code does not apply to the regulations referred to in the Family Smoking Prevention and Tobacco Control Act." This would eliminate the short-circuited process by which Congress can override FDA rules under the current bill.

I think that for each of the loopholes above, public health advocates deserve an explanation as to: (1) why each of these compromises are present in the legislation; (2) who requested or demanded that these compromises be present in the legislation; and (3) why the Campaign for Tobacco-Free Kids did not insist upon their removal from the bill. Knowing the source of these loopholes as well as the reasons for their inclusion in the bill and the precise reasons why the Campaign for Tobacco-Free Kids did not insist upon their removal is essential before tobacco control practitioners can make an informed decision about their support or opposition to this legislation.

Perhaps the most concerning aspect of this story is Herzog's conclusion that the chances for passage of this bill in its present form are slim. This means that in order to secure its passage, amendments that further weaken the bill will almost certainly be required. Do public health advocates really want the Campaign for Tobacco-Free Kids to be in a position of making decisions for all of us about further compromises in the legislation?

I don't think so. I think they have done enough damage already.

AJPH Paper on "truth" Campaign Suggests No Effect on Youth Smoking

A paper published in the March issue of the American Journal of Public Health, which examined the relationship between exposure to the American Legacy Foundation's "truth" campaign and the prevalence of youth smoking, concluded that the campaign "was associated with significant declines in youth smoking prevalence" (Farrelly MC, Davis KC Haviland L, Messeri P, Healton CG. Evidence of a dose-response relationship between "truth" antismoking ads and youth smoking prevalence. Am J Public Health 2005; 95:425-431). Now, the results of that study have been called into question by Dr. Joel Moskowitz of the UC Berkeley School of Public Health, who published electronic letters in AJPH as well as the BMJ (British Medical Journal) which point out that the dose-response relationship found in the study actually does not support the hypothesis that the campaign was effective in reducing smoking prevalence.

Moskowitz writes: "The theoretical rationale for inclusion of the GRP-squared term was to test whether the campaign had diminishing returns" (p. 428). This would suggest an L-shaped relationship between campaign advertising and smoking prevalence; not the U-shaped relationship found. The results suggest that the campaign had no detectable effect on smoking prevalence among those who resided in media markets that received higher levels of exposure which included students in most major metropolitan areas. Yet, the paper obscured this finding and failed to address its policy implications. Did an overdose of truth render the campaign ineffective? Or were the models improperly specified to estimate campaign effects?

When examined by grade level, the effect of truth advertising on smoking prevalence was significant only for students in grade 8 in media markets with moderate exposure (Table 2). That the campaigns impact did not sustain through high school suggests that truth advertising was no more effective than school-based, smoking prevention programs (e.g., Wiehe et al., 2005)."

The Rest of the Story

I evaluated the study in light of the alternative interpretation of the results presented by Dr. Moskowitz. My interpretation of these results is that they fail to support the conclusion of a significant effect of the "truth" campaign on youth smoking prevalence.

First, it is important for the reader to understand that the study failed to find any significant relationship between the intensity of exposure to the "truth" campaign and youth smoking prevalence under the assumption that campaign effects would increase linearly with campaign exposure. This is probably the most sound initial assumption, since the study measures not actual, individual-level exposure but the penetration of various media outlets in a geographic region (which is used as a proxy for actual exposure).

This basic result is hidden in the second half of the final paragraph on page 428 of the paper, and the quantitative result is not provided in the paper: "We also estimated a set of regressions excluding the quadratic GRP term (GRP squared) (results available on request). In this set, the effect was marginally statistically significant for 12th-grade students (OR=0.879; P<.07) but statistically nonsignificant overall and for 8th- and 10th-grade students."

This means that youth smoking did not decrease as campaign exposure increased linearly over the entire range of exposure (from 647 to 22,389 GRPs). Gross rating points (GRPs) represent the percentage of the target audience that is reach by the campaign multiplied by the number of times they are reached. If the campaign had a significant effect on youth smoking, then one would expect smoking prevalence to fall as exposure increased. This was not the case.

The paper attempts to find a relationship between campaign exposure and youth smoking by using an alternative assumption about media effects - that there are "diminishing returns" as exposure gets very high (i.e., once you reach a certain level of exposure, additional exposure is unlikely to have much of an additional effect on smoking prevalence).

While this is not an unreasonable assumption to test, the study results failed to detect a relationship that was consistent with this pattern of diminishing returns. Instead, the paper found support for a U-shaped relationship, in which the campaign was found to be associated with lower smoking prevalence at moderate exposure levels, but to have minimal, if any, effect at both very low and very high exposure levels.

This type of relationship is really not consistent with the conclusion that the "truth" campaign was effective in reducing youth smoking prevalence. While results that showed diminishing returns would be consistent with such a conclusion, the fact that there was not an observed effect among youths living in the areas with the absolute highest exposure to the campaign is not.

I will try to demonstrate this problem with some examples:

1. Under the basic analysis of the study, in which smoking rates in 2000-2002 were compared to those in the the baseline period (1997 to 1999), the results show that at an exposure level of 22,000 GRPs (the highest level), the odds ratio for youth smoking is 0.96, indicating essentially no effect of campaign exposure.

2. In the comparison of smoking in 2002 versus the baseline period, the results show that at an exposure level of 20,000 GRPs (about average for the major metropolitan areas with highest exposure), the odds ratio for youth smoking is 0.97, again indicating essentially no effect of campaign exposure.

3. In the analysis restricted to 8th-grade students, which was the only one to find a campaign effect (there was no significant effect of the campaign on 10th-grade or 12th-grade students), the results show that at an exposure level of 19,000 GRPs, there is no effect of campaign exposure (odds ratio is 0.99), and at an exposure level of 22,000 GRPs, exposed youths are actually more likely to smoke (i.e., there is actually a reverse effect of the campaign at very high exposure levels).

The reason why these findings are not apparent in the paper is that, as Dr. Moskowitz points out, Figure 2 cuts off at an exposure level of 15,000 GRPs, which leaves out a large part of the sample. Had the figure been extended to show the results for the full range of exposure, it would have become apparent that there was no campaign effect detected for youths with very high campaign exposure. It would have become clear that the pattern was not consistent with a hypothesis of diminishing campaign effects, but rather, consistent with the absence of an effect of the campaign on youth smoking prevalence.

The important point, I think, is that the results just don't appear to support a conclusion that the "truth" campaign resulted in a significant decrease in youth smoking prevalence. They certainly do not, I believe, support a causal conclusion.

While there are plenty of reasons to support and continue funding anti-smoking media campaigns such as the "truth" campaign, I do not see the results of this particular study as being one of them.

10 Years After Synar: CDC Study Shows Youths Still Able to Purchase Cigarettes

Ten years after tobacco control efforts began to focus heavily on interventions to reduce youth access to tobacco products, a CDC study released last week reveals that the majority of minors (age <18) are still easily able to obtain cigarettes. Nationally in 2004, of current smokers less than 18 years old, 64% were not asked to show proof of age and 62% were not refused purchase due to their age. These results show that national efforts to reduce youth access to cigarettes over the past decade have been largely unsuccessful in preventing youths from obtaining cigarettes and thereby reducing youth smoking.

The Rest of the Story

Ten years is long enough for an experiment that as early as 1996, Dr. Stan Glantz suggested to us was an unfortunate diversion of resources (see: Glantz SA. Preventing tobacco use--the youth access trap. American Journal of Public Health 1996; 86(2):156-158). No matter how reluctant we are, it is time to conclude that the experiment has failed.

There simply is not evidence that as implemented in widespread practice, youth access laws and their enforcement have any significant effect on youth smoking. While there have been a few studies that found an effect, these were generally in specific communities that implemented an unusually aggressive program that cannot likely be sustained or easily replicated elsewhere. The totality of the evidence, in my opinion, documents that youth access interventions do not significantly decrease youth smoking (see, in particular: Fichtenberg CM. Glantz SA. Youth access interventions do not affect youth smoking. Pediatrics 2002; 109(6):1088-1092).

Research conducted here in Massachusetts, where a heavily-funded statewide tobacco control program with a huge emphasis on youth access interventions (including enforcement) was in place for a decade (from 1993-2003), revealed that these initiatives had no effect on youth smoking behavior (see: Thomson CC, Gokhale M, Biener L, Siegel MB, Rigotti NA. Statewide evaluation of youth access ordinances in practice: Effects of the implementation of community-level regulations in Massachusetts. Journal of Public Health Management and Practice 2004; 10:481-489).

