Just the facts, please: Judge Kessler’s new history of the tobacco wars - Part 2


Author: John Luik
Article Published: 22/08/2007


“Just the facts, please.” That’s what Jack Webb said week after week to both witnesses and villains alike on the classic television program Dragnet.

CLICK HERE TO READ PART 1


No fancy theories, no embellishment, just the facts. And that same attention to what is really the case- to the facts of the matter- is what most people expect from the court system, particularly at the US district court level where the trial judge acts as the fact finder.

But these expectations have little place in the courtroom of Clinton appointee US District Court Judge Gladys Kessler whose recent decision in the US government’s long-running case against the tobacco industry is often much closer to fiction than to fact. What Kessler has done is to re-frame the smoking and health story of the last fifty years into a story of unparelled villainy on the part of the tobacco industry. According to Kessler, the industry has systematically used bad if not corrupt science along with its advertising and public relations muscle to deceive smokers, the government, the public health establishment and the public about the perils of smoking.

While the industry’s fraud is wide-ranging according to Kessler, it is most easily observed in the way in which the industry has addressed such issues as addiction, less hazardous cigarettes, nicotine “ manipulation” marketing to children, and ETS.

Addiction

Judge Kessler believes that the quibbles about whether there is a viable scientific definition of addiction and whether smoking fits that definition are mere distractions on the part of the Defendants from the core “fact” that smoking involves the “compulsive and uncontrollable use of nicotine” and is thus properly described as an addiction. But Judge Kessler’s pronouncements notwithstanding, the fact that remains is that the idea of addiction is much debated: there is not a scientific consensus. Indeed, the Government’s chief addiction witness Henningfield, told the court that the only common factor in the conflicting definitions of addiction is difficulty in quitting.

Indeed, smoking as an addiction fails the DSM’s first criterion of substance dependence (the DSM does not use the word addiction)- tolerance in which the addicted person needs “markedly increased amounts of the substance”. Nor does it arguably meet three of the remaining six criteria. Again, one looks in vain for a match between some of the standard descriptions of addicted behaviour and smoking. For instance, “Addicts value their preferred drugs above everything else “, “The addict’s drug of choice is more important than family, health, finances, and sometimes even food, shelter and freedom from imprisonment”, “A chemically dependent person also loses the ability to perceive and admit his addiction”, - all current descriptions of addictive behaviour which fail in any respect to describe smoking.

Even more importantly, Kessler’s own definition of addiction as “ compulsive and uncontrollable” behaviour fits uncomfortably with the empirical evidence about smoking. If smoking is genuinely compulsive and uncontrollable how does one account for the fact that about 50 million people in the United States alone, plus additional millions around the world have quit, many of them without any assistance? Kessler denies that stopping smoking is “a simple act of willpower”, but she provides no scientific evidence that it or indeed stopping any other “addictive” behaviour is at bottom anything other than an act of willpower. How would one describe the quit process of millions as other than an act of willpower?

This is more than a semantic quibble for it goes to the heart of the meaning of the smoking as addiction claim. If smokers are able to stop smoking then Kessler’s understanding of addiction as uncontrollable is not only wrong but beside the point. Kessler, of course, despite her imprecise language, probably means simply that smoking can be difficult, even extremely difficult to stop. But this is something that is quite different from the way many smokers and indeed nonsmokers, not to say the anti-tobacco movement think about addiction.

But Kessler faults the industry not simply for producing an “ addictive product”, but also for engaging in a fraudulent conspiracy of concealing the addictive character of smoking from smokers and the government. This, however, is an extremely odd finding given that the difficulty of stopping smoking- and even the addictive tag- have been known since well before the current tobacco industry came into existence. For instance, the New York Times in the 1880’s was describing smokers as addicted to tobacco, while US President John Quincy Adams wrote in 1845 about being “ addicted to tobacco” in his youth. So the difficulty in stopping smoking or even the description of smoking as an addiction is hardly some novel idea or some secret that the tobacco industry has been able to conceal.

Less Hazardous Cigarettes and Nicotine Manipulation

According to Judge Kessler, the industry’s deceptive enterprise went well beyond its position on addiction: it also included the “ fact “ that the industry knew, “ for decades” , “ That there is no clear health benefit from smoking low tar/low nicotine cigarettes as opposed to conventional full-flavour cigarettes.” The evidence, however, suggests otherwise. Stellman and Garfinkel (1989) using the American Cancer Society database of one million men, demonstrated that there is a dose-response relationship between tar intake and lung cancer. Sir Richard Doll in examining the mortality rates from smoking-related diseases in the U.K. between 1950 and 1984 noted that the decline in death rates was not due to the less smoking but to changes in the constituents of cigarettes- that is lower tar levels. In a similar vein, the U.K. Independent Scientific Committee on Smoking and Health concluded in 1988 that “past reductions in the yields of tar and associated cigarette smoke components have reduced the risk of lung cancer and possibly of chronic obstructive airways disease.” More recently (2003) Kabat found “ a reduction of risk [ of lung cancer] on the order of 20 to 30 percent for smokers of lower-tar cigarettes.”

These findings are further confirmed in the Government’s own evidence. For instance, using data from NCI Monograph 13 which compares lung cancer mortality of recent US smokers who smoked lower tar cigarettes with mortality rates of older smokers who smoked higher tar cigarettes, it becomes clear that younger smokers have a reduced lung cancer death rate. Indeed, the Government’s own expert, Dr. Jonathan Samet, said that filtered, reduced tar cigarettes are “ lower risk.”

