Showing posts with label Covid-19. Show all posts
Showing posts with label Covid-19. Show all posts

Wednesday, July 7, 2021

The British Medical Journal Falsely Claimed “Harm Reduction Advocates and the Tobacco Industry Capitalised on the Pandemic to Promote Nicotine”

 

The British Medical Journal (BMJ) on June 2 published an article, titled “Research Integrity”, authored by two investigative journalists.  Aping the position of the World Health Organization, they accuse harm reduction advocates and the tobacco industry of undermining decades of tobacco control.  The BMJ notes that the article was “externally peer reviewed.” 

The journal has a rapid-response comment system that is managed by the editors.  I submitted a comment on June 9, detailing specific scientific problems with the article’s content.  It was not published, so I present it here. 

_________________________________________

 

The Editor 

British Medical Journal 

Dear Sir,

The recent article by Stéphane Horel and Ties Keyzer claimed that “the tobacco industry capitalised on the [covid 19] pandemic to promote nicotine” when “two preprints published in quick succession in April 2020… made headlines worldwide. They were also picked up by libertarian media outlets… The World Health Organization worried that decades of tobacco control could be undermined.” (Reference 1) 

Horel and Keyzer then stated: “It has since been roundly disproved that smoking protects against covid-19. Among other studies (2,3,4) the OpenSafely dataset, based on the primary care records of 17.3 million adults in the UK, found that smoking, when adjusted for age and sex, was associated with a 14% increased chance of covid-19 related death (5).”

Horel and Keyzer implied that the four research citations (assigned different reference numbers here) “roundly disproved that smoking protects against covid-19.”  It is ironic that the article by Horel and Keyzer was published in BMJ under the topic of “Research Integrity,” because their own research may not have reached the level readers deserve in a quality medical journal.  In fact, a close look at their four studies, and others that they omit, roundly disproves their disproval claim. 

Three of the four studies (2,3,4) cited by Horel and Keyzer report positive associations, but they need further clarification.  For example, the first study did not employ rigorous diagnostic criteria: study participants used an app launched via radio, TV and social media in the UK to report covid-19 “symptoms” and “whether they thought that they already had COVID” (2).  The second study found that smokers were 3.5 times more likely to have confirmed covid-19 (95% confidence interval, CI = 2.4 – 6.1) than never smokers, but this was only true for participants with low education (3).  However, the risk for highly educated smokers was not elevated at all.  A longitudinal follow-up study found that current smokers had a slightly, but non statistically significant, elevated odds of confirmed covid-19 (minimally adjusted odds ratio (AOR) = 1.24, CI = 0.85 – 1.24) (4).  Finally, Horel and Keyzer carefully describe the OpenSafely study (5) as evidence, saying that current smoking, “when adjusted for age and sex, was associated with a 14% increased chance of covid-19 related death.”  True enough.  But what they fail to mention is that, when the result was fully adjusted for confounding factors, the effect of current smoking became statistically significantly protective (AOR = 0.89, CI = 0.82 – 0.97).

Horel and Keyzer also failed to accurately cite and acknowledge studies that have shown a protective effect of current smoking on covid-19 (6,7,8).  They mentioned such a study from China but didn’t reference it, which is unfortunate because it was published in the New England Journal of Medicine (6).  They also mentioned and cited a study from France (7), but characterized it only as published quickly and as the origin of media hype. 

Horel and Keyzer completely omitted other studies, such as one involving veterans in the U.S., which found that smokers were much less likely to test positive for covid-19 than nonsmokers (AOR = 0.45, CI = 0.35 – 0.57) (8).  Another omission was a rapid evidence review of 28 observational studies finding that “Current data suggest that smokers in the community appear to be less likely to test positive for SARS-CoV-2 compared with never smokers,” “Across 405 studies, recorded current but not past smoking prevalence was generally lower than national prevalence estimates. Current smokers were at reduced risk of testing positive for SARS-CoV-2 and former smokers were at increased risk of hospitalisation, disease severity and mortality compared with never smokers.” (9)  However, one omission by Horel and Keyzer is especially inexplicable, because the study was published by this journal (BMJ) (10).  In that study smokers were significantly less likely than non-smokers to be diagnosed with COVID-19 and to be admitted to an intensive care unit (ICU), and the latter effect was dose-dependent.  The adjusted hazard ratios for ICU admission was 0.26 (CI = 0.19 – 0.37) for light smokers and 0.07 (CI = 0.01 – 0.47) for heavy smokers.   

In summary, there is substantial evidence that current smoking may be negatively associated with a covid-19 diagnosis and its subsequent course, including death. 

