Thursday, September 14, 2006

IN MY VIEW: It's Time to Talk; Tobacco Control Movement Must Open Itself Up for Discussion with Critics

If there's one thing that both good science and sound policy require it's openness to challenge. In fact, I would define the process of scientific advancement as one in which existing paradigms are subject to criticism, challenged, examined systematically, and then either supported or refuted. And I would argue that the process of policy development entails the consideration of a wide range of policy options followed by a systematic examination of each. In both the science and the policy domains, openness to challenge is an essential element for the advancement of the field and a requirement to achieve excellence.

Unfortunately, as I've revealed in The Rest of the Story over the past months, the tobacco control movement has become increasingly insular, blindly dogmatic, and incessantly closed to questioning of both its scientific claims and its policy prescriptions.

It has reached the point where the movement is not even willing to respond substantively to its critics (even if such a critic is one of their own). Any questioning of the established dogma is disallowed, and is met with ad hominem attacks on the critic. Any questioning means, ipso facto, that the questioner has allied himself with the tobacco industry's side and maybe even receives tobacco money. The cause is so noble that the means to the ends are not subject to challenge.

Without realizing it, we have become what Foucault called a truth regime.

The Rest of the Story

A fascinating article in the journal Public Understanding of Science suggests that the anti-smoking movement has become so partisan in its ideology and actions that it is no longer capable of carrying on scientific inquiry (see: Ungar S, Bray D. Silencing science: partisanship and the career of a publication disputing the dangers of secondhand smoke. Public Understanding of Science 2005;14:5-23).

Ungar and Bray write: "We use the term partisan to describe those trying to mute the reporting or circulation of scientific claims. Partisan is a felicitous metaphor, as it encompasses two levels -- ideas and actions. At the first level, a partisan is a firm adherent to a belief or cause; the partisan tends to have an unreasoned allegiance to this, and not to truth. This contravenes, of course, the normative complex surrounding openness in science."

By this definition, the anti-smoking movement is decidedly partisan. While there is nothing wrong with a firm adherence to a belief or cause (it is quite an admirable quality), we cross the line from scientific-based advocacy to unreasoned allegiance when we ally ourselves with the cause (the agenda) and not to truth.

This is precisely what has occurred in our movement. Our firmest alliance is to the agenda, not to truth. One need only scroll through The Rest of the Story briefly to see numerous examples of how anti-smoking groups are not letting the scientific facts get in the way of their desire to make the most dramatic claims, especially about the effects of acute secondhand smoke exposure and the health benefits of smoking bans. The allegiance to the agenda over the truth has infiltrated the entire movement, from the smallest, local grassroots organization all the way up to the Surgeon General himself.

Ungar and Bray continue: "At the second level, a partisan is a member of a ... band harrassing an enemy. For our purposes then, partisanship involves not only a dogmatic adherence to a belief, but also the use of a wide range of tactics to silence opponents of that belief in any arena in which it is presented, reported or used. Partisans seek not only to authoritatively lay down their (scientific) position, but to shield it by engaging in silencing skirmishes that can include, among other things, intimidation, slander and discredit...".

There is nothing wrong with the tobacco control movement laying down its position, even in an authoritative manner. However, shielding it from challenge by silencing critics through intimidation and personal attack puts it into the realm of Foucault's truth regimes. Yet that is exactly what we are doing. Kicking someone off of a list-serve because you do not like the opinions they are expressing is a quite literal form of silencing critics. But this happened to me twice in a matter of months. I did experience intimidation, slanderous attacks, and attempts to discredit me personally.

I should note here that the primary mechanism by which the tobacco control movement silences its critics is what Ungar and Bray term "self-silencing." In most cases, overt intimidation and discrediting is not necessary. The fear of retaliation is so great that most members of the movement, finding themselves in a position of disagreeing with the dogma, will choose to silence themselves rather than to risk their reputations and their careers by speaking out.

Ungar and Bray, in describing self-silencing, appear to have an insightful understanding of the current nature of the tobacco control movement: "Indeed, the ideal form of silencing approaches Foucault's concept of truth regimes: specifically, 'self-silencing,' which is likely to occur when forms of discourse seem so patently obvious and sanctioned by leading institutions that they are presented as givens and are difficult or impossible to challenge. Here competing ideas are ignored because they are not only unbelievable, but they do not fit with the prevailing forms of talk institutionalized in the speech community."

The danger of scientific partisanship is that it represents the antithesis of science. By definition, it precludes sound science. Or as Ungar and Bray put it: "If fully realized, scientific partisanship entails, as noted above, closure, intimidation, and silencing, rendering science impossible."

Here is how Foucault describes his regimes of truth: "Each society has its regime of truth, its 'general politic' of truth: that is, the types of discourse which it accepts and makes function as true; the mechanisms and instances which enable one to distinguish true and false statements, the means by which each is sanctioned; the techniques and procedures accorded value in the acquisition of truth; the status of those who are charged with saying what counts as true." (from: Foucault M. Power/Knowledge: Selected Interviews and Other Writings. 1972-77. New York: Pantheon, 1980).

The anti-smoking movement has a simple mechanism for distinguishing true and false statements: simply determine whether the statement supports or opposes the tobacco control agenda. And it has a simple way of according value to the acquisition of truth: give value to anything that provides data which support the agenda and discredit or devalue anything that does not support the agenda.

A perfect example of this is my own research. When I produced research showing that secondhand smoke poses a serious occupational health hazard for bar and restaurant workers, I was widely praised by the tobacco control movement, was considered an important leader in the field, had my work widely cited, and my comments (even if judged repetitive) were welcomed without hesitation in all tobacco control discussion forums.

However, when I produced research showing that the claims about the reduction of heart attacks attributable to smoking bans were premature, that anti-smoking groups' claims about the acute cardiovascular effects of secondhand smoke were untrue, or that refusing to hire smokers represents employment discrimination, I was immediately dismissed from the list-serves, branded as a traitor, and condemned by my colleagues.

The tobacco control movement has become a regime of truth. A regime that cannot be challenged, even from within. Neither the agenda nor the science purported to support that agenda is subject to challenge. There is no legitimate discourse about the justification for anti-smoking groups' claims, statements, or actions.

I have responded to the development of this regime of truth in the only way I know how: by writing about it and bringing it to public attention. The regime cannot be toppled by bringing it to the attention of the tobacco control community. That type of challenge is heresy. But the public may be willing to listen. I know that you, my readers, are. For that, I am ever grateful.

Note: For purposes of full disclosure, I must mention that it has been a long-term dream of mine to one day bring Foucault into the discussion of tobacco control. Mission accomplished.

Tuesday, September 12, 2006

Nicotine Yield of Philip Morris Cigarettes Drops in 2005; Yields of Philip Morris Cigarettes Have Actually Declined Since 1997

According to reports submitted to the Massachusetts Department of Public Health (MDPH) by Philip Morris, the nicotine yield of its cigarettes (as measured by a machine method prescribed by Massachusetts regulations that simulates actual smoking behavior) fell from an average of 1.76 mg per cigarette in 2004 to 1.69 mg per cigarette in 2005. The nicotine yield of Marlboro cigarettes fell from 1.84 mg per cigarette to 1.80 mg per cigarette, and over the full period 1997-2005, dropped from 1.85 to 1.80.

These findings, which are being released today on The Rest of the Story and are consistent with data presented by Philip Morris, contradict conclusions presented in a MDPH report which asserted that there has been a significant increase over time in the nicotine yield of Philip Morris cigarettes, including its Marlboro brand.

The Massachusetts Department of Public Health had presented data showing that nicotine yield in Marlboro cigarettes increased steadily from a 1.7 mg average in 1998 to a 1.9 mg average in 2004. What the report failed to disclose is that the nicotine yield of Marlboro cigarettes in 1997 was 1.85 mg, meaning that between 1997 and 2004 there was essentially no change in nicotine yield of Marlboro cigarettes.

In addition, the report did not disclose that in 2005, Marlboro nicotine yield dropped to an average of 1.80 mg, meaning that there was actually a decline in the average nicotine yield of Marlboro cigarettes over the entire period 1997-2005, from 1.85 mg to 1.80 mg.

It turns out that for some reason, 1998 was a particularly low year for Marlboro nicotine yield. While averaging between about 1.8 and 1.9 mg for every other year in the period 1997-2005, the average was only about 1.7 mg in 1998. Thus, using 1997 as the starting period in the report led to the appearance of a substantial increase, when in fact the levels have been fluctuating but relatively steady over the past 9 years.

