Friday, April 29, 2005

Philip Morris Uses its Support of FDA Legislation to Gain Good Will at Shareholders Meeting

At yesterday's Annual Shareholders Meeting, Louis C. Camilleri, Chairman and Chief Executive Officer of Altria Group, Inc., used the company's support of recently introduced FDA tobacco legislation to help gain good will for Philip Morris by painting it as "a responsible tobacco company." It was one of three company initiatives that Camilleri relied upon for this purpose; the other two were Philip Morris' website smoking cessation resources and its programs to reduce sales of tobacco to minors (e.g., the "We Card" program).

According to Camilleri's statement: "We are encouraged that legislation has been reintroduced in the U.S. House and Senate to provide the Food and Drug Administration with authority to regulate tobacco products. We support the bills in their entirety because they would establish, for the first time, a comprehensive and coherent national tobacco policy in this country. Importantly, the legislation will also provide a framework and standards for products that could potentially reduce the harm caused by smoking, and define the appropriate ways to communicate about those products."

The Rest of the Story

If Philip Morris is using its support of FDA tobacco legislation to gain good will and improve its public relations, which is clearly intended to improve its bottom line, then several public health groups deserve at least honorable mention for helping to facilitate this public relations coup for the nation's largest tobacco company.

First, by virtue of having negotiated the bill in the first place and having agreed to enough major political concessions without any public health justification so that Philip Morris and its Congressional supporters were appeased, the Campaign for Tobacco-Free Kids can certainly chalk this up as one of its own public relations accomplishments.

Second, by virtue of following the Campaign's lead and agreeing to publicly support a bill that is largely designed to help protect and preserve Philip Morris profits, the American Cancer Society, American Lung Association, and American Heart Association deserve some of the credit for this tobacco company public relations victory.

Third, by failing to consult with its own membership before taking a position on the bill and for disseminating misleading information about the bill (chiefly, the omission of its most vigorous supporter - Philip Morris), the American Public Health Association certainly deserves some of the credit for this public relations bonanza for Altria and its Philip Morris subsidiary.

It is interesting that all of these public health organizations have no problem seeing through the smokescreen in front of the other two "accomplishments" that Camilleri cited: the company's assistance to smokers and its support of the "We Card" program. I don't think the idea that smokers would turn to the Philip Morris web site for help quitting smoking is one that is fooling too many public health groups, or that an initiative that emphasizes to kids how smoking is an adult thing is going to get too many public health groups to honestly believe that Philip Morris is now committed to doing something to substantially reduce its profits (and there is published evidence of the lack of efficacy of programs like "We Card").

But for some reason, the smokescreen in front of the third prong of Altria's public relations attack - its support of "comprehensive" FDA tobacco legislation, is so thick that only those outside the beltway (with due exception for ACSH) seem to be able to see it for what it is.

Fortunately, I do not think the bill has a serious chance of passage through the House under its current political composition and with the current Administration and House leadership. Plus, the House Republicans are going to have a field day when they start getting calls from public health advocates urging them to vote down this legislation for the sake of the public's health.

Unfortunately, the public relations victories that Philip Morris is gaining and will continue to gain, even if the bill goes down the tubes, are very real. At the end of the day, it will be quite sad that we - through some of our major public health groups that purportedly represent us - will shoulder some of the blame for these public relations victories for the nation's leading tobacco company.

Wednesday, April 27, 2005

New Navy Study Shows Attrition Higher Among Smokers

A study conducted by researchers at the Naval Post Graduate School in Monterey, California and released earlier this week reported that Navy recruits who smoke are more likely to leave the service without completing their enlistment than nonsmokers. Examining first term attrition among 6,950 Navy recruits, the researchers reported attrition rates of 50% for heavy smokers (one pack per day or more), 37% for light smokers, and 27% for nonsmokers.

The study found that smokers were more likely to also have a history of other "misbehavior," including truancy, suspensions, legal problems, and dropping out of school. While the study concludes that a policy of not recruiting smokers would lower attrition, it points out that a more effective policy would be refusing to recruit anyone who smoked heavily as a youth even if they subsequently quit, because the factors associated with smoking initiation appear to be the ones that are predictive of increased attrition, not the actual smoking behavior at the time of enlistment.

The Rest of the Story

Some tobacco control advocates may read the results of this study as providing additional rationale for smokefree hiring policies, since it provides evidence that smokers have higher attrition rates. However, we should not be hasty here.

What the study actually demonstrates is that it is possible to identify a series of factors related to youth behavior that quite accurately predict rates of attrition, at least in terms of military enlistment within the first year of service. And while active smoking is one such predictor, it is probably not the best one. Even better would be a history of having smoked heavily as a youth, regardless of whether or not one smokes at the present time. And better yet might be the age of onset of smoking experimentation. Other excellent predictors suggested by the study authors include the age at which a person wears tattoos or undergoes body piercings.

The bottom line here is that smoking is simply a proxy for a constellation of rebellious behaviors that probably reflect the degree to which a youth rejects adult authority. And it is most likely that propensity to reject authority that ultimately explains the relationship between smoking and attrition, not the smoking behavior itself.

This study highlights the profound dangers of tobacco control advocates promoting policies in which employers refuse to hire smokers for reasons other than a direct negative impact of smoking itself on job performance or a conflict of interest between that behavior and the mission of an employer. First, if smoking is serving only as a proxy for other factors that are truly related to employee retention, then such a policy is unfair to many smokers who may not in fact share those factors and therefore be individually not at high risk for job attrition.

Second, because smoking is just one of many factors that may influence attrition and because its relationship with attrition may not be causal, but spurious, it would be unfair to pre-judge smokers based on this one characteristic without examining the other characteristics that are actually related in a causal manner with attrition.

Third, such a policy is problematic because it demands an answer to the question, "where do we draw the line?" Do we promote policies to not hire anyone who started to smoke at a young age, even if they do not smoke now? Do we promote policies to not hire anyone who started smoking as a teenager, but not anyone who started smoking as an adult? Do we promote policies to not hire anyone with a history of having missed more than 10 days of school per year? How about refusing to hire anyone who ever wore a tattoo or engaged in body piercing? Each of these policies could probably be justified on the basis of a strong relationship with attrition rates.

Finally, perhaps the greatest danger of this type of thinking is that it is really the beginning of the creation of a sub-class of citizens, who, by virtue of a disadvantaged childhood and adolescence, are deemed ineligible to be a part of the employed in our society. Do we as public health practitioners really want to promote policies that significantly limit the jobs available to what is generally a poorer and less-educated segment of our population? Do we really want to contribute to making it harder, not easier, for these individuals to obtain employment and make a living to support themselves and their families and to give themselves an opportunity to pull themselves out of the lower class?

While employers may, at least in some states, legally make hiring decisions based solely on smoking status (absent a direct effect on job performance or a direct conflict of interest with employer mission), I do not think that we as public health practitioners can responsibly promote such policies. In fact, I think it should be our role to seriously question (i.e., oppose) them.

Tuesday, April 26, 2005

APHA Decides to Help Philip Morris Achieve Key Legislative Priority

The American Public Health Association (APHA) announced in its newsletter released today that it is working to help ensure the passage of Philip Morris' key legislative priority for the 2005 Congressional session: the FDA tobacco bill. The APHA states that the legislation, introduced in both houses of Congress in March, would "allow FDA to take action on many fronts, such as regulating tar, nicotine and other tobacco product components; promoting cessation to reduce disease risk; and requiring manufacturers to release research on the health effects of tobacco product use."

The Rest of the Story

In its 2004 annual report, Philip Morris revealed its own legislative priorities for the 2005 Congressional session: "Although PM USA has been increasingly successful in pursuing its societal alignment initiatives, regrettably, Congressional legislation providing for regulation of the tobacco industry by the U.S. Food and Drug Administration (FDA) was not passed in 2004. Although this was a significant disappointment, obtaining FDA regulation of the tobacco industry remains a key priority."

It is unclear why the nation's leading public health membership organization has decided to make Philip Morris' key legislative goal for the 2005 its own goal as well.

At very least, one would think that an organization with as much public health policy influence as APHA would, given the fact that it is about to work to help achieve a key Philip Morris initiative, attempt to conduct a careful and comprehensive analysis of the legislation, consulting with individuals within its membership who have conducted detailed analyses of this policy proposal. Instead, APHA has jumped onto a fast-moving train that I am afraid is bound for a public health disaster.

Perhaps even more disturbing is the fact that one would expect APHA to provide a full accounting of the strengths and weaknesses of the proposed legislation, especially since its members are naturally going to wonder how supporting a Philip Morris priority bill could possibly be in the best interests of the public's health. However, APHA reveals only that the bill will regulate tar, nicotine, and other tobacco constituents, promote cessation to reduce disease risk, and require manufacturers to release health effects research.

