Wednesday, August 31, 2005
New Study Concludes that Nicotine Increases Appetite: The Dangers of Extrapolation from Mice to Humans
The study apparently found that mice exposed to nicotine were more likely to respond for food, even for weeks after their last nicotine exposure. The authors conclude that smoking may actually increase weight in smokers and that these findings may help discourage people from taking up smoking because of weight concerns.
According to the press release: "A new study by Yale researchers shows that prior nicotine exposure in mice can increase their motivation to respond work for food, weeks after their last exposure to nicotine, a finding that runs counter to the popular belief that nicotine exposure curbs appetite. ... Although acute nicotine can act as an appetite suppressant, these data are the first to suggest that repeated exposure to nicotine has the opposite effect, that nicotine increases motivation for food for weeks following exposure to the drug. ... This research suggests that when young people take up smoking to regulate their weight, this may be counterproductive in addition to being harmful to their health. ... the research might help discourage people from starting to smoke to regulate their weight."
The Rest of the Story
This story I think really demonstrates the dangers of making too much of pure science and laboratory research and of a perspective that would put greater reliance on what happens in an animal laboratory than in the actual human world.
There is abundant human experience as well as clinical research to document that smoking has a significant, and often profound effect on appetite suppression. And because of that effect, along with other factors (such as smoking's effect on the body's metabolism and level of stimulation), smoking has been well-documented to be associated with weight loss or weight suppression.
While the magnitude of weight gain associated with smoking cessation has perhaps been overstated, it does amount, on a population level, to an average of about 4 pounds per smoker. So there seems to be little question, based on human experience and clinical studies, that smoking is associated with appetite and weight suppression.
In fact, the Surgeon General has concluded that 80% of smokers will gain weight after quitting (although, again, the magnitude of the weight gain is small). And the mechanism for this weight gain is also clear: "Increases in food intake and decreases in resting energy expenditure are largely responsible for postcessation weight gain."
The fact that mice in a cage that were exposed to nicotine were more likely to press a lever to obtain food is hardly evidence that the overwhelming experience of smokers through the years has been wrong and that we should change our thinking to believe that nicotine actually increases appetite rather than decreases it.
But that appears to be precisely what the press release is concluding.
The press release states that this research "suggests that when young people take up smoking to regulate their weight, this may be counterproductive." Thus, it is actually suggesting to the press covering this story that based on this one study in mice, we should abandon just about everything we know based on years of human experience (and based on clinical studies involving no fewer than 20,000 human subjects).
Had the release simply reported the finding and made note of the fact that the finding is unexpected based on current beliefs, that would have been fine. The problem here is that the release goes way beyond the conclusion that should be made from this research, and makes a sweeping assertion that suggests throwing out existing belief based on real-life human experience and replacing it with a contrary finding based on the behavior of some mice.
I treated many smokers in my career as a physician, and there is no question based on my experience that in general, smoking is an appetite suppressant and that it does appear to be associated with at least some degree of weight suppression. I will certainly continue to believe what my experience and existing clinical research shows rather than abandoning that because of the behavior of some mice in a cage.
While one could argue that there would be nothing wrong with suggesting to people that smoking actually will increase weight - on the grounds that if it helps prevent smoking then it will be good for the public's health - there are two major problems with that.
First, it raises the question of ethics. Is it appropriate to send false messages for good purposes?
Second, and possibly more significantly, if public health advice ends up being contrary to popular experience, then public health authorities are quickly going to lose credibility. If public health officials, based on this research and its associated press release, actually begin to counsel people not to smoke because they may gain weight, but this ends up flying in the face of people's actual experience (or their observations in other people), then public health's credibility will suffer. This is precisely the type of thing that could lead to an eventual erosion of the credibility, and thus impact, of public health messages.
The rest of the story suggests that too much reliance on what happens in an animal lab rather than in the real human world can result in a loss of perspective that results in inappropriate conclusions, but more importantly: inappropriate messages being sent to the public.
Tuesday, August 30, 2005
According to the American Legacy Foundation, Condé Nast Publications - a corporate partner of Legacy - is a "leader" in the tobacco control movement. So let's look at the contributions that Condé Nast Publications (publisher of Vogue, Glamour, and GQ) is making to tobacco control this week.
The Rest of the Story
This month's issue of Glamour features a full-page ad for Camel cigarettes, with the "Pleasure to Burn" theme. However, Condé
Nast takes action to counteract the effects of this promotion of cigarettes to women:in the same issue, a whole 1/4 page column warns women to ignore the beautiful full-page Camel ad and instead, to "Quit smoking! (It's easier than you think)."
The most recent issue of Vogue features a beautiful 2-page spread for Kool cigarettes, showing a trumpet player holding a cigarette, with a green jazzy backdrop and the slogan "Be Authentic. Be True."
And this month's issue of GQ features a full-page Kool ad, with the theme: "Be Original. Be True."
Once again, I think the American Legacy Foundation should be ashamed of itself for having the gall to contribute to the promotion of cigarettes to women by partnering with a corporation that is sending messages like these to millions of women reading its premiere fashion magazines, while at the same time pretending to be a true champion for decreasing the impact of tobacco on women's health in this country through its sponsorship of the Circle of Friends campaign.
Judging by the actions of its corporate partner, the American Legacy Foundation appears to be passing along the legacy of smoking Kool and Camel cigarettes to America's women (although admittedly it also contributes on the other end by sponsoring programs to help women quit smoking - I guess it at least helps ensure that there will be a need for Legacy's programs).
Let me reiterate that this post is not written to criticize Condé Nast for publishing these ads. Cigarettes are a legal product, it is legal for a magazine to accept tobacco ads, Condé Nast is not a public health organization, and I would not expect Condé Nast to unilaterally make a decision not to accept cigarette ads and decrease its advertising revenue.
But it does show the hypocrisy in the American Legacy Foundation's decision to partner with Condé Nast, publicly crediting this Corporation with being a leader in the anti-tobacco movement, all the while condemning the high youth exposure to cigarette advertising in magazines out of the other side of its mouth and supporting programs to get women who might be enticed by these cigarette ads to later quit.
This isn't leadership. This is hypocrisy at its worst.
Congratulations to Condé Nast Publications and the American Legacy Foundation for their excellent contributions to tobacco control this week through contributing to the exposure of millions of Americans to cigarette advertising in the most premiere fashion magazines in the nation.
Monday, August 29, 2005
This is the third of a series of three posts that will address the 3 major monetary remedies: a smoking cessation program, a national anti-smoking education campaign, and youth smoking reduction targets. This post will deal with the third of these - the request for the industry to be fined if a set of youth smoking reduction targets are not met.
3. FINES FOR FAILURE TO MEET YOUTH SMOKING REDUCTION TARGETS
DOJ has proposed as a remedy "targeted reductions in youth smoking of 6% per year between 2007 and 2013, for a total reduction of 42% among those 12-20 years old. ... If Defendants fail to meet the yearly targeted reductions, they will be assessed $3,000 per youth above the target levels. ... The assessment, imposed for each youth in excess of the target levels, exceeds Defendants’ financial gain from each such youth. ... It is thus a forward-looking remedy aimed at preventing and restraining future racketeering violations." The remedy is designed to work by "eliminating the economic incentives that defendants experience to market cigarettes to young people."
The government goes on to argue that this remedy is an attractive one because it allows the tobacco companies complete flexibility in deciding how to meet the target levels. They can decide the appropriate mix of price-related, advertising-related, and other measures to meet the targets. In addition, DOJ argues that reaching these targets is feasible, as a 42% increase in cigarette price would result in the required reduction in smoking prevalence among young people. In summary, DOJ argues that this proposed remedy is "an efficient and effective means of removing the economic incentive for Defendants to engage in future RICO violations that make their cigarette brands appealing to young people."
The Rest of The Story
This is clearly the strongest of the three proposed monetary remedies. In contrast to the proposed national smoking cessation program, this remedy is clearly designed to prevent and restrain future RICO violations, not to remedy the damages caused by past or by future violations. And unlike the proposed public education and counter-marketing campaign, I believe this proposed remedy would in fact create an economic incentive for the companies not to engage in youth marketing, because it would fine the industry more for failing to achieve the smoking reduction limits than the amount of money that the companies would reap from recruiting new youth smokers.
