Profile of a man closing his ears

    These products are safer than cigarettes – why don’t the regulators want to know?

    30 January 2018

    ‘Evidence-based policy’ is the mantra of the public health lobby, but two events last week revealed how empty this slogan can be when ideology is in play.

    The first took place at the European Court of Justice in Luxembourg and involved snus, an issue that I have written about before. It is hard to imagine a more unscientific and counterproductive health policy than the EU’s ban on this smokeless tobacco product. Snus has been popular in Scandinavia for two centuries and in the past thirty years has led to mass abstinence from cigarettes in Sweden (which has an exemption from the ban) and Norway (which is not in the EU). Both of these countries once had similar smoking rates to the rest of Europe. Today, their smoking rates are among the lowest in the world: 11 per cent in Norway and just seven per cent in Sweden. To put that in context, the EU average is 26 per cent.

    The snus ban was introduced at a time when it was assumed to cause oral cancer. A great deal of evidence has subsequently shown that it does not, and both Norway and Sweden have low rates of the disease. It was also believed that snus could act as a ‘gateway’ to smoking, but this fear has turned out to be baseless. All the evidence shows that it is a gateway from smoking, and a relatively harmless one at that.

    Last week, the European Court of Justice began to consider the case for repealing the ban after proceedings were initiated by the snus company Swedish Match and the independent charity the New Nicotine Alliance. I won’t go into the legal arguments, but they centre on human rights rather than trade. The question being asked of the judges is why the EU is denying smokers the right to switch to a product that could significantly improve their health and extend their life? And if, as the EU insists, its policies demand a ‘high level of health protection’ then why is it protecting the most dangerous tobacco products at the expense of the safest?

    Given the weight of evidence that has amassed since the EU banned snus in 1992, repealing the ban should be a breeze. But evidence only gets you so far in political battles and, make no mistake, this is about politics. Fundamentally, it is about whether EU institutions, national governments and ‘public health’ campaigners can admit that they have made a mistake. It seems that they will not.

    Those who went to Luxembourg for the hearing were astonished to hear representations from the British, Norwegian and EU institutions using long-debunked zombie arguments from a quarter of a century ago to support continued prohibition. ‘The lying in court proper was mortifying,’ says Atakan Befrits of the International Network of Nicotine Consumer Organisations. ‘I stopped counting at 82 direct lies, not counting the just misleading statements. Two government lawyers and three EU institution lawyers regurgitating 20 year old Swedish lies with almost religious conviction.’

    The New Nicotine Alliance’s chairman, Professor Gerry Stimson, is one of the pioneers of harm reduction for drugs and has worked in tobacco harm reduction for a decade. He was encouraged to see that the judges had read the numerous documents that had been submitted to them and was pleased to hear some ‘very pointed comments’ from them about the selective use of evidence by the prohibitionists. Furthermore, he recalls one of them making a ‘rather pointed comment that perhaps the legislators found it very politically inexpedient to make any changes to a longstanding ban’.

    Nothing has been decided yet and it will be three months before we get a preliminary judgement from the Advocate General, but it is dispiriting to hear that even the British government – which has put harm reduction at the centre of its tobacco control strategy and has actively supported vaping – refuses to accept the science on snus. Without support from national governments, repealing the ban will be an uphill struggle.

    Meanwhile in the USA, the government’s Tobacco Products Scientific Advisory Committee (TPSAC) was looking at Philip Morris’s recently launched product, iQOS. The Food and Drug Administration has been in charge of regulating tobacco products since 2009 and has talked a good game on harm reduction. Sensibly enough, the FDA says it wants to use less draconian legislation for safer nicotine delivery devices than for cigarettes. If a ‘modified-risk product’ is shown to be demonstrably less hazardous, it can be labelled and advertised as such, thereby allowing smokers to make an informed decision to switch.

    Alas, these fine words have not been accompanied by action. If any tobacco product is patently less hazardous than cigarettes it is snus. Even those who support its prohibition in the EU admit that. Snus has never been illegal in the USA and it should be a shoo-in to get a reduced-risk label. In 2014, Swedish Match filed 120,000 pages of evidence to the FDA in the expectation of getting their product labelled with the warning: ‘No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.’ Hardly a roaring endorsement, but an improvement on the existing label which states: ‘This product is not a safe alternative to cigarettes’. But even this small change was too much for the FDA who turned down the application.

    For all the FDA’s talk about proportionate regulation and the ‘continuum of risk’, the number of products it has classified as safer than cigarettes is zero. iQOS was the latest candidate. Philip Morris reputedly invested $3 billion in developing this novel product which is neither a cigarette nor a vape. Heating the tobacco rather than burning it, iQOS releases much lower doses of the chemicals in cigarettes that are believed to be dangerous.

    Last month, the UK’s Committee of Toxicology found that users of iQOS were exposed to between 50 and 90 per cent fewer toxic chemicals and said that there was ‘likely to be a reduction in risk for cigarette smokers who switch’ to them. It is available in 30 countries, including Japan where it has become remarkably popular, taking 12 per cent of the total tobacco market and causing a sharp fall in conventional cigarette sales.

    The Tobacco Products Scientific Advisory Committee, which advises the FDA, was given 200,000 pages of scientific evidence to read and voted 8 to 1 in favour of the view that ‘switching completely from cigarettes to the iQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.’ So did they recommend that iQOS be put on the market with a reduced-risk warning? No. When it came to the question of whether ‘switching completely to iQOS presents less risk of harm than continuing to smoke cigarettes’, it voted 5 to 4 against.

    As Clive Bates, former director of Action on Smoking and Health, said last week, the belief that iQOS causes as much harm as cigarettes despite delivering far fewer harmful chemicals requires a certain amount of doublethink. ‘The idea that dramatically reduced exposure to toxins does not translate to reduced risk to health requires a novel and implausible theory of the human body,’ he tweeted. ‘So what is the magical thinking guiding this ‘scientific’ panel?’

    There seems to be a principal-agent problem when new nicotine products are assessed by people who are steeped in ‘public health’ dogma, especially when those products contain tobacco. Bates argues that ‘panel members have strong ‘virtue signalling’ incentives to oppose tobacco industry innovation, even if highly beneficial to people at greatest risk. They can enter the room, turn up the pedantry dial to maximum, sit back and relax, lob in the odd insincere question and vote down the claims, all the time faking an appearance of trying to do the right thing.’

    And so we have two products which are manifestly less harmful than cigarettes, both of which have a track record of getting people to stop smoking. One is illegal in the EU. The other is illegal in the USA. Neither of them can be labelled as less harmful and neither can be marketed as a reduced-risk product. At best, the government prevents manufacturers from putting truthful statements on these products. At worst, it prevents them from selling them at all.

    So much for evidence-based policy. So much for helping smokers who find it difficult to quit. The events of last week, which could have been two steps forward for harm reduction, demonstrated the futility of expecting scientific evidence to resolve arguments that are, at heart, about politics and ideology.