Of course Judge Kessler brings up the red herring of compensation, but she fails to recall a large amount of credible evidence showing that vent blocking, for instance, does not occur in a significant percentage of low-tar smokers and when it does it fails to substantially increase tar yield. Of course, even if compensation were a substantial issue, it still cannot gainsay the evidence of health gains from lower tar products.

Equally unconvincing are Kessler’s “ facts” about nicotine manipulation which she claims was done in order to maintain maximum levels of addiction. For one thing she appears to misunderstand not only the smoking process but also the cigarette manufacturing process. Given that the typical smokers only consumes about 1 mg of nicotine from each cigarette and that the average cigarette contains about 15 mg of nicotine, what advantage accrues from “ adding” additional nicotine?

For another thing, despite Kessler’s claims, neither former FDA Commissioner David Kessler, nor for that matter any of the other Government witnesses, was able to provide any credible evidence that demonstrated that the industry “manipulated” nicotine levels, either through changing the tar/nicotine ratio or by the use of ammonia.

Youth Marketing

With out doubt the most emotional aspect of the Government’s case was its charge that the industry targets children through its marketing activities and that this marketing was important both in initiating and continuing youth smoking. Kessler accepts both of these claims. With respect to marketing she says that the evidence is “clear and convincing—and beyond any reasonable doubt” that the defendants marketed to underage smokers and then lied about doing so.

But once again the evidentiary record contradicts Kessler’s “facts”. While four of the Government’s witnesses in their initial expert opinion claimed that the industry had targeted underage smokers, none was able under cross examination to point to any marketing plan that contained such “targeting.” Indeed, Kessler seems unable to differentiate between the industry’s research of young smokers who had already made a smoking decision and marketing plans designed to create young smokers. In her “facts”, for instance, she cites a 1974 Philip Morris Marketing Research memo that refers to “the most important segment of the Marlboro franchise, smokers aged 18-24” as if this were evidence of marketing malfeasance despite the fact that cigarette purchases by this age group were perfectly legal in 1974.

Again she refers to a 1984 R.J. Reynolds document as evidence of youth marketing which talks about “Young adult smokers” which leads one to wonder just what would count as a non-youth smoker for Kessler.

Equally unconvincing is Kessler’s claim that the facts show that the industry’s “marketing contributes substantially to the initial demand for and continuing use of cigarettes by young people.” The claim is peculiar first because Kessler notes that the advertising-smoking initiation relationship is “not an empirically verifiable phenomenon”- in other words it is not open to scientific verification. But if not subject to science, what basis does Kessler have for claiming that it is a factual conclusion that marketing contributes to “initial demand”?

The claim, however, is peculiar in another sense in that there is extensive social science, that is factual evidence, which fails to show a connection between both total cigarette consumption and advertising, and advertising and youth smoking. Indeed, Kessler who cites the UK’s Smee Report on tobacco advertising, apparently failed to read the report’s econometric analysis of the possible effect of advertising on tobacco consumption- including young people’s consumption- which concluded that “advertising does not have a statistically significant effect in any form.”

Finally, Kessler’s claim is odd in that she is forced to rely for her “factual” conclusion on nothing more than a few studies offered by the government, none of which even attempted to look at the connection between exposure to marketing and starting to smoke, but instead relied on a series of proxies for advertising exposure- the methodologies of which were all discredited in court.

ETS

Without doubt the most egregious example of Judge Kessler’s incompetence as a finder of fact, particularly with respect to the science which is so much a part of this case, is her conclusion about ETS. According to Kessler the conclusion of the public health community that “ETS causes disease in nonsmokers”, is “definitive”. Moreover, the industry itself knew that ETS was a health hazard and “crafted and implemented a broad strategy to undermine and distort the evidence indicating passive smoke as a health hazard.”

First, Kessler mistakes the “consensus of the public health community” for a scientific consensus when in fact the two are very different things. Second, rather than examine exactly what the scientific evidence actually says, Kessler relies entirely on the expertise of one Government witness, Dr Samet to interpret the evidence. According to Samet, epidemiologists and public health officials have “quite consistently shown… that secondhand smoke causes disease, including lung cancer, in nonsmokers.” It is difficult to know which is more outrageous here, Samet’s claim or Kessler’s uncritical reliance on it.

For instance, of the 75 studies on ETS and lung cancer, only 14 show a statistically significant association, while of the 42 studies on ETS and heart disease, only 18 are statistically significant. Even more odd is the fact that the relative risk for heart disease in smokers is 1.7 while that of nonsmokers exposed to secondhand smoke is 1.3, even though their exposure is 1/500th less, a finding that cannot be explained by any understanding of dose-response relationship or extrapolation of risks from active smoking to passive smoking, both methods favoured by Samet. Equally compelling, but unnoticed by Kessler is the fact that of some 24 studies examining lung cancer risks among nonsmokers in the workplace, 19 find no statistically significant link between secondhand smoke and lung cancer.

Indeed, this pattern of statistically non-significant results has continued unchanged since the first epidemiological studies in the 1980’s, which is telling since studies of real as opposed to phantom risks are usually weak at first but gain strength and clarity with time.

Then too, Kessler seems completely unaware of the fact that the EPA report which she cites failed to establish a statistically significant association between ETS and disease in nonsmokers, or that it, along with Samet’s biological plausibility thesis were savaged by a US District Court in 1998. Or even that Samet’s IARC project failed to establish a statistically significant connection between both residential and occupational ETS exposure and disease in nonsmokers.

At the end of the day Judge Kessler has produced a story of the tobacco wars of the last 50 years that is deeply flawed in almost every respect. Instead of attempting to discharge her responsibility to arrive at the truth, to provide the facts, she has provided instead a decision that is a mélange of bias, selective data, scientific ignorance and confused reasoning.




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