There are a number of reasons why widespread efforts to restrict the sale of tobacco products to minors would not be expected to be effective in reducing youth smoking:

• Youths have a wide variety of sources of access to cigarettes, and half of youth smokers do not even rely on purchasing their own cigarettes. If youths want to smoke, they can obtain cigarettes even if unable to purchase for themselves.
• Compliance checks as conducted by tobacco control groups are essentially meaningless exercises, because they do not simulate real-life conditions, in which youths are able to lie about their age or present false identification.
• Even if there were no alternate sources of cigarettes other than purchasing in a store, compliance would have to reach extremely high levels to reduce youth access to cigarettes. If even one store in a community sells to minors, youths have ready access to cigarettes.

There are now a number of interventions that have been so well documented to reduce youth smoking that it makes no sense to place our resources into a losing strategy. It is time to heed Dr. Glantz's warning from 1996 and avoid the youth access trap. Resources should be shifted into programs that we know work.

Corvallis, Oregon to Consider Banning Smoking in Parks

The Corvallis City Council will soon consider a proposal to ban smoking in all parks, according to Portland's CBS affiliate (KOIN). The article lists several other Oregon communities that have banned smoking in parks, including Wasco County, which apparently does not allow smoking in either parks or their associated parking lots. The new trend in consideration of proposals to ban smoking in non-enclosed, outdoor public places seems to have been initiated by the passage in 2000 in Friendship Heights, Maryland of a law banning smoking in all public places, including outdoors. That law included "smoking on sidewalks, streets, patches of grass or any other area owned by the village." It was presumably the first smoking ordinance to include not only enclosed public places, but areas outside the enclosed areas (such as sidewalks, streets, parking lots, etc.).

The Rest of the Story

Since the power to enact public health laws such as smoking bans in public places derives from the state's police powers, which must be exercised with reason (see preceding post), I do not see a general justification for banning smoking in outdoor places that are not enclosed. Our public health policy initiatives must be based on reasonable evidence of a public health need, and I am not aware of data suggesting that outdoor exposure to secondhand smoke in open places is a significant health hazard. I also do not find it reasonable to expect that people cannot take measures to avoid secondhand smoke exposure in most open public places, like parks and parking lots. The situation is different in some outdoor places that are enclosed, such as a stadium or outdoor section of a restaurant where people are relatively confined and there may be exceptions when the limitation on smoking is placed for reasons other than protection from secondhand smoke (such as not wanting smoking to take place in a children's area, such as a school playground) . But in general, for an open, outdoor public place, I simply do not find a strong public health justification for intervening.

I think that public health practitioners may actually do more harm than good by promoting such measures. It casts the idea of regulating smoking in public places as being overly intrusive and takes the focus away from the real issue that is most relevant to such regulations - health risks to exposed employees in enclosed workplaces. By framing the issue in a way that detracts from the proper use of the state's police powers, general outdoor smoking bans may actually undermine efforts to protect employees who are heavily exposed and actually need protection.

Superior Court Finds Problems with Exemptions in Rhode Island Smoking Ban

A Rhode Island Superior Court judge on March 31 issued an order extending the state's ban on smoking in bars and restaurants to include all private clubs, which had, in the original 2004 legislation, been granted an exemption until October 1, 2006. All other bars and restaurants in the state became smoke-free as of March 1, 2005. The order was in response to a lawsuit filed by a group of bar owners who are challenging the constitutionality not of the state's action to eliminate smoking in public places, but of the law's exemption of certain bars and restaurants: private clubs and small bars that do not prepare their own food.

According to an April 1 Boston Globe article: "Newport Superior Court Judge Stephen Fortunato Jr. ruled that temporary exemptions for Class C and D establishments with ten or fewer employees were irrational, and therefore unconstitutional." A preliminary hearing on the matter is scheduled for April 11, and in the meantime, the legislature may consider a bill to remove the questionable exemptions.

The Rest of the Story

The basic authority of the state to regulate smoking in bars and restaurants derives from the police powers granted to it by the 10th Amendment of the Constitution, which allow it to enact reasonable laws to protect public health, public morals, public safety, and the general welfare of the community. The key relevant limitation here is that the laws must be fair, sensible, and rational.

Given this context, I can see how Judge Fortunato Jr. may have a point in his decision to extend the smoking ban equally to bars regardless of their license type. A careful analysis of the exemptions in the law reveals that the two which the judge has questioned are:

1) The exemption of bars holding class D licenses: these are private clubs run by nonprofit or charitable organizations organized prior to 1900 and which have held a class D license since at least July 1, 1983 (see definition of class D license as well as definition of nonprofit organization); and

2) The exemption of small bars holding class C licenses: these are bars with fewer than 11 employees that do not serve any food prepared on the premises, except in Newport, where they may prepare food, and which may provide, but not sell popcorn, crackers, bread, pretzels, sausage of any type, pickles, sardines, smoked herring, lupino beans, and potato chips (see definition of class C license).

This means that in granting these exemptions, the legislature was treating as different, for example:

• a class C bar with 10 employees and a similar bar with 11 employees;
• a small bar that serves complementary lupino beans with its drinks and a similar bar that charges for those lupino beans;
• a private club that obtained its alcoholic beverage license on June 30, 1983 and a similar club that obtained its license on July 1, 1983; and
• a small bar in South Kingstown that serves pre-packaged and heated sausages and a similar bar in Newport that cooks up its own sausages.

While courts have generally granted legislatures wide discretion in factors that may be considered in applying public health laws, there may exist a limit beyond which certain exemptions will be viewed as irrational because they do not appear to be based on reason. The distinctions above do seem rather arbitrary, and there may be a legitimate case to be made before the Superior Court by the bar owners.

Regardless of the outcome of the case (and I think most likely it will become moot as the state will probably end up amending the smoking law to eliminate the exemptions), this story should be instructive for public health practitioners. It highlights the importance of public health advocates and organizations being consistent in their efforts to protect bar and restaurant workers from the hazards of secondhand smoke. If we are going to ask the state to impose its police powers in order to protect the public's health, then there should be good sense behind our decisions about who is to bear the burden of protection. In other words, if we are supporting legislation that exempts certain workplaces from regulation, then we must be able to justify, on public health grounds, the exemption of those particular workplaces. The fact that exempting certain workplaces makes a bill more politically acceptable is not a sufficient justification for us to support and advocate for such a regulatory approach.

If we make a finding that secondhand smoke is a substantial hazard for bar employees, then it is presumably an equal hazard for workers regardless of the type of bar in which they work. Regulation should then apply to all workplaces across the board, unless there is very strong and sound reason, based on public policy considerations, not to apply the law equally. Political palatability is not, I believe, a strong or sound justification for failure to support the equal application of public health regulations.

Perhaps the most disturbing example of the misuse of the police power with regard to regulation of smoking in workplaces is, I believe, the Oklahoma Board of Health's 2002 emergency smoking rule, which required bars and restaurants to either become completely smoke-free, create separately ventilated smoking areas, or allow smoking throughout the facility, and exempted restaurants with fewer than 50 seats. If the Oklahoma Health Department made a finding that secondhand smoke was a significant health hazard, then what sense did it make, from a public health perspective, to demand that workers either be completely protected from this hazard or completely unprotected? And what sense was there to apply the law based on the number of seats, especially since one would expect higher smoke concentrations in precisely the smaller establishments that were exempt? There was no public health justification for such an inconsistent application of the law. The inconsistency between the findings of the law and its construction would have, in my opinion, resulted in the invalidation of this regulation by the court considering the legal challenge to these rules had the legislature not intervened and enacted its own law.

If there is doubt in public health practitioners' minds about whether eliminating smoking in bars and restaurants is justified then they should not be promoting such legislation; however, once a finding is made that such an action is justified, then it should be applied equally to all businesses. From a public health perspective, the uneven application of health protections based on arbitrary (from a public health standpoint) distinctions between workplaces is not justified. While legislators may legitimately bring other considerations into the picture, we should not be in the business of treating businesses differently solely because we want to gain political support for our initiatives.

UPDATE (April 6, 2005; 9:55 pm): According to an article in today's Providence Journal-Bulletin, the Rhode Island House voted today to extend the state smoking ban to small bars and private clubs. The Senate is expected to quickly pass a similar bill.

American Cancer Society President Allegedly Calls Tobacco Manufacturers "Terrorists"

According to an article in today's Jerusalem Post, American Cancer Society president Dr. John Seffrin told members of the Israel Cancer Association that all those involved in the production and marketing of tobacco products are "terrorists." The article quotes Seffrin as stating that by 2020, "one third of all deaths worldwide will be caused by tobacco and its terrorists." The article states that: "In repeatedly calling the purveyors of tobacco terrorists, Seffrin noted that they knowingly push a product that kills."

