Studies: Cigarette Nicotine Yields Page 2

The paper presents a figure (Figure 1) which shows the trend in average nicotine yields of 18 Marlboro family brand styles between 1997 and 2006. The paper concludes: “A multilevel regression analysis of the nicotine yields in smoke of the 18 Marlboro brand styles reported in each year from 1997 through 2006, as reflected by the MDPH data, shows a statistically significant increasing temporal trend of 0.008 mg/year (p,0.001). Average figures for nicotine yield for these Marlboro brands and the regression line showing a linear, nonrandom trend in nicotine yield in smoke are shown in fig 1.”

This finding directly contradicts the public statement of Philip Morris regarding Marlboro’s nicotine yields. According to the Tobacco Control article: “PM USA issued press releases, observing that the apparent trend in nicotine yield in smoke from 1998 to 2004 was not present when data from 1997, 2005 and 2006 were included. The PM USA website also shows simple linear average nicotine yields in smoke for 18 Marlboro cigarette styles reported in all years from 1997 through 2006, claiming no significant temporal trend and concluding that ‘year-to-year variations in nicotine occur as part of the normal processes of growing tobacco and manufacturing cigarettes.’ The present analysis shows a significant temporal increase in nicotine yield in smoke, contradicting the PM USA claims.”

Importantly, the paper also notes that: “All cigarettes are highly addictive and deadly, and relatively minor changes in nicotine yield may not significantly alter the product’s addictive properties.” and that “The increase over time in nicotine yield in smoke does not necessarily signify any change in exposure within the population of smokers, particularly as smoking behaviour among humans is compensatory and will adjust for differences in smoke yield.”

Finally, the paper notes that “Human studies, including measures of smoking topography and biomarkers of exposure, may be necessary to predict consumer and population effects.”

The Rest of the Story

The rest of the story is that the article reports an average nicotine yield of Marlboro cigarettes in 1997 of approximately 1.85 mg/cigarette, and an average yield in 2006 of approximately 1.85 mg/cigarette.

You’re not reading that incorrectly.

The average nicotine yield of Marlboro cigarettes in 2006 was, according to this article itself (not relying upon Philip Morris’ own data), no higher in 2006 than it was in 1997.

So if the nicotine yield of Marlboro cigarettes was no higher in 2006 than in 1997, then how could there have been a significant, linear trend of increasing nicotine yields of Marlboro cigarettes during this time period?

The answer is: there could not have been such a trend. Such a trend of linearly increasing yield of nicotine yields is not consistent with the study findings, which demonstrate essentially no difference in the yields of Marlboro cigarettes in 2006 vs. 1997.

The curious reader may ask himself or herself: then how does one conclude that there was a trend of linearly increasing nicotine yields?

The answer is that you fit a line to data which clearly do not show a simple linear pattern.

If you examine Figure 1, what you’ll see is that the nicotine yield of Marlboro cigarettes increased rather steadily from 1997 through 2003, and then decreased rather steadily from 2003 through 2006. The nicotine level ended up exactly where it had started. But it went up for a few years, and then back down.

In other words, the trend in nicotine yields exhibits an upside-down “V” pattern.

The appropriate way to model this would be to fit two lines: a line with increasing nicotine yield between 1997 and 2003, and a line with decreasing nicotine yield between 2003 and 2006.

In other words, what appears to have actually happened is that Marlboro’s nicotine yields increased between 1997 and 2003, but decreased between 2003 and 2006.

Because the period of time during which the increase occurred was longer than the period of time during which the decrease occurred, if you fit a simple line (a single line) to the data, you are going to find a line with a positive slope. But that line does not really indicate what occurred during the study period.

In my opinion, these data clearly demonstrate that Philip Morris was correct and the article is wrong regarding the observed pattern. There was indeed no net increase in nicotine yields of Marlboro cigarettes between 1997 and 2006. The nicotine yields did not increase by 0.008 mg/year. What happened is that the nicotine yields increased by about 0.016 mg/year between 1997 and 2003, and then decreased by about 0.033 mg/year between 2003 and 2006.

What’s most interesting to me is the fact that while Philip Morris is apparently being blamed for increasing the nicotine yield of its Marlboro cigarettes between 1997 and 2003, the company is not simultaneously being praised for having decreased the nicotine yields between 2003 and 2006.

In fact, the decreasing nicotine yield of Marlboros between 2003 and 2006 is “impressive.” The rate of decline in nicotine yields is twice what the rate of increase was between 1997 and 2003.

Note that I’m not arguing here that Philip Morris did or did not intend to increase or decrease its nicotine yields within Marlboro cigarettes. These data cannot demonstrate whether or not the changes reflect a true attempt to control these levels on the part of the company, or whether the changes merely reflect random variations. While the variation in nicotine does not appear to be random, neither does it appear to represent a linearly increasing trend.

While I would not have thought that I would be taking the side of Philip Morris in a conflict over the interpretation of scientific data, I do find myself in that position based on my review of this research.

Perhaps an even most interesting aspect of the paper, to me, is the fact that the article itself acknowledges that the observed changes in nicotine yield are essentially meaningless, because “relatively minor changes in nicotine yield may not significantly alter the product’s addictive properties,” and because “the increase over time in nicotine yield in smoke does not necessarily signify any change in exposure within the population of smokers, particularly as smoking behaviour among humans is compensatory and will adjust for differences in smoke yield.”

If it is true that relatively minor changes in nicotine do not necessarily alter the product’s addictive properties and that the increase (or decrease) in nicotine yields in smoke does not necessarily signify any change in exposure within the population of smokers, then what exactly is the significance of this research?

If it is true, as the authors conclude, that one can only draw inferences about “consumer and population effects” by conducting “human studies, including measures of smoking topography and biomarkers of exposure,” then what exactly does this paper tell us about consumer or population implications of the data reported therein?

The answer is: nothing. And the paper acknowledges that, quite appropriately.

But that raises the question of what the value or importance of this research is. It’s not clear to me. However, there’s no question that the research has been used to support two things: (1) promotion of a specific policy end – the FDA tobacco legislation; and (2) the opportunity for anti-smoking groups to take a crack at the tobacco companies for increasing yields which, on our own admission, have nothing to do with actual human consumer or population effects, addiction potential, or health.

RJR responds to Mass. Dept of Health

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.
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Tobacco firms blow smoke on study

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.