There has been much hum on the wires about the FDA seeming to put reduced nicotine cigarettes (or Very Low Nicotine Content - VLNC) front and centre of its revised tobacco control strategy. Invariably there are arguments for and against. So here is my brief take on the debate.
VLNC advocates argue that a VLNC will stimulate quitting because the cigarette will not be delivering its essential ingredient – nicotine. There is a hope too that if young people take up VLNC cigarettes, they are less likely to become lifetime smokers again because the product will not be satisfying. And VLNC may be a pathway to quitting perhaps in the same way that moving heroin users onto methadone and then gradually reducing the dose of methadone does help some people become free of drug use altogether.
But even at this level of argument there are problems. The big one is that if America’s 38 million smokers are faced with a product that doesn’t deliver much of the reason for smoking, they simply won’t buy it. What happens next in the interests of public health would depend very much on how accessible were the new generation of reduced risk products, especially on pricing. The obvious unintended but completely foreseeable consequence would be the growth of an illicit cigarette market. Forecasting the size of such a market is not possible as so many other factors would be involved. But at its simplest, and as American organised crime discovered in the 1920s, if the government tries to shut down a mass market psychoactive product used for centuries, you provide the drug instead and grow obscenely rich in the process.
What about young people and smoking? It has often been observed that smoking is more than just about the cigarette. Simply speaking from my own personal experience, I started smoking in my early teens (I stopped just after my 30th birthday). Why did I start? Simply because my best friend, who happened to be the cool kid on the block also smoked. And I carried on because everyone else around me was smoking too including my dad – who owned a tobacconist shop where I worked as a kid long before I started smoking. I was literally surrounded by cigarettes; it just seemed a normal part of life like eating chocolate or drinking tea. I can honestly say I never ‘craved’ a cigarette, I don’t believe I was ‘addicted’ to nicotine, but it remained something that was cool to do especially as I spent a lot of time in music clubs and playing in bands.
My point is that if you accept that there is more to smoking than the nicotine, some young people might simply carry on smoking (so much easier than messing around with bits of kit) – or even be initiated into smoking on the promise that – “Hey guys and girls these new cigarettes are the business. Get the great taste of tobacco without the nasty risk of addiction”. Ah, you say, but the industry would not be allowed to promote the product to young people or anyone else. Really? So how would the FDA imagine that people will be encouraged to switch away from ordinary cigarettes?
And for those young people who actually did crave nicotine, they could end up boosting industry profits through buying more VLNC cigarettes or further damaging their health by inhaling more deeply (which I understand happened with ‘light’ versions, although the product construction might have been different). And of course, there could be a genuine ‘gateway’ effect as teenagers seek out the real deal.
All this is of course is highly speculative. The FDA says it wants to engage in a public dialogue on this issue, so hopefully all these points and more which urge caution on the issue of ‘going large’ on VLNC will emerge. In truth, trying to impose what would amount to a prohibition on cigarettes will probably never get through Congress anyway, on purely fiscal grounds – the potential losses at State level of substantial wodges of cash from tax and the Tobacco Master Settlement.
An interesting development in New Zealand. Following a decision in March to legalise the sale of e-cigarettes, the government has announced that it will establish a pre-market approval system for smokeless tobacco and nicotine-delivery products, other than e-cigarettes. Associate Health Minister Nicky Wagner said, “There are a number of products available internationally…that may be significantly less harmful than tobacco smoking. By creating a pathway to enable the sale of these products in New Zealand, smokers will have access to less harmful alternatives. The Government is proceeding cautiously. Manufacturers will need to demonstrate their products are significantly less harmful than tobacco smoking and that their introduction into New Zealand will contribute to a smoke-free future.”
The idea of manufacturers having to prove recreational drug product safety is not new in New Zealand. For some years, novel psychoactive substances (NPS) otherwise known as ‘legal highs’ were widely available in so-called ‘dairies’, the equivalent of local grocery stores. NPS are basically designed to have effects similar to existing controlled drugs such as cannabis, ecstasy or amphetamine, but are molecularly structured to remain outside the law.
Sales in New Zealand were relatively under the radar, but when the media got hold of the story, there was community outcry and the government shut down most, but not all, of these shops. The net result was that instead of many shops selling NPS quietly, the few that were left now had highly visible queues of ‘undesirables’ hanging around in the streets.
The government then decided that all NPS would be banned save for some synthetic cannabinoid products (which actually bear no resemblance to the plant other than they act on the same brain receptors as cannabis). More media and political outrage, so everything was banned.
What the government then proposed was that they would allow a regulated market in NPS, a world first, on payment of a $2m license, so long as the manufacturer could prove product safety. This was hailed as a bold and innovative move by drug law reform groups around the world – and it was. The government did not have to go down that path. The proposal was enshrined in the 2013 Psychoactive Substances Act. However, the number of licenses applied for is precisely zero. Why?
Primarily because the government stipulated that for the purposes of testing new products, animal testing was banned. Any new drug could only be tested on humans. Now I’m sure there would have been long queues of psychonauts eager to be human guinea pigs. But no manufacturer would have taken the risk. Moreover, there are two fundamental and inter-linked problems with the idea of ‘safe’ NPS.
The first is cost. Big Pharma spend millions of dollars to bring a new product to market; the pharmaco-diligence required is staggering. Only companies with the deepest pockets can manage this, not least because you could spend millions of dollars on clinical trials that fail where the company sees no return on investment. No NPS manufacturer could even begin to compete at this level. The biggest NPS entrepreneur in New Zealand, Matt Bowden, went bust simply because of the blanket ban and hopped off to Thailand leaving a mountain of debt in his wake.
The second is politics. How do you ensure a non-medical recreational drug is ‘safe’? Is ‘safe enough’, good enough? You can imagine that the safety bar would be set so high that like VLNC cigarettes, nobody wants the product and they return to the illicit market. And if a ‘government sanctioned’ new recreational drug went on sale resulting in hospital admissions or worse, however few, the political pressure to repeal the legislation would be overwhelming.
Hopefully prospective manufacturers of reduced risk products won’t face these battles because the national and international evidence is piling up in favour of endorsing their relative safety and so the substantial public health benefit of the products.
And finally, if you have an hour to spare be entertained by a documentary on BBC I-Player concerning an alleged bribery scandal involving an EU Health Commissioner and Swedish Match. You have 10 days left to watch.