So do I then think that Judge Kessler will order such a remedy and that the remedy will be upheld on appeal should she decide in favor of the DOJ in the case?
Not a chance. And here is why:
The proposed remedy, while it may be designed to prevent and restrain future RICO violations, is hardly an efficient means of doing so and it may not even be effective. The remedy is not at all directly tied to future RICO violations and the connection is, in fact, so remote that I would find it hard to believe that a court would approve such a plan. As I pointed out in my May 23 post, youth smoking prevalence is a measure only indirectly tied to future RICO violations. There are a number of reasons why youth smoking prevalence targets may not be met, of which continued marketing to youths is only one.
To understand the quite indirect connection between youth marketing and youth smoking prevalence targets, consider the following two scenarios.
First, suppose that the companies were to completely stop marketing to kids. However, suppose that the entertainment industry began to portray smoking in movies more often and in an ever more glamorous way. According to some research, this would be expected to result in a monumental increase in youth smoking. So despite the fact that the tobacco companies stopped marketing to youths completely and thus refrained from RICO violations, the youth smoking prevalence targets would not be met because of the actions of a party over which the tobacco companies have no control.
The research demonstrates that while tobacco marketing does influence youth smoking behavior, it is only one of a large number of factors. Eliminating youth exposure to cigarette marketing would certainly be expected to lower youth smoking prevalence, but there are a number of other factors over which the tobacco companies do not have control which could come into play and could work in the opposite direction. The overall result could be that the youth smoking reduction targets are not met, even though the tobacco companies have acted appropriately.
This hardly seems like a just approach (to penalize the companies even though they discontinued RICO violations). And it may in fact turn out that the companies have an economic incentive to continue youth marketing. Because if it appears that they are going to have to pay the fines whether they market to kids or not, then the incentive is clearly for them to market to kids. They might as well reap the benefits of an increased customer base.
Now here's a second possible scenario. Let's assume that the American Legacy Foundation's efforts to secure funding for the continuation of the "truth" anti-smoking campaign are successful and that it is as effective as Legacy claims. A 22% reduction in youth smoking therefore occurs and continues for several years. Thanks to Legacy's efforts, there would be a dramatic reduction in youth smoking prevalence, and there would be no need for the tobacco companies to alter their marketing behavior because they wouldn't have to pay the fines anyway. (Remember that the smoking prevalence changes that Legacy attributes to itself were observed in presumed presence of continued tobacco marketing to youths.) Thus, external factors that influence youth smoking could reasonably work in such a way that the youth smoking reduction targets are achieved without changes in youth marketing, and the proposed remedy would not in fact be effective in preventing and restraining these future RICO violations.
Whether these scenarios are likely to occur or not (and by the DOJ's own expert's testimony, the second scenario will likely occur if the public education and counter-marketing remedy is ordered), the very fact that these are possible and not totally unreasonable scenarios demonstrates my point that the proposed youth smoking reduction targets are quite indirectly tied to future RICO violations.
The government mentions in its brief that youth smoking prevalence reduction targets were a part of the failed 1997 global settlement that was ultimately rejected by Congress. And that seems to be the appropriate place for a public health strategy of this nature to be considered. I think you could potentially legislate such an approach to dealing with tobacco-related disease, but I don't see how a court can fashion this type of approach as a remedy in a RICO case. Youth smoking prevalence is just far too indirectly tied to RICO violations to make it appropriate for a court to impose that broad a remedy for such narrow a purpose.
The rest of the story suggests that none of the monetary remedies that the government has proposed is likely to be ordered by Judge Kessler and/or upheld by the D.C. Court of Appeals because they either are: (1) designed to provide equitable relief for, rather than prevent future RICO violations (smoking cessation); (2) ineffective at preventing future RICO violations (public education and counter-marketing campaign); or (3) far too indirectly tied to future RICO violations to make them an effective preventive remedy (youth smoking reduction targets).
I think that pretty much does it for any reasonable chance of a substantial monetary remedy in the DOJ case - I imagine probably to the great disappointment of many anti-smoking groups who seem to be in this mainly for the money. Unless, of course, the Supreme Court decides to hear the case and rules in the government's favor. Had the anti-smoking groups spent less time and less of their donors' money whining about the loss of money and issuing public, political attacks on individuals for decreasing the monetary requests, and more time helping to fashion effective remedies that would directly restrain future RICO violations by directly regulating tobacco industry marketing practices, then I think the public interest and the public's health would have been far better served.
Saturday, August 27, 2005
This is the second of a series of three posts that will address the 3 major monetary remedies: a smoking cessation program, a national anti-smoking education campaign, and youth smoking reduction targets. This post will deal with the second of these - the request for the industry to be required to fund a national public education and counter-marketing campaign.
2. NATIONAL PUBLIC EDUCATION AND COUNTER-MARKETING CAMPAIGN:
DOJ argues that "the Court can prevent and restrain future racketeering activity by requiring Defendants to fund public education and counter-marketing activities. Counter-marketing in conjunction with other remedies will diminish the future 'returns' to Defendants of making fraudulent and deceptive statements and fraudulently marketing to youth because it will reduce the profitability of such conduct."
"Counter-marketing campaigns have been linked to significant reductions in youth smoking initiation, as well as declines in adult smoking prevalence. Accordingly, as discussed below, counter-marketing: (1) dilutes the impact of Defendants’ fraudulent statements made for the purpose of maintaining and attracting new smokers; and (2) dilutes the efficacy of Defendants’ marketing efforts targeted towards underage smokers. Counter-marketing will prevent and restrain Defendants from making fraudulent statements and marketing to youth by eliminating or substantially reducing the economic incentive to engage in such conduct. ... As Dr. Bazerman explained, 'If a counter-marketing campaign is effective in the long-term, it will remove from the marketplace a population of consumers and potential consumers of defendants’ products, namely children. Thus, their incentive to market to this population will be eliminated and their behavior will change accordingly.'"
The Rest of The Story
What is interesting here is that DOJ is making a very different argument to support its request for a counter-marketing campaign compared to the argument it used to support its request for a smoking cessation program. The latter argument was essentially a plea for equitable relief: that is, for a program that would help redress the damages, on a population basis, of the harms that are expected to result from the defendants' continued RICO violations in the future.
Here, however, DOJ is arguing that the remedy is appropriate because it will prevent and restrain future misconduct by the defendants. This is once again, very different from what I thought DOJ would argue. I thought the government would attempt to convince Judge Kessler that a national smoking cessation program would deter future RICO violations, but instead the basis for the government's request is that such a program would provide necessary remedial relief for future RICO violations. Here, I expected DOJ to argue that a counter-marketing campaign was necessary to remediate false or misleading claims of the industry and thus help to undo the damages caused by its RICO violations (in other words, these could be considered to be "corrective communications.") Instead, DOJ is actually arguing here that this remedy fits directly into the jurisdiction given the court by section 1964(a) of the RICO statute because it will prevent and restrain future RICO violations.
The issue that needs to be considered here is thus very different from in my first post. The issue here is not whether a remedy designed to prevent future misconduct is permissible, but instead, whether or not the requested remedy will in fact prevent and restrain future misconduct, and whether it is specifically designed to do so.
Here, DOJ is not suggesting that the counter-marketing program will have any direct effect of preventing and restraining future RICO-related misconduct. The argument is that the effects of the program will create an economic incentive for the companies not to engage in such unlawful behavior.
But how would a counter-marketing campaign create a strong economic incentive for the companies not to commit future RICO violations (which in this case is primarily deceptive and fraudulent marketing to youths)? The argument is that such a campaign would dilute the impact of any deceptive statements intended to mislead youths about smoking and dilute the impact of any fraudulent marketing aimed at influencing youths to start smoking. And that because the effects of such youth marketing would be reduced, cigarette companies would no longer have a financial incentive to engage in such youth marketing practices.
And it is here that I think that the argument not only falls apart, but is actually the opposite of what it purports to be.
