The new endgame

| October 1, 2017

Some strategies to phase out combustible cigarettes are more sensible than others.

By George Gay

It has been well said that if you hold to a constant political position while living in the same country, sooner or later you will be tried for treason. In a similar vein, if, two years or so ago, you were talking with serious intent about the tobacco endgame, you were considered by many people to be “one prawn short of a barbie.” But now, if you’re seriously examining a closely related issue, the traditional tobacco cigarette endgame, you’re seen as cooking on all burners.

On June 29, I attended an event hosted by Philip Morris (PM) Limited in London that was staged on the back of the question: Can Britain go smoke-free in the next 10 years? A couple of weeks later, I read a piece by Jackie Horne on http://asia.nikkei.com in which she said Philip Morris International could be looking to begin talks with governments—the Japanese and South Korean governments, I believe—within five years on phasing out traditional cigarettes. Then, at the end of July, the U.S. Food and Drug Administration (FDA) came out with its “comprehensive plan for tobacco and nicotine regulation.” And at the beginning of August, New Zealand announced that it was going to legalize the sale there of previously banned smokeless tobacco products if manufacturers could demonstrate that they were significantly less risky than were traditional tobacco cigarettes.

As some readers will have noted, I was a little disingenuous in my introduction. You cannot sensibly make a direct comparison between most of the endgames envisaged two years ago and the more recent ones, for at least one major reason. Those of two years ago were based on the idea that, in one way or another, tobacco products should be made unavailable to those not already using them—and that was basically it. Under such schemes, those born after a certain year—say, 2000 in a country with a legal tobacco buying age of 18—would not be allowed to buy tobacco products. Such schemes, therefore, would allow those who were already smokers to continue to smoke if they so wished but would make it difficult and unwise for young persons to start smoking.

Although such schemes had merit, many people decided, without any evidence as far as I could see, that they couldn’t be made to work. I was reluctant to treat them so dismissively, but they certainly had two major and related problems. Firstly, they seemed to assume that anybody too young to buy cigarettes legally would not, when they reached 18, 21 or whatever, want to use some mild relaxant or stimulant that was legally available over the counter and that, unlike alcohol for instance, didn’t make them lose their mental faculties. And secondly, they seemed to throw onto the “too hard” pile already-smokers. In other words, they offered no alternative products to traditional tobacco cigarettes. They didn’t always rule them out specifically, but such alternatives were not part of the offer.

Some of the new endgames, on the other hand, seek to “encourage” smokers to shift to other products that are less risky, while others are based on authorities not actively discouraging these alternative products. And each of these strategies is backed by policies that seek to make the consumption of traditional tobacco cigarettes less appealing, though just how less appealing differs from market to market.

Defining success

Does this mean, therefore, that the new endgames are good and the old ones bad? I don’t think so. It seems to me that the new schemes are far better simply because they do offer alternatives to smoking, but, in my estimation, some of the old schemes had positive aspects, while some of the ideas that one can infer from what is known of the new schemes seem positively potty.

Overall, I think that the way to judge the value of these old or new schemes is to look—once they have been evaluated as having a reasonable chance of success—at how long they would take to come to fruition. And I fail to see why others would do otherwise, given that, we are told by the World Health Organization, each year 6 million to 7 million people die from tobacco-related diseases.

One of the interesting points made by PM on June 29 was that while smoking rates were declining in the U.K., it could take 30–50 years or longer before everybody had quit—before there were no smokers left. The question that had to be asked was how the number could be reduced to zero as quickly as possible.

Now I don’t want readers to get all dewy-eyed about this because, clearly, PM, as well as selling the idea of reduced harm, was selling its iQOS heated-tobacco device—something that it made no bones about. But then why not? In the U.K., 1.5 million smokers have switched to e-cigarettes because of the intervention of this new idea and this new technology. And iQOS is a newer technology that has gone through a few iterations to emerge at the point where it apparently offers an experience closer to smoking than that offered by e-cigarettes.

Although the experience with e-cigarettes in the U.K. has been impressive, it has not been overwhelming. According to PM, while about 90 percent of U.K. smokers have tried vaping these products, only 15 percent have switched to them. Contrast that with iQOS in Japan, where 80 percent of people who have tried the product have been able to stop smoking.

Now you can argue that Japan is a special case. For one thing, its consumers are generally receptive to new products. And for another, Japan’s laws have deprived smokers of nicotine-delivering e-cigarettes; so heat-not-burn devices have not had to compete with these products. But it nevertheless seems to me that whichever way you cut them, PM’s sales in Japan have been impressive. And when I say impressive, I’m not talking only about the commercialization of iQOS, which apparently has taken 10 percent of the cigarette market in three years; I am talking about the potential harm reduction that this commercialization has engendered. In Japan, something like 130,000 people die each year of smoking-related diseases.