The Rest of the Story

Assuming that the article is accurate and Seffrin did in fact call tobacco manufacturers like Philip Morris "terrorists," is it not then egregious that Seffrin's American Cancer Society is standing shoulder-to-shoulder with this "terrorist" group in pushing for legislation (the FDA tobacco bill) that will significantly aid the "terrorist" organization? Is the American Cancer Society not aiding and abetting a "terrorist" group by working with Philip Morris to secure legislation that is highly desired by this company, so much that the company's web site touts how much Philip Morris is "committed" to this legislation and how "diligently" the company is working to promote it?

How hypocritical can a public health organization be? How can you, on the one hand, call Philip Morris a "terrorist" group, and then on the other, work side-by-side with Philip Morris to advance legislation that it dearly wants? Are you not then supporting "terrorism?"

I completely reject any reference to tobacco manufacturers and marketers as "terrorists," and if Dr. Seffrin made this remark (and there is no reason to believe that the Post is not being accurate in its reporting), I think it is inappropriate, irresponsible, and plainly wrong.

Terrorism is defined as "The unlawful or threatened use of force or violence by a person or an organized group against people or property with the intention of intimidating or coercing societies or governments, often for ideological or political reasons." There is nothing that tobacco manufacturers are doing that could even remotely be considered to be terrorism. Their manufacturing and promoting of tobacco products are lawful, they are not using force or violence against people or property, and they certainly do not have an intention of intimidating or coercing societies or governments.

This appears to be yet another example of an inappropriate tactic being used by a public health organization to promote the tobacco control cause. Here, the American Cancer Society is apparently misusing and perhaps abusing the English language to rile up an Israeli audience about the tobacco problem, knowing that terrorism is a problem that has profound emotional significance for this group.

I certainly support efforts to mobilize citizens to take action about the problem of tobacco in our society. But these efforts should be based on some degree of integrity, reasonableness, and appropriateness. To call tobacco manufacturers terrorists is none of these three.

The ends do not justify the means, even in tobacco control. Just because we are working for a noble and important cause does not justify the use of misleading and inappropriate tactics. Comparing tobacco manufacturers to terrorists does a disservice not only to the families of those whose lives have actually been lost due to terrorism, but to the integrity of the tobacco control movement.

The Citizens' Commission Amicus Brief: Further Commentary

In a previous post, I commented on what I believe to be an inappropriate omission in the amicus brief submitted by American Legacy Foundation-funded Citizens' Commission to Protect the Truth in the DOJ lawsuit: namely, the failure to disclose that the Citizens' Commission is funded by the Legacy Foundation. I think here it is also worth commenting on the substance of the Commission's argument, leaving aside the issue of whether or not there is an inherent conflict of interest in presentation of the basic argument.

The two basic arguments presented in the brief are that: (1) an appropriate remedy for the tobacco company defendants' violations of the RICO statute is to order them "to fund a public education and youth smoking prevention campaign"; and (2) that "the American Legacy Foundation's truth® campaign should be the organization so funded.

The brief argues that ordering the tobacco companies to fund a public education and youth smoking prevention campaign is an appropriate remedy because it will help prevent and restrain further violations of RICO: "requiring the Defendants to fund independent third-parties' marketing and advertising campaigns, such as the truth® campaign, prevents future violations by affecting the Defendants' future conduct and shifting the focus of the Defendants' future marketing activities. Such a remedy will require the Defendant tobacco companies to fund effective, independent smoking prevention programs, thereby avoiding the type of public misinformation campaign engaged in by the Defendants. Impacting Defendants' conduct by requiring them to fund third-party anti-smoking campaigns is an effective and authorized way both to address the Defendants' RICO violations and to satisfy the requirements set forth by the Circuit Court of Appeals, by aiming to prevent continuing and future violations rather than cure those of the past."

The Rest of the Story

I think that a careful analysis of this argument reveals it to be flawed. The main problem is that the argument incorrectly assumes an either-or scenario for the tobacco company's marketing activities. Either the companies continue their past patterns of deceptive marketing or they fund the Legacy Foundation and change the manner in which they market their products.

But it seems to me that there is another, more likely possibility: that the companies will fund the Legacy Foundation AND continue their past patterns of deceptive marketing. There is nothing that writing a check out to the American Legacy Foundation will do to change the basic marketing practices of the industry. Just because they are told they must pay for a "truth" campaign does not mean that they cannot or will not continue to use deceptive marketing practices to promote the use of their products. In other words, requiring Defendants to fund the truth® campaign will do nothing to deter future RICO violations. I think the argument fails.

Breaking the brief down, the central argument really rests on two basic premises:

(1) "Ordering the tobacco companies to fund an effective, independent smoking prevention campaign will serve precisely the function contemplated by [RICO civil remedies provision] by directing the manner in which Defendants will market their product."

This premise is flawed because having the Defendants write out a check for a third-party anti-smoking campaign does nothing to direct their marketing activities. They can continue to market the product however they wish, including using deceptive techniques to entice youth to smoke, undermining public health efforts to educate the public about the true risks of smoking, and targeting youths in their advertising. They can even directly undermine the anti-smoking campaign in their own marketing if they want to. If anything, the tobacco companies would be freer to continue their deceptive marketing, because they could use the fact that they are funding the truth® campaign to increase their public good will and detract attention from their marketing practices.

(2) "Placing the onus on the tobacco companies to fund a public education and smoking prevention campaign will effect a shift in the tobacco companies' marketing focus and conduct by forcing them to fund effective anti-smoking and smoking prevention advertising by third parties, rather than the current pro-smoking marketing in which the tobacco companies still are currently engaged."

This premise is flawed because forcing the companies to fund a smoking prevention campaign does not require them or entice them in any way to discontinue "the current pro-smoking marketing" in which they are currently engaged. If anything, it would give the companies more of an incentive to aggressively market their product. They would have to be increasingly effective in their "pro-smoking marketing" in order to offset any negative impacts of the independent anti-smoking campaign.

Frankly, the idea that forcing the companies the fund the truth® campaign will put an end to their current pro-smoking marketing or even to the deceptive aspects of their pro-smoking marketing seems to me to be weak at best and uninformed at worst.

Truly, what it sounds like to me is that the American Legacy Foundation and/or its grantee are struggling to come up with a way to get Legacy funded. The argument presented in the amicus brief seems to me to be so flawed that it makes one wonder whether this is more of a thinly-veiled attempt to promote Legacy's funding rather than a serious attempt at offering an important substantive evaluation of the relevant legal issues to the court.

In actually reading the relevant statute, I find it very difficult to imagine how the funding of a third-party anti-smoking campaign would even remotely serve the function contemplated therein: "The district courts of the United States shall have jurisdiction to prevent and restrain violations of section 1962 of this chapter by issuing appropriate orders, including, but not limited to: ordering any person to divest himself of any interest, direct or indirect, in any enterprise; imposing reasonable restrictions on the future activities or investments of any person, including, but not limited to, prohibiting any person from engaging in the same type of endeavor as the enterprise engaged in, the activities of which affect interstate or foreign commerce; or ordering dissolution or reorganization of any enterprise, making due provision for the rights of innocent persons."

The situation would be different if a huge amount of money were involved. Huge punitive damages, whether they take the form of disgorgement of past profits or otherwise, could deter future RICO violations. But this is not the argument being made in the brief, and it is also not a remedy that is likely, unless the Circuit Court panel's decision is overturned.

The situation would also be different if the amicus brief were calling on the judge to impose direct marketing restrictions on the companies. That seems to be much more in line with what section 1964(a) has in mind.

I'm all for the idea of trying to extract whatever damages and remedies we can out of the tobacco companies in the interest of protecting the public's health. But those remedies must fall within the confines of the law. And here, I simply don't think that requiring the tobacco companies to fund the truth® campaign is a remedy that is consistent with 18 U.S.C. section 1964(a).

German Cancer Research Centre Calls for Ban on Cigarette Additives

According to a news article in this week's BMJ, scientists from the German Cancer Research Centre in Heidelberg are calling for a ban on tobacco product additives because they may increase the risk of cancer and may enhance the likelihood of nicotine addiction. The article explains that cigarette additives may be used for a variety of ends, including: (1) improving the taste of cigarettes, and thereby making them more palatable for young smokers; (2) increasing the addictive strength of nicotine within cigarettes; and (3) allowing smokers to take deeper puffs, and thus inhale a greater amount of carcinogenic and toxic substances.

The Rest of the Story

The folly that characterizes the absurd regulatory approach for which U.S. public health organizations (such as the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, and American Lung Association) are lobbying is apparently not restricted to this country. While this cancer research center is calling for the removal of additives from cigarettes, it does not appear to be expressing any particular urgency regarding the addictive and carcinogenic potential of the cigarette itself.