If it is true that the requested public education and counter-marketing campaign would dilute the impact of deceptive and fraudulent tobacco industry marketing to youths (and we'll set aside for now the question of whether the evidence supports that the campaign will actually be effective), then what I think the logical response of any tobacco company would be is to increase their youth marketing, to become more aggressive in this marketing, in order to overcome the decreasing effectiveness of the marketing and to yield a steady and continuing stream of new customers.
In other words, the likely impact of a counter-marketing campaign (assuming, in the first place, that it was tremendously effective) would be to create a strong incentive for companies to increase and strengthen their youth marketing activities. (see my March 30 post for a more detailed discussion of this issue)
In addition, by allowing cigarette companies to hide behind the fact that they were funding a national anti-tobacco media campaign, it would actually decrease public and political pressure on the companies to refrain from youth marketing. The environment, I believe, would be one in which the incentive for and feasibility of continued youth marketing violations would actually be strengthened, not eliminated or substantially reduced.
In order to defend its argument, I think that the government is boxed into a corner. There is only one argument it can make to save this line of reasoning. This argument is that the counter-marketing campaign will be so effective that it completely immunizes youths against exposure to tobacco marketing and that no marketing they subsequently are exposed to will have any impact on their behavior.
Unfortunately, such an argument is based on pure fantasy. I wish there was a media campaign that could completely prevent the effects of tobacco marketing on youths, so that the impact of this marketing on kids would be completely negated. But there simply is not any such campaign available. In fact, I don't see any credible evidence to even support a contention that the proposed counter-marketing campaign by the American Legacy Foundation will have any effect on youth smoking behavior, because I believe that the present evidence most reasonably supports a conclusion that the Legacy's "truth" campaign did not have any impact on youth smoking behavior.
But let's assume, for the sake of argument, that everything Legacy has concluded about its own campaign is true, and that the campaign would indeed cut smoking among youths by 22%. Let's even assume that the campaign would be more than twice as effective as claimed and that it would cut smoking by 50%. If true, this would create a tremendously strong incentive for the cigarette companies to be ever more aggressive in marketing their products to youths, because they would have to be twice as successful among the smaller proportion of youths available to them in order to maintain their customer base.
Let's even accept the argument that Legacy could fashion a campaign that would completely immunize 50% of youths against any and all tobacco marketing. Let's assume that after seeing a few "truth" ads, 50% of all youths would have no capability whatsoever of being influenced in any way by tobacco marketing in any way, shape, or form. What that means is that the tobacco companies would have an enormous financial incentive to figure out a way to design a youth marketing strategy that was twice as effective as current strategies, since their available customer base would have been reduced in half.
The only way out of this conundrum would be to argue that the Legacy Foundation's campaign would be 100% effective in immunizing all kids against any and all influence of exposure to tobacco company public relations and marketing activities. And that is pure fantasy.
There is one other possible way out, which is to argue that the tobacco companies could not effectively market their products to youths because of the other remedies (such as direct marketing restrictions) being requested. But if that's the case, then there is no need for the counter-marketing campaign in the first place.
And if the government were to argue that the other remedies would not completely restrain the companies from marketing to youths, but enough so that they could not counteract the effects of decreasing marketing effectiveness, then the government would be putting its entire remedy request in jeopardy, because it would be admitting that the other requested remedies would not be effective in preventing and restraining future RICO violations.
In short, I believe that the government's defense of its request for a national public education and counter-marketing campaign run by the American Legacy Foundation is weak and unlikely to be compelling to the Court. It relies on the argument that the requested campaign will essentially be effective in immunizing all kids against the influence of tobacco public relations and marketing activities, which is impossible. As I've argued, there isn't even strong evidence that the current national anti-smoking campaign has prevented any kids from starting to smoke, since the campaign appears to be ineffective among kids with the highest exposure to the "truth" ads.
The rest of the story suggests that DOJ's argument used to support the request for a public education and counter-marketing campaign is uncompelling because such a campaign would actually strengthen, not weaken the financial incentive for companies to market their products to youths.
Tennessee Attorney General Accuses Country Music Star of Master Setttlement Agreement Violation for Pulling Skoal Out of Pocket on Stage
Summers made the request in order to stop the country music artist from promoting smokeless tobacco to youths present at her concerts. However, he based the request at least in part on his contention that Wilson's removal of the Skoal can during her concerts may violate the terms of the Master Settlement Agreement (MSA) signed by the state of Tennessee and by the U.S. Smokeless Tobacco Company, manufacturer of Skoal.
Summers wrote: "The company that manufactures Skoal, the United States Smokeless Tobacco Company, has signed the Smokeless Tobacco Master Settlement Agreement, which prohibits targeting youth for tobacco product sales. Attorney General Summers is also contacting the manufacturer about the use of its products at Wilson’s concerts."
The media interpreted Summers' statement as suggesting that Wilson was violating the MSA, and reported the story as such. According to the Associated Press article on the topic, "A warning letter said the routine might violate the 1998 tobacco settlement, which forbids tobacco ads targeting young people."
The Rest of the Story
While the Attorney General of Tennessee can certainly request that Wilson stop using the Skoal can in her performance so as not to promote the use of smokeless tobacco to young people, it seems inappropriate for him to invoke the Master Settlement Agreement and threaten to use the force of law to try to convince Wilson to alter her act.
Because the MSA is a contract between the tobacco companies and the states, it clearly does not apply to individual country music artists and what they choose to do during their performances. It cannot apply to such individuals, because they are not party to the contract.
The Tennessee Attorney General's suggestion that Wilson's act violates the MSA is preposterous, and his contention is in direct conflict with the First Amendment to the Constitution, as well as other consitutional rights, including due process. There is no way that the state of Tennessee can impose requirements on the musical performance of an artist who is not party to the MSA contract. The MSA prohibits targeting of youths by the tobacco companies which signed the Agreement, not by country music performers.
The only exception to this would have been if Wilson was being paid by the smokeless tobacco company for using the Skoal in her performance, in which case it could have been interpreted as the tobacco company, rather than Wilson, which was promoting the product. But that is not the case, as Wilson stated that she has no relationship with the U.S. Smokeless Tobacco Company.
In the end, Wilson voluntarily agreed to discontinue the use of the Skoal can in her act. However, the fact that Summers apparently saw fit to inappropriately invoke the MSA in trying to influence Wilson's actions is unfortunate.
It's great that Attorney General Summers is concerned about the promotion of smokeless tobacco to youths, but that concern certainly doesn't justify the threatened unjustified intrusion into an individual's First Amendment rights.
Thursday, August 25, 2005
Today marks the first of a series of three posts that will address the 3 major monetary remedies: a smoking cessation program, a national anti-smoking education campaign, and youth smoking reduction targets. This post will deal with the first of these - the request for a national smoking cessation program.
1. SMOKING CESSATION PROGRAM:
DOJ argues that "As a result of Defendants’ pervasive marketing efforts, the Court can find as a matter of fact that smokers will continue to be affected by Defendants’ fraudulent conduct occurring after the date of a final judgment in this case. For this reason, the Court should require Defendants to fund a smoking cessation program targeted at a population equal in size to those smokers who are reasonably likely to be the future victims of Defendants’ conduct, specifically addressing Defendants’ future violations with forward-looking relief. ... funding a smoking cessation program in an amount determined by the reasonably likely future effects of Defendants' post-judgment fraudulent activity in order to elminate the impact of Defendants' future fraud is quintessentially forward-looking."
The Rest of The Story
What is quite interesting here is that DOJ is specifically not claiming that its proposed smoking cessation remedy will help prevent and restrain future RICO violations, as I thought they would try to claim. Instead, the government is arguing that because future RICO violations cannot be effectively restrained in short order by other remedies, it is necessary to have some remedy available for smokers who continue to be affected by the defendants' misconduct in the future (in particular, during the first year after judgment is issued). And the smoking cessation program is designed to serve as a remedy for the future effects of future violations.
