Using models disconnected from reality to justify huge ‘endgame’ interventions

New Zealand is planning to introduce so-called ‘endgame’ measures, including the removal of nicotine from legally available tobacco. We examine and review the modelling used to justify the measure and find multiple fatal flaws.

With thanks to Dilbert @SottAdamsSays

In this blog, we take a look at modelling used to justify ‘endgame’ legislation under discussion in New Zealand. Among other things, this would reduce nicotine in cigarettes and other tobacco available through legal channels to minimal levels. We find the modelling and data assumptions bear no relation whatsoever to the underlying processes and the effects that such legislation would trigger. Deep cuts in smoking are assumed as inputs to the model. Unsurprisingly, therefore, the model results show deep cuts in smoking, and this determines the resulting health benefits. But the assumptions have no grounding in reality and misinterpret and misuse trial findings.

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Chaos, waste and failure: what is wrong with FDA tobacco regulation, and how could it improve?

This is my response to the operational review of the performance of the FDA’s Center for Tobacco Products by the Reagan-Udall foundation. The heart of the problem is the lack of a coherent regulatory strategy, grounded in real-world understanding

…and now we go live to Silver Spring, Maryland

The Reagan-Udall foundation is conducting an “operational review” of the FDA’s handling of its tobacco and nicotine brief. The review was commissioned by Robert Califf, the FDA’s Commissioner. I have submitted comments through the stakeholder portal. Please consider making your own submission – it’s easy.

My contribution is available below, in a formatted PDF version and via the stakeholder portal.

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A powerful declaration makes a compelling case for tobacco harm reduction

Spain has a vocal and well-funded tobacco control establishment. But the data suggest its traditional approach is failing. 170 national and international experts call for a rethink and make the case that Spain embraces tobacco harm reduction as a real-world public health strategy.

Prevalence of daily tobacco use in the last 30 days in the population aged 15-64, by sex
and age (%). Spain, 2019/2020 EDADES, 2021 figure 1.1.13 (Full report PDF)

The post provides the text of a letter sent to the public health authorities in Spain and related commentary. To go straight to the letter in PDF format, it’s here: Less Harm: International Declaration for a Smoke-free Spain, in English and en español.

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Rethinking U.S. tobacco and nicotine regulation (part 1)

A fundamental rethink of U.S. regulation of reduced-risk products is now essential and urgent. This introductory post looks at a set of 11 possible principles that could guide a revised regulatory framework. Readers’ views are solicited.

Here is a proposal to reshape U.S. regulation of reduced-risk tobacco products:

A science-based regulatory framework for implementing tobacco harm reduction should conform to the following 11 principles:

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From FDA to PMI – a sell-out or a bold move for public health?

Matt Holman resigns as Director of the Office of Science at the Center for Tobacco Products at the FDA. He is moving to the tobacco company Philip Morris International to be Vice President of US Scientific Engagement & Regulatory Strategy. What to make of this? I write him an open letter.

Dear Dr Holman

You are making an interesting move at an important time, and I want to write an open letter to you to remark on its significance.

I am sure many will criticise your move as treachery or a sell-out, but this is a predictable knee-jerk reflex and overlooks the public health fundamentals. I hope you ignore the inevitable criticism and remain focused on the enormous public health prize that you can pursue in your new role. I think it is an ethical and high-integrity move, and I hope you make the most of it.

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Independent review of tobacco policy in England misses the point

England aims to reduce smoking to less than 5% by 2030, but this will need mass switching to smoke-free products as a consumer alternative to smoking, and it must be achieved by consent rather than coercion

Meeting the 2030 smoke-free target (5%) requires an accelerated decline
[Source: ONS, Adult Smoking Habits in England]
Note: a linear trend continuing from 2010-2020 should not be assumed as a given or ‘business-as-usual’ in the absence of further measures

The government has established a ‘smoke-free’ goal to reach 5% adult smoking prevalence in England by 2030. This represents a significant acceleration in progress (see chart above with linear trends). As a prelude to announcing a plan to achieve the goal, Ministers appointed Javed Khan OBE to head an independent review of tobacco policy to make recommendations for measures to meet the target and contribute to reducing health inequalities.

Here is what Dr Khan has come up with:

These are recommendations to the government, not government policy. We have yet to see what the government will actually do and when it will get around to doing it.

In this blog, I set out an overview critique of the Khan programme and then look at each of the fifteen recommendations in more detail. Finally, a few words on what should be done.

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The FDA forces Juul to pull the most successful anti-smoking product ever

The U.S. Food and Drug Administration is to force the popular Juul vaping products off the US market for spurious and unjustifiable reasons

The U.S. Food and Drug Administration, the regulator of consumer tobacco and nicotine products in the United States has today denied applications from Juul Labs Inc. for its vaping products. FDA will require the company to pull its products from the market. This is an absolutely terrible decision with no basis in ethics, public health, or good regulatory practice.

The key extracts from FDA’s announcement and my statement in response follow below.

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Fake news alert: WHO updates its post-truth fact sheet on e-cigarettes

The World Health Organisation continues to present misleading information about e-cigarettes that spreads doubt and confusion among the public, media and policymakers. This post reviews its latest Q & A and finds multiple errors of analysis, misleading statements, and obvious biases.

The World Health Organisation provides information on e-cigarettes that contains false and misleading statements while overstating risks and ignoring opportunities

The World Health Organisation maintains a Q & A on e-cigarettes. It was updated on 25 May 2022.

This has been updated several times (see history below). In each of its incarnations, this web page has presented a profoundly misleading account of the risks and benefits of e-cigarettes. It ignores the fact that eight million people are dying annually from smoking (around the same order as COVID-19) and that hundreds of millions of smokers could benefit from switching to low-risk alternatives to smoking. The Q & A is primarily a vehicle for promoting prohibition and generating hostility to the pragmatic public health strategy of tobacco harm reduction. It is anti-scientific, its information is misleading, and its effect or purpose is to sow confusion and doubt rather than to candidly explain e-cigarettes.

I have set out the main sections of the latest Q & A below with a short general commentary on each section followed by the main claims in each section drawn out in block quotes followed by comments.

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Will Brazil rethink its vaping prohibition?

“O Brasil vai repensar sua proibição de vaping?” Brazil is consulting on lifting its ban on vaping products. Will it recognise the perverse consequences of prohibition and shift to risk-proportionate regulation? We argue it should rethink its approach to nicotine.

Prohibition is about the worst regulatory response to safer alternatives to smoking

Brazil’s public health agency, ANVISA, has been consulting on whether the long-standing policy of prohibition of vaping products should be retained or lifted. The consultation questionnaire seeks comments on a technical document.

Shortcut to full response (PDF).

Here’s my take…

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Health Canada heading in the wrong direction on tobacco and nicotine policy

Health Canada’s review of its tobacco and vaping legislation focuses only on reducing youth vaping. It shows no awareness of the links between smoking and vaping, between adults and adolescents, and the case for harm reduction at all ages

Health Canada’s tobacco policy continues to depart from a true public health mission

This blog takes a critical look at Canada’s ongoing review of its tobacco and vaping legislation. Health Canada produced a discussion document to inform the review, posed twenty-two questions and invited comments. Responses from me and David Sweanor are set out below.

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