Still, is 10 years long enough to completely reorientate the U.K. market? It’s impossible to say, of course. At this stage, nobody knows whether somebody will find a flaw in the reduced-harm credentials of heat-not-burn devices, or whether somebody might come up with an even more efficacious product. Certainly, the optimists among the invitees at PM’s London event would have been cheered when they were reminded how far the iPhone had come since being launched 10 years ago. On the other hand, the pessimists might have been recalling that it was also the 10th anniversary of the start of the global financial crisis, and you could argue that, since then, almost nothing has happened with respect to developing a financial system that is more robust than the one that fell apart 10 years ago.

And perhaps there is a lesson here. Perhaps huge, global problems such as the financial crisis or 6 million to 7 million deaths a year are just too big to be fixed by the good and the great sitting around thinking about them. Perhaps they can be fixed only by the unexpected—new technologies such as those that have delivered e-cigarettes and heat-not-burn devices—or by things that have been staring us in the face for years without most of us having recognized them fully, such as snus.

No sense of urgency

This is why I’m less than excited about the FDA’s recent conversion to the continuum of risk and harm reduction. Yes, it was good to see it draw back from the brink of sending years of vaping progress over the cliff edge, but, still, this is not an organization that is going to have a positive feel for timing or the unexpected. It will bang on at every opportunity about how each year 480,000 U.S. citizens die prematurely from smoking-related diseases, but this knowledge seems to engender in it nothing like the sense of urgency that you will find at PM and, indeed, British American Tobacco.

Look at the FDA’s record. As far as I can work out, in January 2011, Swedish Match North America (SMNA) started the formal process of submitting an FDA modified-risk tobacco product (MRTP) application, and, on Aug. 27, 2014, it became the first company to complete such an application. The application—which basically sought only to change, in respect of one brand of snus, what one expert observer described as “egregiously inaccurate” health warnings—involved the submission of something like 1,000 pages of evidence with about 120,000 pages of supporting documents. On July 31, 2015, at the request of the FDA, SMNA supplied additional information. At the very end of 2016, SMNA’s application was eventually denied, or a decision was deferred, which, in practice, amounted to the same thing. U.S. smokers were to continue to be misled by egregiously inaccurate health warnings about what is probably the lowest-risk tobacco or nicotine product available—a product with a proven record of converting smokers.

If you take the view that the SMNA application took six years, then using the FDA’s own figures, during that time 2,880,000 U.S. citizens died as a result of tobacco use. And if you take only the 2 1/2 years from when the application was lodged to when the decision was deferred, the death toll was 1,200,000. Of course, these people wouldn’t have been “saved” by a different decision, but very many would have been as the years rolled by and more smokers, encouraged by new, more accurate health warnings, switched from smoking to snus use.

Perhaps it isn’t helpful or healthy to rake over the past in this way, but for me it is a useful reminder of what might happen when the FDA talks about its latest plan being a multiyear road map, with, unspoken, each year seeing the death of another 480,000 tobacco users. As I understand it, the iQOS application currently before the FDA involves about 2.5 million pages of documents. If it took the FDA 2 1/2 years to get through 120,000 pages of documents, it’s going to take … oh, you do the math. But bear in mind that our solar system is due to burn out in 5 billion years’ time.

Nicotine and addiction

I have a problem also with the FDA’s thoughts on nicotine and addiction. As I understand it, the idea is that the nicotine deliveries of traditional tobacco cigarettes should be reduced gradually to nonaddictive levels in order to encourage smokers to quit or to shift to lower-risk vapor products that provide higher levels of nicotine—providing such a reduction proves practical. In fairness, I should say that it is encouraging—from a rational point of view, if not from a timing point of view—that the FDA intends to consult on possible unintended consequences that would result in lowering nicotine levels in traditional tobacco cigarettes.

And I wouldn’t be too concerned about the potential unintended consequence that everybody seems to be picking up on (and that therefore surely cannot be a “potential unintended consequence”)—the one that says the sale on the duty-paid market of only lower-nicotine delivery cigarettes might cause smokers to switch to illicit cigarettes. Governments and tobacco manufacturers are old enough and big enough to look after themselves if they start to lose revenue and income because of such a switch.

One worry that I do have concerns who is going to pick up the tab for lowering nicotine in this way, assuming there is a cost associated with licensing the technology for producing the leaf tobacco needed? Smokers cannot afford it. In the U.S., state and local cigarette tax increases have been shown to be pushing them toward the federal food stamp program.

But the worst consequence—it certainly wouldn’t be unintended because everybody associated with tobacco is aware of it—would arise if lowering nicotine caused smokers to suck harder on their cigarettes to get the nicotine they seek. Such a development would have the potential to increase smokers’ health risks in at least two ways. It would change the way they smoke, something that could alter the type of risk they face and the magnitude of that risk. Additionally, sucking harder would mean that they would draw into their lungs more of the tar that just about everybody wants to reduce and has been working to reduce through the promotion of vapor products.