The MDPH report also concluded that nicotine yields of Philip Morris brands overall increased significantly from 1998 to 2004. It is indeed true that the average nicotine yield of all reported Philip Morris cigarettes increased from 1.68 mg in 1998 to 1.76 mg in 2004. However, the average nicotine yield of Philip Morris cigarettes dropped to 1.69 mg in 2005, meaning that over the entire period 1998-2005, there was no change in the nicotine yield of Philip Morris cigarettes.

Philip Morris did not report the nicotine yield of any non-Marlboro cigarettes in 1997, but given the substantially higher yields of Marlboro in that year and the general relationship between Marlboro and non-Marlboro yields, it is almost certain that the average nicotine yield of Philip Morris cigarettes as a whole actually dropped from 1997 to 2005.

In summary, it seems pretty clear from the Philip Morris reports submitted to MDPH that between 1997 and 2005, the average nicotine yields of Marlboro cigarettes and all Philip Morris cigarettes decreased.

The Rest of the Story

The rest of the story is that in contrast to the report, which gained widespread media attention and led to newspaper articles throughout the nation implicating Philip Morris in a scheme to increase its nicotine levels over the past seven years or so, the truth appears to be that there has been no real change in nicotine yields of Philip Morris cigarettes, including Marlboro, over the past nine years.

There has certainly been some year-to-year fluctuations in the nicotine yields, but what was reported as a clear trend over time turns out to have been fluctuation around a relatively steady level. If anything, nicotine yields in 2005, the most recent year for which data are available, are slightly lower than they were in 1997, the first year in which these data were reported.

This story demonstrates the dangers of leaving out specific years of data when trying to draw conclusions about trends in a phenomenon over time. By failing to consider the 1997 data and beginning the analysis in 1998, the report obtained a falsely low idea of the baseline nicotine yields of Philip Morris cigarettes, and therefore this created the appearance of a significant trend of increasing nicotine yields in recent years.

In addition, by failing to consider the 2005 data, which demonstrate that the nicotine yields of Marlboros and Philip Morris cigarettes as a whole decreased, the report created a false appearance not only that nicotine yields were steadily increasing, but that they were increasing at the present time.

Had the report considered just the 1997 data and ignored the 2005 data, it would have been clear that Marlboro's average nicotine yields have not increased, as the results for Marlboro cigarettes would have been 1.85 mg in 1997 and 1.84 mg in 2004.

Had the report considered just the 2005 data and not the 1997 data, it would have also been clear that Philip Morris' average nicotine yields have not increased, as the average results for Philip Morris cigarettes would have been 1.68 mg in 1998 and 1.69 mg in 2005.

The combination of not considering data from either 1997 or 2005 resulted in the appearance of a substantial increase in nicotine yields of Philip Morris (including Marlboro) cigarettes that does not seem to accurately reflect the true time trend.

While I had previously been critical of the conclusions of the report and the statements made regarding the report by some anti-smoking groups, even in the face of an accurate depiction in the trend of nicotine yields of Philip Morris cigarettes, the revelation that nicotine yields of Philip Morris cigarettes have not been steadily increasing during the past decade and that they have not even increased overall during this time period seems to render my previous criticism moot.

At least for Philip Morris. Data are not available for the brands manufactured by other cigarette companies, so it may well be that conclusions regarding increases in nicotine yields of those companies' brands over time are valid.

This story also illustrates why the conclusions of studies like those reported from Helena, Pueblo, and Saskatoon need to be viewed more critically. There are year-to-year fluctuations in many types of data and it is very easy to be misled into thinking that a particular change from one year to another reflects a true trend, when in fact it is just a statistical fluctuation. And even if it is a real change, it is incredibly difficult to pin down the reason for that change.

One needs at least two years of data before a trend is evident. In Massachusetts, the 2005 data made it clear that what appeared to be a trend of increasing nicotine yields over time was probably not a true trend at all. Imagine how crazy it is to conclude that a trend is present in Helena or Pueblo when there is only data available for about one year following the implementation of the smoking bans.

As I am fond of saying, let's not be hasty. Here, premature conclusions by tobacco control groups led to what turns out to be misleading, widespread newspaper coverage of an important tobacco policy issue.

While I have already explained why the public has been misled by the interpretation of what an increase in nicotine yields would mean for smokers and passive smokers, it now appears that the public has also been at least partially misled about the basic conclusion that nicotine yields of cigarettes have increased steadily and significantly over time.

I think this illustrates my observation about how the agenda seems to have overtaken the science in the tobacco control movement. We seem to be so anxious to disseminate information to advance our agenda that we are no longer being careful and rigorous in our science, and especially in our public communications. I think it's time to slow down and led the science dictate the agenda, rather than the reverse.

Monday, September 11, 2006

Attorneys General Hide Legacy Conflict of Interest in Presenting Data on Effectiveness of Truth Campaign

The Attorneys General of 41 states last week sent a letter to the major Hollywood film studios requesting that they show anti-smoking commercials before any of their movies that depict smoking. Included with the letter was a DVD containing three anti-smoking ads for the studios to use. These ads are from the American Legacy Foundation's "truth" anti-smoking campaign.

In attempting to document the effectiveness of these ads in reducing youth smoking rates, and thus provide a strong rationale for why the studios should show these ads, the Attorneys General cited research which they purported shows that the "truth" campaign substantially reduced rates of youth smoking in the United States:

"Legacy, created by the states' 1998 tobacco litigation Master Settlement Agreement, is a national public health foundation devoted to prevention and cessation of tobacco use. According to peer-reviewed research, 22% of the overall decline in youth smoking during 2000 to 2002 is directly attributable to Legacy's national smoking campaign, known as truth. The study found there were approximately 300,000 fewer youth smokers in 2002 as a result of the truth campaign."

The Rest of the Story

I think the Attorneys General are presenting a premature and unsubstantiated claim that the "truth" campaign explains 22% of the decline in youth smoking between 2000 and 2002. I don't for a second believe that the one study being cited, which didn't even measure the exposure of a single youth to the "truth" campaign, can credibly be used to conclude that the campaign reduced youth smoking and to quantify the size of the effect. Especially when the research itself actually showed that the campaign was not effective.

But that's not the rest of the story.

The rest of the story is that the Attorneys General are hiding an important piece of information that I think is essential to reveal in any credible presentation of the relevant facts: the study they refer to simply as being "peer-reviewed research," was actually paid for, conducted by, and co-authored by the American Legacy Foundation. This represents a substantial and significant conflict of interest that affects the interpretation of the research findings and conclusions and which therefore must be disclosed, not hidden.

How likely do you think it is that the Legacy Foundation would author a study showing that its "truth" campaign was not effective? Knowing the way in which the Foundation has gone about its business, I find it difficult to believe that is even in the realm of possibility. So yes - there is a huge bias inherent in this research study and it most likely is substantial enough to affect the conduct, interpretation, and reporting of the research.

And in fact, I view this bias as being every bit as important as when we anti-smokers insist that tobacco industry funding of research or of authors of research papers be disclosed and argue that this conflict severely biases and discredits the research.

By failing to disclose this conflict of interest, I think the Attorneys General are misleading the studio owners and the public. They are making it sound like the research concluding that the "truth" campaign has substantially reduced youth smoking was some sort of independent, peer-reviewed research, when in fact it was not independent at all: it was conducted by, paid for, and authored by the American Legacy Foundation.

Why is it so important that this information be hidden from the public? When you start seeing continuing efforts to hide information like this, I think it's time to suspect that there is some reason why it needs to be hidden.

And I think there is good reason why it does need to be hidden. This is not research which the Attorneys General nor Legacy apparently want to be subject to any scrutiny. Perhaps they realize that a study which finds no effect of the "truth" campaign at the highest levels of exposure does not bode well for supporting a conclusion that the campaign was effective. Perhaps they realize that if the "truth" comes out about the failure to disclose this conflict of interest, the bias inherent in the study, and the weak evidence upon which their sweeping conclusions are based, the wind will be sucked out of their sails.

Thursday, September 07, 2006

Faith Leaders Appear to Be Hoodwinked by FDA Tobacco Legislation; Campaign for Tobacco-Free Kids' Campaign of Deception Appears to Be Working

According to an article in the Douglas Daily Dispatch, a coalition of faith leaders (Faith United Against Tobacco) is calling for legislation that would put an end to special protections for the tobacco industry and level the playing field between tobacco products and other consumer products regulated by the Food and Drug Administration (FDA).