Here's why I think this is a losing argument:
From the get-go, DOJ is admitting that this remedy is not designed to prevent and restrain future RICO violations. Right out of the box, this does not bode well for the remedy, since the civil remedies provision of RICO [18 USC 1964(a)] states that: "The district courts of the United States shall have jurisdiction to prevent and restrain violations of section 1962 of this chapter by...". It does not state that the courts have jurisdiction to remedy, repair, fix, undo, or patch up the effects of RICO violations, whether in the past or continuing in the future. Instead, section 1964 outlines a procedure [see 18 USC 1964(c)] for persons injured by RICO violations to sue the defendants: "Any person injured in his business or property by reason of a violation of section 1962 of this chapter may sue therefor in any appropriate United States district court...".
It does not appear to me that Congress had in mind a civil remedies scheme by which courts would take on the role of remedying the effects of RICO violations for the population. Instead, Congress fashioned a system by which courts would act to prevent and restrain future violations on a population basis, and then individuals could seek redress for the injuries they may have suffered by suing in federal court. Had Congress intended for the courts to redress the wrongs committed by RICO violators on a population basis, would it not have specified a procedure to do so, or provided the courts with such jurisdiction in section 1964(a)?
Without section 1964(c), the government might have an argument because it could claim that the law is vague on what to do about redressing the effects of RICO violations and that the D.C District Court sitting in 2005 should have the freedom to provide population redress for violations in a way that is not inconsistent with the provisions of section 1964(a). But Congress appears to have specifically considered the problem of a need for redress from RICO violations, and its decision appears to have been to deal with this through individual lawsuits, not a population-based, court-designed system to remedy the wrongful acts.
Most importantly, however, the DOJ's argument here does not address the D.C. Court of Appeals' ruling, which clearly stated that: "The Government would have us interpret § 1964(a) instead to be a plenary grant of equitable jurisdiction, effectively ignoring the words 'to prevent and restrain' altogether. This not only nullifies the plain meaning of the terms and violates our canon of statutory construction that we should strive to give meaning to every word, ... but also neglects Supreme Court precedent...".
The Court of Appeals has made it clear that it will not interpret section 1964(a) in a way that ignores the presence of the phrase "to prevent and restrain violations." It seems to me that issue has already been decided once. And it will certainly be decided the same way the second time around.
In one case then cited by the Court of Appeals, the Supreme Court "held that compensation for past environmental cleanup was ruled out by the plain language of the Resource Conservation and Recovery Act which authorized actions “to restrain” persons who were improperly disposing of hazardous waste." In that case, redress for past environmental wrongs was not permitted because the language of the statute in question provided jurisdiction to restrain the environmental violations.
Unless the RICO statute specifically granted jurisdiction to provide equitable relief, or unless it had been left so vague as to not make it clear what the nature of the jurisdiction were, then it is quite clear that the Appeals Court will interpret it to disallow equitable relief (on a population basis) for the wrongs suffered as a result of RICO violations.
Finally, there is nothing in the D.C. Court of Appeals' decision that leads me to believe that it will have any different interpretation of the civil remedies provision of the RICO statute as it would apply to past violations versus future violations.
The D.C. Court of Appeals seems exquisitely clear in spelling out that: "The structure of RICO similarly limits courts’ ability to fashion equitable remedies." I don't quite see any vagueness or ambiguity here. The law is simply not being interpreted in a way that gives courts the ability to fashion equitable relief. They can only act to prevent and restrain future violations. But what DOJ is asking for is clearly a form of equitable relief.
It appears that DOJ has succesfully addressed the issue of a backwards-looking versus a forwards-looking remedy, but they have not addressed the rest of the appellate court's decision, which dealt with the difference between injunctive and equitable relief.
The rest of the story suggests that DOJ's defense of its proposed smoking cessation remedy is weak and unlikely to be compelling, because while it does address the issue of a backwards-looking versus forwards-looking remedy, it fails to confront the most basic issue at hand: the fact that the RICO statute's civil remedies provision has been interpreted by the D.C. Court of Appeals to preclude courts from fashioning population-based equitable relief (i.e., remedies that will redress RICO violations).
I don't think it matters whether those RICO violations to be redressed occurred in the past, or will occur in the future, and I suspect that the appellate court won't think it matters either. Because the fact is that the statute has been interpreted in a way that makes it clear that courts may only impose injunctive (preventive) relief, not equitable relief.
For these reasons, I believe that the proposed smoking cessation remedy will not be ordered by Judge Kessler, or if ordered, will certainly be overturned by the D.C. Court of Appeals.
UPDATE (August 25, 2005; 10:30 pm): It should now be clear just why I have been arguing for weeks now that the change in the proposed smoking cessation remedy from $130 billion to $10 billion is of no particular consequence and doesn't weaken the case. If anything, it strengthened the case slightly by at least changing the remedy from a backwards-looking one into a forwards-looking one. After reading the post-trial brief, I think it seems quite clear that the decision to change the smoking cessation remedy was not an example of political interference to protect the tobacco industry, but instead, a strategic legal decision. At this point, I think the information available suggests that all the fuss the D.C. health groups and ANR made over this issue, including their personal and political attacks, were unwarranted.
Wednesday, August 24, 2005
Well - the Campaign for Tobacco-Free Kids (TFK) made a big mistake. Exactly one year ago, it ran what I think was a very deceptive and disingenuous campaign to promote the FDA tobacco legislation. This campaign was highlighted by a communication to TFK constituents stating that Big Tobacco was opposing the FDA legislation and was mounting a huge campaign to defeat it.
This was, in my opinion, quite clearly an intentional failure to disclose that the largest member of Big Tobacco by far - Philip Morris - was in fact supporting the legislation and using its massive lobbying and public relations resources to promote the bill's passage.
By neglecting to mention this critical fact, and by not being forthright about Philip Morris' support for the bill, I believe that TFK misled its constituents into believing that this was simply an issue of public health vs. Big Tobacco: that everyone in public health supported the bill and that everyone in Big Tobacco opposed it. But this was not the truth. In fact, the Campaign was well aware that Philip Morris supported the bill and that many tobacco control advocates believed that it represented a huge bailout for Big Tobacco that would harm the public's health. This "nuance" was not revealed to TFK's constituents in the above communication.
The mistake actually continues to this day. Today, on its web site, TFK still implies that Big Tobacco is fighting the FDA's efforts to regulate tobacco, even though the largest company of Big Tobacco is actually pushing vigorously for such legislation.
A special report, entitled "Tobacco vs. the FDA" is described as outlining "the Food and Drug Administration’s tireless efforts to regulate tobacco as a drug and the industry’s escalating legal challenges, which continue to block the federal government from protecting American children."
I think it is misleading, and probably just plain inaccurate, to state that the tobacco industry is continuing to block the federal government from regulating tobacco, since Philip Morris is pushing the federal government to do so. In fact, Philip Morris expressed significant disappointment that the 2004 FDA tobacco legislation failed, and has made the re-introduced FDA bills its key legislative priority 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."
By calling the report "Tobacco vs. the FDA," I think TFK is implying to the public that Big Tobacco is against FDA regulation. This is misleading, and I think furthers my argument that a correction is warranted.
It would be more accurate to title the report "Michael Siegel vs. the FDA" than it is to imply that it is Big "Tobacco vs. the FDA." While I am clearly and unequivocally opposed to the FDA legislation and have and will work vigorously to kill it, Big Tobacco is not clearly and unequivocally opposed and the largest company of Big Tobacco has and will in fact work vigorously to get this legislation enacted.
The Rest of the Story
Look - a mistake is a mistake and even if hundreds or thousands of public health advocates were, or continue to be, misled by the Campaign's inaccurate or misleading statements, I think TFK's actions could be forgiven if they simply corrected the problem and apologized.
For two months now the clock has been ticking, and I believe TFK is well aware that there is a legitimate concern that their claims, both now and in the past, have misled a substantial number of public health practitioners.
It is quite clear, I believe, that TFK is not going to apologize or to correct the problem, and that its deceptive and misleading campaign, highlighted by its current claim that this is a story about "Tobacco vs. the FDA," is going to continue.
It does not appear that honesty is going to be forthcoming from TFK.