This is the public health paradigm at its worst: regulate the ingredients that are added to the cigarettes, but not the addictive and carcinogenic constituents of the cigarette smoke itself. In other words, the baseline toxic qualities of tobacco products are viewed as being acceptable from the standpoint of societal policy, but not so for anything added to the products. As I pointed out with the FDA tobacco legislation now before Congress, health groups are supporting a bill that bans flavorings added to cigarettes, but does not require FDA to do anything about "naturally" present carcinogens and toxins. And the bill requires notification to consumers of any adverse health effects of substances added to cigarettes, but not of any health risks due to constituents "ordinarily present" in the product.

The underlying senselessness of federal regulation of tobacco products is that the product is inherently toxic, addictive, and carcinogenic. It is not the additives and flavorings that are responsible for the addictive, toxic, and carcinogenic effects. It is the cigarette itself. And setting performance standards to eliminate a few of the offenders is not going to address the problem. Nor is banning cigarette additives.

At this point, one may ask: Am I calling for the banning of tobacco products, or for continuation of the status quo regarding these products? The answer is: Neither.

Banning tobacco products altogether is not an acceptable option, especially based on this country's experience with prohibition of alcohol.

Neither is the status quo. However, arguing against FDA regulation of tobacco products as proposed by Philip Morris and the Campaign for Tobacco-Free Kids is not equivalent to arguing for the status quo (as suggested by the Campaign in a March 21 communication to individual tobacco control advocates). Far from it.

Those of us who are attempting to point out the irrationality of the FDA legislation are actually calling for major changes in the practice of tobacco control in this country. Most importantly, we are suggesting that the persistent, relentless, and probably futile efforts of our national organizations that are devoting substantial resources to this cause should be shifted to areas for which there is evidence of an effect on the public's health.

We agree that the status quo - with the most prominent national tobacco control organization making federal regulation a goal beyond all goals, in the context of a Congress that has almost never enacted effective tobacco control legislation and is certainly not going to start now - is completely unacceptable. We know what works in tobacco control - and that's where our resources should be directed.

IN MY VIEW: Smokers are Not the Problem - Let's Not Treat Them That Way

I have received a number of comments regarding my views that: (1) increasing cigarette taxes to fund non-tobacco-related projects is inappropriate public health policy; and (2) policies that make off-the-job smoking a criterion for employment decisions are generally inappropriate. I therefore thought it might help to explain how I have come to these views.

I am in the field of tobacco control because as a physician, I view this as the way in which I can work to promote the best interests of the patient. I entered tobacco control because such a large number of my patients were smokers and it became clear that preventing smoking and encouraging smoking cessation on a population-level were the most important goal I could pursue. I also spent two years working in a methadone maintenance clinic and observed the difficulty my clients had overcoming their addiction to cigarettes, which was every bit as strong as their addiction to heroin, cocaine, alcohol, or other drugs. Thus, from my background and experience, I view smokers not as the problem, but as the patients or clients who I am trying to serve through my public health practice.

Now the types of policies that one supports may be different if one views one's role as helping patients who smoke, rather than if one views smoking, and therefore smokers, as a public health problem. I view tobacco products (and the manufacturers of those products) as the problem, not the act of smoking those products, and certainly not the smoker (the majority of whom we know are addicted to the product).

This is the perspective I bring to bear in analyzing public policies regarding the regulation of smoking and tobacco products. In this light, employee policies that refuse to hire smokers, fire employed smokers, or impose excess charges on employees who are addicted to nicotine are not public health policies. They do not appear to me to be crafted in the interest of addressing the problem of tobacco products. Instead, they appear to me to be crafted in the interest of punishing smokers for a behavior that I as a physician know is a powerfully addictive one that is extremely difficult to stop. (Here I am referring to policies regarding smoking off-the-job; smoking in the workplace and/or on-the-job are appropriate areas of workplace policy, as are many aspects of lawful employee behavior).

Similarly, policies that use smokers as a way to fund programs that we as a society should be funding anyway do not appear to me to be crafted within the confines of purely public health interests. I think support for these policies is largely a political decision, in which public health organizations are using the economic benefits of an increased cigarette tax to the state to achieve a particular end. Since there is available an alternative policy that would achieve the same end but in a way that is not regressive and does not punish the most heavily addicted and often the poorest smokers, a decision to support the kinds of cigarette tax increases for which many public health groups are now advocating implies to me a rejection of the more sound (from a public health perspective) alternative.

I think our evaluation of these policies reflects more than just our specific views on the most immediately relevant concerns. It also reflects the overall paradigm with which we practice. The way in which we frame the problem has implications for how the public views the problem. While it may not seem that supporting policies such as Weyco's that fire smokers is relevant to the overall practice of tobacco control, I think that the public perception of our actions is an important result that must be considered. If our positions on issues tend to frame the problem as one of individual behavior, then that's the way the public will tend to view the problem as well. And that is going to eventually become an obstacle to the promotion of the most important and potentially most effective tobacco control policies.

New Mayo Clinic Study Reveals Problems with Lung Cancer Screening

An article in the April issue of Radiology reports the results of a study of the use of helical CT scanning as an approach for the early detection of lung cancer among high risk smokers (Swensen SJ, Jett JR, Hartman TE, et al. CT screening for lung cancer: five-year prospective experience. Radiology 2005; 235:259-265). A group of 1,520 adults ages 50+ was followed for four years, receiving a baseline chest CT scan and four annual follow-up CT scans. The purpose of the study was to determine whether this approach would save lives by detecting lung cancers earlier than they would otherwise be detected, allowing for earlier and more effective treatment.

The study found that CT scan screening did not significantly reduce lung cancer deaths. Nor did it result in a shift to the detection of more very early cancers. But this screening did create problems for patients because of a very high false positive rate. False positive tests mean the finding of a lung nodule on the CT scan that turns out not to be cancerous. About three-fourths of the patients had a lung nodule detected, and of these, only 4% turned out to have cancer. Thus, well over 1,000 cancer-free patients were told they had a lung nodule suspicious for cancer and had to have further diagnostic procedures, sometimes involving surgical or other procedures (i.e., biopsy).

The Rest of the Story

While chest CT scan screening of current and ex-smokers at high risk for lung cancer turned out not to have any benefit to them, it did cause significant morbidity and mental distress. Being told that one has a nodule that could be cancerous tends to create substantial anxiety. For many of these patients, they had to live with this unnecessary anxiety for six months or even a year before they were able to be told that there was nothing to worry about. For others, they had to undergo further diagnostic tests, sometimes surgery.

Even among patients with new lung nodules greater than 4mm in size detected (nodules that were not present on the initial CT scan), the false positive rate was 92%. This means that the overwhelming majority of patients with newly diagnosed lung nodules (92%) did not have lung cancer.

Because of the anxiety produced by being told that one has a potentially cancerous lung nodule as well as the significant morbidity (and even mortality) associated with some of the interventions used to definitively diagnose these nodules, this study reveals that the CT screening approach resulted in more harm than good for these patients.

In order for a screening test to be effective for a relatively uncommon disease (and lung cancer is still uncommon, even in high risk smokers), the false positive rate must be extremely low. In other words, the test must not detect a large number of nodules that turn out to be benign. Otherwise, these patients will suffer a great deal of unnecessary anxiety and possibly morbidity and mortality. There would certainly have to be strong evidence of a significant mortality benefit in the population to recommend the use of such a screening test. In this case, helical CT scanning simply does not meet these criteria.

In more general terms, the results of this study underscore the pointlessness of devoting substantial resources to lung cancer screening. We should be focusing our resources in the area where we know we can have an effect: prevention of lung cancer through interventions to prevent smoking initiation and encourage smoking cessation.

A central tenet of medicine is "first, to do no harm." Screening for lung cancer, even in high risk individuals, appears to violate this basic principle.

Health Group Claims FDA Performance Standards Would Make Cigarettes Less Harmful

In a web site report that was shared with individual tobacco control advocates this week, the Campaign for Tobacco-Free Kids argues that FDA performance standards proposed in the FDA tobacco legislation re-introduced in Congress last Thursday would make cigarettes less harmful. These performance standards refer to authority that would be given to FDA to require tobacco manufacturers to reduce or eliminate certain tobacco product ingredients or smoke constituents. The report went on to explain that these performance standards are in fact the primary way by which this legislation would make tobacco products less harmful.

According to the report: "These bills provide FDA with the authority to require changes to tobacco products to protect the public health, such as the reduction or elimination of ingredients, additives, and constituents, including smoke constituents ... A performance standard would be the primary way in which FDA would require tobacco products to be made less harmful."

The Rest of the Story

While on first impression, these performance standards might sound like a reasonable idea, closer inspection reveals that the idea is actually quite absurd. If tobacco smoke contained one or perhaps a few carcinogens, then it would make sense to attempt to regulate the safety of the product by setting standards for the presence of, or levels of, these carcinogens. But with over 40 known carcinogens, what sense is there in proposing to regulate the safety of the product by setting performance standards that would eliminate or reduce levels of just a number of these carcinogens? And what evidence is there to support an assertion that getting rid of a few of these carcinogens would make any significant difference in reducing the overall harm of the product?