According to the article: "Members of Faith United Against Tobacco, a diverse coalition of clergy and lay members throughout the country, sent a letter to all Congressional candidates urging them to support legislation that gives the U.S. Food and Drug Administration (FDA) authority over tobacco products. The legislation would protect kids from tobacco and save lives. 'We have spoken out on this issue because we have spent too much time burying mothers, fathers, sisters and brothers who die because they became addicted to tobacco products when they were young,' the faith leaders wrote in the letter. 'We know that the tobacco companies continue to spend billions of dollars marketing their deadly product to children and far too many high school students smoke. It is time to protect our children and families.'"

"'The religious community is taking on a critical social challenge - the escalating death and illness from tobacco products,' said James Winkler, General Secretary, General Board of Church and Society, United Methodist Church. 'What we are asking for is not overly burdensome. It would simply level the playing field between tobacco and other products. There is consensus in the faith community - both conservative and liberal - that this product must be regulated.' Unlike other products we consume, tobacco products are virtually unregulated. The FDA legislation would finally end the special protection enjoyed by the tobacco industry and protect our children and the nation's health instead."

The Rest of the Story

The rest of the story is that the legislation the coalition is advocating is a Philip Morris-supported and partially Philip Morris-crafted bill that would institutionalize special protections for the tobacco companies and permanently uneven the playing field between tobacco and other products regulated by the FDA.

Rather than end the special protection enjoyed by the tobacco industry, the Philip Morris legislation is laden with loopholes, presumably inserted as a compromise to appease the nation's largest cigarette company, that would tie FDA's hands and ensure that decisions regarding regulation of tobacco products are made in the realm of politics rather than science.

The bill would prohibit FDA from having complete control over the regulation of tobacco products, reserving the most important aspects of regulation (such as whether to eliminate the nicotine) to Congress, where the cigarette companies can use their political influence to block any meaningful changes.

There is no other consumer product for which the regulation of the most critical aspects of safety is placed squarely in the hands of Congress, rather than FDA. This bill would, in fact, create unprecedented special protections for Big Tobacco. Worst of all, these special protections would be institutionalized. The opportunity to craft effective federal regulatory legislation for tobacco products is not going to come around again any time soon. Why would these faith leaders want to permanently bar FDA from addressing the most essential aspects of tobacco policy?

The answer is that I don't think they do. I don't believe that these faith leaders are trying to pull one over on the American people. I believe that they are indeed sincere about not giving the tobacco industry special protections and that they are simply not aware of the fact that the legislation they are supporting is laden with loopholes, inserted specifically to protect cigarette company profits, which would provide unprecedented special protections to Big Tobacco.

How could the faith leaders be so off base, then, in their support for this legislation? The answer, I believe, is that they are victims of the campaign of deception being waged by the Campaign for Tobacco-Free Kids. The information being put out by the coalition of faith leaders wreaks of the Campaign's influence. It spouts TFK propaganda left and right. Clearly, it appears that the coalition of faith leaders received most of their information about the FDA tobacco legislation from TFK. And that's why I think they are in the unfortunate position of supporting a bill that is completely contrary to their expressed desires.

Regardless of how one feels about FDA regulation of tobacco products (and personally, I'm about as enthusiastic for that as a solution to the tobacco problem as I am for the Red Sox letting Johnny Damon go), what I would hope we would all agree on is that public health groups should be honest, forthright, and transparent in their advocacy for public policies, and should fully disclose all relevant information about proposed legislation to groups they are trying to recruit to support his legislation.

Here, it appears that TFK has failed in its ethical obligation to fully disclose the relevant information. I have yet to see TFK, in any of its propaganda, disclose the fact that it essentially negotiated this bill with Philip Morris, with Congressman Waxman (and perhaps others) as an intermediary. The Campaign has failed to admit that it and Philip Morris were the two major players at the negotiating table, and that the loopholes in the bill are public health compromises that were inserted only in order to appease Philip Morris and protect tobacco company profits.

I think we'll be waiting for hell to freeze over (or the Cubs to win a World Series) before the Campaign for Tobacco-Free Kids discloses the truth about how this bill came to be. Every time I have seen them asked about it, they refuse to discuss it. Refusing to discuss it is in my mind unethical, because the process by which public health groups develop policy ought to be transparent to the public. It is the public's right to know.

But the public is not going to hear the truth from the Campaign. For that, they have to rely on The Rest of the Story.

Wednesday, September 06, 2006

IN MY VIEW: GLOBALink Tobacco Control Forum and Others Like It are Little More than a Platform for Groupthink

When I first joined the GLOBALink tobacco control forum, I thought it would be an excellent opportunity to share in meaningful discussion of tobacco policy issues with public health practitioners from all over the world.

The introductory information sounded wonderful: "GLOBALink is the leading international tobacco control community serving all those active in tobacco-control, and public health. GLOBALink members range from individuals to international organisations worldwide, and include information centres, news editors, cancer societies, health educators, project officers and congress organisers."

In particular, I was interested in the discussion forums, which were advertised as allowing "users to exchange views on a broad range of issues." There are specific discussion forums on secondhand smoke and smoking in the workplace, in which I was particularly interested.

With respect to tobacco control policy discussions in the U.S. in particular, I also signed up for the Smokefree.net discussion forums, whose main goal was listed as "To facilitate communication among smokefree advocates." In particular, I was most interested in the tp-talk (i.e., 'tobacco policy' talk) and the localets-talk (i.e., local environmental tobacco smoke) discussion lists.

The Rest of the Story

After my experience with both of these forums, I am of the opinion that they are little other than mechanisms that allow the tobacco control movement to sink into the depths of groupthink. Rather than stimulating discussion, my impression is that these forums stifle meaningful discussion. Instead, they serve to propagate dogma and rhetoric and to silence potential critics of the tobacco control movement's actions, tactics, and established wisdom, no matter how unscientific, flawed, or unjust they might be.

In coming days, I will be exploring how this occurs and what it means. I will be introducing a series of columns on GROUPTHINK in tobacco control.

For now, let me focus on one observation.

In the past several years, I have never seen the anti-smoking movement respond substantively to a critic. Instead, the response is always an ad-hominem attack and discrediting of the critic (not the criticism). My own experience on the GLOBALink and tp-talk list serves demonstrates this pattern.

Why is it that we are unable to deal with criticism or questioning in any way other than attacking the critic or questioner? What could possibly be lost by actually dealing with the substance of the criticism? If the criticism is wrong, then it would seem to our advantage to discredit the argument on its merit. That would put it to rest once and for all.

Note that I'm not talking here about criticism from the tobacco companies or their paid consultants. I'm talking about criticism from groups or individuals who are not affiliated with the industry. And in my case, I'm talking about criticism and questioning from someone within the tobacco control movement.

There's a sure way to shut me up. And that's to show that my argument is wrong. If I'm wrong about something, the last thing in the world I would want is to continue stating it and misleading people.

Throughout my career, I have always prided myself in taking the time to respond to people who expressed disagreement with me. As a public servant at CDC, I didn't just ignore mail from citizens who expressed differing opinions or criticized aspects of my work, I responded to them. And my response was always on the substance of the issue, not the credentials or personal attributes of the individual. We are in the field of public health, and this is the way I think we should treat the public.

I have to say that I was appalled by the way many tobacco control advocates made personal attacks against individuals on these list-serves (GLOBALink was the worst). Again, I'm not talking about attacking tobacco companies or their paid consultants, I'm talking about attacks against individual, private citizens. I don't think that's a proper use of a forum such as this one. And I can tell you that despite the quick effort to get rid of me from the list-serves for expressing disagreement with the dogma of the movement, there was no action to try to quell these derogatory personal attacks.

I am happy to no longer have to be exposed to these elements of the tobacco control groupthink mentality. It makes each day just a little more pleasant.

Misrepresentation of Nicotine Report Leading to Confusion

The misrepresentation of the Massachusetts Department of Public Health (MDPH) report demonstrating that nicotine yields have increased by about 10% over the past seven years is leading to widespread confusion about the health and policy issues involved in regulating nicotine.

Thanks largely to the propaganda being spewed forth by the Campaign for Tobacco-Free Kids, the public is not receiving a fair and accurate portrayal of the concepts that are necessary to understand in order to rationally formulate policy regarding the regulation of nicotine in cigarettes.

Take this editorial appearing in today's Huntington Herald-Dispatch.

According to the editorial, a new study [the MDPH report] "shows it's harder to quit smoking now than in the past." The editorial concludes that "Increasing the nicotine content of cigarettes to keep people hooked has to stop -- now."

The Rest of the Story

Let's not be hasty.

First of all, the report does not conclude that, or provide any evidence that quitting smoking is more difficult now than in the past because companies have increased the nicotine yields of their cigarettes by about 10%.

I didn't hear anti-smoking groups applauding the cigarette companies for decreasing the addictiveness of their products and making it easier for smokers to quit when the companies substantially reduced the nicotine yields of their products over past decades.