In terms of the regulation of tar, nicotine, and other constituents, APHA gives no indication how FDA regulation would produce a substantially safer cigarette. The organization also fails to reveal that the legislation explicitly prevents FDA from eliminating nicotine or banning an entire class of existing cigarettes, provisions that will give the tobacco industry the ability to block almost any meaningful regulation of tobacco consituents that would substantively change the way the cigarette is made.

In terms of promoting cessation, APHA gives no indication how FDA regulation would lead adult smokers to quit smoking. The organization also fails to reveal that by putting a virtual FDA stamp of approval on cigarettes, the legislation may well undermine current tobacco control efforts and could be expected to actually increase cigarette consumption.

In terms of releasing research on the health effects of tobacco, APHA gives no indication how this research would in any way promote the public's health. What more information beyond the fact that cigarettes are deadly and kill over 400,000 people each year is necessary to motivate actions to reduce tobacco use?

APHA should be ashamed to be walking shoulder to shoulder with Philip Morris through Congress, helping the nation's chief tobacco company to achieve its key legislative priority. But it should be even more ashamed for failing to reveal the truth behind the legislation, hiding from the public the fact that it is vigorously supported by Philip Morris, and not informing its membership of the critical loopholes in the legislation which protect the profits and political and legal interests of Philip Morris.

Monday, April 25, 2005

New Study Shows Dramatic Reduction in Illegal Sales to Minors

A study published in this month's issue of Tobacco Control reports a substantial reduction in the rate of illegal sales to minors, as measured by compliance checks conducted in accordance with the 1992 Synar Amendment. Violation rates in the 50 states dropped from a high of 73% in 1996 to a high of only 36% in 2000. And while in 1996, only one state reported a violation rate below 10%, seven states reached single digit violation rates in 2000. An additional 22 states had violation rates below 20% in 2000, compared to only two in 1996. The article concludes by calling for a continued emphasis on enforcement of youth tobacco sales laws.

The Rest of the Story

What the study does not reveal is that the compliance checks used in complying with Synar are an artificial exercise that is not consistent with reality and therefore tell us very little about what the actual rates of illegal sales to minors are.

The chief problem is that youths testing for violations are: (1) not allowed to lie about their age; (2) not allowed to present false identification or make up excuses about where their identification is; (3) not actually trying to purchase cigarettes for themselves and therefore not fully motivated to do what is necessary to obtain them; and (4) not based on "on-the-street" knowledge of youths about what outlets are likely to sell to minors and therefore not representative of the proportion of youth cigarette purchase attempts that take place at a given outlet.

Thus, the fact that violation rates in compliance checks in some states were as low as 6% does not mean that 94% of actual cigarette purchase attempts by youths are unsuccessful (or anything close to that).

When actually buying cigarettes, youths can lie about their age, present false identification, make up excuses about where their identification is, or rely on a host of other factors, such as honing in on outlets that are known to sell to minors, taking advantage of particular sellers, such as friends or acquaintances who they know will sell to them, purchasing cigarettes as part of a group of youths, some of whom may be known to the cashier, and many others.

It is also important to note that purchasing cigarettes is only one way that youths can obtain them, and in recent surveys, represents the mode of access for only about half of the cigarettes that youths smoke.

It is perhaps for these reasons that studies of the effect of youth access laws on youth smoking have shown no consistent impact on smoking initiation as well as no consistent relationship between violation rates in compliance checks and youth smoking (see, in particular: Fichtenberg CM. Glantz SA. Youth access interventions do not affect youth smoking. Pediatrics 2002; 109(6):1088-1092 and 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).

While this particular article calls for a continued emphasis on youth access programs, it is not clear to me why such an emphasis would be warranted based on what I feel are convincing data that these programs, as actually implemented on a widespread national basis, work.

Three years ago, Ling et al. called for an end to youth access tobacco programs (see: Ling PM, Landman A, Glantz SA. It is time to abandon youth access tobacco programmes. Tobacco Control 2002;11:3-6). I have seen nothing published in the past three years that would call that recommendation into question and a considerable amount of evidence that reinforces it.

I believe that youth access programs served an important purpose during the past decade: mainly, they served as an intervention around which community coalitions could mobilize and thus they helped create a community tobacco control infrastructure. Now it is time to use that infrastructure to implement interventions that work.

Sunday, April 24, 2005

IN MY VIEW: Something is Not Always Better than Nothing

Public health advocates are often faced with an interesting dilemma: is it better to support compromise legislation that has been watered down from what advocates initially supported, or to oppose such legislation in the hopes of getting a stronger bill enacted in the future? An example of this dilemma is the Georgia Smokefree Air Act of 2005, which bans smoking in family-oriented restaurants, but exempts adult-only restaurants and bars, and which allows smoking in enclosed, separately ventilated areas of restaurants. The legislation, passed by the Georgia House and Senate, is on the governor's desk awaiting his signature or veto. It is unclear whether the governor will sign the bill or not, but it is clear that public health advocates in Georgia are strongly supporting this watered-down legislation and consider it to be a "success."

While it may, in general, be a difficult decision that requires a careful weighing of potential consequences, I do not see much of a difficulty with this particular legislation. This is because the "something" that the bill does is, from a public health perspective, close to "nothing," yet it comes at the expense of posing a rather large imposition on the restaurant business in Georgia.

On the one hand, the bill allows smoking in certain areas of restaurants: namely, those that are enclosed and separately ventilated, and it completely exempts any restaurant that bans kids. Thus, the bill provides no guarantee of protection from secondhand smoke exposure for ANY restauarant worker in the state of Georgia. Workers in adult restaurants are not protected at all, and workers in restaurants that choose to be family-oriented are protected only at the discretion of their employer, who can choose to create a smoking room, with, notably, no size restriction. In other words, a Georgia restaurant that serves families can be in full compliance with the Act if it creates a smoking area that makes up 90% of the restaurant seating, as long as the smoking and non-smoking areas are enclosed and ventilated separately. Only a privileged sub-class of restaurant workers in Georgia are even afforded this opportunity for "protection."

On the other hand, the bill intrudes upon the autonomy of the restaurant business by forcing owners to make a decision about how to run their businesses (i.e., whether to cater to families or just adults), a decision that is necessary solely because of the legislature's inability to enact a consistent public health policy.

One might argue that the "achievements" within the bill, such as the restriction of smoking in family-oriented restaurants to enclosed, separately ventilated areas are still "worth" something, and that public health advocates should accept the current bill and then come back in the future and attempt to "strengthen" it.

But this argument fails because by forcing restaurants to make expensive alterations to their physical establishments (i.e., creating smoking rooms) as well as their overall marketing plans (i.e., becoming an adult-oriented establishment, firing youth workers, and recruiting and hiring new adult workers) in order to allow smoking, Georgia advocates are actually providing a very strong reason for the legislature not to intervene and eliminate smoking in the future. Is it really fair to force restaurants to make these expensive changes, only to come back in a year or two and eliminate smoking entirely? Whether it is or not, this is certainly an argument that will be used by opponents to stronger legislation and it will make it very difficult to enact a stronger bill in the future.

I think the best chance of achieving a smoke-free workplace for all bar and restaurant workers in Georgia is to scrap the current bill and come back next year with a renewed effort to promote one that actually makes some public health sense and which creates a level playing field for all bars and restaurants in the state. If one looks at the experience of the states that have enacted 100% smoke-free bar and restaurant laws, one sees that most of them enacted these bans from scratch, not as a result of amending previously-passed bans that had significant exemptions.

But I have yet to mention the two strongest arguments against supporting the current legislation. First, by doing so, it frames the issue of secondhand smoke as one of personal choice on the part of restaurant patrons. If we are only aiming to protect restaurant customers, then I think there is a valid argument that these patrons have a choice about whether to go to a smoke-free restaurant or not. I don't see a compelling reason to intervene when there are already a large number of smoke-free restaurants that are available to nonsmokers.

By supporting legislation that provides no guaranteed protection for workers and focuses on protecting kids from secondhand smoke, advocates are sending a message that the purpose of this legislation is to protect kids, and that somehow, exposure to secondhand smoke is not a problem for adult restaurant workers.

Ultimately, this type of framing of the issue is going to damage the overall effort to guarantee smoke-free workplaces for all workers.

But perhaps the strongest argument against supporting the current legislation is that it is simply not justifiable from a public health perspective. If secondhand smoke is bad enough so that the government needs to intervene to protect youths who eat out at certain restaurants for a few hours at a time, then why aren't workers -- who spend eight or more hours at a time in this environment -- being given protection from the same alleged hazard? And why is the limited protection that is provided being afforded to workers based on whether or not they happen to be employed in a restaurant that ultimately decides to allow versus to exclude children?

I don't think we can or should rely on political concerns to justify legislation that is, from a public health perspective, inappropriate, unfair, and devoid of common sense.