Unfortunately, we simply do not know which specific carcinogens of the 40+ carcinogens in tobacco smoke and which specific toxins of the 4000+ chemicals in tobacco smoke are responsible for what diseases, what quantities of these chemicals produce what effect, and what the effect of removing these chemicals will be, as well as how the combination of chemicals removed will affect disease risk, if at all, and whether the processes used to alter the chemical makeup of cigarette smoke will introduce new chemicals that may even be more hazardous to health. There is absolutely no evidence to support a contention that requiring removal of a few selected substances in tobacco products would substantially reduce the health risks of smoking. Thus, any claim of public health relevance of such a requirement is completely unsubstantiated.

Consider the following list of carcinogens in tobacco smoke (from the 1989 Surgeon General's report): Benz(a)anthracene, Benzo(b)fluoranthene, Benzo(j)fluoranthene, Benzo(k)fluoranthene, Benzo(a)pyrene, Chrysene, Dibenz(a,h)anthracene, Dibenzo(a,i)pyrene, Dibenzo(a,l)pyrene, Indeno(1,2,3-c,d)pyrene, S-Methylchrysene, Quinoline, Dibenz(a,h)acridine, Dibenz(a,j)acridine, 7H-Dibenzo(c,g)carbazole, N-Nitrosodimethylamine, N-Nitrosoethylmethylamine, N-Nitrosodiethylamine, N-Nitrosopytrolidine, N-Nitrosodiethanolamine, N’-Nitrosonomicotine, 4-(Methylnitrosamino)- 1-(3-pyridyl)-1-butanone, N’-Nitrosoanabasine, N-Nitrosomorpholine, 2-Toluidine, 2-Naphthylamine, 4-Aminobiphenyl, Formaldehyde, Acetaldehyde, Crotonaldehyde, Benzene, Acrylonitrile, 1, 1 -Dimethylhydrazine, 2,Nitropropane, Ethylcarbamate, Vinyl chloride, Hydrazine, Arsenic, Nickel, Chromium, Cadmium, Lead, Polonium-210.

If FDA decided to require the elimination of 10 of these carcinogens (which is an optimistic assumption given the nature of the regulatory process), and the resulting list of carcinogens in cigarettes was as follows, would the product be substantially safer to smoke? Benz(a)anthracene, Benzo(b)fluoranthene, Benzo(j)fluoranthene, Benzo(k)fluoranthene, Benzo(a)pyrene, Chrysene, Dibenz(a,h)anthracene, Dibenzo(a,i)pyrene, Dibenzo(a,l)pyrene, Indeno(1,2,3-c,d)pyrene, S-Methylchrysene, Quinoline, Dibenz(a,h)acridine, Dibenz(a,j)acridine, 7H-Dibenzo(c,g)carbazole,, N-Nitrosoethylmethylamine, N-Nitrosodiethylamine, N’-Nitrosoanabasine, N-Nitrosomorpholine, 2-Toluidine, 2-Naphthylamine, 4-Aminobiphenyl, Formaldehyde, Acetaldehyde, Crotonaldehyde, Benzene, Acrylonitrile, 1, 1 -Dimethylhydrazine, 2,Nitropropane, Ethylcarbamate, Vinyl chloride, Hydrazine, Arsenic.

It should be clear how absurd this strategy for regulating the safety of cigarettes is from a public health perspective. To me, it seems misleading for public health groups to give the public the perception that performance standards will somehow make cigarettes a safer product. After all, these same public health groups are protesting the use of words like "mild" and "light" by cigarette companies, claiming that smokers are being misled into thinking that such cigarettes are safer. If public health practitioners are truly concerned about the adverse impact of unsubstantiated health claims, then they should certainly not be making any health claims that they cannot substantiate themselves. And the claim that performance standards "are in fact the primary way by which this legislation would make tobacco products less harmful" seems to me to be misleading, based on the above analysis.

Along similar lines, the health groups are touting that the legislation's requirement that cigarette companies disclose the complete list of ingredients, additives, and constituents in tobacco smoke would be an important public health victory. Given the complex nature of tobacco smoke, I doubt that such a requirement could be met, short of years and years of laboratory work. Nevertheless, even if it could be met, it has no relation whatsoever to the health of the public. What else do we need to know beyond the fact that cigarettes are deadly? Having a complete list of the thousands (and according to the National Cancer Institute, there may be hundreds of thousands) of smoke constituents is not going to help make tobacco products safer.

It seems to me that the effort to try to regulate the safety of tobacco products through an ingredient-by-ingredient approach is absurd, senseless, and a complete waste of resources. We simply cannot regulate the safety of this particular product, and we should not try to do so. Shouldn't we be concentrating our efforts on trying to get people to quit smoking and preventing them from starting to smoke, rather then pretending that the Food and Drug Administration will, in its infinite wisdom, be able to give companies a list and magically produce a safer cigarette?

I certainly hope that there are enough sensible public health advocates out there who realize how absurd this FDA tobacco legislation is. It would be a disaster for public health, and more specifically - a disaster for smokers, who would be grossly misled by the impression that the product is going to become safer, if this legislation were to be enacted.

Washington State Considering Cigarette Tax Hike to Fund Education; 11 Other States Considering Tax Increases

Washington Governor Christine Gregoire has proposed a 20 cent per pack increase in the state cigarette excise tax, with a 60 cent per pack increase to follow in January 2007, in order to fund an initiative that would reduce school class size and create more student slots in state colleges, according to an article in Tuesday's Seattle Post-Intelligencer. Washington currently has the ninth-highest cigarette tax in the nation. According to the article, 11 other states are considering cigarette tax increases during the current legislative session. Public health advocates are generally among those who support these cigarette tax proposals. For example, in Texas, health advocates were the ones cited in a recent article as pushing for a tobacco tax increase, which would "help stretch the thin state budget."

The promotion of cigarette tax increases as a part of tobacco control practice started with the highly successful Proposition 99 in California, an initiative that increased the cigarette tax by 25 cents per pack and allocated 25% of the revenues to tobacco prevention and education programs, tobacco research, and smoking cessation programs (an approach that was followed in Massachusetts, Arizona, and Oregon). More recently, however, tobacco control and public health organizations have begun to promote cigarette tax increases to fund non-tobacco-related programs; this year, many of the tax increases that health advocates are supporting are being proposed to make up for general state budget shortfalls or to fund completely non-health-related programs that have been cut due to these budget shortfalls.

The Rest of the Story

While initially an advocate for cigarette tax increases as a public health and tobacco control strategy, I have come to change my position and I no longer view these tax increases as an appropriate public health approach unless the revenue (at least a significant portion of it) is used in a way that directly benefits smokers. I just cannot see a public health justification for using smokers as a way to raise revenues to fund programs that the government should otherwise be funding from general revenues.

In other words, if public health practitioners are faced with a decision about how to promote the funding of necessary and worthwhile health programs, then a justified approach would be to encourage policy makers to allocate funds towards those programs. That may mean arguing that these programs are more of a priority than some other currently funded programs or it may mean arguing for some new source of revenue. But it does not seem appropriate to repeatedly call on smokers to be the ones to share the burden of funding all of these programs that are not being funded adequately.

When cigarette taxes are raised substantially without allocating a portion of the funds to directly benefit smokers, then I believe those taxes are regressive. Because of the strength of nicotine addiction, it is a fact that the costs of the funded programs will be borne by smokers. If we in tobacco control are correct in our assertion that nicotine is powerfully addictive, then the reality is that smoking does not represent a choice that people make that they can quickly and easily change. So there is no way to avoid the consequence that for the large majority of smokers (who are going to be unable to quit), they will be paying the increased costs that are necessary to fund programs that should have already been funded by other means.

I find the situation quite different when the purpose of the tax increase is to provide funding that, in some way, benefits smokers directly. I think it can be effectively argued that providing smoking prevention programs as well as services to encourage smokers to quit and help them to succeed represents a direct benefit to smokers. After all, any smoker could potentially take advantage of the services being made available to them and it is reasonably in the interest of any smoker to encourage future generations to avoid this addiction. In this case, while smokers are being asked to shoulder the burden of funding certain programs, at least they are directly benefiting from the increased costs. The direct benefits of the policy accrue to both smokers and nonsmokers.

But the kind of tax increases for which public health and tobacco control advocates are currently lobbying are in most cases aimed at building roads and bridges, providing health services, paying for education, or funding a host of programs and services that the government should arguably be providing already. There are no direct benefits to the overwhelming majority of heavily addicted smokers who will not quit due to the cigarette tax, yet they are the ones shouldering nearly the full burden of the costs. I do not think it unreasonable to ask that public health practitioners insist that at least a portion of the resulting revenues be used for programs that will directly benefit the smokers who are providing the essential funds.

