Pfizer has been having problems with its stop-smoking drug varenicline, known as Chantix in the USA and as Champix in the UK. It has had to recall batches of the drug because it contains quantities of a carcinogen that exceed the Food and Drink Administration’s safe level. The FDA isn’t enforcing the recall, however. Instead, it has temporarily increased the acceptable level of N-nitroso-varenicline from 37 nanograms per day to 185 nanograms per day.
There is an obvious irony in using a potentially carcinogenic product to quit smoking. There is an added irony in the carcinogen in this instance being a nitrosamine. Nitrosamines are some of the main cancer-causing agents in cigarettes.
The FDA’s explanation for bending the rules is that it doesn’t want to discourage the use of a product which is still much less dangerous than smoking. “The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline,” it said.
This is a pragmatic response to an imperfect situation and yet it comes at a time when the United States is going to war on e-cigarettes. Last year, the FDA banned the sale of all vape cartridges containing flavours other than tobacco and menthol. Studies have shown that when e-cigarette flavours are banned, more people smoke cigarettes. A range of flavours is vital if you want smokers to switch to vaping.
Like varenicline, e-cigarettes might not be 100 per cent safe, but they are a lot safer than the alternative. Advocates of vaping can point to a wealth of evidence showing that the risks are tiny compared to the risks of smoking – at least 95 per cent lower, according to the Royal College of Physicians. Since the overwhelming majority of vapers are smokers or ex-smokers, it is the relative risk that matters, not the absolute risk.
We are in a similar position with the vaccines for Covid-19. They are not perfect. They offer around 95 per cent protection from severe disease and death, but that is sufficient for life to get back to normal. As with all vaccines, there can be side effects. Serious complications are rare but they do happen. Overall, they provide a massive net gain.
When the AstraZeneca vaccine was found to be associated with blood clots in a small number of cases, the World Health Organisations’s Global Advisory Committee on Vaccine Safety urged its continued use because, it said, “the AstraZeneca vaccine’s benefits outweigh its risks”. It added that: “The question with any pharmaceutical or vaccine is whether the risk of taking it is greater or less than the risk of the disease it is meant to prevent or treat.”
And yet the WHO is also fiercely opposed to e-cigarettes. A WHO report published last month called for countries to either ban their sale completely or subject them to harsh, tobacco-style regulation. It is eager to stress that “e-cigarettes are harmful to health” although it is far from clear what those risks are. When it comes to vaccines, the WHO is interested in relative risks and the overall effect on the health of the population. When it comes to vaping, however, it cannot see beyond tiny – and largely hypothetical – absolute risks.
From the perspective of health, it might be better if nobody smoked or vaped, but that is not a realistic proposition. We have to meet people where they are. It would be better if Covid-19 disappeared off the face the planet, but that isn’t going to happen either.
In an imperfect world, we often have to settle for second best. A 95 per cent reduction in risk is a lot better than no reduction at all. If health agencies took the lessons they learned from regulating pharmaceuticals and applied them to people’s lifestyle choices, we would have more sensible laws and a healthier population.