TABEXPO

February 2008

Thinking about risk

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The issue of tobacco harm reduction continues to raise more questions than answers.

George Gay

On the day after I returned home following November’s TABEXPO, the tobacco exhibition and congress held in Paris, I heard a news item on the BBC that reported on a book containing advice for women who wanted to conceive or who were having problems with a pregnancy.

One of the pieces of advice for helping them to conceive suggested that they take the slime from around the mouth of a hare after it had eaten mallow, and drink it mixed with wine. It will come as no surprise that the book in question was published in 1671 and is now a collector’s item.

But while the book might seem almost primitive to today’s reader, it was written by a doctor, William Sermon, who would no doubt have been in touch with the then-latest medical knowledge. So the news item was a timely reminder that what doctors and scientists tell you today might be, let’s say, open to reinterpretation somewhere down the line.

And these days reinterpretation seems to occur almost while the ink is still wet on the original pronouncement. The pack-labeling of tar yields, much touted in the recent past, has fallen out of favor as it has become generally realized that, as the tobacco industry pointed out from the start, yield, as measured by a machine, does not equal human exposure. And it is open to speculation why little seems to have been done with the enormous amount of tobacco products data collected in Canada since the start of this century.

Given such a background, it was interesting to sit in on the congress papers that addressed, directly or indirectly, the attempts being made to assess and reduce the risks posed by tobacco consumption. The papers were erudite but crafted so that they could be understood by the congress audience, some of whom, like me, were not scientists.



No ready solutions

And let me say from the outset that there wasn’t even a whiff of hare’s slime in these presentations by a number of eminent speakers. Unlike Dr. Sermon, these scientists weren’t espousing ready solutions; rather, they seemed to be saying they were making progress by discovering how much they still had to learn about tobacco products and, especially, tobacco smoke.

In fact, to the outsider at least, it seemed difficult to imagine on the basis of the information presented how it would ever be possible to devise a tobacco product that was lit and yet fitted into a rational, generally accepted definition of a product offering a significantly reduced risk. It doesn’t help that some of those in authority seem disinclined to address this issue, while those who are willing to take a lead have no authority, a situation that leaves the tobacco industry trying to design reduced-risk products for which there is no agreed definition.

In such an environment, tobacco manufacturers have taken the only course open to them by defining for themselves what might constitute reduced-risk products and how these might be assessed, along with other important issues such as product stewardship—for instance, making sure that modifications to products do not increase the risks they pose.



Questions, questions

But so far, there seem to be many more questions than answers, especially in respect of cigarettes, which account for by far the biggest share of tobacco consumption. Cigarette smoke, three-quarters of which is made up of nitrogen and oxygen, has been shown to comprise about 5,000 chemical compounds at widely ranging levels of inclusion, though the size of this number is limited to an extent by the effort put into identifying these compounds, some of which are specific to tobacco smoke. And there seems to be no agreement about how many of these compounds might play a role in “tobacco-related” diseases, the number of which seems to increase daily as the results of the latest health studies are released or—it sometimes seems—escape. Some investigators are working on the basis of the 44 “analytes” in the Hoffmann list, which on investigation turns out to be more than one list.

There are gaps in the Hoffmann list, and at least one other list of the toxicants in cigarette smoke names 149 compounds. There is more than one method for analyzing some of the Hoffmann analytes but no standardized methods for analyzing most of them. But perhaps this doesn’t matter because, apparently, according to the World Health Organization’s definitions, there are few if any laboratories independent enough of the tobacco industry to analyze these compounds objectively.

There is acknowledgement that little is known about how Hoffmann analytes react with each other and with other smoke compounds, so it is difficult to predict what will be the result—even whether it will be biologically positive or negative—of removing single toxicants through filtration or other methods. And while scientists are able to test for yields of, and exposure to, toxic compounds in smoke, they cannot truly test for harm in humans except through the time-consuming and costly process of highly controlled clinical trials.



Risk assessment

In an attempt to address some of these issues, untold numbers of animals are being subjected to what one speaker said were generally unreliable experiments. One has to wonder whether it is ethical to cause such suffering in order to test products that humans consume voluntarily knowing there is an apparently fearful risk attached to them. In many parts of the world, discrimination of various kinds has rightly been rooted out from our societies, and it will surely be the case in the future that people will look back on such species discrimination with indignation.

Some scientists already have a healthy disdain for such experiments. In a letter to the Daily Telegraph some years ago, Kathy Archibald, director of Europeans for Medical Progress, wrote: “… it is genetics … that explains why [other] animals are doomed to fail as experimental models of Homo sapiens. The human genome project has revealed that small genetic variations between species create profound biological differences that preclude extrapolation from one species to another.

“Studying dogs and rodents to elucidate human disease is archaic: the cutting edge of science today is focused on variations between individual people at the level of “snips” (single nucleotide polymorphisms). This is where the clues to diseases and their treatments will be found.”

One thing that is possible, however, is risk assessment, either at the level of an individual or in respect of populations. And once you have risk assessment, risk management is theoretically possible, though it might prove impossible in the light of regulatory or political decisions, the most obvious example of which seems to be the ban on snus within the EU outside of Sweden. The longer this ban is imposed, the more outrageous it seems to be given that many scientists—both those working within and without the tobacco industry—appear to accept that the consumption of snus is up to 90 percent less risky than cigarette smoking.

The ban is presumably held in place by the lobbying efforts of those who espouse a “quit or die” policy and who cannot conceive of a society where tobacco consumption is carried on by people who have been provided with factual information about the relative risks of products and made decisions appropriate to how they want to live their lives. One speaker said that the debate with such people was being won, but that it was important that they were allowed to change their positions without looking stupid. It is undoubtedly as well that they come on board, but such sensitivity to their feelings seems misplaced if, as we are told, the issue is one of life or death for untold numbers of people.