Unfortunately, since TFK is the largest and most influential organization within the anti-smoking movement, its actions really do tend to represent the values and character of the entire movement. So I think the clear impression to the public is that honesty and integrity are not going to be forthcoming from the anti-smoking movement.
It appears that TFK's political agenda - which is for some reason an obsession with enacting protectionist legislation for Philip Morris that is the world's chief tobacco company's highly desired legislative goal - is going to trump concerns over honesty, forthrightness, and integrity.
And this is the group that wants to "represent the health interests of the American people?" First, TFK needs to learn the importance of being honest and forthright in their public statements, and the importance of being able to take into consideration other factors (like ethics) in addition to its own political desires. Then, maybe we can talk about representing the interests of the American people.
The rest of the story casts a dark shadow on the entire anti-smoking movement because TFK's lack of honesty, integrity, and forthrightness, but most importantly, their simple unwillingness to admit a mistake, reflects poorly on all groups in the movement.
Tuesday, August 23, 2005
According to the Foundation: “Vice Chancellor Stephen Lamb has reasonably defined vilification and personal attack in a way that will allow our foundation to continue to tell American youth the facts about tobacco and the industry that markets its products to them. This decision will save hundreds of thousands of lives and we are grateful for it. ... The truth® campaign will one day go down in the annals of public health history for saving millions of young lives from tobacco addiction and premature death."
To support its far-reaching claims, Legacy cited a single study - a March 2005 AJPH study that it alleges proves that the "truth" campaign resulted in a 22% reduction in smoking among teens during its first two years: "The American Journal of Public Health published findings in March 2005 crediting truth® with accelerating the overall decline in youth smoking by 22 percent in the campaign’s first two years, 2000-2002. This translates to 300,000 fewer youth smokers in 2002 due to the truth® campaign."
In addition, Legacy claims that an independent group of public health leaders rallied to help save the "truth" campaign: "Former Health, Education and Welfare Secretary Joseph Califano, who himself had declared tobacco as 'Enemy #1' during his tenure, rallied a prestigious group of the nation’s public health leaders, The Citizens’ Commission to Protect the Truth."
The Rest of the Story
The real truth, as I see it, is that the AJPH article in question actually showed that the "truth" campaign was not effective in reducing youth smoking. It demonstrated that at the highest levels of exposure -- those that would be most likely to affect smoking behavior if such an effect were real -- there was no effect on youth smoking, or in some cases, actually an increase in smoking rates.
The paper inadvertently cut off Figure 2 at a moderate exposure level of 15,000 GRPs, which left out a large part of the sample. Had the figure been extended to show the results for the full range of exposure, it would have become apparent that there was no campaign effect detected for youths with very high campaign exposure. It would have become clear that the pattern was not consistent with a hypothesis of diminishing campaign effects, but rather, consistent with the absence of an effect of the campaign on youth smoking prevalence.
Overall, I do not think this paper provides strong evidence, or actually any evidence, that the "truth" anti-smoking media campaign was responsible for a reduction in youth smoking between 2000 and 2002. It certainly does not provide evidence upon which one could credibly state that the "truth" campaign was responsible for a 22% reduction in youth smoking during that time period. It certainly does not provide evidence upon which one could reasonably conclude that the effects of the "truth" campaign have continued since 2002, and it does not provide evidence to back up a claim that the "truth" campaign will, in the future, "continue" to have dramatic effects on youth smoking.
In short, I think the American Legacy Foundation is making greatly exaggerated claims about the effects of its campaign that are not documented by, or even consistent with, the existing scientific evidence.
To claim that the campaign will save "hundreds of thousands of lives" or less modestly, "millions of young lives" is, I believe, not a credible or responsible claim based on the actual evidence that is available.
Clearly, more work needs to be done to determine the effect, if any, of the "truth" campaign on adolescent smoking rates. And as I stated earlier, there are plenty of reasons to support and continue funding anti-smoking media campaigns such as the "truth" campaign; however, I do not see the results of the AJPH study that Legacy cites as being one of them.
But beyond the lack of scientific integrity that I see here are two probably more important problems. First is the fact that the study which Legacy cites is its own study, funded by itself, and whose senior author is in fact the President and CEO of the Legacy Foundation.
While this fact is appropriately disclosed in the article itself, it is not revealed to the public in Legacy's press release. The press release tries to (in my opinion deliberately) pull the wool over the public's eyes by making them think that this was an independent study.
The release states that: The American Journal of Public Health published findings in March 2005...", making it sound like the Journal published an independent evaluation of the "truth" campaign. What really happened is that "The American Legacy Foundation published findings in March 2005...".
Since the president and CEO of Legacy was in fact the senior author on this paper, it is clearly a conflict of interest for her to be involved in this research, and such a conflict should be disclosed not only in the paper itself, but any time these results are presented publicly by Legacy.
So we now have a lack of ethical integrity on top of the lack of scientific integrity.
But perhaps the most disturbing aspect of the story is how Legacy makes it appear as if former HEW Secretary Califano and his Citizens' Commission to Protect the Truth independently came to the aid of Legacy. The real truth is that Califano and his Citizens' Commission were paid by Legacy to come to the aid of Legacy. They were paid to the tune of $1.5 million.
The rest of the story reveals that the American Legacy Foundation, in praising itself and making claims that it is going to save millions of lives, is making completely unsubstantiated and unfounded claims based on a single paper which they themselves authored and that they have failed to disclose in their public statement that the paper was actually authored by themselves, or that the group that has supposedly come forward independently to support its funding is actually being paid by Legacy to come forward to support Legacy.
If this is the kind of scientific and ethical integrity that characterizes the anti-smoking movment, I'm not sure I want to continue to be a part of it.
According to the American Legacy Foundation, The Hearst Corporation - a corporate partner of Legacy - is a "leader" in the tobacco control movement. So let's look at the contributions that The Hearst Corporation (publisher of Cosmopolitan, Esquire, and Popular Mechanics) is making to tobacco control this week.
The Rest of the Story
This month's issue of Cosmopolitan features a full-page ad for Kool cigarettes, with a beautiful green jazzy backdrop and the slogan "Be True." It contributes further to tobacco control, however, by including an 8-page insert showing attractive images of a variety of jazz musicians smoking while recording in a music studio.
And its message is clear: "It's about old world class and new world style. It's about uptown attitude mixed with downtown vibe. It's about pursuing your ambitions and staying connected to your roots. It's about being authentic and original. Kool. Be True."
Not to be beat, however, the issue also features a full-page Camel ad, with the "Pleasure to Burn" theme and a seductive pose of a woman smoking a Camel. The ad directly precedes an article on "Hot New Sex Tricks," blending in such a way to almost make the young female reader think that the Camel cigarette is itself an enticement to sex.
But Legacy's partner then goes on to do a great service to the nation's young women. It includes an entire 2-column, 1/4-page article buried back on page 326 on the effects of smoking on fertility, entitled "Steer Clear of Cigarettes." Certainly, this blurb will be effective in counteracting the pro-smoking messages of the full-page Kool and Camel ads and the 8-page Kool cigarette insert.
But don't think for a minute that the Hearst Corporation, as partner of Legacy, is shirking its responsiblities to contribute to tobacco control among the young men of America. In this month's issue of Esquire, it features a full-page Camel ad with the theme "Pleasure to Burn," and showing a young male smoking on a Camel.
And Esquire also features a 2-page Kool (Be Smooth, Be True) ad right smack in the middle of its "The Sexiest Woman Alive" mystery column (you'll have to read the magazine for the answer - I'm not giving it away).
Lest anyone accuse Legacy and its partner - Hearst - of only making contributions in the area of cigarettes and not smokeless tobacco, Popular Mechanics features a full-page Skoal ad, promoting its new Peach Blend flavor: "Catch the next big juicy flavor." For anyone who is not aware, that is "Bold juicy flavor that lasts a long time. Go ahead, take a dip."
Popular Mechanics is apparently an equal opporunity tobacco product promoter, as it also contains a full-page "Pleasure to Burn" Camel ad.
And to top off the tobacco control contributions of Legacy and its partner - Hearst Corporation - for this week, Popular Mechanics also contains a half-page ad promoting "Discount Smokes," cartons of cigarettes as low as $10.99. Plus $5.00 off your first order (but a 3-carton minimum order is required). These prices seem too good to be true.