There are two other problems with promoting cigarette taxes as a way to raise general revenues or fund non-tobacco-related programs. First, if public health practitioners support this approach then it seems that they should similarly support taxation on other products that represent unhealthy behaviors, such as drinking alcohol, eating lots of fast food, or driving an SUV (which I believe increases mortality in motor vehicle accidents). However, I have not heard any tobacco control or public health organization lobby for an increased tax on alcohol, fast food products, or extremely large automobiles (or any other "unhealthy" consumer product) in order to fund much-needed government programs. If the argument for levying a tax on fast food products in order to decrease school class size sounds weak, then I can't see why an argument for levying a tax on cigarettes for the same purpose is a strong one.

Second, when cigarette tax revenues are used to fund specific programs or to make up for budget shortfalls, the state then becomes reliant upon cigarette consumption to maintain these programs and services. It creates, instantaneously, an inherent incentive for the government not to be successful in sharply reducing smoking. The long term impact of this reliance on sustained smoking as an essential source of revenue may well negate the positive short-term effect of the tax on reducing cigarette consumption. I don't see this as a problem when the revenue is being allocated specifically to establish well-funded tobacco prevention and cessation programs, because the incentive to maintain smoking prevalence is moot - the state has already funded what should be an effective program to reduce cigarette consumption. But in the absence of such a program, the reliance on cigarette revenues will make it infinitely more difficult for health advocates to ever succeed in convincing legislators to fund a program that, if it works, will substantially reduce funding for other state programs.

While the successful cigarette tax-funded tobacco control programs such as those in California and Massachusetts should serve as models for public health and tobacco control practitioners, the deterioration of this policy approach into an all-out attempt to raise cigarette taxes as a source of revenue for any program under the sun is, I think, unfortunate, unfair to addicted smokers, and unjustified on public health grounds.

Tobacco Industry Escape Clause Revealed in Campaign for Tobacco-Free Kids/Philip Morris-Supported FDA Tobacco Legislation

The FDA tobacco legislation introduced in Congress Thursday, which is supported by Philip Morris and the Campaign for Tobacco-Free Kids, contains an escape clause that would allow Philip Morris or any other tobacco company to appeal to Congress to overturn any major regulation that the company does not like. The legislation explicitly gives Congress the ability to review and, by majority vote, to overturn, within 60 days, any major tobacco rules promulgated by FDA, resulting in such rule having no force or effect.

Given the lobbying power of Big Tobacco in Congress, this essentially gives the companies the ability to block any substantial tobacco rules that would be expected to have significant financial consequences -- precisely those which might otherwise have public health benefit. The legislation makes it easier for Big Tobacco to obtain a Congressional override of an FDA rule by prescribing rules for the consideration of such override legislation that limit the ability of legislators who oppose such a measure to kill it (i.e., it prescribes rules that take away many of the procedural moves by which legislation can normally be killed).

The Rest of the Story

By keeping all major regulatory decisions within the oversight of Congress, the legislation politicizes what should be primarily scientific and public health issues. This provision in the legislation essentially represents an "escape clause" by which the tobacco companies could escape unfavorable regulation simply by mobilizing enough support within Congress to pass a joint resolution of rule disapproval. And the rules governing the procedure by which such a joint resolution is considered are geared towards making it more difficult than normal to kill such a measure.

The bill achieves this escape for Big Tobacco by making any major FDA rules subject to section 801 of Title 5 of the United States Code (Congressional review of agency rulemaking). However, the bill could presumably have exempted these regulations from Congressional review just as easily. In fact, the bill does exempt from Congressional review the advertising and youth access regulations that the Secretary of Health and Human Services would be forced to promulgate (the 1996 FDA regulations). However, the remainder of the rules that FDA is given the authority to promulgate are not exempted from the Title 5, Section 801 provisions.

Presumably, the simple inclusion in the legislation of a clause stating that ‘‘Section 801 of Title V of the United States Code does not apply to the regulations referred to in the Family Smoking Prevention and Tobacco Control Act" would allow FDA to regulate tobacco products without explicit Congressional review and would eliminate the short-circuited process by which Congress can override FDA rules under the current bill.

That the Campaign for Tobacco-Free Kids has stated that this legislation is "strong" and puts "protection of the public health first" is unfortunate, given their presumable knowledge that this "Philip Morris escape clause" was tucked away into the bill, apparently with the Campaign's approval.

Northwestern Mutual Imposes Surcharge on Smoking Employees; Action Comes Just Weeks after Weyco, Inc. Fires Four Smokers

The Milwaukee-based Northwestern Mutual Life Insurance Company has announced that starting next year, it will impose a $25 per month health insurance coverage surcharge on employees who smoke - whether they smoke at work or at home, according to an article in the Milwaukee Journal Sentinel. Apparently, the surcharge will apply not only if the employee smokes, but also if a covered family member smokes. The article cites a Northwestern Mutual spokeswoman as saying: "We are not seeing this as a punishment in any way. We're just looking at different ways to incentivize people."

This announcement comes in the wake of Okemos, Michigan-based Weyco, Inc.'s decision to fire four employees who continued to smoke after a new policy requiring employees to quit smoking went into effect this past January. The policy makes it a firing offense for employees to smoke, whether they smoke at work or at home. The policy was announced one year in advance and smokers were offered cessation classes. Most of the smokers apparently quit, but four who did not were fired. A Lansing State Journal article quoted Weyco owner Howard Weyers as explaining that: "You can do whatever you want, but if you're going to work here, you can't be a smoker, like you can't be a drug user."

A third approach, in addition to firing smokers or imposing health insurance surcharges, that seems to be increasingly used by employers, reportedly in an effort to control health-realted expenses, is the refusal to hire smokers in the first place. For example, Union Pacific Corporation apparently instituted a pilot program in which it rejects the application of any prospective employee who indicates that he or she smokes.

The Rest of the Story

The actions of Weyco, Inc., Northwestern Mutual Life, Union Pacific Corporation, and other companies raises a question that is broader and perhaps more important than the question of employment policies regarding smokers: Is it appropriate for an employer to interfere in the legal, off-duty, private activities and lifestyle decisions of workers? There is little question that an employer has a legitimate interest in controlling behavior of its employees on-the-job. For many reasons, smoking while at work may be viewed as interfering with the performance of one's duties, may impose excess maintenance and cleaning costs, and may violate building smoking policies. However, there does not seem to be a legitimate employer interest in controlling employee's lawful activities off the job, or at least certainly not an interest so substantial that it would justify the degree of intrusion into an employee's private life that these policies represent.

These policies regarding smoking raise the question of what other life decisions employers will try to control next. Will they start imposing surcharges on, refusing to hire, or firing workers who are overweight, eat a lot of fast food, or fail to get enough physical activity? The argument that these smoking policies are simply an effort to "incentivize" workers does not hold water. So would a policy to require employees to lose weight, eat nutritious food, or engage in a certain amount of physical activity. And the comparison between smoking and drug use that the Weyco owner made is not relevant, since smoking is a legal activity; no one would argue that an employer should not be able to make employment decisions based on criminal behavior on the part of their workers.

As courts have thus far upheld employers' rights to use smoking as a factor in hiring decisions, some states have enacted laws that specifically disallow companies to refuse to hire smokers. But perhaps these laws are tailored too narrowly. Should the law not reflect the value that society places on freedom to engage in lawful activities and have autonomy of personal decision-making (as long as one does not engage in illegal behavior) outside of the workplace? Should such laws not simply state that lawful activities performed outside the workplace are not in the realm of factors that can be considered in employment decisions?

Regardless of the legal issues raised by these smoking employment policies, it is important to recognize that from a public health and tobacco control standpoint, there is no justification for promoting these policies, which represent an infringement on the autonomy of individuals to make lifestyle choices outside of the workplace, even if they may be unhealthy choices.


UPDATE (March 25, 10:00 am): For a published debate over this issue, see the April 2005 issue of Tobacco Control: Gray NJ. The case for smoker-free workplaces. Tobacco Control 2005; 14: 143-144 and Chapman S. The smoker-free workplace: the case against. Tobacco Control 2005; 14: 144.