Thursday, April 21, 2005

Estimates of Obesity-Related Deaths Falling Rapidly; Smoking Remains Overwhelmingly the Leading Cause of Preventable Death

A paper published in Wednesday's issue of JAMA (Journal of the American Medical Association) reported that obesity causes an estimated 112,000 deaths per year in the United States, down markedly from the estimate of 400,000 reported in an article in the same journal in March 2004.

Authors from the Centers for Disease Control and Prevention (CDC) originally reported last March that overweight causes an estimated 400,000 annual deaths, although this figure was later reduced to 365,000 due to a computational error. Now, authors from CDC, UC Berkeley, and the National Cancer Institute report, using a different methodology and more recent data, that the estimated deaths attributable to obesity are 112,000 per year. However, being overweight (but not obese) was associated with 86,000 fewer deaths; thus, the paper reported an estimate of 26,000 annual deaths attributable to excessive weight (overweight and obesity combined). The precision of this estimate was low enough, however, that a conclusion of 0 excess deaths from excessive weight could not be ruled out.

The Rest of the Story

In reporting their estimate of 400,000 annual overweight-related deaths, the authors of the original JAMA findings claimed that "poor diet and physical inactivity may soon overtake tobacco as the leading cause of death." Not surprisingly, the media as well as medical and public health organizations widely disseminated this conclusion as being the main finding of the research. Typical headlines read: "Obesity to Overtake Smoking as Leading Cause of Death," "CDC Reports Obesity Overtaking Smoking as No. 1 Killer," "Obesity Now Rivals Smoking as Killer," and "Poor Diet, Inactivity Becoming a Leading Cause of Death."

Ten months following publication of these findings, the authors reduced the estimate to 365,000 deaths a year due to a computational error. Now, a more rigorous methodology has produced an estimate of 112,000 excess annual deaths due to obesity, but only 26,000 excess deaths due to excessive weight. Due to imprecision in the calculation, the authors could not conclude that this figure was statistically different from 0. Thus, after all the fanfare surrounding the original report and its prediction that overweight would soon overtake smoking as the leading cause of death, it is now not even clear that the adjusted overall death rate for individuals with excessive weight exceeds that for normal weight individuals.

There are a number of improvements in the methodology for estimation of obesity- and overweight-attributable deaths in the more recent JAMA paper that suggest Wednesday's estimate is more reliable than the March 2004 figure (as opposed to these estimates simply reflecting chance variation). First, and most importantly, the 2005 paper incorporates more recent mortality data: all three NHANES (National Health and Nutrition Examination Survey) cohorts were used, which means that follow-up data were available through 2000 rather than just through 1992. Mortality risk associated with obesity and overweight was markedly higher in NHANES-I than in the more recent NHANES-II and NHANES-III.

Second, the 2005 paper accounts more fully for the fact that the mortality risk associated with obesity decreases with age. If not properly accounted for, this will result in inflated estimates of deaths because mortality risk estimates derived from younger individuals cannot be accurately applied to older individuals whose actual obesity-related risks are considerably lower.

What is clear from Wednesday's article is that obesity is a major public health problem that causes substantial mortality. However, more modest levels of excess weight do not appear to be a major health problem; in fact, they may produce lower mortality risk. What this likely means is that national standards for defining overweight may have to be changed. They likely need to be increased to reflect the apparent lack of current evidence for harmful sequelae of what is now considered to be modest levels of excess weight.

What is also clear is that neither excessive weight, however it is defined, nor obesity is even close to causing the tremendous death toll attributable to tobacco products.

Finally, this story underscores the importance of public health researchers coming to terms with the limitations of the methods available to them, and taking great steps not to over-interpret study results when these methods are substantially limited. This is especially important for quantitative estimates. While the only real research danger of over-interpretation is quantitative inaccuracy, there is a more important danger of producing inaccurate media and other reports that may inappropriately influence public policy, such as, in this case, the allocation of scarce resources.


1. Mokdad AH, Marks JS, Stroup DJ, Gerberding JL. Actual causes of death in the United States, 2000. JAMA 2004;291:1238-1245.
Mokdad AH, Marks JS, Stroup DJ, Gerberding JL. Correction: Actual causes of death in the United States, 2000 (letter). JAMA 2005;293:293-294.
3. Flegal KM, Graubard BI, Williamson DF, Gail MH. Excess deaths assocaited with underweight, overweight, and obesity. JAMA 2005;293:1861-1867.

UPDATE (April 28, 2005; 2:20 pm): In an excellent article on this topic on the American Council for Science and Health's (ACSH) Facts and Fears site, Dr. Ruth Kava, Director of Nutrition at ACSH points out that my conclusion that overweight may not be a public health problem, based on the reduced mortality risk in this group, may be inaccurate and unwise for two reasons. First, some individuals who are in excellent physical shape because they exercise regularly may actually have increased body muscle mass which places them into the higher BMI group, thus making it appear that overweight is protective (note that BMI does not distinguish between lean body tissue and fat). Second, looking only at mortality ignores the other potentially harmful sequelae of overweight in terms of morbidity - including diabetes, hypertension, and osteoarthritis. Please see Dr. Kava's post for a nice discussion of this issue.

See also Associate Director of ACSH Jeff Stier's excellent article on the obesity mortality estimates and CDC's handling of this situation.

Wednesday, April 20, 2005

DC Appeals Court Will Not Hear DOJ Disgorgement Appeal

The District of Columbia Appeals Court today announced its 3-3 decision not to hear the Department of Justice's appeal of the February decision of a three-judge Appeals Court panel that disallowed disgorgement of past tobacco industry profits as a potential remedy in the government's lawsuit against the tobacco industry. Although the Department of Justice may appeal this decision to the Supreme Court, the chances of the Supreme Court hearing the case are apparently not great.

Assuming that this decision is not overturned by the Supreme Court, it means that disgorgement of past profits will not be a remedy available to District Court Judge Gladys Kessler should she decide in favor of the government in this case. Since past profits for which disgorgement was being sought were estimated to be on the order of $280 billion, today's announcement is certainly a major victory for the tobacco companies.

Nevertheless, there are still a number of important remedies that the government may ask Judge Kessler to impose should DOJ prevail. Among the potential remedies that have been mentioned are:
  • requiring substantial changes in cigarette advertising and marketing, including measures to prevent the marketing of cigarettes to youths and to prevent certain deceptive aspects of the marketing, such as the potential health value of "light" and "low-tar" cigarettes;
  • requiring substantial changes in cigarette labeling and packaging, including larger, stronger, and more graphic warning labels;
  • requiring substantial changes in retail tobacco sales practices;
  • requiring certain disclosures from the companies, including manufacturing methods, marketing research, smoke constituents, additives, and ingredients, and certain research;
  • forcing the companies to fund an independent anti-smoking media campaign; and
  • forcing the companies to fund smoking cessation programs for current smokers.
The Rest of the Story

I think it is important for public health practitioners who are observing this case to realize that there are only two of the above remedies that would both have a substantial impact on improving the public's health and be likely to withstand a tobacco industry appeal.

Despite widespread talk about the possibility of a District Court decision forcing tobacco companies to fund a national anti-smoking media campaign and/or smoking cessation programs, such as today's Campaign for Tobacco-Free Kids statement that the trial judge may "require the industry to pay billions of dollars -- possibly tens or hundreds of billions -- to fund programs to prevent kids from smoking and help smokers quit," I do not think such a remedy is likely to withstand an almost certain tobacco industry appeal should Judge Kessler decide in the government's favor and impose such remedies.

I have explained previously why I believe that in contrast to what the Citizens Commision to Protect the Truth argued in its amicus brief, forcing the companies to fund an independent anti-smoking media campaign is not an appropriate remedy under the RICO civil remedy provision. Briefly, forcing the companies to fund a smoking prevention campaign does not require them or entice them in any way to discontinue their current deceptive, pro-smoking marketing. If anything, it would give the companies more of an incentive to aggressively market their product, as 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.

In short, I do not think that forcing the companies to fund the truth® campaign or something similar is a remedy that is consistent with 18 U.S.C. section 1964(a) (the civil remedies provision of the RICO statute), because it is not a remedy that is going to prevent future violations of the Act.

Remember that the relevant provision of the RICO statute states: "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 key is that any remedy fashioned under this provision must prevent and restrain future violations, not punish or remedy the effects of past violations. If the relevant violation is deceptive or fraudulent marketing, misrepresentation of the harms of the product, and targeting of youths, then the appropriate remedy seems to be the first two mentioned in the list above: requiring substantial changes in cigarette advertising, marketing, labeling, and packaging. With the availability of such a direct remedy that is consistent with section 1964(a), it is difficult to imagine the D.C. Appeals Court upholding a District Court decision to force the companies to fund an anti-smoking media campaign.