Honestly - I think the American Legacy Foundation should be ashamed of itself for having the gall to contribute to the promotion of cigarettes to women while at the same time pretending to be a true champion for decreasing the impact of tobacco on women's health in this country through its sponsorship of the Circle of Friends campaign: "The American Legacy Foundation began the national, grassroots social movement Circle of FriendsTM in 2002 with the goal to reduce the impact smoking has on women. The campaign focuses on women because of their special place in our society as positive change agents in their families and communities."
If women have such a special place in our society as positive change agents in their families and communities, then isn't it shameful that the American Legacy Foundation has partnered with a Corporation that, this very month, is running no less than 10 full pages of advertising for Kool and Camel cigarettes? What kind of change does Legacy want women to orchestrate in their families and communities - judging by the actions of its corporate partner, it appears to be passing along the legacy of smoking Kool and Camel cigarettes.
One thing seems true: Since it is contributing to strong tobacco promotions like these, perhaps Legacy does indeed need more money to carry out its programs - since with ads like these, many more youths and young people are going to start smoking and then be in need of Legacy's services.
Let me reiterate that this post is not written to criticize Hearst for publishing these ads. Cigarettes are a legal product, it is legal for a magazine to accept tobacco ads, Hearst is not a public health organization, and I would not expect Hearst to unilaterally make a decision not to accept cigarette ads and decrease its advertising revenue.
But it does show the hypocrisy in the American Legacy Foundation's decision to partner with Hearst, publicly crediting this Corporation with being a leader in the anti-tobacco movement, all the while condemning the high youth exposure to cigarette advertising in magazines out of the other side of its mouth and supporting programs to get women who might be enticed by these cigarette ads to later quit.
This isn't leadership. This is hypocrisy at its worst.
Congratulations to The Hearst Corporation and the American Legacy Foundation for their excellent contributions to tobacco control this week through contributing to the exposure of millions of youths to cigarette advertising.
Monday, August 22, 2005
There are two major bases for Sullum's questioning of this widely used statistic among anti-smoking advocates.
First, he suggests that there are other factors related to exposure to smoking in movies that could also be related to smoking risk: "The problem with attributing this association to the modeling effect of cinematic smoking is that it's impossible to control for all the differences in personality and environment that make kids more likely to see movies with a lot of smoking in them, which already tend to be R-rated movies."
Second, he suggests that the magnitude of the alleged effect is simply not plausible. If cinematic smoking does cause 52% of all smoking and advertising causes another 34%, than movies and advertising cause 86% of all smoking, leaving only 14% to be explained by other causes: "Methodological difficulties aside, the size of this alleged effect is implausibly large, to put it mildly. Glantz says cinematic smoking accounts for even more real-life smoking than advertising does: 52 percent vs. 34 percent. Is it even conceivable that exposure to movies and advertising causes 86 percent of smoking? That all other factors in life together contribute only 14 percent?"
The Rest of the Story
If I'm reading the statistic correctly, it means that 1 in every 2 kids who start smoking in the U.S. do so because of exposure to smoking in movies and 1 in every 3 kids who start smoking do so because of exposure to traditional advertising. This means that 5 of every 6 kids who smoke do so because of advertising and exposure to smoking in movies, leaving all other causes of smoking to contribute to only 1 of 6 cases of smoking initiation.
And it implies that if no kids ever went out to the movies, the number of smokers would be reduced in half. And if all cigarette advertising were eliminated as well, the overall smoking initiation rate would be cut by 5/6.
It also implies that if all other causes of smoking were eliminated, including parental smoking, parental approval of smoking, smoking in the household, exposure to smoking on television, and exposure to smoking in restaurants, then the number of new smokers would only be cut by 1/6.
It doesn't take a rocket epidemiologist to realize that this is simply implausible. And as a researcher who has for years studied numerous causes of smoking initiation, I don't for a minute believe that all causes of smoking other than advertising and movies explain only one-sixth of all smoking initiation.
Sullum is, I think, insightful in calling out the two major reasons why the statistic is flawed. First, and most importantly, it is simply implausible. Beyond any scientific or methodologic concerns, the implausibility of the statistic is the most important reason why I reject it.
Second, there is a serious methodologic concern, which is the likelihood that smoking in movies is related to a constellation of factors that affect smoking risk. It is extremely unlikely that smoking in movies is single-handedly responsible for 1/2 of all kids who start smoking. Instead, it is more likely the case that exposure to smoking in movies is indicative of a constellation or pattern of social, environmental, and behavioral factors that are directly related to smoking uptake.
Although the study from which the statistic was derived controlled for a number of other factors related to smoking risk -- "grade in school, sex, school, friend smoking, sibling smoking, parent smoking, receptivity to tobacco promotions, school performance, sensation-seeking propensity, rebelliousness, self esteem, parent's education, authoritative parenting, and perception of parental disapproval of smoking" -- there are still likely to be factors that are directly related to exposure to smoking in movies that were not measured (and perhaps, cannot be measured).
In other words, I'm not faulting the study itself - it was an exquisitely well conducted study that did an outstanding job of controlling for potential confounding variables. What I'm suggesting is inappropriate is the casual epidemiology that led to the far-reaching and definitive conclusions from the study that I do not think were warranted.
It is one thing to take a study like this and conclude that exposure to smoking in movies is a significant and substantial cause of smoking and that policy changes, such as requiring movies that portray smoking to carry an R rating, would therefore be effective in reducing youth smoking rates. But it is quite another to take a single study like this and attempt to quantify a precise estimate of the number of kids who start smoking simply due to this single exposure, and then to extrapolate out to conclude that this single exposure will cause a precise number of deaths which could be prevented simply by eliminating this single exposure.
The problem with such casual epidemiology is that it assumes a very simplistic (and probably incorrect) view of the world, in which there is no inter-relationship between various social factors and environmental exposures that kids experience. In reality, life is much richer and more complex, different exposures are intertwined, and the causes of a behavior as complex as smoking are multifactorial, interactive, and collinear.
In casual epidemiology, it may seem that there is a simple line diagram that explains a behavior like smoking. Draw a series of boxes for each contributing factor and then draw a straight line over to a box containing smoking and you have a "casual" epidemiologic model for smoking behavior.
But I think it more likely that there is a "web" of causation - a series of lines that are intertwined, boxes that overlap, lines which lead in both directions. This is not to say that the basic epidemiologic conclusion is incorrect (that exposure to smoking in movies is a cause of smoking); it is simply to say that one needs to exercise caution in taking a single exposure and deriving a precise estimate for the number of cases it causes of such a complex behavior as smoking.
The other major problem with casual epidemiology is that it tends to assume a very simple model of causation - one in which there are independent causes, each of which is necessary and sufficient to cause the relevant outcome. But might there not instead be a more sophisticated pattern of causation, one in which it is the combination of a number of factors that lead to a complex outcome such as smoking. Some of these contributing factors may be necessary to cause the outcome and some may be sufficient, but most are probably neither necessary nor sufficient.
Before I close, I must emphasize that I am not here suggesting that: (1) exposure to smoking in movies is not a substantial cause of smoking; (2) exposure to smoking in movies should not be reduced to lower smoking initiation rates; or (3) an intervention to require movies that portray smoking to carry an R rating is inappropriate.
In fact, I can think of a number of reasons why it may be quite appropriate for movies that portray smoking to carry an R rating, most of which have to do with my concerns as a parent who wants to be able to have some control over what my child is exposed to when the child is away from the home.
But I don't believe that exposure to smoking in movies is single-handedly responsible for half of all kids who start smoking and that requiring an R rating of movies that portray smoking will save 120,000 lives a year.
I'm afraid that the situation is a bit more complex, and we'll have to do a bit more than simply tackle the problem of smoking in movies if we really want to cut the rate of adolescent smoking in half.