Brad Rodu

 

References

1.  Horel S, Keyzer T.  Covid 19: How harm reduction advocates and the tobacco industry capitalised on the pandemic to promote nicotine.  BMJ 2021. 373 doi: https://doi.org/10.1136/bmj.n1303 (Published 02 June 2021)

2.  Hopkinson NS, Rossi N, El-Sayed Moustafa J, et al.  Current smoking and COVID-19 risk: results from a population symptom app in over 2.4 million people.  Thorax 2021. https://doi:10.1136/thoraxjnl-2020-216422   

3.  Jackson ‍‍SE, Brown J, Shahab ‍‍L, et al.  COVID-19, smoking and inequalities: a study of 53 002 adults in the UK.  Tob Control 2020. https://doi:10.1136/tobaccocontrol-2020-055933  

4.  Holt H, Talaei M, Greenig M, et al. Risk factors for developing COVID-19: a population-based longitudinal study (COVIDENCE UK). MedRxiv 2021 [preprint]. https://doi:10.1101/2021.03.27.21254452

5.  Williamson EJ, Walker AJ, Bhaskaran K, et al. Factors associated with COVID-19-related death using OpenSAFELY. Nature 2020;584:430-6. https://doi:10.1038/s41586-020-2521-4  pmid:32640463

6.  Guan WJ, Ni Z, Hu Y, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med 2020 382, 1708–1720.  https://DOI:10.1056/NEJMoa2002032

7. Miyara M, Tubach F, Pourcher V, et al. Low rate of daily active tobacco smoking in patients with symptomatic COVID-19. Qeios. 9 May 2020. https://www.qeios.com/read/WPP19W.4

8. Rentsch CT, Kidwai-Khan F, Tate JP, et al. Covid-19 testing, hospital admission, and intensive care among 2,026,227 United States veterans aged 54–75 years. MedRxiv 2020 https://doi.org/10.1101/2020.04.09.20059964.

9.  Simons D, Shahab L, Brown J, et al. The association of smoking status with SARS-CoV-2 infection, hospitalisation and mortality from COVID-19: A living rapid evidence review with Bayesian meta-analyses (version 11). Qeios 2021. https://doi:10.32388/UJR2AW.13

10.  Hippisley-Cox J, Young D, Coupland C, et al.  Risk of severe COVID-19 disease with ACE inhibitors and angiotensin receptor blockers: cohort study including 8.3 million people.  BMJ Volume 106, Issue 19, 2020 https://heart.bmj.com/content/106/19/1503

 

Competing interests: The author’s research is supported by unrestricted grants from tobacco manufacturers to the University of Louisville and by the Kentucky Research Challenge Trust Fund. The sponsors had no knowledge of this work and therefore had no input or other influence in the design, analysis, interpretation, or in the preparation of and decision to submit the rapid response.

 

Friday, April 9, 2021

The Case For Prohibition: Built on a False Premise and Disconnected From Reality

 

BR note: In January John Ioannidis and Prabhat Jha published a Lancet Global Health commentary asking “Does the COVID-19 pandemic provide an opportunity to eliminate the tobacco industry?”

 Clive Bates graciously provided the answer: IT DOES NOT.  Clive’s PubPeer response is reproduced below, with his permission.  It will never be read by prohibition promoters, but it’s a brilliant exposition of why all bans should be banned.

By Clive Bates

The flaws in the reasoning in this piece are many and fatal. I will examine some statements in the commentary pulled out as bold quotes. But to give a short answer to the question in the title: no, it does not.

“An opportunity to eliminate the tobacco industry” (Original Ioannidis-Jha quotes are in “bold”)

When did eliminating the tobacco industry become a public health goal? The goal should be to reduce or eliminate the harms (cancer, cardiovascular and respiratory disease etc) that arise primarily from smoking. A determined by as yet non-existent World government could theoretically 'eliminate the tobacco industry' but it wouldn't eliminate the demand for the drug nicotine. Eliminating supply while being unable to eliminate demand is a recipe for trouble.

If it was ever attempted, it would change the way nicotine is supplied: it is a common fallacy in public health to assume that banning something makes it disappear. The authors could have cited experience from the war-on-drugs or attempts at alcohol prohibition to better grasp this issue. In fact, the most promising approach to reducing health harms would not eliminate the tobacco industry at all but push it towards meeting the demand for nicotine with non-combustible products - vapour, heated or smokeless tobacco. Moving the industry away from being 'merchants of death' is a more realistic goal than eliminating it and failing in the attempt.

The authors do acknowledge the obvious:

“Most importantly, public health has little experience in enforcing major changes that disrupt markets”

Yes, that is a quite problem, given the authors propose a major disruption of markets - and in products that are addictive.

This would be a gigantic measure covering a market with more than one billion consumers and >$800 billion dollars revenue per year worldwide. It also provides a large tax base with WHO recommending that there should be at least 70% excise tax share in the final consumer price of tobacco products.

The most important knowledge for this proposal is how markets - legal and illicit - would react to it. And on that, the commentary is weak.

“The main counterarguments are financial (eg, economic damage or lost jobs) and defences of personal choice.”