I think it is particularly important for readers to be aware of the central reasoning of the Appeals Court panel in disallowing disgorgement as a potential remedy: "Section 1964(a) provides jurisdiction to issue a variety of orders 'to prevent and restrain' RICO violations. This language indicates that the jurisdiction is limited to forward-looking remedies that are aimed at future violations. ... Divestment, injunctions against persons’ future involvement in the activities in which the RICO enterprise had been engaged, and dissolution of the enterprise are all aimed at separating the RICO criminal from the enterprise so that he cannot commit violations in the future. Disgorgement, on the other hand, is a quintessentially backwardlooking remedy focused on remedying the effects of past conduct to restore the status quo. ... It is measured by the amount of prior unlawful gains and is awarded without respect to whether the defendant will act unlawfully in the future. Thus it is both aimed at and measured by past conduct."

A third-party anti-smoking media campaign has no direct bearing on the tobacco companies engagement in fraudulent, deceptive, or youth-targeted marketing efforts and is thus unlikely to be viewed as "aimed at future violations" or as being awarded with respect "to whether the defendant will act unlawfully in the future." Instead, it appears to be aimed at "remedying the effects of past conduct to restore the status quo."

For the same reasons, I do not think that forcing the companies to fund smoking cessation programs for smokers is consistent with section 1964(a), nor is it likely to be upheld by the Appeals Court. I do not see how funding a smoking cessation program has anything to do with changing tobacco company conduct with regard to the alleged RICO violations. Such a remedy appears to be aimed at "remedying the effects of past conduct to restore the status quo," exactly what the Appeals Court ruled was not permissible under RICO.

While requiring changes in retail tobacco sales practices and requiring certain tobacco company disclosures may be appropriate remedies, I have presented evidence in previous posts why youth access approaches and disclosure of tobacco smoke constituents, additives, and ingredients are not likely to have any substantial benefits in terms of reducing tobacco use and improving health or saving lives.

Therefore, it is my opinion that the Department of Justice should focus the remedies portion of its case on the following two remedies that I think are both consistent with section 1964(a) (and likely to withstand appeal) and likely to have substantial public health benefits in terms of reducing tobacco use and improving health:
  • requiring substantial changes in cigarette advertising and marketing, including measures to prevent the marketing of cigarettes to youths and to prevent certain deceptive aspects of the marketing, such as the potential health value of "light" and "low-tar" cigarettes; and
  • requiring substantial changes in cigarette labeling and packaging, including larger, stronger, and more graphic warning labels.
In fact, I think that barring an unexpected Supreme Court reversal of the Appeals Court's disgorgement ruling, the potential value of the DOJ case now rests upon how successful it is in bringing about substantial, meaningful changes in tobacco product advertising, marketing, labeling, and packaging, which could directly prevent the tobacco companies from engaging in most of the alleged RICO violations in the future.

One final note. The kinds of changes in tobacco marketing required to effectively prevent future violations are not likely to be agreed to by the tobacco companies voluntarily in any settlement discussions, especially since the threat of massive punitive damages in the form of disgorgement payments has been all but eliminated and the threat of massive punitive damages in the form of payments for media campaigns and smoking cessation programs is I think quite weak given the Appeals Court's reasoning in disallowing disgorgement. In other words, the legal considerations discussed above put the tobacco companies in the driver's seat in settlement negotiations. They can demand just enough loopholes in any settlement so that it will have the appearance of being meaningful, but not really be in the public's best interest. For this reason, I believe that any truly meaningful changes in tobacco industry conduct are going to have to come from successful litigation of the case.

It is interesting to note that if my reasoning is accurate, then the American Legacy Foundation's only real chance of obtaining funding as a result of this lawsuit is for the suit to be settled. While requiring companies to fund the "truth" campaign is not, in my view, an appropriate remedy, the Foundation has made enough of a public spectacle of itself and its importance and has paid for the assistance of enough influential health figures to make me think that maybe, just maybe, the DOJ lawyers are going to cut out a slice of pie for Legacy should the Department decide to settle.

Tuesday, April 19, 2005

Georgia Governor Considering Whether to Sign Workplace Smoking Bill

Georgia Governor Sonny Perdue has until May 10 to decide whether or not to sign the Georgia Smokefree Air Act of 2005, which was passed by the legislature. The bill would eliminate smoking in workplaces, including restaurants, with some exceptions. The bill is widely supported by public health groups, which are lobbying the Governor to sign this legislation. The Georgia Alliance for Tobacco Prevention touts the passage of this legislation as being a "success."

The Rest of the Story

What may not be clear to casual observers of this debate in Georgia is that the "few exceptions" in the bill are so large that they create a loophole that essentially negates the very purpose of the bill.

First, all bars are exempt, assuming that they do not allow or employ youths, which is most likely already the case. So while the legislature apparently feels that restaurant workers are deserving of protection from secondhand smoke, for some reason bar workers are not. So much for a level playing field by which all establishments would be subjected to the same health requirements.

Second, any restaurant that chooses to cater to adults only (and not to employ youths) is also exempt. While many restaurants will certainly choose to continue as family-oriented establishments, many will not. So the legislature is basically establishing a two-tiered hospitality industry in Georgia, whereby restaurants will basically be divided into family-oriented and adult-only establishments.

What kind of absurd public health message is this legislation sending? Secondhand smoke is such a problem that the government must intervene to ban smoking in all workplaces and restaurants, but it is not so great a problem that it needs to protect bar workers or to protect workers in adult-oriented establishments, just workers in family-oriented ones?

To make matters much worse, the bill also allows smoking in enclosed, separately ventilated rooms in restaurants, even ones that are family-oriented. OK - so the logic here is getting even more convoluted: secondhand smoke is so bad that it is not acceptable to allow smoking in family-oriented restaurants, but it is somehow acceptable to allow smoking in adult-oriented restaurants and even in family-oriented restaurants, so long as the smoke is confined to certain areas so that exposure will be heavily concentrated among employees working in those areas with little exposure among workers in other areas.That makes a lot of public health sense to me!

While I don't necessarily blame the legislature for this mess, since this kind of reasoning seems to be common among elected officials, I do not find it acceptable for public health organizations to be supporting such a ludicrous approach to the protection of workers from secondhand smoke.

Either secondhand smoke is or it is not a substantial occupational health hazard. If it is, then all establishments should be treated equally and a level playing field should be created so that all workers can breathe clean air. If it is not, then the government should not be intervening to such a degree that it is basically telling private establishments that they need to declare themselves as family-oriented or adult-oriented, and there are no other choices for how they are free to market themselves.

I certainly hope that Governor Perdue has the wise sense to see how absurd this approach to regulating a health hazard is, and that he chooses to veto the legislation. There is simply no public health rationale for supporting such an inconsistent approach to the regulation of what is being purported to be a substantial occupational health hazard.

(May 9, 2005; 11:15 pm): Governor Perdue today signed the legislation into law. I think this is quite unfortunate, and is going to substantially set back public health efforts not only in Georgia, but elsewhere in the country as well. It is truly an embarrassment for public health.

Monday, April 18, 2005

Grant Awarded to Study Burley Tobacco Production

The Golden LEAF Foundation, a North Carolina non-profit corporation, has awarded a $264,800 grant to North Carolina State University to help research and expand the production of burley tobacco in the state, according to an article in the Winston-Salem Journal.

The article states that: "Though burley is generally known as a mountain tobacco, the N.C. State effort will install curing structures and research plots at research stations near Whiteville, Kinston, Rocky Mount and Reidsville - far to the east of the plant's usual environs. 'It's to determine where burley can be successfully produced,' said Tommy Bunn, the executive vice president of the Leaf Tobacco Exporters Association and a member of Golden LEAF's board." The researchers who wrote the grant application apparently explained that: "If production in 2005 is successful, there is the potential to expand production to 100 million pounds in the next five years, which can produce $150 million in farm income for producers in North Carolina."

The Rest of the Story

This research effort to help expand tobacco production in North Carolina is being funded by revenues from - you guessed it - the multi-state tobacco settlement. The Golden LEAF Foundation was set up to receive and administer about half of the tobacco settlement funds that North Carolina receives from the tobacco companies under the Master Settlement Agreement.

So funds resulting from a lawsuit that was brought on behalf of the state to recover costs related to treatment of tobacco-related diseases are being spent on helping produce more tobacco, which can in turn produce even more tobacco-related disease. What a nice economic cycle: the tobacco industry pays the state to keep off its back, the state gives a portion of the money to support more tobacco production, which benefits the tobacco farmers and the tobacco industry, and best of all, helps bring even more tobacco settlement revenue to support the whole cycle.

As I said in an earlier post, the Master Settlement Agreement has been an unmitigated public health disaster.