UPDATE (August 23, 2005; 8:35 pm): An astute reader and commenter has pointed out that attributable and preventable fractions can add up to more than 100%, assuming a multifactorial theory of causation for smoking initiation (which is of course probable). Thus, my argument above that the claim that exposure to smoking in movies causes 50% of smoking initiation is implausible because it implies that other factors can contribute to only 50% is wrong. My reasoning was based on a single cause assumption. This argument does not, therefore, render the claim that exposure to smoking in movies causes 50% of smoking initiation to be invalid or implausible. Neither does the claim that eliminating all other causes of smoking (beyond movies and advertising) would have to eliminate only 1/6 of all smoking.
For readers who are not epidemiologists, what this all means is that if a behavior like smoking is caused by multiple contributing factors, then if you add up the percentage of smoking caused by each individual factor, it can and will exceed 100%. Take the simple assumption that smoking in movies and parental smoking are both necessary and together are sufficient to cause smoking. In this case, movies cause 100% of smoking initiation and parental smoking causes 100% of smoking initiation. Eliminating smoking in movies will eliminate 100% of smoking, as will eliminating parental smoking. Clearly, these percentages add to more than 100%.
Having said all this, and now apologizing to my readers for having fallen into this single cause thinking, it does not affect my underlying criticism of the claim that exposure to smoking in movies causes half of smoking initiation. The reason is that the claim that is being made is that exposure to smoking in movies is a NECESSARY cause for half of all smoking initiation, not just a CONTRIBUTING cause. And this is what I find to be implausible.
In addition, before concluding that exposure to smoking in movies is single-handedly responsible for 50% of smoking initiation, one would have to rule out the possibility that exposure to smoking in movies is simply a measure of a constellation of other exposures that are related to smoking. It may be, for example, that kids who go out to R-rated movies are also more likely to be exposed to smoking in social settings, and thus, more likely to have a higher perception of community smoking prevalence (a known risk factor for smoking). Since it is difficult to control for all major potential confounding variables, it is critical that one be cautious in making precise claims of the number of lives that would be saved by eliminating a particular factor related to smoking initiation. Drawing such a conclusion from a single study is, in my view, not particularly reasonable.
Thursday, August 18, 2005
The argument in favor of using chest CT scans for lung cancer screening in current and ex-smokers is that this procedure can detect tumors far earlier than they are normally detected (based on the appearance of symptoms or the appearance of tumors on conventional chest X-rays). With earlier detection, definitive treatment for lung cancer is more likely to be possible, resulting in a reduced death rate from the disease.
The argument in opposition to using chest CT scans for lung cancer screening is that there is not yet any documented evidence that the procedure will save lives yet there is substantial evidence that the procedure will result in a large number of false positive tests, creating widespread anxiety among patients and requiring the use of additional screening or in some cases, invasive and risky diagnostic procedures. In addition, there is no evidence that the benefits of the use of this procedure as a screening tool would outweigh the costs (estimated at $39 billion on a national basis).
The Rest of the Story
Although it would be tremendously beneficial for there to be an effective screening test that could detect lung cancer at an early and treatable stage, there is unfortunately no such screening test presently available.
First, there is as yet no published evidence that spiral CT scanning is effective in reducing mortality from lung cancer via the early detection of tumors at a treatable stage. Until such documentation is available, it would be premature to recommend this procedure as a screening test on a population level.
Second, the false positive rate is currently far too high to make spiral CT scanning effective and appropriate as a population screening tool. Use of such a screening procedure on a population basis would result in millions of patients with false positive results, creating widespread anxiety, requiring intensive follow-up screening, and in some cases, necessitating the use of invasive and risky diagnostic procedures.
Third, because of the first two problems, it is not at all clear that the cost of population screening for lung cancer among smokers and ex-smokers would be outweighed by the potential benefits.
In summary, there is simply no justification at the present time to support the recommendation for chest CT scanning on a population level for screening for lung cancer among current smokers or ex-smokers.
Wednesday, August 17, 2005
Tobacco Company Defendants in DOJ Case Claim that Government and Anti-Smoking Groups Presented a Public Health Wish List
According to the filing: "The Government could not have been clearer in its central message to the Court throughout the trial of this case: the Court should heed the clarion call of public health. From its first witness (former FDA Commissioner Dr. David Kessler) to its last (long-time tobacco control advocate Matthew Myers) and at every stage in between, the Government brought in the leaders of the tobacco control movement to share their vision of the nation’s progress toward a smoke-free society. No one was excluded: the designers of community anti-smoking interventions, the pillars of the Surgeon General’s reports, the Surgeon General himself, and even a cameo appearance by former President George Bush. ...
the Government has repeatedly invoked the mantra of 'improving public health' in an extralegal attempt to justify a series of multi-billion-dollar remedies—including a national cessation program, a public education and countermarking campaign, and a youth smoking penalty—that in no way meet the D.C. Circuit’s standard. This naked overture to use the judicial process in service of public health policy both corrodes the judicial function and openly flouts RICO law. It compromises the proper function of the courts because 40 years of history since 1964 has established the executive branch’s own dominant and continuing role as the architect of tobacco control. ...
The Government’s use of public health as a talisman of justice also is unapologetically contrary to law—indeed, the very law articulated by the Court of Appeals for application in this case. This is a RICO case. And those five simple words frame the only question that should be addressed now that the trial is over."
The Rest of the Story
On this one occasion, I think the tobacco companies have got it exactly right. There is no question in my mind that the government and the anti-smoking groups involved in this case have treated it as a public health policy forum regarding what national actions could be taken to reduce tobacco use in the nation.
It has basically been a free-for-all, in which various anti-smoking groups have put in requests for their pet programs:
- Not surprisingly, the American Legacy Foundation (through its front group: the Citizens' Commission to Protect the Truth) put in its request for billions of dollars for a national anti-smoking media campaign along the lines of its existing "truth" campaign.
- The Campaign for Tobacco-Free Kids and a number of other major anti-smoking groups intervened in the case largely in order to put in their own request for a multi-billion dollar national smoking cessation program for current smokers.
While I disagree with much of the tobacco industry's defense in the case, especially its defense to the RICO charge itself, I pretty much agree with its defense to the specific remedies requested by the government.
Specifically, I agree that "the Government has repeatedly invoked the mantra of 'improving public health' in an extralegal attempt to justify a series of multi-billion-dollar remedies—including a national cessation program, a public education and countermarking campaign, and a youth smoking penalty—that in no way meet the D.C. Circuit’s standard. This naked overture to use the judicial process in service of public health policy both corrodes the judicial function and openly flouts RICO law."
I would only add that another effect of the anti-smoking groups' actions in this case is that it corrodes their own credibility and integrity, since it has the appearance that these groups have put the law aside in an attempt to achieve huge monetary gains for the anti-smoking movement that are inappropriate under the law.
A study published in this week’s Canadian Medical Association Journal implicates secondhand smoke exposure among adolescents as a cause of smoking initiation in this population (see: Becklake MR, Ghezzo H, Ernst P. Childhood predictors of smoking in adolescence: a follow-up study of Montreal schoolchildren. CMAJ 2005;173:377-9).
The study followed 191 Montreal schoolchildren (average age 9 at baseline and 13 at follow-up) for four years, examining the relationship between secondhand smoke exposure at baseline (measured by salivary cotinine levels) and smoking initiation (defined as having smoked at least one cigarette per week for one month or more). The analysis revealed that controlling for socioeconomic status and household smoking, secondhand smoke exposure was a significant predictor of progression to smoking.
The study also found that increased lung capacity (forced vital capacity) was a significant predictor of smoking initiation among the older children. The paper concludes that “lung size (or some associated characteristic) increases the uptake of environmental tobacco smoke, maximizes the influence of passive smoking in childhood and induces smoking in adolescence.”
Overall, the paper concludes that “enhanced susceptibility to environmental tobacco smoke in childhood increases the risk of nicotine-seeking behavior in adolescence.” The media reported this study as having suggested that exposure to secondhand smoke as children may lead adolescents to later take up smoking.
The Rest of the Story
Before adding smoking to the list of things caused by secondhand smoke exposure, I think one must strongly consider the possibility that the observed association between secondhand smoke and risk of smoking was a spurious one, due to a third factor (known as a confounding variable) that is related both to secondhand smoke exposure and to smoking initiation.