But now all of the sudden increasing the nicotine yields is proof that cigarette smoking is more addictive?

Rest assured, one of the foremost experts on nicotine addiction in the world - Dr. Neal Benowitz at UCSF - is not convinced that we know the impact on addiction of the MDPH report findings on increased nicotine yields:

"I don't think we know what the consequences are for the population in terms of addictive behavior and how hard it is for people to quit."

Well if we don't know what the consequences are, it's tough to sell me on the idea that we need to stop this from happening, as this editorial, and more importantly, the campaign of deception by the Campaign for Tobacco-Free Kids demands.

If you want to sell me on regulation of nicotine, then try selling the idea that we need to simply get rid of it. After all, if we can't tolerate the cigarette companies manipulating (i.e., controlling) nicotine levels, then the solution is to get rid of the nicotine. Outside of that, the cigarette companies are, by definition, going to be controlling (i.e., manipulating) the nicotine levels of their products. They have to. They have no choice (unless they want to put out a product that is so random in its nicotine delivery that they lose most of their customers).

So clearly, it's not the manipulation (e.g., increase) in nicotine levels that is the problem here that is unacceptable and that needs to be addressed. If any problem needs to addressed through regulation, it's the addictive nature of cigarettes (i.e., the presence of nicotine) itself.

As I've pointed out, increasing nicotine levels could actually limit cigarette consumption and smoking intensity, reducing tar intake and having some marginal health benefits. So prohibiting the companies from doing this makes little public health sense.

In fact, the prestigious Institute of Medicine, in a 2001 report on harm reduction, recommended the use of nicotine-enriched cigarettes in clinical trials because of their potential to reduce smoking-induced harm:

“Potential advantages of this trial are that the low-tar/moderate-nicotine product, if it reduces harm, could be used as a reference product for future regulation of marketed products.”

The type of rhetoric being presented in this editorial and in the Tobacco-Free Kids' public statements reveals a very shallow understanding of the health and policy issues related to regulation of nicotine content in cigarettes.

I do not blame the editorial board of this paper at all. They are getting their information from the tobacco control community, and it is our fault that we are not communicating these policy issues appropriately. Unfortunately, it appears that our obsession with getting FDA legislation enacted and our eagerness to blast the tobacco companies for everything is getting in the way of our ability to communicate tobacco science and health issues accurately and with the proper perspective.

Tuesday, September 05, 2006

2006-2007 Academic Year Opens With Two Important Posts

In the first, I discuss the next in what is becoming a long series of fallacious claims by anti-smoking groups.

In the second, I comment on why I think one prominent anti-smoking group lacks integrity and why they make me ashamed to be a member of the tobacco control movement.

Newest Fallacious Claim: Passive Smokers Breathe in More Nicotine than Smokers

According to a press release issued by the Massachusetts Department of Public Health (MDPH) last week: "Non-smokers, especially children, who are exposed to secondhand smoke can inhale up to seven times the amount of nicotine inhaled by a smoker."

This press release accompanied a new report showing that nicotine yields of cigarettes increased by approximately 10% from 1998-2004.

Presumably, the reason why this claim was made was to attempt to demonstrate that the report's findings have implications not just for smokers but for nonsmokers as well. By suggesting that nonsmokers inhale much higher amounts of nicotine than smokers, the press release is implying that the increase in nicotine yields is likely to be harming the health of nonsmokers in addition to smokers.

The press release highlights a number of adverse health effects of nicotine among smokers, including the following:
  • "Increased levels of nicotine may make it more difficult for the average smoker to quit.
  • Increased levels of nicotine consumed by pregnant women can lead to developmental delays in childhood as well as low birth weight infants.
  • Nicotine changes the way that insulin works in the body. Smoking raises blood sugar levels, placing smokers at higher risk for developing diabetes and making it harder for those who already have diabetes to control blood sugar levels.
  • Medications that treat depression and other mental illnesses can lose their effectiveness when combined with nicotine."
It is following these adverse health effects of nicotine among smokers that the press release informs the public that nonsmokers may inhale seven times the amount of nicotine as smokers. Thus, it appears this claim was made in order to make the public think that the increased nicotine yields of cigarettes over the past 7 years are resulting in an adverse health impact on nonsmokers as well as smokers.

The Rest of the Story

Assume that a nonsmoker spends 12 hours a day in the most heavily polluted smoke-filled room imaginable: an enclosed smoking lounge. Based on research I published, the level of nicotine in such a lounge is about 70 ug/m3 (micrograms per cubic meter). These are about the most extreme assumptions one could make about the concentration and duration of a nonsmoker's exposure to secondhand smoke.

Assuming a respiration rate of 1.2 m3/hr (cubic meters per hour), the nonsmoker will inhale 70 x 1.2 x 12, or 1008 ug (micrograms) of nicotine during that day.

Based on the MDPH report, a smoker inhales 1.9 mg, or 1900 ug (micrograms) of nicotine per cigarette.

Thus, the most heavily exposed nonsmoker, under the most extreme conditions, will inhale the same amount of nicotine as a smoker who smokes 1008/1900, or 0.53 cigarettes a day.

In order for the above health claim to be true, the smoker would have to smoke 0.53/7, or 0.076 cigarettes per day.

In other words, in order for it to be true that nonsmokers inhale 7 times the nicotine as smokers, even under the most extreme secondhand smoke exposure conditions, a smoker would have to only smoke one-tenth of a cigarette per day.

In still other words, the claim is mathematically impossible. If a nonsmoker inhales 7 times the nicotine as a smoker during a day, then that smoker is lying about his or her smoking behavior.

Under reasonably high exposure conditions (let's say a nonsmoking bar worker who is exposed for 8 hours to a nicotine concentration of 30 ug/m3), the nicotine intake of that nonsmoker will be 288 ug of nicotine, or 0.15 cigarette equivalents. In other words, in a relatively high exposure situation, the nicotine exposure of a nonsmoker is about 130 times less than that of a 1 pack per day cigarette smoker.

It is important to recognize that the relevant health claim is not merely an exaggeration or an overstatement. It is simply false.

What troubles me the most is not that the claim is false. Anyone can make a mistake and report inaccurate information. What troubles me is that the claim was apparently being made with a specific purpose: to try to convince people that the increasing nicotine yields of cigarettes has implications for the health not only of smokers, but of nonsmokers as well.

As I've already argued, it is not even clear to me that increasing nicotine yields have produced adverse health effects among smokers, because there is no documentation that overall nicotine intake has increased. It may be that just as smokers compensate for reduced nicotine delivery by increasing their consumption and smoking/puffing intensity, they may also compensate for increased nicotine delivery by reducing their consumption and smoking/puffing intensity.

But to argue that the increased nicotine yields of cigarettes has an implication for the health of nonsmokers is really pushing it too far. And as it turns out, it requires a fallacious health claim to support such an assertion.

In Calling for FDA Legislation to Reduce Nicotine Addiction, Anti-Smoking Organization is Full of It; And Devoid of Integrity

In response to last week's Massachusetts Department of Public Health (MDPH) report concluding that nicotine yields of most major cigarettes increased by about 10% from 1998-2004, a leading anti-smoking organization bemoaned the adverse impact of these increased nicotine levels and argued that the observed nicotine increase demonstrates the need to enact Philip Morris' FDA tobacco legislation that is currently pending in Congress.

A statement by the Campaign for Tobacco-Free Kids lamented: "The fact that the tobacco companies have been able to secretly increase nicotine levels in tobacco smoke occurred only because no federal or state agency currently has regulatory authority over cigarettes or what tobacco companies put in cigarettes. ... In light of ... the new report findings, it is critical that Congress enact legislation granting the U.S. Food and Drug Administration (FDA) authority over tobacco products that would require tobacco companies to disclose to the FDA and seek approval before making changes to their products that could make them more harmful or more addictive."

I have already commented that increased nicotine yields do not necessarily translate into increased levels of addiction and higher levels of adverse health effects. Just as smokers compensate for reduced nicotine yields by increasing puffing and smoking intensity, they may also compensate for increased nicotine delivery by reducing puffing and smoking intensity. High nicotine cigarettes have been explored by cigarette companies and public health authorities alike as a potential method for reducing the adverse health impact of cigarettes, since such a product could theoretically reduce overall cigarette consumption, decreasing tar delivery and carcinogenic risk.

Here, I argue that the Campaign for Tobacco-Free Kids' rhetoric about the disaster represented by the increased nicotine and the MDPH report demonstrating the need for Philip Morris' FDA tobacco legislation amounts to little more than hot smoke and reveals a lack of public health integrity on the part of this leading anti-smoking organization.