IN MY VIEW: Employee Privacy Protection Bill Needs to Be Debated on its Merits

My post on the recently introduced Employee Privacy Protection Act in Michigan, which would prohibit employers from firing or refusing to hire workers based on lawful, off-the-job behavior that does not directly impair their job performance, has generated considerable debate. The most common argument against the bill (Senate Bill 381) seems to be that there is a hidden agenda behind the filing of the bill, which is to advance the interests of the tobacco industry.

I have to admit that when I began researching the issue for my original post, I expected to find such a motive behind it. Being a tobacco control practitioner and having heard all the rhetoric about this type of legislation being nothing more than a tobacco industry ploy to give smokers the kind of rights against discrimination that are granted to persons based on race, color, creed, sex, age, or disability, all in an effort to protect tobacco industry profits, I naturally expected to find the tobacco industry behind the scenes, using Senator Bernero to push their legislation for them.

But the truth is that I found something far different. The legislation, in fact, appears to be nothing more than a sincere reaction on the part of Senator Bernero to the plight of the four women, now unemployed and in danger of not being able to support their families, who were fired by Weyco Inc. because they smoked while off the job and were not able to overcome the powerful grip of their addiction to nicotine. The truth is that Senator Bernero appears to have filed this legislation not on behalf of the tobacco industry, but on behalf of the four unemployed women, who contacted him about their problem. It is this which appears to have directly motivated the filing of this legislation, not any tobacco industry motive or hidden agenda.

Senator Bernero's agenda, in fact, seems very clear. He appears to be sincerely interested in protecting the privacy of employees in his state, and to ensure that their ability to make a living and to support themselves and their families is not taken away because of lawful off-the-job behavior that has no relevance to their performance of their job duties.

This means that tobacco control practitioners are going to have to address this legislation on its merits, not on the motivations of those who introduced the bill. It is not going to be possible, or even accurate, to dismiss the bill simply on the basis of it being part of a tobacco industry hidden agenda. The apparent sincerity of the sponsor of the bill in attempting to protect employee privacy rights is going to need to be respected, and the debate is going to have to, perhaps for the first time, address the relevant issues at hand and not simply the evilness of the tobacco companies.

So what remains then is the question, which I have not yet heard answered by opponents of Senate Bill 381, of whether tobacco control advocates support the right of employers to fire workers who eat an unhealthy diet, do not get enough physical activity, or engage in other unhealthful behaviors, assuming that these behaviors are lawful, occur off-the-job and off company premises, and do not directly interfere with job performance. In other words, is there something unique about smoking that distinguishes it from other unhealthy behaviors in such a way that it is appropriate to fire people for smoking but not for those other behaviors? Or, is it the case that tobacco control advocates who oppose this legislation really feel employers should be able to fire workers for any unhealthful activity, even if it does not directly impinge upon job performance?

Why is it that we in tobacco control seem so unwilling to answer this critical question? Perhaps it is the case that in all previous situations like this, we have been able to dismiss legislation simply on the basis of it being advanced as part of a tobacco industry hidden agenda, which might have allowed us to beg the question. But that is the case no longer.

Friday, April 15, 2005

Michigan Senator Introduces Bill that Would Prohibit Firing of Smokers

Michigan State Senator Verg Bernero introduced a bill Wednesday that would make it illegal for an employer to refuse to hire or to fire an employee based on any lawful, off-the-job activity that takes place off company property. The legislation, if enacted, would invalidate the recently instituted policy of Okemos-based Weyco Inc., which allows employees to be fired for smoking, even if off-hours and off company premises (see previous post). According to yesterday's article in the Detroit Free Press, the bill is endorsed by the ACLU, which believes the bill will help protect workers' privacy rights. The bill (Senate Bill 381) is titled "The Employee Privacy Protection Act."

The bill states that an employer "shall not fail or refuse to hire or recruit, discharge, or otherwise discriminate against an individual with respect to employment, compensation, or a term, condition, or privilege of employment because the employee engages in, or is regarded as engaging in, a lawful activity that is both off the employer's premises and during nonwork hours." However, the bill does provide exceptions for "an activity that directly impairs an established bona fide occupational requirement or an employment activity or responsibility of a particular employee or a particular group of an employer's employees" and for "an activity that creates a substantial conflict of interest with the core mission of the employer or violates a written bona fide conflict of interest policy that has been disseminated to employees."

The Rest of the Story

While I am certainly a strong supporter of smoke-free workplace policies, I do find it to be an invasion of worker privacy to make hiring and firing decisions on the basis of smoking that takes place off-the-job and off the workplace premises. As I explained earlier, these policies regarding smoking raise the question of what other life decisions employers will try to control next. Will they start refusing to hire, or firing workers who are overweight, eat a lot of fast food, or fail to get enough physical activity? For this reason, I support Senator Bernero's legislation and hope that tobacco control practitioners in Michigan will not oppose it.

It should first be noted that this legislation is not similar to legislation in a number of states that disallow discrimination specifically on the basis of smoking. Smoking, as a potentially modifiable behavior, is not considered in this bill to be similar to factors such as race, sex, or sexual orientation. Second, it is important to note that the bill does not even mention smoking. It is not specific to smoking, but applies equally to all lawful, off-the-job activities.

I think this legislation is going to force tobacco control practitioners to confront the important question of whether their position on this issue is consistent with overall principles of public health practice, rather than merely with the goal of reducing smoking. If the only consideration of tobacco control practice is the extent to which a measure may reduce smoking, then there is justification for opposing Senate Bill 381. But if tobacco control is viewed as a part of the larger practice of public health (which it should be), then the goal of reducing smoking must also be weighed against the degree to which a policy may interfere with individual rights, freedom, and privacy, which are also (or at least should be) highly regarded public health values.

The reason why I think this issue is going to force our hand is that if tobacco control advocates are going to oppose this legislation, then they now must articulate whether they narrowly support hiring and firing decisions based on smoking, or whether they broadly support the consideration of lawful off-the-job activities as fair grounds for employment decisions.

So we will now find out whether tobacco control practitioners who support the right of employers to fire workers who smoke also support the right of those employers to fire workers who eat too much saturated fat, don't get any physical activity, or fail to protect themselves from the sun's ultraviolet radiation.

If practitioners support the right of employers to consider all of these health-related behaviors in employment decisions, then I think they are simply off-base, and do not appreciate the importance of workers' privacy and autonomy in their personal lives. But if practitioners support the right of employers only to consider one personal off-the-job behavior -- smoking -- as a factor in employment decisions, then they are in a bind because they either are revealing that they are not considering this issue from an appropriately broad public health perspective, or they will need to explain exactly why smoking should be considered uniquely.

It is not clear to me why smoking represents a behavior that should uniquely be considered in employment decisions. While it is certainly one of the most important risk factors for chronic disease, other health-related behaviors, such as diet and physical activity, are also major risk factors for chronic disease. And there does not seem to be anything about off-the-job smoking that affects an employee's ability to perform on the job or her costs to the company, outside of the increased morbidity and health costs associated with disease. But these are also sequelae of other health-related behaviors.

If anything, it seems to me that tobacco control practitioners should be sensitive to the powerfully addictive nature of nicotine and should understand and acknowledge that quitting smoking is an incredibly difficult thing to do. How can we, on the one hand, argue that smokers deserve compensation for smoking-related injuries in lawsuits because they were addicted to nicotine and couldn't quit, and then on the other hand, expect that anyone who really wants to keep their job should be expected to overcome this addiction that is every bit as powerful as addiction to heroin, cocaine, or alcohol?

It will be interesting to see what position tobacco control practitioners take on this legislation. I hope that they will think carefully before any decision to oppose the bill, however, because that would, in my view, be a position that is inconsistent both with the principles of public health practice and with the paradigm with which we view smoking in other contexts.

New Study Reveals Genetic Component to Nicotine Addiction

A study published in the current issue of Behavioral Neuroscience reports that researchers have identified genetic factors that may relate to susceptibility to nicotine addiction. According to the American Psychological Association press release on this article, "Understanding how genes change nicotine receptors may foster better treatments." Senior author, Dr. Jerry A. Stitzel from the University of Colorado, stated that: “By identifying genes that contribute to whether an individual will become addicted, we will gain important knowledge about the biology of addiction. With that, we will be in a much better position to design more effective treatments for addiction. This approach may also lead to treatments tailored to the ‘genetic profile’ of the smoker.”

This study is not the only one examining potential genetic factors in nicotine addiction. New Zealand researchers are apparently studying gene variants that may influence nicotine metabolism (and therefore addiction). They are apparently testing individuals for these genetic variants and have claimed that "Genetic tests based on this could enable personalised nicotine replacement therapy to be developed, making it more likely that it will be successful." Similar studies are ongoing elsewhere.

The Rest of the Story

While I'm all for tobacco research, I really don't see much value in this line of inquiry. Let's stipulate, for the purposes of argument, that there is indeed a very strong genetic influence on nicotine addiction. OK, so what should we be doing differently?