Ethical issues

But to be fair, delay might not be such a bad thing. There are perhaps some issues that should be addressed before the public is exposed to the idea of relative risk. One of these has to do with costs and competitiveness. What should be done, for instance, if a material supplier, let’s say a filter manufacturer, comes up with a very expensive filter that could be demonstrated to reduce a smoker’s exposure to all of the known toxins in tobacco smoke by 95 percent, while providing a fully satisfying smoke? Would it be ethical to provide such a product only to the rich? Or perhaps it would it be appropriate to grant government subsidies to lower the cost of production, even though this might encourage people—more people perhaps—to indulge in a still-risky habit?

The question of sensitivity seems to come up more often than one might expect in the midst of the rough and tumble of scientific debate. One of the most potent weapons at the disposal of people working on harm reduction seems to be the reduction of a smoker’s exposure to “tar,” which reduces his or her exposure to both known and unknown compounds. And one way of achieving this is through increasing nicotine levels so that the tar-to-nicotine exposure ratio is reduced. However, we seem here to be on an adventure with Alice in Wonderland because raising the issue of increasing nicotine is apparently felt to be politically unwise at the moment. I suppose that it’s regarded as a heresy for which one might be consigned to the fire but for the fear of the smoke you might give off.



Semantics

Little of what was said was completely new, but the congress was a good opportunity for expert speakers to present much useful information to a wider audience than is normally exposed to it. And at least one of the speakers suggested that a major challenge was to extend the audience still further by presenting smokers—the men and women in the street—with factual information about the various tobacco products available and their relative risks. It is difficult to argue with this statement, and a good starting point would be the observation made by another speaker that only the dead were not at any risk. But I came away with a sinking feeling that it would be extremely difficult to provide factual information to smokers, even provided that some of the basic uncertainties described above could be ironed out and that the information suppliers wouldn’t be reined in by the sensitivities of various groups, and provided that regulators allowed such an idea to get off the ground.

A number of speakers made the point that it was a “given” that smoking caused morbidity and mortality. Now, as the representative of the man—even, at a stretch, the woman—in the street, I interpret that as meaning smoking causes disease and death in everybody who smokes, because, to me, if just one smoker dies a non-accidental death that is not caused by his or her smoking, then the general causal statement cannot be made.

However, on questioning what was the point of determining risk factors in something that was known to kill you, I was told that the statement “causes mortality” was not meant to mean that smoking leads to the death of every smoker. It apparently is shorthand for “causes premature death in some smokers.” Now there seems to be something of a difference between these two statements, and that difference would have to be addressed before any meaningful communication could be made with smokers. For too long already smokers have been bombarded with fictions such as, “smoking kills.”

To my mind, “smoking causes mortality” is propaganda; while “smoking causes premature death in some smokers” edges closer to being information. Closer—but is the latter statement the most accurate information we can make available? I cannot help thinking that the truth lies nearer “statistically, smokers have a higher risk than do nonsmokers of dying from the effects of a number of diseases, including lung cancer, heart disease …”

Such a statement has too the advantage of not including the rather suspect concept of “premature death.” With the risk of sounding like an apologist for fatalism, if Mr. X, aged 26, is hit by a bus and killed while going home, it is somewhat odd to say that he died prematurely. If he hadn’t been hit by the bus and he had gone on to live to be 96, he wouldn’t have been Mr. X. The argument about premature death is a kin to the question that is often posed about how much more an artist/performer would have contributed if he/she had lived to be 84 rather than dying of a drug overdose at 29. The answer, of course, is that he or she would probably have created nothing but would have ended up with an exceptionally fine stamp collection. The only way that Mr. X could be judged to have died prematurely would be by making the fairly crude comparison of his age at death with the average age of death of men living in his country. And even here the ground becomes very uncertain as we stagger from the particular to the general.



Always catching up

Is this important? I think so. If information is going to be presented to smokers, it has to be, as far as we can ascertain from our current state of knowledge, the truth, determined through the most rigorous investigations we can mount. It is all too easy to make well-meaning statements without really thinking them through. One such statement makes what at first reading seems to be the perfectly reasonable assertion that we will never have a tobacco product or a tobacco cessation product that is as risk free as not consuming. But is this true? Perhaps in the laboratory, but it is probably chilling remote from normal human activity in which people who stop smoking don’t necessarily stop taking risks.

It is factually and ethically wrong to present as the truth what one group believes is good for another group, unless it happens to be the truth. And it is ethically wrong for the tobacco industry to be complicit in presenting such “information.” With the tobacco industry under extreme pressure already, we certainly don’t want smokers sipping on hare’s slime, even though it might have been mixed with a good Bordeaux.

Looking at the wider picture, these congress sessions indicated clearly that the tobacco industry is genuinely acting in a responsible way given the formidable—perhaps unprecedented—challenges being thrown at it. The industry, led of course by the major manufacturers, seems to be mounting a huge effort to address the issue of reducing the risk of tobacco consumption.

But there is an inescapable feeling that, in as far as traditional cigarettes are concerned, it will always be playing catch-up. One of the campaigns it is currently involved in concerns trying to come up with a method by which cigarettes can be tested in a way that will better reflect the way that smokers smoke—so that the gap between yield and exposure becomes smaller. But of course, the way in which smokers smoke is changing as that effort is in progress. Take a look at smokers standing outside buildings in those countries where smoking is banned inside. These people, especially if they are on their own, invariably take what seem to be shorter puffs but at much shorter intervals than does a smoker at ease over his pint of beer. If you listen carefully, you can hear the anti-tobacco groups practicing their howls of protest: Why didn’t you tell us this would happen when we introduced public-places bans?