The Rest of the Story

Let us, for the sake of argument, accept the Campaign for Tobacco-Free Kids' implied assertion that the sale of addictive tobacco products is not acceptable, and that federal regulation is necessary to resolve this problem.

If that is the case, then what is the solution?

Mandating reductions in nicotine levels may seem intuitively to be the solution, but the truth is that reduced nicotine yield cigarettes result in a process known as compensation: smokers inhale more intensely and more rapidly and increase their cigarette consumption to make up for the reduced nicotine delivery. These changes in smoking behavior result in nearly equivalent overall nicotine intake with very low-nicotine and high-nicotine cigarettes.

For this reason, anti-smoking groups (including the Campaign for Tobacco-Free Kids itself) have blasted the cigarette companies for marketing low-nicotine cigarette products, arguing that these products give a false sense of security by implying reduced nicotine delivery when in reality, nicotine intake is essentially the same.

In fact, the cigarette companies' marketing of low-nicotine cigarettes was precisely one of the activities that led to Judge Kessler's conclusion that they were guilty of racketeering.

Requiring significant reductions in nicotine delivery of cigarettes could truly be a public health disaster. By substantially increasing the tar to nicotine ratio in cigarettes, smokers might actually suffer increased health effects because the very low nicotine levels could cause them to smoke more and thus inhale more tar. It could also give smokers a false sense of security about the addictive potential and health effects of smoking (even without fraudulent marketing by cigarette companies).

Thus, mandated reductions in nicotine levels could produce a double whammy in terms of creating a public health disaster: more direct harm due to increased cigarette consumption and indirect harm due to the false sense of security implied by the availability of lower nicotine cigarettes.

While mandating increased levels of nicotine (or increased nicotine/tar ratios) could potentially have some marginal health benefit for smokers, this approach would obviously not address the addiction problem that the Campaign for Tobacco-Free Kids alleges to be concerned about.

Therefore, there is only one solution to the addiction problem: get rid of the nicotine. Requiring the gradual reduction and then elimination of nicotine from cigarettes is the solution to the problem about which the Campaign for Tobacco-Free Kids complains.

One would naturally assume that the reason the Campaign thinks the increased nicotine yields demonstrate the need for FDA legislation is that FDA legislation would allow FDA to eventually force the elimination of nicotine from tobacco products, putting an end to the addiction problem.

However, if you read the fine print of the legislation, you'll find out that the bill does exactly the opposite: it precludes FDA from eliminating the nicotine from cigarettes. It reserves to Congress (and therefore to politics) the authority to make such a decision. Of course, that allows Big Tobacco to use its influence to ensure that such a measure will never see the light of day.

So in essence, the legislation that the Campaign for Tobacco-Free Kids suggests is so essential because of the addiction problem does exactly the opposite of what would be needed to solve that problem: it ties the FDA's hands forever, disallowing it from ever eliminating nicotine from cigarettes and potentially making this product non-addictive. It institutionalizes the addictive nature of tobacco products and makes sure that there can and will be no attempts to address this aspect of the tobacco epidemic.

In other words, the Campaign for Tobacco-Free Kids is full of it.

On the one hand, they are suggesting that cigarettes need to be regulated by FDA precisely because they are capable of producing addiction. On the other hand, they are supporting legislation that would ensure that FDA could not (now or ever) appropriately address the addictive nature of cigarettes by getting rid of the nicotine that makes the product addictive.

If the Campaign for Tobacco-Free Kids had any sincerity or integrity at all, they would demand that the proposed legislation be amended to remove this politically-motivated, definitive, and permanent obstacle to FDA regulating the nicotine content of cigarettes.

How can you with any sincerity and integrity argue that FDA needs to be able to regulate the nicotine content of cigarettes to make sure that people do not get addicted to cigarettes but then turn around and lobby for legislation that permanently bars FDA from having complete control over the nicotine levels in cigarettes?

And why is it that the Campaign refuses to demand such a revision to the legislation? The only possible reason is that the bill would lose Philip Morris' support. In other words, the Campaign has essentially agreed to this severe public health compromise in order to appease the economic interests of a company that is responsible for producing a product that kills hundreds of thousands of Americans each year.

If anyone should be attacked for acting in secrecy, it's the Campaign for Tobacco-Free Kids, not the tobacco companies. After all, the tobacco companies' actions in increasing nicotine yields are not a secret. They were reported to the government and are all over the headlines of newspapers throughout the country.

But the provisions of the FDA legislation which preclude it from eliminating nicotine from cigarettes are being kept a secret by the Campaign, and most people reading the Campaign's propaganda will make the assumption that the legislation will allow FDA to do just that. The Campaign is not fulfilling its ethical obligation to fully inform the public (and other public health and tobacco control groups) of the details of the legislation it is asking them to support.

I'll come clean with something here: the actions of the Campaign for Tobacco-Free Kids are making me extremely uncomfortable identifying with the tobacco control movement. Being a person of (I hope) some integrity, it is disappointing to wake up each morning to remember that the leading anti-smoking group is demonstrating a lack of integrity.

Before anyone misinterprets what I'm saying, I am not arguing that society should necessarily make a decision that we cannot accept the sale of a harmful product that is addictive. I am not arguing that the FDA should ban nicotine from cigarettes.

My argument is that you cannot both suggest that the sale of an addictive product is unacceptable and then support legislation that institutionalizes the addictive nature of that product.

If we are going to argue that cigarette companies should not be allowed to sell an addictive product, then we cannot with any integrity support legislation that would require forever that the product remain addictive.

If we don't feel that the addictive nature of cigarettes needs to be eliminated then that's fine, but we have no business pretending that eliminating the addictive properties of cigarettes is essential and that legislation we are supporting would do just that.

There's something I feel is a little more important to the effectiveness of the tobacco control movement right now than whether or not regulation of tobacco products is put into the tied hands of the FDA.

What's far more important is that we restore some integrity to the movement. I should be able to wake up and feel proud to be a member of the tobacco control community, not ashamed.

Monday, September 04, 2006

GUEST COLUMN: Doral's Nicotine Up Most, But Sales Down Most - By Bill Godshall

This special Labor Day edition of The Rest of the Story features a guest column, contributed by Bill Godshall, Executive Director of Smokefree Pennsylvania.

In this thoughtful piece, Bill presents a cogent analysis of the relationship between nicotine yields of one cigarette brand - Doral - and the brand's market share during the period 2000-2006. The analysis was prompted by the release earlier this week of a report by the Massachusetts Department of Public Health which found that nicotine yields of cigarettes uniformly increased by about 10% during the period 1998-2004.

This report was used by the Campaign for Tobacco-Free Kids to argue that the nicotine dose of consumers has increased, resulting in a greater level of addiction and adverse health effects. The Campaign for Tobacco-Free Kids has complained that the increase in nicotine yields of cigarettes necessitates legislation that would allow FDA to regulate tobacco products (although as I noted, to appease Philip Morris, the legislation would preclude FDA from eliminating nicotine from cigarettes).

Bill's analysis suggests that the Campaign for Tobacco-Free Kids has been too quick to jump to judgment. It is not so simple to conclude that increasing nicotine yield of cigarettes results in increased addiction and adverse public health effects. If anything, increased nicotine yields might reduce smoking and puffing consumption and intensity, decreasing tar intake and subsequent health effects.

The nicotine reductions that would likely come with FDA legislation supported by the Campaign for Tobacco-Free Kids and Philip Morris could actually harm the public's health. It's critical that tobacco control and public health organizations consider the rest of the story, as Bill nicely presents below.

Doral's Nicotine Up Most, But Sales Down Most
by Bill Godshall, Executive Director, Smokefree Pennsylvania

While many news stories have cited the MA Department of Public Health's report in claiming that increased nicotine levels in cigarettes have made them more difficult to quit smoking (since that's what the MDPH press release and fact sheets insinuated), cigarette sales data reveal that the cigarette brand (Doral) with the highest increase of nicotine since 1998 is also the cigarette brand that has lost the most market share since 2000.

As such, it appears premature to claim that increasing nicotine levels in cigarettes makes them more addictive or more difficult to quit.

According to the MDPH report, the three brands with the highest nicotine content increase were Doral 85 Filter Light Hard Pack (36%), Doral 85 Filter Light Soft Pack (33%), Doral Filter Full Flavor Soft Pact (33%).

There are 11 sub brands of Doral 85 and 9 sub brands of Doral 100 (note the number is the cigarette's length in mm), with Doral 85 comprising the overwhelming majority of Doral sales. It is also almost certain that Doral 85 Full Filter and Doral 85 Light have the highest market shares of all Doral sub brands, and that their combined market share represents the overwhelming majority of all Doral sales.