Campaign for Tobacco-Free Kids Releases List of What FDA Tobacco Legislation Would Do

The Campaign for Tobacco-Free Kids today released a list of what it claims the Philip Morris-supported FDA tobacco legislation would do. According to the Campaign, the legislation would:

• Reinstate the 1996 FDA rule on youth access to tobacco and tobacco marketing;
• Give FDA the broadest possible authority to further restrict tobacco marketing;
• Require detailed disclosure of product content;
• Give FDA broad authority to require changes in tobacco products;
• Strictly regulate explicit and implicit health claims;
• Ban terms like "light," "mild," and "low";
• Require larger health warnings
• Expand state and local authority to regulate tobacco advertising

The Rest of the Story

Here is my account of what the FDA tobacco legislation would do, revealing the absurdity of this legislation from a public health perspective:

• It bans the presence of strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee in cigarettes, but does not inherently disallow the presence of hydrogen cyanide, carbon monoxide, N-nitrosodimethylamine, benzene, radioactive polonium 210, or nitrogen dioxide.
• It requires FDA to ban any tobacco product that contains a severely harmful chemical defect, but explicitly prevents FDA from doing the same with tobacco products that contain thousands of severely harmful chemicals, so long as those chemicals are ordinarily contained in tobacco products.
• It provides for stringent regulation to prevent adulterated or misbranded products, but leaves the "pure" and "properly branded" deadly products largely unregulated.
• It requires that manufacturers report any adverse health effects of its products that are unexpected, but the expected 400,000 or so deaths per year due to these products require no special attention.
• It expresses grave concern for the tremendous harm to the public health caused by tobacco products that falsely purport to reduce disease risk, but does not require that FDA do anything about the high-dose products.
• It strictly regulates new tobacco products introduced to the market for safety and health, but allows existing products to continue killing hundreds of thousands of Americans each year (there is no requirement that FDA do anything to regulate existing products).
• It allows FDA to reduce or eliminate specific smoke constituents, but no one knows which constituents and in what combination and amounts are responsible for disease, nor does anyone know whether reducing or eliminating some of these constituents would have any effect whatsoever on health.
• It expresses grave concern over youth access to tobacco products and calls for comprehensive restrictions on the sale of tobacco products to minors, but it explicitly prevents FDA from regulating the sale of cigarettes in any specific retail establishments (including malls, grocery stores, restaurants, gas stations, convenience stores, bowling alleys, and even pharmacies).
• It provides for extremely rigorous and comprehensive (and probably impossible) tobacco company reporting of brand-specific levels of tobacco smoke constituents, but does not require any particular action concerning the many constituents that are already known to be harmful.
• It requires the FDA to prescribe labeling requirements for the proper use of the tobacco product. How does one properly inhale dangerous chemicals and deadly carcinogens?
• It requires FDA to consider periodically new medical data on cigarette risks, but the existing evidence on the established risks of cigarettes can be largely ignored.
• It requires notification to all tobacco product users of the substantial health risks of any new tobacco products, but no special notification procedures for the existing deadly products.
• It requires FDA to recall and ban any tobacco product that contains a manufacturing defect that is not ordinarily present in tobacco products, but a serious defect - such as producing death - is fine, so long as the deaths are caused by an ordinary constituent of the product rather than a new manufacturing defect.
• It allows the FDA to prescribe strict regulations to protect the public's health from sub-standard packing and storage, but the fact that what is being packed and stored is inherently dangerous is of little concern. The FDA may prescribe stringent regulations to eliminate any pesticide residues on the tobacco, but the rest of the toxins inside the tobacco are not necessarily regulated.
• It essentially ensures that true reduced risk products never enter the market, and that existing high-risk products never leave it.
• It explicitly gives Congress the authority to immediately review and overturn any FDA-promulgated regulations that it does not like.

The Campaign for Tobacco-Free Kids' concluded that: "The language is carefully crafted to curtail abuse and to ensure the FDA has the broad authority over tobacco products it needs to protect public health and save lives."

I think a more accurate conclusion regarding the legislation would be: "The language is carefully crafted to limit FDA's authority in order to protect Philip Morris and its profits."

American Legacy Foundation Defends its Award to Time Inc.

In a statement posted on Globalink Thursday, the American Legacy Foundation defended its award to Time Inc. for "progress in tobacco-free publications" (see previous post and update).

The first paragraph of the response stated: "The American Legacy Foundation has for several months been aware of the concerns expressed by some members of the tobacco control and public health communities regarding the selection of Time Inc., as a recipient of the 2005 Progress in Media award at our annual American Legacy Foundation Honors event. This award for progress is just that: an award to encourage progress, not reward success. The foundation also presents three other awards: one each for public service, community activism and corporate leadership. ... Some awards honor leadership, others encourage progress, and others are based on research and activist leadership."

The response also attacked the author of this blog, accusing him of joining forces with the tobacco industry:

"So to those critics who believe we have 'exited tobacco control,' we disagree. And we note with interest that they have oddly joined forces with their enemies in the tobacco industry, who share their fervor for eliminating our organization."

The Rest of the Story

The American Legacy Foundation's response to criticism of its award to Time Inc. is, in many ways, even more problematic than the actual award.

The primary response of the Foundation was that the award was not an award to "reward success" but to "encourage progress." What a bunch of crap!

First of all, the verb award is defined as "to give as due or merited" (Random House Dictionary of the English Language). Thus, it implies that the recipient has done something to deserve the award. The Legacy Foundation can define the word, after the fact, however they may please, but the clear meaning of the award, as it is going to be interpreted by the public, is that Time, Inc. is being recognized for some sort of merit in tobacco control. In fact, the invitation to the awards dinner explains in some detail the "accomplishments" for which Time Inc. was being recognized.

Second of all, nowhere in the invitation to the awards dinner was there any implication that Time Inc. was being awarded solely to encourage them to make progress, rather than to recognize them for making progress. The invitation itself stated that the award was being given for "progress in tobacco-free publications" and for "reaching millions with an anti-tobacco message." The very name of the award - "Progress in Media" - makes it very clear that the award is recognizing progress.

Third, the very idea of giving an award to "encourage progress" is absurd. In 20 years in tobacco control and public health, I've never seen a public health group give an award to an organization that has done significant harm to the public's health solely to encourage progress. Generally, those of us in public health try to change harmful corporate behavior by criticizing that behavior, not by rewarding it.

If the American Legacy Foundation really wants to give an award to "encourage progress," why don't they simply give an award directly to Philip Morris? After all, if they want to encourage progress, the best place to start would be directly at the source.

What is most disturbing about the American Legacy Foundation's response is that they apparently have the audacity to believe that we - individual practitioners in tobacco control - are stupid enough to buy the explanation that they gave the award not to reward progress, but simply to encourage it. How stupid do they think we are? Even my children understand that when they they are awarded for something, they are being rewarded for an accomplishment of some sort, not that they are being told that we're unhappy with their behavior and want them to change - so here's a reward.

Instead of publicly issuing such a stupid response, why couldn't the Foundation simply admit their mistake and apologize? That's all that's required. No fancy explanations, no strange re-definitions of unambiguous, well-recognized words. Just a simple admission of a mistake, and a simple apology.

Finally, I cannot allow the Legacy Foundation's accusation that I have "oddly joined forces with [my] enemies in the tobacco industry" to go unmentioned. The statement is a pure lie - I have not joined forces with the tobacco industry and they know it. So does everyone in tobacco control.

Nevertheless, the Legacy Foundation's statement accusing me of joining forces with the tobacco industry is not most disturbing to me because it is an untruthful personal attack. It is most disturbing to me because it suggests that their view is that anyone within public health who criticizes their actions must be working with the tobacco industry. They apparently view their "truth" campaign as so sacred, and so important, that anything anyone says that may in any way interfere with Legacy's efforts to secure funding for that campaign, even if such efforts are viewed as being inappropriate, is tantamount to helping out the tobacco industry.

Actually, by having the courage to speak out and help ensure that the means by which public health practitioners achieve their desired ends are ethical, appropriate, justified, truthful, and carried out with integrity, we are helping to strengthen and improve the public health movement, not the tobacco industry.

Philip Morris and Health Groups Applaud Re-Introduction of FDA Tobacco Legislation

The nation's largest tobacco company and four prominent health groups today joined together to support legislation that would give the FDA authority to regulate tobacco products. In statements issued today, Philip Morris USA (web site) and a coalition of the Campaign for Tobacco-Free Kids, the American Cancer Society, the American Heart Association and the American Lung Association (press release) expressed support for bills introduced today concurrently in the Senate and the House. The Altria web site provided a link to the Campaign for Tobacco-Free Kids press release, emphasizing the nexus between the tobacco manufacturer and some members of the public health community on this issue. Philip Morris also noted that it has "worked diligently with the public health community" in reaching this "policy solution."

Among the bill's provisions cited by both Philip Morris and the coalition of health groups as benefiting the public's health are strengthened cigarette warning labels, full ingredient disclosure, authority for FDA to eliminate terms like "light" and "low-tar," authority for FDA to require removal of certain harmful tobacco smoke components, a ban on candy and fruit flavored cigarettes, and authority for FDA to help prevent the sale of tobacco to minors.