The research doesn't seem to have any useful implications for efforts to prevent smoking. Even if we were able to identify precisely those kids who are most at risk for becoming addicted, would we deliver our interventions only to those kids? There are so many factors, both genetic and environmental, that influence smoking initiation, that our interventions to prevent smoking will always have to be broad-based and targeted at a large segment of the (if not the entire) youth population. And I can't see doing genetic testing on kids to determine which ones will receive certain interventions. Most importantly, the interventions that have been found to be most effective in preventing smoking are societal-level, population-based interventions, not individually delivered ones.

Could the research have important implications for smoking cessation interventions? Again, the most successful interventions we have to encourage smoking cessation are population-based (such as aggressive marketing campaigns and smoke-free laws). It's not clear to me how even an individual-level intervention, such as nicotine replacement therapy, would be altered based on a genetic test to make a substantial difference in the effort to help smokers overcome their addiction. What is it that we can't already measure? For example, we already have ways of determining the strength of someone's addiction to nicotine. Usually, it's quite readily apparent. In fact, usually the smoker herself knows exactly what the strength of cessation difficulty is. I don't think there's anything that you couldn't ascertain from a simple, inexpensive, and carefully conducted interview with a smoker that you could ascertain from a fancy and expensive DNA test.

In short, I don't see any substantial value in this line of research into genetic susceptibility to nicotine addiction. It has no important implications for the practice of tobacco control, either for the prevention of smoking or the encouragement of smoking cessation. It does not seem to provide any essential information that we cannot already obtain if we are careful enough and take enough time to talk to our patients. It may be detracting from and/or reducing funds available for research that really does have important implications for public health policy and practice. And it may even help the tobacco industry in its litigation by allowing the companies to argue that genetic susceptibility, not corporate behavior, is the most salient factor in nicotine addiction (although that's not a reason to fail to conduct this research if it were otherwise important).

We really already have a very good idea of what works and what does not work in tobacco control. I think it's time that we start putting our money into implementing these proven strategies, rather than just doing more basic research to find out fancier and more expensive ways of ascertaining information that we can already find out, if we only are willing to take the time to talk to the affected individuals.

Wednesday, April 13, 2005

Campaign for Tobacco-Free Kids Manipulating Kids to Promote FDA Legislation

Today is Kick Butts Day, a national day of youth advocacy on the tobacco issue run by the Campaign for Tobacco-Free Kids. The Campaign is asking youths throughout the country to "Stand Out, Speak Up, and Seize Control in the fight against Big Tobacco."

The Rest of the Story

While the Campaign's goal of encouraging youths to advocate for tobacco control policies seems laudable, surprises await for those who take the time to read what the Campaign is actually telling kids, and not telling them.

The online Kick Butts Day guidebook links youths to a Campaign for Tobacco-Free Kids web site that provides education and guidance about tobacco control activities in which youths are encouraged to take part. And one of those activities is advocacy in support of the Tobacco-Free Kids and Philip Morris-supported legislation to grant FDA authority to regulate tobacco products.

The web site tells kids that: "Tobacco products are deadly and addictive, yet they're almost completely unregulated by the government to protect our health and safety. That's because Congress has not granted the FDA, which regulates food and other consumer products, the authority to regulate tobacco. There are many actions that the FDA could take to better protect people from tobacco products and the tobacco industry's deceptive marketing. The Campaign for Tobacco-Free Kids has a special report on FDA regulation and a series of factsheets that summarize what effective FDA regulation of tobacco products means."

"How does effective FDA regulation help people? If effective FDA regulation becomes a law, the FDA could regulate how tobacco products are made, marketed and sold. Here are some examples of how:
• The FDA could require tobacco companies to take out some of the dangerous chemicals in tobacco products so they won't be as harmful or addictive.
• The FDA could stop marketing that targets youth.
• The FDA can crack down on stores that sell cigarettes to youth.

The Campaign for Tobacco-Free Kids goes on to tell youths to "Write, call or e-mail your U.S. Representatives and Senators and tell them you support FDA regulation of tobacco products. Send them information about effective regulation of tobacco. Tell them not to support any bill that protects the tobacco industry instead of our health," and to "Organize your community around the importance of FDA regulation."

Importantly, a March 17, 2005 report that the Campaign refers kids to states that: "The FDA’s authority to regulate tobacco products would be comparable to its existing authority for drugs, devices, and foods."

And most importantly, nowhere on any of the Campaign's youth web sites and in none of the reports or fact sheets to which the Campaign refers youth does the Campaign inform the kids they are trying to recruit to promote the FDA legislation of a critical piece of information: that Philip Morris, the nation's largest tobacco company, supports the very same FDA legislation, is actively lobbying for its passage, and has told its shareholders that the defeat of last year's FDA legislation was "a significant disappointment" and that passage of this year's legislation is "a key priority."

I believe that the Campaign for Tobacco-Free Kids' actions are unethical and inappropriate because it appears that the Campaign is manipulating kids to further its own legislative goal of enacting S. 666 and H.R. 1376. It certainly appears that the Campaign is being intentionally deceptive in its presentation of the critical issues regarding this legislation to the youths it is trying to recruit to promote these bills. There a number of elements of this deception:

First, the Campaign states that: "The FDA’s authority to regulate tobacco products would be comparable to its existing authority for drugs, devices, and foods." Presumably, this statement, released on March 17, 2005 (the date S. 666 and H.R. 1376 were introduced) refers to the FDA legislation that was introduced. Such a statement is grossly misleading, if not inaccurate and false.

The very first provision of the FDA legislation is that: "Tobacco products shall be regulated by the Secretary under this chapter and shall not be subject to the provisions of chapter V." So the very premise of the entire legislation is that tobacco products are not to be regulated under the same rules by which FDA regulates drugs and devices (and foods). In fact, FDA's authority to regulate tobacco products under the legislation is not at all comparable to its existing authority for drugs, devices, and foods. Far from it - the FDA's authority to regulate tobacco products is completely different from its authority to regulate drugs, devices, and foods.

Second, the Campaign is asking youths throughout the country to "Stand Out, Speak Up, and Seize Control in the fight against Big Tobacco." Is it not then only fair to inform these youths that Big Tobacco (at least in the form of its largest and most important and influential component - Philip Morris) - supports FDA regulation of tobacco products, supports the specific legislation that youths are being recruited to promote, viewed last year's defeat of the essentially identical FDA legislation as a signficant disappointment, and views the passage of the legislation this year as a key priority.

It seems to me that if you are going to try to recruit kids to support FDA legislation, then they at very least have the right to know that Philip Morris is vigorously supporting and lobbying for that legislation. To omit this critical piece of information is deceptive, and it is hard to imagine that it is anything other than intentional deception, since it's difficult to believe that it represents a simple oversight on the Campaign's part. The Campaign obviously made a deliberate decision not to include this information in its recruitment package provided to the kids.

Third, the Campaign instructs youths to tell their Congresspersons not to support any bill that protects the tobacco industry instead of health. But the Campaign fails to inform youths that there are a number of provisions in the legislation that are there specifically to protect the tobacco industry and that have no health protection purpose. The Campaign itself has admitted that these are compromises; there is no disagreement that these provisions are specifically there to protect the tobacco industry.

Fourth, the Campaign leads kids to believe that by taking out "some of the dangerous chemicals in tobacco products," these products will not be "as harmful." Is the Campaign not aware that such an assertion is misleading, since the Campaign itself, on the very same Kick Butts web site, empasizes to kids that "There are over 4000 chemicals in a single puff of cigarette smoke, and 69 of them are known carcinogens." Is the Campaign ready to make a public statement that removing just some of these 4000 chemicals and 69 carcinogens will produce a safer cigarette? Is it not hypocritical to suggest such a fact to kids on the one hand, and then on the other hand, to complain about how terrible it is that cigarette companies may make even mild claims (such as that a product reduces exposure to a given substance) without having solid documentation of the reduced risk?

As the Campaign itself has stated: "These bills would prohibit tobacco companies from making any explicit or implicit health claims, such as reduced risk of disease or reduced exposure to specific toxins, without first proving to the FDA that the scientific evidence is adequate to conclude BOTH 1) that the product as actually used by consumers will significantly reduce the risk of disease to individual consumers AND 2) that the product as marketed will benefit the health of the population as a whole." Is it unacceptable for tobacco companies to make health claims without incontrovertible evidence but somehow acceptable for the Campaign for Tobacco-Free Kids to make just about the very same contention to kids, but without any solid documentation?

Finally, is it not deceptive to tell kids that the FDA legislation will allow the Agency to "stop marketing that targets youth" when the Campaign knows full well that the Supreme Court of the United States has overturned even far less restrictive advertising laws on the grounds that they are too sweeping to satisfy the requirements of the First Amendment of the Constitution?