Yet, according to Rob Campagnino of Prudential Equity Group and cigarette sales data, Doral has had the following overall cigarette market share in the U.S.:

6.3% in January 2000
6.3% in January 2001
5.5% in January 2002
5.8% in January 2003
5.2% in January 2004
5.0% in January 2005
4.6% in January 2006
4.4% in July 2006

By dropping from 6.3% to 4.4%, Doral has lost far more market share (1.9%) than any other cigarette brand since 2000. The second largest declining brand was Winston, whose market share dropped from 5.0% in January 2000 to 3.8% in July 2006, a 1.2% decline.

And while Doral's advertising and promotional expenditures are not available, Doral's huge decline in market share doesn't appear to be due to price changes, as Doral price increase has been less than the industry average.

According to IRI pricing data (not including convenience store sales), the overall average price of Doral was:

$2.25 in January 2000
$2.35 in January 2001
$2.52 in January 2003
$2.52 in January 2004
$2.43 in January 2005
$2.42 in January 2006
$2.46 in July 2006

According to IRI pricing data (not including convenience store sales), the overall average price of cigarettes was:

$2.99 in July 2002
$2.98 in January 2003
$2.93 in January 2004
$3.08 in January 2005
$3.22 in January 2006
$3.27 in July 2006

According to the Tax Burden on Tobacco, the weighted average retail price of cigarettes in the U.S. was:

$2.93 in November 1999
$3.12 in November 2000
$3.37 in November 2001
$3.72 in November 2002
$3.71 in November 2003
$3.74 in November 2004
$3.89 in November 2005

Thus, while the average price of Doral (not including convenience store sales) increased by $.21 (from $2.25 to $2.46) since January 2000, the average price of all cigarettes (not including convenience store sales) increased by $.28 (from $2.99 to $3.27) since July 2002, and the average price of all cigarettes (including convenience store sales) increased by $.96 (from $2.93 to $3.89) since November 1999.

Friday, September 01, 2006

Would Kids Exposed to Secondhand Smoke Be Better Off Smoking Themselves?

On today's Reason Online Hit & Run blog, Jacob Sullum has a clever piece which takes off from my post criticizing the inaccuracy of California state Senator Deborah Ortiz's claim that "children are effectively smoking a pack and a half a day for every hour they are exposed to smoke in a car."

Sullum writes: "So if a 6-year-old travels a half-hour each way to and from school, during which time his mother smokes a total of, say, half a dozen cigarettes, he might as well be smoking a pack and a half? He'd be better off smoking a whole pack by himself than he is riding in a car with someone else who is smoking? This sort of nonsense, rather than emphasizing the hazards of secondhand smoke, implies that the risks of a pack-a-day cigarette habit are barely worth worrying about."

The Rest of the Story

This is an insightful and important point. The only thing we're doing by twisting and distorting these data to try to create a more dramatic sound bite is to undermine the public's appreciation of the hazards of active smoking. If the public really were to believe that kids sitting in a car with someone smoking for an hour were as bad as that kid actually smoking a pack and a half of cigarettes, then they would probably not view a pack-a-day cigarette exposure as being much to worry about.

Think about it:

We've told the public that active smoking is no worse than being exposed to 30 minutes of secondhand smoke.

We've told the public that active smoking produces only as much heart damage as 30 minutes of secondhand smoke exposure.

We've told the public that active smoking is similar to a brief exposure to secondhand smoke in that both increase the risk of heart disease and lung cancer.

We've told the public that active smoking is less hazardous than passive smoking because secondhand smoke contains asbestos (mainstream smoke is known not to contain asbestos).

We've told the public that active smoking is less hazardous than passive smoking because secondhand smoke contains plutonium (mainstream smoke is known not to contain plutonium).

In other words, we've basically told the public that active smoking isn't all that it's been cracked up to be. Isn't that far worse than what the tobacco companies have done? At least they have just questioned whether there is enough evidence that smoking is harmful. They haven't actually quantified the risk and disseminated to the public the conclusion that active smoking is about equivalent to a brief inhalation of secondhand smoke.

With friends like ourselves, we don't really need the tobacco companies as enemies. Or, in other words, the cigarette companies can just sit back and watch as we self-destruct due to our insatiable desire to over-dramatize the hazards of secondhand smoke.

CHALLENGING DOGMA (Post #11): Maintaining Cigarette Addiction by Increasing Nicotine Yields is the Sign of a Rogue Industry

As we've seen in the past few days, one aspect of the dogma of the current anti-smoking movement is the belief that maintaining addiction to cigarettes by controlling the nicotine yield of cigarettes is a sign of a rogue industry that needs to be regulated in order to be brought under control and to protect the public's health.

The Massachusetts Department of Public Health (MDPH), in releasing its report showing that nicotine yields of cigarettes increased approximately 10% between 1998 and 2004, cast this change as a detriment to the public's health and as one which would increase the addictive power of cigarettes. More pointedly, the Campaign for Tobacco-Free Kids (TFK) cast this increase in nicotine levels as a sign of a rogue industry that is out of control and needs to have the nicotine content of its products regulated in order to protect the public's health and prevent the companies from "secretly" increasing levels of the addictive agent of cigarettes.

In response, TFK is pushing legislation that it claims would resolve this problem. However, if you actually look at the Philip Morris-supported bill that TFK is advocating, it would tie FDA's hands and prevent it from doing precisely the thing that is necessary to resolve the problem: eliminating the nicotine from cigarettes. Thanks to TFK's lobbying and its refusal to consider strengthening the legislation, FDA would be permanently enjoined from resolving the addiction aspect of the smoking epidemic.

Thus, TFK is blowing smoke when it laments the increase in nicotine levels and whines that this means its pet legislation is necessary. That pet legislation would preclude exactly the remedy that is called for if one were serious that the addictive properties of cigarettes are a massive public health problem that needs to be regulated.

To be sure, the anti-smoking movement casts the industry's use of nicotine to addict its customers as sinister and inappropriate. Yet the movement fails to call for the removal of that nicotine from cigarettes. In fact, the movement is actively pushing for legislation that would permanently preclude the removal of nicotine from cigarettes by the Food and Drug Administration.

Something is seriously wrong here. Where is our consistency? Where is our integrity?

The problem is the blatant hypocrisy, and the impenetrable dogma. You can't adopt the dogma that the industry is a rogue one because it addicts its customers and then attempt to institutionalize the addictive component of the product. It just doesn't make any sense.

If it is the case that society has accepted the production and sale of this toxic and addictive product, then the industry is not so rogue and not so sinister for producing a toxic and addictive product. What makes the industry rogue and sinister is that it continues to deny that its product is addictive and that it finely controls nicotine yields of cigarettes in order to maintain the addiction of its customers.

Remember that there is nothing fraudulent about the industry producing an addictive product. The fraud (that was proven in the DOJ case) is in the industry's lying about the addictiveness of its product and refusing to admit the truth about its knowledge of the addictive nature of nicotine and about its fine control of nicotine levels in order to maintain addiction.

Mixing up these two may seem like a fine point, but it is a critical one to understanding tobacco control and intervening appropriately.

If we truly feel that it is unacceptable to allow an industry to market a highly addictive tobacco product, then we should be trying to fashion a policy approach that will phase out the addictive nicotine from cigarettes.

There should be no particular alarm at the fact that cigarette companies are trying to maintain addiction among their customers and that to do this, they have increased nicotine yields somewhat over the past 7 years. OF COURSE they are trying to maintain addiction among their customers. That's what their job is! If they didn't do this, they wouldn't be doing their job!

Why it is that we feel that tobacco companies should somehow decide to try to lose the bulk of their customers is beyond me. Why we would expect that the companies would do this I cannot even fathom.

No - controlling nicotine levels in cigarettes does not make the tobacco companies a rogue industry. What it makes them is a wise and profitable industry that is doing exactly what it should be doing.

The tobacco companies' sole purpose is to do business. They are not in the public health field. Protecting the public's health is not part of their mission. If it's legal to put nicotine in cigarettes, then they have every incentive to control that nicotine as best as they can to maximize the addiction of their customers. Why wouldn't they do that? It would be a self-destructive business decision to do anything other than that.

What they shouldn't be doing is lying, deceiving the public, and breaking the nation's laws. So if you (TFK) have a problem with the companies putting nicotine in cigarettes, then call for the elimination of nicotine from cigarettes. Don't get behind a bill that Philip Morris supports because it contains a clause that precludes the elimination of nicotine from cigarettes. Make addicting people to nicotine against the law, not an institution permanently protected by the government of the United States.