The Rest of the Story

Based on a detailed analysis of the specific provisions of the legislation, it is clear that it fails to protect the public’s health in any substantial way, and that in fact, it would be detrimental to the public’s health in a number of ways:

• The way in which the bill frames the problem of tobacco use in our society is inconsistent with the public health paradigm. The bill stringently regulates new products and reduced risk products, but essentially allows existing, high-risk products to continue killing hundreds of thousands of Americans each year.
  
• The bill completely ties the hands of FDA in terms of complying with the very legislation that sets requirements for its action. The loopholes in the legislation are huge, and not only benefit the tobacco industry, but institutionalize tobacco and addiction to tobacco products in our society. The fatal flaw of the legislation is the unacceptable degree of restriction of FDA’s potential actions which makes it impossible for FDA to act appropriately within the legislative mandate it is given.
• Tobacco companies will benefit from this bill because they will be able to use the fact of being regulated by FDA to achieve improved public opinion by taking advantage of the public perception that the tobacco problem is basically taken care of. The public’s perceived level of the health risk posed by ordinary tobacco products will decline as the public perceives the fact of FDA regulation as automatically meaning that the product must be reasonably safe, or at least safer. The bill will likely result in increased deaths compared to no legislation at all, as the bill will:
• make it virtually impossible to research, develop, introduce, and market new potentially less hazardous tobacco products;
• undermine current and future litigation and the public health remedies that are likely to result from such litigation, as tobacco companies will be able to successfully use the argument that they are already thoroughly regulated; and
• reduce the public's perception of the inherent harms of cigarettes.

• Additionally, there are no documented mechanisms by which the legislation will save lives:
• Research has documented that the kinds of marketing restrictions imposed by the bill are not effective in reducing youth smoking, or even in reducing youth exposure to cigarette advertising. The more stringent of the advertising restrictions will certainly be challenged in court, and may be found to violate the First Amendment.
• Performance standards and disclosure requirements of the bill will not improve the public’s health. It is simply not known which specific carcinogens of the 40+ carcinogens in tobacco smoke and which specific toxins of the 4000+ chemicals in tobacco smoke are responsible for what diseases, what quantities of these chemicals produce what effect, and what the effect of removing these chemicals will be.
• The Modified Risk Product section of the bill would make it virtually impossible for modified risk products to enter the market, while at the same time, allowing reduced exposure products to essentially be falsely marketed as reduced risk products. In effect, it protects the existing high-risk products on the market and precludes any harm reduction approach to tobacco control.

The basic approach taken by the legislation is quite absurd from a public health perspective:

• The measure would stringently regulate new and potentially less hazardous tobacco products while doing little to prevent the most harmful form of tobacco – existing cigarettes – from continuing to cause the deaths of nearly half a million Americans each year.
• Although the bill would enable the FDA to prevent the introduction of new cigarette brands that falsely claim to reduce the risk of disease, it would permit Marlboro and the other most popular existing cigarette brands to continue business as usual.
• The bill bans the use of strawberry, grape, chocolate, or similar flavoring additives in cigarettes but does not mandate the elimination (or even reduction) of toxic gases like hydrogen cyanide or the more than 40 known cancer-causing constituents of cigarette smoke such as benz(a)pyrene, benzene, and radioactive polonium.

Philip Morris now stands shoulder to shoulder with the Campaign for Tobacco-Free Kids, the American Cancer Society, the American Heart Association, and the American Lung Association in lobbying for passage of this legislation. Even if a detailed analysis of the bill did not reveal the reasons why Philip Morris supports the legislation, one would have to question the judgment of the health groups in helping the leading tobacco company achieve the federal policy result it most desires.

If this bill passes, it will be devastating for the tobacco control movement as well as for the public's health.

Partnership between Attorneys General and Big Tobacco Exposed; Attorneys General are Vigorously Protecting Major Tobacco Companies

A little-noticed New York federal district court decision issued in September has brought to the forefront how strongly the nation's attorneys general, including the current treasurer of the American Legacy Foundation, have worked to protect the interests of the nation's leading tobacco companies.

In the case, plaintiffs (importers that buy from small tobacco manufacturers that did not participate in the Master Settlement Agreement [MSA]) assert that the MSA and certain state laws related to MSA provisions violate antitrust laws because they have created an "output cartel" by the major tobacco companies that unfairly and illegally inhibits competition from smaller companies. In January 2004, a New York federal appeals court ruled that the MSA could indeed be challenged on antitrust grounds.

Now, a New York district court judge has issued an injunction against the state law, effective in 2003, that essentially forces non-participating tobacco companies to make full MSA payments to all states, even if they sell in only one or a few states. The injunction finds that this law, which is similar to laws passed in 38 other states, is not justified on any public health or other basis and is likely to violate antitrust laws. The judge found that: "The only purpose [of the law] appears to be a desire to accommodate the PMs [participating manufacturers - i.e., big tobacco companies], and to protect them unduly against competition from the NPMs [non-participating manufacturers - i.e., small tobacco companies]."

The Rest of the Story

The MSA represents, and has created, a strong partnership between the state attorneys general and the major tobacco companies. This partnership is evidenced by the extent to which the AGs have gone to protect Big Tobacco from harm:

• The MSA itself imposed escrow payments by non-participating manufacturers -- companies that were not even parties to the agreement -- by requiring states to pass such laws in order to receive their full share of MSA payments.
• The MSA made payments to the Public Education Fund contingent on the large tobacco companies retaining their overwhelming market share.
• Most of the attorneys general joined in the submission of an amicus brief in the Price vs. Philip Morris case in Illinois, urging the judge to reduce the $12 billion bond payment that he had required of the company after his Madison County trial court issued a $10.1 billion judgment against Philip Morris (see separate posting on the amicus brief). Signatories included William Sorrell (Vermont), now treasurer of the American Legacy Foundation and Christine Gregoire (Washington), former board chair of the American Legacy Foundation.
  
• It appears that at least some of the attorneys general (most notably, Bob Butterworth of Florida [which settled its tobacco lawsuit independently with the companies]) played a role in supporting state legislation (enacted in at least 23 states) that places limits on the amount of the appeal bond that tobacco companies must pay in order to challenge a guilty verdict.
• According to a recent Fortune article (Roger Parloff, Is the $200 billion tobacco deal going up in smoke? March 7, 2005), Attorney General William Sorrell of Vermont wrote a letter to all state attorneys general in September 2003 warning them that the success of non-participating tobacco companies was threatening the market share of Big Tobacco and urging them to take action to protect Big Tobacco from this competition: "Increasing sales by [nonparticipating manufacturers] will sharply reduce the next scheduled payments. These results underscore the urgency of all states taking steps to deal with the proliferation of [nonparticipant] sales."

The MSA has in fact set up a partnership between the states and the tobacco companies, and the attorneys general have gone to great lengths to come to the financial rescue of Big Tobacco in order to protect both of their financial interests. The financial interests of the states and Big Tobacco are irretrievably intertwined because of the MSA.

Despite anything that the attorneys general or their public anti-smoking foundation - the American Legacy Foundation - may say about the public health benefits of the settlement, the alliance that it has created between the states and Big Tobacco is a complete public health disaster that dwarfs any small positive impact that the MSA may have had on the public's health.

In my view, the MSA and what it has created - including the actions of the nation's attorneys general and the American Legacy Foundation, which have undermined public health goals for financial interests - is and will continue to be the greatest public health blunder of my lifetime.


UPDATE (March 16, 10:30 pm): The New York state Senate today passed a bill that would cap at $100 million the bond tobacco companies would have to post in order to appeal a damage award against them. According to a Newsday article, a spokesman for Governor Pataki confirmed that the reason for this bill was to protect the state's MSA payments (in other words, to protect the financial health of Philip Morris). This is just the latest example of the public health damage created by the partnership between the states and the tobacco companies.

UPDATE 2 (March 20, 10:30 am): A Louisville Courier-Journal article reported yesterday that a federal district judge this week issued an injunction against part of a 2004 Kentucky law that essentially forces non-participating tobacco companies to make full MSA payments to all states, even if they sell in only one or a few states. This now marks the second instance in which an injunction has been issued againstan MSA-related state law intended to protect Big Tobacco from smaller potential competing manufacturers. A federal judicial panel is considering whether to consolidate related cases in New York, Kentucky, Oklahoma, Tennessee and move them all to the New York court.

UPDATE 3 (March 28, 4:15 pm): The Arkansas House passed a bill that would limit the bond tobacco companies would have to pay to appeal an unfavorable court decision to $25 million, regardless of the amount of the damages awarded. Under current law, the companies would have to post bond for the full amount of the damages in order to appeal the decision.