Manipulation is defined as "influencing or managing shrewdly or deviously," and devious as "not straightforward...misleading...deceptive." It certainly seems to me that the Campaign for Tobacco-Free Kids is influencing kids to promote FDA legislation, and that the Campaign is doing so in a devious way - a way that is not straightforward, but rather is quite misleading and quite deceptive.

I find the Campaign's manipulation of kids to be not only highly inappropriate, but also unethical, because it violates accepted standards of professional public health conduct that require public health organizations to provide the public with full and accurate information that is necessary to make decisions on policies. This is what the APHA Public Health Code of Ethics calls the "community-level" equivalent of the individual-level ethical principle of informed consent:

"Public health institutions should provide communities with the information they have that is needed for decisions on policies or programs and should obtain the community’s consent for their implementation. ... there is a moral obligation in some instances to share what is known. For example, active and informed participation in policy-making processes requires access to relevant information. ...Such processes depend upon an informed community. The information obtained by public health institutions is to be considered public property and made available to the public."

I think that the obligation to share the information relevant to the decision whether to support a public health policy is particularly important when it is children that are being recruited to promote such a policy. This is because kids are far less able to find out the necessary, relevant information on their own, and they are more susceptible to the possibility of manipulation of their attitudes.

The rest of the story reveals that the Campaign for Tobacco-Free Kids is manipulating kids to promote FDA tobacco legislation by presenting them with incomplete and misleading information about that legislation. These actions, I think, violate established standards of ethical public health practice. This story should once again underscore to tobacco control and public health practitioners the obligation for us to use appropriate and ethical means to pursue our intended ends, regardless of how noble and important we think those ends might be.

Monday, April 11, 2005

UC Academic Council Missing the Point in Tobacco Funding Policy Debate

In May 2004, the faculty of the UC Berkeley School of Public Health voted to adopt a policy that the School would accept no new research grants from the tobacco industry. Three other schools and a total of seven academic units within the UC system have similar policies. The UC Academic Council recently decided that only the Regents, not UC academic units, can make a decision not to accept tobacco industry funding. Now, a coalition of UC faculty and others is attempting to convince the UC Board of Regents to overturn this decision and allow individual Schools to set their own policies. The group is circulating a petition calling on the UC Regents to intervene and allow individual Schools and academic units within the UC system to establish their own policies regarding acceptance of tobacco industry funding.

Two members of the UC Administration - Vice Provost for Research Larry Coleman and Regent Judith Hopkinson - have argued that policies like that adopted by the UC Berkeley School of Public Health violate academic freedom by restricting potential funding sources for faculty researchers. A recent Sacramento Bee article quoted Coleman as stating: "Academic freedom is like the First Amendment. It has to be absolute, or no one has it. If you start making value judgments about the appropriateness of a funder, then there's no place to stop." A San Francisco Chronicle article quoted Hopkinson as stating: "While I abhor the practice of many of the tobacco companies, I do believe this is an issue of academic freedom. I think it is the wrong precedent to set. There are a lot of people who feel strongly about different things. ... Taking such a position universitywide could lead to restrictions on stem-cell research or other controversial research."

In contrast, the coalition defending the right of individual UC Schools to set their own policy regarding tobacco industry funding have argued that the Academic Council's action represents an infringement of the relevant faculty's efforts to protect academic freedom by protecting academic integrity of their faculty and their institutions. In addition, it has argued that "Accepting money from the tobacco industry is inconsistent with the mission of the University of California, Berkeley School of Public Health, ‘the promotion and the protection of the health of the human population.’"

The Rest of the Story

What should, I think, be a relatively straightforward discussion, is, I believe, being obscured by a failure on the part of the UC Academic Council and at least one of the Regents to appreciate the nature of and reasons for the UC Berkeley School of Public Health's decision not to accept research funding from tobacco companies. I believe the actual issue at hand has been distorted by turning the debate into a discourse on academic freedom. And perhaps the arguments offered by some of the proponents of the School's policy have contributed to this distortion of the issue.

I don't see this as properly a debate over academic freedom. But neither do I see it as a debate over the integrity of tobacco industry-funded research. Rather, I see this as a dispute over whether individual schools within the UC system can properly set their own policies to protect the best interests of their faculty and their institutions by guarding against what they perceive to be the most egregious of conflicts of interest in research.

The University of California, Berkeley's Faculty Handbook states, with respect to research conducted by the faculty, that: "The University' s overall policy on conflict of interest is that none of its faculty, staff, managers, or officials shall engage in any activities which place them in a conflict of interest between their official activities and any other interest or obligation." Note that a conflict of interest does not have to be a financial one. Any situation in which a faculty member engages in research which creates a conflict between competing interests of that faculty member may be perceived by a School as representing a conflict of interest, and since the policy stresses that no faculty may engage in such an activity, it is a legitimate interest of the School to adopt policies that, for example, eliminate the possibility of such a conflict of interest.

Now, since helping to fulfill the mission of the School is certainly one of a faculty member's central interests, it follows that any research that is not consistent with the mission of a School (i.e., which conflicts with the School's mission by creating a competing interest on the part of the faculty member or the institution itself) would represent a severe conflict of interest that may be prohibited by University policy. And it would certainly be a legitimate interest of the School to prevent such a substantial conflict of interest from arising by specifying appropriate policies.

Before continuing this argument, two points are critical:

First, there is nothing inherent in the consideration of potential conflicts of interest between funded research and a School's mission that would, on its face, render illegitimate a School's interest in adopting policies regarding the conduct of such research, including policies that relate to the source of funding for that research. So for example, if a School of Public Health researcher sought to study ways in which to re-design automobiles such that they would require less maintenance but would result in far more fatal crashes, no one would likely argue that the School could not prohibit the researcher from accepting funds to conduct such research. In the School's view, there is an inherent conflict between the interests of the research and the interests (specifically, the mission) of the School. I don't see the UC Regents or the UC Academic Council intervening to preempt schools from adopting this type of policy.

Now suppose, instead, that a researcher aimed to do "appropriate" research, but that it was to be funded by an organization whose interests conflicted so greatly with the School's mission that the School had to prohibit such funding in order to prevent such an egregious conflict from arising. Specifically, let us consider a faculty member applying for funding from an organization that promotes the widespread use of marijuana among children. Let us also suppose that the research itself, to study the health effects of marijuana on the respiratory system, was potentially beneficial and that there were to be no strings attached (i.e., no control over the research, its review, its publication, etc.). I doubt that anyone would object to the School of Public Health disallowing that faculty member to accept research funds from such an organization, even under these favorable scientific circumstances.

Indulge me one final step to advance this argument. Suppose that the citizens of California pass an initiative that legalizes marijuana. Does that action immediately make the School of Public Health's policy not to accept research funding from the group promoting marijuana use among children a violation of academic freedom? I think not. If it was not a violation of academic freedom for the School to adopt a policy disallowing funding of research from the Society for the Promotion of Marijuana Use Among Kids before marijuana was legalized, then I do not see how the decision of a majority of California citizens to legalize marijuana would suddenly turn the School's policy into an infringement of academic freedom. After all, the School's consideration of what represents an egregious conflict with its overall mission is dependent on all factors related to the research and funder that are at hand, not only on the legality of the funder's action.

Clearly, a school policy that aims to protect the reputation and integrity of the school and its faculty members by restricting the nature and source of funding of research conducted within that school in order to ensure that the most egregious of conflicts between funded research and the school's mission do not occur is not inherently an infringement of academic freedom. In contrast, that policy is designed to, and in the above situation, would be effective in protecting academic freedom of the school's faculty by helping to preserve the very reputation and integrity of the school and ensuring that the work of the school and its faculty are consistent with its mission. In fact, such a policy would be simply a specific expression of the university's conflict of interest policy.

So if the UC Berkeley School of Public Health setting a policy regarding a source of research funds that the School will not accept is not inherently an infringement of the academic freedom of its faculty members, then the argument against allowing the School to set such a policy relies upon making a distinction between accepting funding from an organization that promotes marijuana use among children and one that promotes tobacco use among children. And the distinction, as I have shown, cannot simply be based on the legality or illegality of the behavior that the relevant organization is promoting.

What we are left with, then, is simply a debate over whether it is legitimate or not for the faculty of the UC Berkeley School of Public Health to view entities that promote cigarette use among kids as being equally egregious a conflict with its mission as entities that promote marijuana use among kids.

And unless the School's reasoning seems entirely illegitimate (and it would be difficult, I think, to make such an argument given the orders of magnitude by which tobacco-related morbidity and mortality exceeds that from marijuana), then the real issue at hand is simply: Who is in the best position to make a decision about how egregious of a conflict with the School's mission it would create to be funded by such an entity - the UC Regents and systemwide Academic Council, or the faculty of the School of Public Health?