It's clear to me that something else is going on here. It's called propaganda and rhetoric. And hypocrisy. But it's devoid of any real public health meaning.

I think it's time to stop pretending that the cigarette companies are supposed to be do-gooders. They're not. They're in business for one purpose and only one purpose - to sell cigarettes. And the way to do that best is to carefully control nicotine levels, increasing those levels if necessary to maintain a constant level of addiction among one's customers. The tobacco companies are doing their jobs. I think it's time that we start doing ours.

Thursday, August 31, 2006

Massachusetts Report Finds Increase in Cigarette Nicotine Yields During Past Seven Years

A new report released this week by the Massachusetts Department of Health (MDPH) concludes that actual nicotine yields of cigarettes have increased by approximately 10% over the period 1998-2004.

The Massachusetts method for measuring nicotine yield is an improvement on the FTC-published methods, which do not adequately account for the actual way in which cigarettes are smoked. Limitations of the FTC method include inadequate puff duration and smoke inhalation and failure to block the filter ventilation holes. "The MDPH testing method better simulates the smoking behavior of the typical smoker under typical smoking conditions. Using the Massachusetts’ method, the amount of smoke inhaled with each puff is increased and the amount of time between puffs is reduced. In addition, 50% of the cigarette filter is covered. Testing for nicotine yield using the MDPH method revealed levels that are more than twice as high as those found by the historical method."

The major conclusion of the MDPH report was the following: "For all brands tested in both 1998 and 2004 (N = 116), the total amount of nicotine delivered to the smoker has increased significantly: 1.72 mg in 1998 compared to 1.89 mg in 2004. ... For each of the major manufacturers (i.e., Brown & Williamson, Lorillard, Phillip Morris, and RJ Reynolds), the increases in nicotine delivered were significant. ... With the exception of Winston cigarettes, all brands that were tested in both 1998 and 2004 had significant increases in nicotine delivered to the smoker. This includes Basic, Camel, Doral, Kool, Marlboro, and Newport cigarettes."

The MDPH press release accompanying the report stated: "“'This data is significant,' said DPH Commissioner Paul Cote, 'since is this is the first US release of information on nicotine yield in more than six years. We want health care providers to know that smokers are getting more nicotine than in the past, and they may need additional help in trying to quit.'

Increased levels of nicotine may make it more difficult for the average smoker to quit. Increased levels of nicotine consumed by pregnant women can lead to developmental delays in childhood as well as low birth weight infants. Nicotine changes the way that insulin works in the body. Smoking raises blood sugar levels, placing smokers at higher risk for developing diabetes and making it harder for those who already have diabetes to control blood sugar levels. Medications that treat depression and other mental illnesses can lose their effectiveness when combined with nicotine. Non-smokers, especially children, who are exposed to secondhand smoke can inhale up to seven times the amount of nicotine inhaled by a smoker."

A statement by the Campaign for Tobacco-Free Kids lamented: "The fact that the tobacco companies have been able to secretly increase nicotine levels in tobacco smoke occurred only because no federal or state agency currently has regulatory authority over cigarettes or what tobacco companies put in cigarettes. ... In light of ... the new report findings, it is critical that Congress enact legislation granting the U.S. Food and Drug Administration (FDA) authority over tobacco products that would require tobacco companies to disclose to the FDA and seek approval before making changes to their products that could make them more harmful or more addictive."

The Rest of the Story


While the methodology of the report appears to be solid and the results valid, the conclusions that are being drawn from it raise some important questions.

There is a "rest of the story" here. And that rest of the story is that you can't have it both ways. You can't argue (successfully) in federal court that "low-nicotine" and "light" cigarettes do not confer any health benefit because smokers simply compensate to achieve a steady delivery of nicotine, but then argue that if switched to higher nicotine yield cigarettes, smokers will not compensate by smoking less (or inhaling less deeply).

Is it not possible that the increased nicotine content of cigarettes may have resulted in decreases in cigarette consumption, reduced puff volume and intensity, reduced puffs per cigarette, and reduced time that the smoke is held in the lungs before exhaling?

In other words, is it not possible that despite the increased nicotine yield, the overall nicotine dose delivered to smokers remained essentially the same?

Just as the overall nicotine dose remains the same when low-yield nicotine cigarettes are smoked, why would the overall dose not remain about the same when higher-yield nicotine cigarettes are smoked?

The MDPH appears to conclude that overall nicotine dose has increased, but this conclusion is made in the absence of any evidence regarding actual nicotine doses to which smokers are exposed. The conclusion assumes no change in cigarette smoking behavior, which is an unreasonable assumption, it seems to me, given what we know about how smokers change their puffing and smoking behavior in response to changes in nicotine yield of their cigarettes.

While it seems undeniably true that cigarette companies have increased the nicotine yields of their cigarettes, it does not necessarily hold that this change has resulted in an increase in overall nicotine dose, and therefore in the resulting adverse health effects that MDPH posits are occurring.

In fact, it is quite possible that higher nicotine cigarettes are (marginally) less harmful, because they result in lower cigarette consumption. If the tar delivery is unchanged, then this will result in a lower dose of tar, and a subsequent (marginal) decline in cancer and other disease risk.

In fact, one possibility that has been considered by public health practitioners (and tobacco companies) is the production of a high-nicotine, low-tar cigarette that would allow smokers to obtain current amounts of nicotine through fewer cigarettes, and therefore with lower tar delivery.

The Campaign for Tobacco-Free Kids laments this finding of increased nicotine delivery and issues its usual whine about how this means that Congress must enact the Tobacco-Free Kids/Philip Morris FDA tobacco legislation. But the lament and whine are meaningless, because would the Campaign have stated anything different if the report had found that nicotine yields had significantly dropped over this time period?

Of course not. The Campaign would simply have argued that the decreased nicotine yields are meaningless because smokers simply smoked more. In fact, they probably would have argued that adverse health effects might have increased, since smokers would be compensating by increasing the intensity of their smoking.

What is the significance of the cigarette companies increasing nicotine yields? Probably very little, other than that they are ensuring that addiction levels are maintained given the widespread passage of smoking bans that are limiting opportunities and places for smokers to smoke and encouraging smokers to cut down on the amount they smoke.

Would the FDA legislation have prevented this occurrence, and if it did, would that have been a good thing? It's not clear that giving FDA the ability to regulate nicotine levels would do any good. If FDA required greatly reduced nicotine levels, it could be a public health disaster, as smokers would greatly increase their consumption and overall tar delivery would be much higher, leading to increased disease and death.

Possibly, FDA could do the most public health good by requiring increases in the nicotine/tar ratio in cigarettes, but it's not clear that they could do this given the language of the current legislation. Obviously, the only real public health good that could come from regulation of nicotine would be to get rid of it, but the legislation ties FDA's hands in that regard, and ensures that any regulatory decision to eliminate the nicotine rests squarely in the hands of Congress (i.e., politics), where the tobacco companies would surely use their influence to block action (or they would tie it up in the courts).

Frankly, the Campaign's lament and whining is little more than hot air.

Incidentally, unless I'm missing something, we may have our next fallacious claim by a tobacco control organization, as the claim that "Non-smokers, especially children, who are exposed to secondhand smoke can inhale up to seven times the amount of nicotine inhaled by a smoker" seems implausible to me. Nicotine is much more heavily concentrated in mainstream smoke than in sidestream smoke, so I don't see how it is possible for a nonsmoker to inhale more nicotine than a smoker.

Things cut both ways, and it just doesn't make sense to me to lament the increased nicotine delivery of cigarettes over time, when in the face of a decreased nicotine delivery over time, we responded by blasting the companies for increasing health risks by forcing smokers to compensate and smoke more.

I guess the companies are in a no-win situation. If they decrease their nicotine yields, we'll blast them because smokers will compensate, nicotine intake won't change, but tar delivery will be higher and there could be a net detriment to the public's health. Now that they increase nicotine yields, we blast them because nicotine intake will increase and cause more adverse health effects, making the assumption that compensation won't take place.

There is one detrimental effect of the increased nicotine yield, which is that smokers who are being forced to cut down, or voluntarily cutting down, due to decreased opportunities and environments to smoke thanks to smoking bans, will not see the reduced nicotine delivery and reduced addiction level that otherwise might occur. This is probably the reason why the cigarette companies are increasing the nicotine yields.

The biggest problem with the Campaign for Tobacco-Free Kids' emphasis on the small increase in nicotine yield of cigarettes and on the regulation of tobacco smoke constituents is that it obscures the real issue, which is that cigarettes are a deadly product. No amount of regulation of specific tobacco constituents is going to change that basic fact. And pretending that it will is misleading to the public and represents a disservice to the protection of the public's health.