The same sorts of effects could be seen if smokers smoked a greater number of lower-nicotine cigarettes because they needed to keep up their nicotine intake or because they decided that lower-nicotine cigarettes were associated with lower risk—not an unreasonable assumption given the misinformation that has been peddled to them over the years.

OK, you might say that the FDA has covered this by saying it intends to investigate nicotine and addiction, but for how many years at 480,000 deaths a year? Why not increase nicotine delivery levels so that smokers ingest lower levels of tar and encourage smokers to switch to lower-risk products by allowing manufacturers of these products to tell the public the truth about them? We need to cut a few corners; we don’t want to take the long way home.

There is another, lesser problem on the horizon, too. Some people have been suggesting for a while that nicotine on its own—say, as it’s delivered by e-cigarettes—isn’t addictive. Addiction occurs only when nicotine is delivered in association with some other element of tobacco, they say. If this is the case, could it be that that element is delivered by heat-not-burn devices as well as by traditional tobacco cigarettes, and, if so, do we have to open a branch line off the continuum of risk to account for the fact that consumers of heat-not-burn products might keep using these products for longer than consumers of e-cigarettes keep using theirs?

Ask the smoker

But one of the biggest bugbears of all forms of endgames comes down to whether anybody knows or cares what smokers want. I have written about this often before, but it bears repeating. Has anybody ventured into the “sink estates” and asked financially impoverished smokers whether they want the new products on offer or whether they are happy with traditional products? Well-heeled representatives of companies, agencies and governments might assume that everybody wants to add an extra 10 years or so to their lives, but have they really thought about the 55-year-old widow living in a flat with a metal security door to keep the vandals from putting burning paper through her letter box? Has anybody asked the homeless? Perhaps these people do want to live an extra 10 years, but I would want to hear that from their own lips.

If the well-heeled in our societies want to improve the lot of smokers, I suggest that in the first instance they stop trying to prevent them from smoking, especially by “denormalizing” them and by raising tobacco taxes because, in the U.K. at least, people in the financially poorest section of society die nine years younger than do those in the richer sections. But, at the same time, for goodness’ sake stop telling them that quitting is hard. Would you tell a child learning to swim that swimming was hard?

In the second instance, the well-heeled should stop sucking the value out of our societies and allow some of the wealth that is created to lift people out of their poverty and out of the sink estates. Or if they cannot bring themselves to do that, perhaps they could find it in their hearts to unban smoking in bingo halls and pubs that want to allow smoking so that our 55-year-old widow can get out again and perhaps have a reason to start thinking about longevity.

Getting on with the job

I have another small worry, too. The idea that companies will start talking to governments about phasing out a legal product is worrying from the point of view of democracy. Our democracies, where they exist, are already being chipped away by, for instance, the signing of international trade deals that include investor-state dispute settlement provisions. If cigarette manufacturers are going to talk to governments about phasing out cigarettes, those discussions should be transparent, and every word of them made public—and they should include smoker representatives, some of whom should not be dressed in sharp suits. Smokers should not be treated as if they are passive bystanders. They’re not children.

But let me end on a positive note. Commercial and competitive issues aside, PM is surely doing a tremendous job in trying to turn the supertanker of tobacco-related disease that has been, despite numerous efforts, sailing into deeper and deeper waters. British American Tobacco, too, has been working phenomenally hard for a long time to produce lower-risk products that are acceptable to smokers, and Japan Tobacco, as I understand it, is following along. All these companies need is to be allowed to get on with the job that they are doing without governments banning their lower-risk products through ignorance or on ideological grounds, and preferably with governments allowing them to explain to the public exactly what they are doing.

This is not to say that some governments are not being helpful. In my opinion, the U.K. government has generally been very progressive in its approach to the use of vapor products for harm reduction. But the New Zealand government is also worthy of mention. In my opinion, it was once reactionary in regard to questions of lower-risk products and harm reduction, but it seems to be becoming more flexible in its approach. While I was writing this piece, a story by Rachel Thomas on http://stuff.co.nz described how the sale of smokeless tobacco products was to be legalized in New Zealand with a view to providing smokers with less risky alternatives to cigarettes.

Associate Health Minister Nicky Wagner was quoted as saying that some smokeless products available internationally, including heat-not-burn, snus, moist snuff, dissolvables and inhaled-nicotine devices, might be significantly safer than are cigarettes. Current laws ban the import, sale and distribution of tobacco products described as suitable for chewing or any other oral use besides smoking, but in her announcement Wagner said the government intended to establish a premarket approval system for smokeless tobacco and nicotine-delivery products, other than e-cigarettes. “This is part of new thinking—a forward-looking approach, building on some of the innovative new technologies that are available intentionally to try and give smokers safer alternatives to tobacco,” she said.

Coming out of New Zealand, that announcement is so encouraging.

Category: Also in TR, Editorial Archives

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