This brings us to the second critical point. The decision regarding what constitutes an egregious conflict with a School's mission is going to be different, depending on what specific School one is talking about. The answer for the UC Berkeley School of Public Health and the UCSF Comprehensive Cancer Center will likely be far different than the answer for the Haas School of Business. After all, the missions of these different programs are widely divergent. And that is, in fact, the critical point.

The UC Regents and the UC Academic Council are simply not in a position to usurp the ability of the individual Schools within the UC system to make their own determinations regarding the nature and magnitude of potential conflicts between faculty research activity and the missions of those individual Schools.

By seizing from the individual Schools the ability to set their own policies regarding the nature of the most substantial potential conflict of interest imaginable - activities that conflict with the very mission of a School - the UC Academic Council has severely infringed upon the Schools' abilities to protect the academic freedom of their individual faculty members and their institutions.

It may be worth noting that by delving into the history of tobacco industry misconduct in research, proponents of the UC Berkeley School of Public Health's policy may actually be hurting their cause. Because such an argument sidelines the actual issue at hand, which is not the integrity of the research, but the decision about who is in the best position to judge whether the research funding will conflict with the mission of the UC Berkeley School of Public Health.

In my view, it doesn't matter whether the tobacco industry will or will not attempt to subvert, interfere with, or in any other way compromise the integrity of research grants to UC faculty members. The problem is not the potential lack of integrity in the research itself, it is simply the conflict between the source of the funding and the mission of the School. And it is because that conflict is so substantial, so egregious, and so absolute that a policy that prohibits faculty from accepting such funds is justified.

So when Larry Coleman argues that as long as the research does not violate University rules (e.g., the lack of industry control over the conduct and reporting of the research), schools have no right to deny that funding, he makes a losing argument. Unless he is prepared to overturn any School of Public Health policy that refuses the acceptance of funds from groups that promote marijuana use, binge drinking (an entirely legal activity), or mass suicide.

But perhaps opponents of the UC Academic Council's vote are not doing themselves any favors by focusing the issue on research integrity. Such a focus actually feeds into, rather than debunks, Coleman's argument.

The strongest argument against the UC Academic Council's action is its usurpation of the right of individual Schools at UC to make their own judgments and set their own policies regarding the most egregious of potential conflicts of interests: conflicts with the mission of those Schools. And taking away that right infringes upon the ability of the Schools to protect academic freedom by setting policies to protect the very integrity, reputations, and best interests of their faculty and their institutions.

It may be instructive to close with a quote from the Boston University Faculty Handbook: "Academic freedom is essential in institutions of higher education if they are to make their proper contribution to the common good. The common good depends upon the free search for truth and its free exposition. It is that which justifies academic freedom, not the interest of the individual faculty member or even the interest of a particular university."

It is, indeed, the interest of the faculty of the UC Berkeley School of Public Health (and, I would add, its alumni) in contributing to the common good that led the faculty to adopt its policy on tobacco research funding. It is the compelling and over-riding interest in that same common good that would justify policies preventing School of Public Health researchers from accepting funds from promoters of marijuana and drug use, binge alcohol use, mass suicide, and yes - even the use of the nation's deadliest consumer product - cigarettes.

Michael Siegel, MD, MPH (UC Berkeley School of Public Health '92)

UPDATE (April 11, 9:30 p.m.): It is worth noting that the above argument counters the slippery slope argument advanced by both Coleman and Hopkinson. This is because it makes it clear that the policy in question is not casting personal value judgments. It is simply making an assessment of the degree of conflict with the school's overall mission. This is not a slope. There is a sharp cut-off that is reached at a point where acceptance of research monies from a funder is seen as presenting a conflict with the school's mission so egregious as to require the elimination of any possibility of such a conflict arising. Stem cell research is not a problem, because it is related to personal values, not to a question of conflict with the school's mission. The fact that "different people feel strongly about different things" is not relevant, as it is not intrinsic to the issue of the degree of conflict with a school's mission. The school's mission allows for widely divergent views and different values in many areas; what it doesn't allow is a conflict with the promotion and protection of the health of the human population.

IN MY VIEW: Not Appropriate to Recommend Lung Cancer Screening for Nation's Smokers and Ex-Smokers

In the wake of the revelation that ABC News anchor Peter Jennings has been diagnosed with lung cancer, many of the nation's smokers and ex-smokers are experiencing anxiety about their own risk of developing lung cancer. Several newspaper articles have mentioned the availability of a new technique - low-dose spiral CT scanning - to detect lung cancer. Desite the potential promise of this screening method, I do not believe the evidence available now supports a recommendation that all concerned smokers and ex-smokers, on a population basis, be screened for lung cancer.

I am aware of no medical organization that has recommended the use of CT scans for detection of lung cancer in asymptomatic individuals, including smokers. The scientific and medical bodies that have examined this issue have concluded either that lung cancer screening of asymptomatic smokers is not recommended or that there is insufficient evidence of the potential harms and benefits to recommend screening at this time.

Here is what the major bodies have recommended:

  • U.S. Preventive Services Task Force (2004): "The U.S. Preventive Services Task Force (USPSTF) concludes that the evidence is insufficient to recommend for or against screening asymptomatic persons for lung cancer with either low dose computerized tomography (LDCT), chest x-ray (CXR), sputum cytology, or a combination of these tests."
  • American Cancer Society (2000): "At this time, the ACS does not recommend routine screening for lung cancer among the general adult population or in individuals who are at higher risk due to tobacco or occupational exposures."
  • Canadian Task Force on Preventive Health Care (2003): "The CTF concludes that there is insufficient evidence (in quantity and/or quality) to make a recommendation as to whether spiral CT scanning should be used for screening asymptomatic people for lung cancer."
  • American College of Chest Physicians (2003): "For individuals without symptoms or a history of cancer, the guideline developers recommend against the use of a single low-dose computed tomography scan (LDCT) or serial LDCTs to screen for the presence of lung cancer."

While there is some evidence (primarily from the Early Lung Cancer Action Program [ELCAP] study) that chest CT scanning can pick up substantially more tumors than chest X-ray and can shift the detection of cancers toward stage I, there is as yet no published evidence that this approach can reduce mortality. More troublesome, however, is the fact that the most recent published study (the Mayo Clinic study) failed to find any benefit of CT screening, either in terms of a shift toward detection of stage I cancers or in terms of decreased mortality.

While this could simply suggest that the methods used in the Mayo Clinic study were not as sophisticated as those used in ELCAP, it points out that the simple fact that a technology exists that can detect cancer early does not mean that this technology will work if put into general practice at this time.

But most concerning is the extremely high proportion of false positive tests in both the ELCAP and Mayo Clinic studies. Even in the ELCAP study, the positive predictive value of CT screening was only 12%. This means that 88% of patients with a lung nodule diagnosed on CT scan turned out not to have cancer. The anxiety created by the finding of a lung nodule is substantial, and at sites that do not have diagnostic follow-up procedures as carefully developed as with ELCAP or with radiologists who have as extensive experience in interpreting follow-up CT findings, many of these false positives will lead to morbidity and even mortality from invasive diagnostic tests.

Based on the published ELCAP findings (and this is a conservative estimate, as most CT scanning sites in the country do not have the kind of experience that ELCAP radiologists have), if the 92 million smokers and ex-smokers were to be screened, approximately 21 million individuals would be diagnosed with lung nodules, and 19 million of these people would have no malignant disease. Is it really fair to these 19 million people to get them all alarmed about their potential lung cancer risk and then for them to find out they do indeed have a lung nodule, but to make them either undergo invasive procedures or simply have to wait 6 months or a year with this anxiety, only to have them find out that nothing is wrong? Especially when we do not have sufficient published evidence to conclude that screening will save lives and that the benefits will outweigh the risks?

While I am open to the possibility that at some point in the future, the evidence will swing in favor of the routine use of chest CT for early detection of lung cancer in asymptomatic, high-risk patients (such as smokers), there simply is not sufficient evidence at this time to support a recommendation for population-based screening of smokers and ex-smokers.

Smokers should certainly quit smoking now to reduce their lung cancer risk, but there is no reason for a mass influx of the nation's 92 million smokers and ex-smokers into their doctors' offices to request a chest CT scan. There is not at the present time sufficient published evidence that warrants a conclusion that presenting to their doctors for lung cancer screening will have benefits to them that outweigh the risks that they will have to endure due to the enormously high false positive rate associated with this screening.

UPDATE (April 11, 2005; 11:50 pm): The American Council on Science and Health has released an excellent statement on this issue. The ACSH recommendations are evidence-based and acknowledge the increased anxiety about this disease among the public, especially ex-smokers. They do not try to channel this anxiety into a screening test that, as of yet has not been shown to have benefits that outweigh the costs of "needless anxiety and even needless surgery."