(Thanks to Bill Godshall for the tip, and for providing a cogent analysis of the potential effects of higher nicotine-yield cigarettes on smoking behavior).

Wednesday, August 30, 2006

JAMA Article Brings Surgeon General's Misrepresentation of Secondhand Smoke Science to the Forefront

An article in the current issue of JAMA (Journal of the American Medical Association), reporting on the recent Surgeon General's review of the health effects of secondhand smoke, brings to the forefront the controversy over whether the Surgeon General misrepresented the science in his public communications surrounding the report's release (see: Kuehn BM. Report reviews secondhand smoke risks: some scientists question risk level. JAMA 2006; 296:922-923).

The controversy stems from the press release and other ancillary materials released by the Surgeon General to accompany the report itself.

Here is what those ancillary materials stated:

According to the Surgeon General's press release:

"Even brief exposure to secondhand smoke has immediate adverse effects on the cardiovascular system and increases risk for heart disease and lung cancer, the report says."

According to the Surgeon General's remarks to the media:

"Breathing secondhand smoke for even a short time can damage cells and set the cancer process in motion. Brief exposure can have immediate harmful effects on blood and blood vessels, potentially increasing the risk of a heart attack."

According to the Surgeon General's accompanying fact sheet:

"Breathing secondhand smoke for even a short time can have immediate adverse effects on the cardiovascular system, interfering with the normal functioning of the heart, blood, and vascular systems in ways that increase the risk of heart attack."

And according to the Surgeon General's accompanying brochure:

"Even a short time in a smoky room causes your blood platelets to stick together. Secondhand smoke also damages the lining of your blood vessels. In your heart, these bad changes can cause a deadly heart attack."

These claims are markedly different from those made in the Surgeon General's report itself, which concludes that chronic exposure to secondhand smoke increases the risk for heart disease, but does not conclude (or even present evidence that) a brief exposure to secondhand smoke can cause lung cancer, heart attacks, or heart disease.

The JAMA Medical News & Perspectives article highlighted the controversy over these claims that brief exposures to secondhand smoke are enough to cause heart attacks, heart disease, and lung cancer: "More controversial [than the claims regarding the effects of chronic exposure] was the surgeon general's emphasis on the immediate risks of exposure to tobacco smoke, particularly acute cardiovascular and lung cancer risks."

"Siegel questioned the surgeon general's comments and promotional materials from Carmona's office that emphasize the acute risks. 'It's very misleading to suggest to the public that you can walk down a street and breathe in a few whiffs of smoke and be at risk of developing heart disease or lung cancer,' he said. 'It takes many years for these chronic diseases to develop, and there's simply no evidence that a brief exposure is enough to cause chronic health problems.' He said he felt the publicity materials and coverage in the media distort the evidence laid out in the report itself."

The reporter apparently sought a response to my critique from a CDC official who co-authored a 2004 commentary which suggested that brief exposure to secondhand smoke might be capable of triggering a heart attack. According to the JAMA article, that official "maintains that the evidence is strong enough that physicians should urge patients with cardiovascular disease or respiratory problems to avoid all exposure to secondhand smoke. He noted that there a large number of individuals who are unaware of the status of their cardiovascular health and may be at risk. He also said that parents need to get the unequivocal message that they should not expose their children to secondhand smoke."

The article concludes: "But Siegel said he believes public health officials should be emphasizing the well-established risks faced by individuals exposed in the workplace or at home, instead of suggesting that everyone is at risk. 'We're really risking our credibility [as public health professionals or officials] by putting out rather absurd claims that you can be exposed briefly to secondhand smoke and you are going to come down with heart disease or cancer. People are going to look at that and say that's ridiculous.'"

The Rest of the Story

I applaud JAMA for the willingness to challenge anti-smoking movement dogma and bring this issue to the attention of the public and the medical community at large. I have become convinced that it is not until the public spotlight is shined upon the misleading claims that are being made that any action will be taken to correct the problem. And this prominent exposure will help, at least to make the public and the medical community aware of what is going on.

To me, the CDC response confirms my assertion that the science has been misrepresented. Apparently in response to my critique of the Surgeon General's public communications about the report, CDC was defensive, but only so far as to emphasize that patients with existing cardiovascular disease may be susceptible to severe health effects from a brief secondhand smoke exposure. The response completely ignored my primary assertion, which is that brief exposure will not cause heart disease and lung cancer in anyone, and will not cause a heart attack in anyone without severe existing coronary artery stenosis.

In other words, it appears that CDC agrees that it is preposterous to assert that a brief exposure poses any problem for a person who does not have severe coronary artery stenosis to begin with, and CDC is unwilling to defend the Surgeon General's misleading claims. At the same time, CDC is also apparently unwilling to suggest outright that the Surgeon General went too far in his press release, remarks, fact sheet, and brochure.

This is not surprising, because it would take a lot for CDC to openly criticize the Surgeon General. Nevertheless, CDC's unwillingness to back up the Surgeon General's health claims does lend support to the validity of my arguments.

I think it is important to continue to press this issue, because it is not until the issue receives widespread public attention that any real response will be forced. On its own, the tobacco control movement has demonstrated no interest in entertaining any scientific challenge to its dogma.

Tuesday, August 29, 2006

California Senate Passes Car Smoking Ban; Inaccurate Scientific Claims Spread to Policy Makers

It appears that the anti-smoking movement's widespread use of inaccurate scientific claims to promote smoking bans has spread to policy makers. In her efforts to promote a ban on smoking in cars with children, California state Senator Deborah Ortiz claimed that a child in a car with a smoker for one hour is effectively smoking 1 1/2 packs of cigarettes.

According to an article on the San Jose Mercury News web site: "Sen. Deborah Ortiz, D-Sacramento, said the Koretz bill was an attempt to 'protect the health of children who cannot protect themselves. We all know that secondhand smoke is hazardous,' she said, 'particularly for young children whose lungs are still developing. Children are effectively smoking a pack and a half a day for every hour they are exposed to smoke in a car.'"

The bill, which would prohibit smoking in any car with a child young enough to require a child safety seat (ages 6 and under or under 60 pounds), passed the Senate on a 23-14 vote and now moves to the state Assembly.

The Rest of the Story

While I oppose this legislation for reasons unrelated to the degree of risk posed by secondhand smoke, I think it is essential that public policy makers accurately present risk information to the public. While secondhand smoke exposure in a car may pose an increased risk for a child to develop upper respiratory infections, middle ear infections, and asthma, it is hardly the case that an hour of exposure is equivalent to that child actively smoking 1 1/2 packs of cigarettes.

There are a number of reasons why this claim is inaccurate, but to start with, the level of secondhand smoke in the car would have to be 8 times higher than the level in the smokiest bar for a one-hour exposure to yield the equivalent exposure as 1 1/2 packs of cigarettes to even the most heavily concentrated component of secondhand smoke compared to mainstream smoke: N-nitrosodimethylamine (NDMA).

While the NDMA exposure, under such conditions, would be equivalent to that from actively smoking 1 1/2 pack of cigarettes, the exposure to all the other chemicals in tobacco smoke would be far less. Thus, it would not be "effectively" the same as smoking 1 1/2 packs of cigarettes. To be accurate, one would have to clarify such a claim by stating that it refers specifically to one or two constituents of tobacco smoke.

More importantly, the exposure levels in cars vary widely and are highly dependent upon whether the windows are open or not. So even if the NDMA exposure levels are correct, in order to be accurate, one would have to clarify such a claim by stating that it refers specifically to driving with the windows closed. It is not sound scientifically to claim that anyone in a car for one hour under any conditions would have this exposure.

Is it just me, or does it not truly seem that nowadays, you can basically say anything you want about the hazards of secondhand smoke? You can claim that it will cause atherosclerosis in 30 minutes, that it will cause fatal arrhythmias, that just a brief exposure will set the cancer process in motion, that it contains asbestos, that it contains plutonium, and that one hour of exposure is equivalent to smoking 1 1/2 packs of cigarettes per day.

While Judge Kessler rejected the idea of having independent monitors to conduct surveillance on the activities of the tobacco companies to make sure that their actions were in line, I think that such a remedy may be required to ensure that anti-smoking groups do not deceive the public.

Back in the old days, we had to back up and support our scientific claims. It must be fun to be an anti-smoking practitioner today. You can basically say anything you want and you don't have to justify it or back it up. I think I entered the anti-smoking movement 20 years too early.


(Thanks to Just the Facts for the tip).