There are a number of probable confounding variables in this study. To start, parental approval or disapproval of smoking and household smoking policies may well explain the observed relationship. Although the study controlled for parental smoking, it is not the case that all parents who smoke have the same attitudes about smoking and transmit those same attitudes to their children. Some parents who smoke may still send negative messages about smoking to their kids and some parents who don’t smoke may fail to express a disapproval of smoking.
In addition, parents who smoke may or may not institute rules about smoking in the household. These rules send kids an important message about how smoking is viewed in the household.
It is very likely that the levels of disapproval of smoking and the nature of household smoking policies are strongly related to the level of secondhand smoke exposure experienced by youths. For example, if parents do not allow smoking in the household, their kids are more likely to get the message that they disapprove of smoking. But they will also be less likely to be exposed to secondhand smoke. So levels of secondhand smoke exposure are almost certainly related both to household smoking policies and to parental disapproval of smoking.
And in turn, each of these two factors is known to be related to the risk of smoking initiation. So the observed relationship between secondhand smoke and smoking initiation could well be due to the fact that secondhand smoke exposure implies a lower level of parental disapproval of smoking and more lenient household smoking policies, rather than to the hypothesis that secondhand smoke exposure somehow causes kids to start smoking.
Another likely confounding variable is peer smoking. Children whose parents’ smoke are also more likely to have friends who smoke and it has been well-established that peer pressure is a significant factor in smoking initiation.
As a reviewer of this paper, I would go so far as to say that I don’t think it provides any solid evidence that exposure to secondhand smoke as a child increases one’s risk of starting to smoke. I find it to be a huge stretch to conclude that secondhand smoke exposure is a cause of youth smoking and I think it is also a stretch to suggest that biologic susceptibility to secondhand smoke exposure (such as increased lung capacity) increases the risk of smoking in adolescence.
The rest of the story suggests that secondhand smoke exposure has been implicated as a cause of active smoking when in fact well-known causes of smoking, such as parental attitudes towards smoking and peer smoking are the more likely explanations of this observed relationship. Secondhand smoke exposure is, in my opinion, related to a number of adverse health conditions, but there is presently no reason to believe that smoking is one of them.
Tuesday, August 16, 2005
The Co-optation of the Anti-Smoking Movement - CHALLENGING DOGMA (Post #5): Tobacco Control as a Grassroots Social Movement
When I started my career in tobacco control, it was truly a grassroots social movement. The individuals involved in the movement were largely unpaid volunteers and they were involved because of a deep personal conviction in the cause, motivated by nothing other than a sincere desire to reduce tobacco-related morbidity and mortality. Similarly, the organizations involved seemed to be motivated solely by a desire to reduce tobacco-related disease.
But there was one thing which we didn’t have in the movement: money. Both individuals and organizations worked either as volunteers or on a shoestring budget. Even many of the researchers in the field did their tobacco research on no budget or on a very low budget. There were no multi-million dollar grants for anti-smoking research or interventions.
Nevertheless, the movement was highly successful. The grassroots nature of the movement gave it great credibility. It also provided great political power, as policy makers and the public viewed proposed tobacco control programs and policies as having originated from the community itself. And most importantly, the local, grassroots nature of the movement resulted in profound changes in social norms at the community level.
At the time, many of us (myself included) felt that if only we had money, if only we could establish a huge infrastructure for tobacco control, then we could really have an impact. If only there were a number of well-funded, national organizations devoted to tobacco control. If only there were well-funded national grant-making organizations that could fund research and intervention at the local level. And if only these national organizations would have the money necessary to be able to access the media: that would give us tremendous political power.
Money, we believed, could extend and enhance the grassroots social movement of tobacco control, bringing it to all communities throughout the country.
The Rest of the Story
Unfortunately, there were a number of consequences of the influx of money into the tobacco control movement that I had not foreseen.
First, money has created an additional influence on both individuals’ and organizations’ actions, beyond simply the desire to reduce tobacco-related disease. That influence is the need to maintain the influx of money to support the individuals’ funding or the organizations’ infrastructure.
One consequence of this is that individuals and groups that are funded by an organization no longer feel at liberty to criticize that organization. But because there are only two groups that supply the bulk of available funding for tobacco control programs (the Campaign for Tobacco-Free Kids and the American Legacy Foundation), those groups end up being essentially immune from public criticism. They can thus take any action they desire, no matter how unethical or inappropriate, without much fear of retribution or even attention to their wrongdoing.
A second consequence of this, in my view, is that it has created a “regulation for regulation’s sake” mentality, whereby the major group – in this case, the Campaign for Tobacco-Free Kids – seems to be intent on pursuing comprehensive federal regulation of tobacco, regardless of the potential effects of such legislation on the overall tobacco control movement and the public’s health. The desire to achieve something at the federal level is apparently so strong that it has led the Campaign and the groups following it to go so far as joining with Philip Morris in helping that company to promote its chief legislative priority for this Congressional session.
This mentality is also in evidence at the state level, where tobacco control practitioners often now seem to be working under the assumption that passing some legislation is better than passing nothing, even if the bill is not appropriate from a public health perspective. The assumption seems to be that we must accomplish something by passing some sort of legislation, so that we can say we accomplished something. But the fact that what we accomplished may actually be harmful to the overall cause of protecting the public’s health seems less important than the fact of “accomplishing” something.
A perfect example of this is the passage of
Second, money has resulted in the appearance of one prominent anti-smoking organization – the Campaign for Tobacco-Free Kids – that in my opinion has essentially taken over the entire movement. There simply is no other organization with the level of resources available and thus there is no competition or opposition to anything the Campaign decides to do or to support.
While there could be no single, dominant organization when no one had money, the fact that one group has huge amounts of money and others have little has created a harmful monopoly in the tobacco control infrastructure.
But what makes the situation even worse is that the Campaign has co-opted the grassroots social movement of tobacco control by taking it upon itself to play the role of “official” representative of the tobacco control movement in all major federal policy matters. It was the Campaign that was at the negotiating table during the global tobacco settlement talks, which ultimately resulted in the Master Settlement Agreement. And it was the Campaign that was at the negotiating table during the talks that ultimately resulted in the federal FDA tobacco legislation that is currently before Congress.
And in my opinion, the Master Settlement Agreement is the worst public health blunder of my lifetime. It would be surpassed as the worst blunder if the FDA tobacco legislation were enacted.
Unfortunately, policy makers in
The creation of the Campaign for Tobacco-Free Kids played a substantial role in the ultimate development of what I think are the two worst existing or proposed national tobacco control policies that have ever been considered: the national tobacco settlement and the proposed FDA tobacco legislation.
Third, I think money has led to the end of the grassroots nature of the tobacco control movement, and to its institutionalization as a money-driven bureaucracy that has little interest in what the grassroots actually think. I simply do not see groups like the Campaign for Tobacco-Free Kids or even the voluntary health agencies really taking the time to listen to their constituencies. They tell their constituencies what to think and what to support. There is no room for dissension or opposition and no interest in engaging the grassroots in the decision-making process.
So rather than being a movement that is driven by the community, through its individual grassroots advocates, the tobacco control movement has become one that is driven by one or two national organizations, without grassroots participation in the decision-making process.
Fourth, and perhaps most importantly, I think that the “monopolization” of the tobacco control movement has pushed aside or perhaps even undermined the work of true grassroots organizations as well as individuals, working at the community level, leaving them essentially powerless. How can a local advocate or advocacy group play any kind of leadership role when the leadership has been usurped away by one or two national organizations?
So I have to say that I was wrong. The availability of money at the national level has not helped the tobacco control movement. It has hurt it.
While the national money has certainly resulted in some “accomplishments,” in the long run, I think it has resulted in, and will continue to result in greater harm to the tobacco control movement. What I see is the degradation of the movement due to its co-optation by one or two well-funded national organizations, with the loss of integrity and character of the movement and its major organizations, the emergence of a regulation for regulation’s sake mentality, and most importantly, the destruction of the grassroots social movement that achieved tremendous success in the effort to reduce the toll that tobacco takes on the health and lives of Americans.