The main counterarguments are actually different: (1) practicality - that it will never be agreed or, if agreed, it will fail quickly, causing a range of harmful side-effects (only a subset of these is economic), and; (2) political - that it is a grossly illiberal, coercive and intrusive overreach of state power into the personal behaviour of millions of people, many of whom may not wish to quit smoking and have options to help them if they do.

Governments do not function as some all-powerful deus ex machina that can just wade in and fix any problem in any way they please. In democracies, governments generally operate within the broad consent of the public and a wide range of stakeholders. They avoid unnecessary conflicts with large sub-populations of the law-abiding public and try to have themselves re-elected.

“The ongoing societal response to COVID-19 offers a precedent for drastic action taken to eliminate the tobacco industry.”

This is the heart of the flaw in the commentary and the false premise on which it is based. It is a surprising misreading of the nature of the major state interventions implemented to hold back COVID-19. The pandemic has justified draconian action because COVID-19 is a highly infectious and virulent communicable disease and one person's actions can seriously threaten the life of another, and in the short term. In our highly social societies, it takes major interventions such as lockdowns and business closures to stem the transmission of the virus. But in many countries, the public has understood the nature of this threat and largely consented to such measures.

Smoking-related diseases, by contrast, are non-communicable with harms that accumulate to the individual over decades of smoking, with the median lifelong smoker losing about 10 years of life in their 70s-80s. The causes, consequences and remedies for smoking-related deaths are simply not comparable with COVID-19.

The authors are effectively asserting that COVID-19 responses have raised the autocratic potency of the state and that this new dirigism can now be put use on other ideas. That is little more than a sleight of hand: the case for tolerating coercive and invasive state action is much stronger for infectious diseases and pandemics. But the authors cannot assume that consent goes beyond the pandemic response.

“Elimination of the tobacco industry would require huge efforts for counselling, cessation support, and dealing with short-term nicotine withdrawal among addicted smokers, which presents an opportunity for serious efforts to scale up cessation. A transition period over a few years might allow gradual but decisive decline and eventual elimination of smoking, and could address smuggling.”

Why would this "huge effort" be forthcoming? Why would it suddenly happen in a post-COVID-19 world when it was already possible before, but has not happened so far anywhere despite the stated urgency of the problem? Was it just that governments didn't feel powerful enough, but now they do? In reality, they have not gained public consent to deal with smoking more intrusively because of COVID-19. Few have shown any sign that they want to try, and those that have tried have failed (see the South Africa experience below).

Governments have tried to discourage smoking since the early 1960s, yet in even the most intense tobacco control environments, recorded adult smoking prevalence is around 1 in 7, predominantly among people of low socioeconomic status or other forms of disadvantage. What kind of big stick will the state have to wield to make these hold-outs comply?

“During the COVID-19 pandemic, sectors of the economy that have few adverse effects on health—eg, airlines, restaurants, tourism, and entertainment (excepting their effect on climate change)—have been sharply curtailed. The demise of these industries would lead to a more impoverished world.”

This is a non-sequitur. The terrible economic harms arising from COVID-19 and the policy responses to it do not in some way justify other economic harms. These industries are facing severe pressure because demand has dried up, not because the authorities have determined that their elimination would be useful in fighting disease or that we have developed an appetite for economic harm.

“Until now, only Bhutan has tried banning cigarettes, with mixed effects (eg, oral tobacco use remains high). This situation might radically change in the COVID-19 era.”

The case of Bhutan is indeed instructive though the authors have not taken its lessons to heart. Bhutan's prohibition has not worked. It has tobacco use prevalence of 25% (34% among men) and the ban has created a black market controlled by Bhutan's enterprising youth. A recent report by the World Health Organisation in Bhutan [1] found that:

Despite efforts on the part of relevant authorities, tobacco black market, as initially feared, has emerged. Shops that thrive on illicit sale of tobacco and its products have found a way around the law. A steady stream of loyal customers continue to sustain these shops that have, over the years, grown into a network of black market. Recent studies have found Bhutanese youth, who are among the highest in the region to be using tobacco and its products, to be at the centre of this burgeoning contraband good. (WHO 2020)

Undaunted by the experience of the one country that has tried to do what the authors suggest, they propose an implementation plan.

“Elimination of the tobacco industry would require huge efforts for counselling, cessation support, and dealing with short-term nicotine withdrawal among addicted smokers, which presents an opportunity for serious efforts to scale up cessation.

A realistic strategy would be to set a clear future date when sales would be banned, with a transition period of heavily taxed sales only through prescribed government shops.”

On what basis is this realistic - whether in Indiana or in, say, Indonesia or India? How would a programme of this scale work and how would it reach hundreds of millions of smokers? What about smokers who do not want to quit? Who would believe this date is credible? Would it be reversed after a populist backlash and election? What level of criminal network response would develop in the interim? What would happen to smokers still smoking on this date?

“Another helpful strategy might be to buy out tobacco cultivators in producing countries and to impose growing restrictions on imports for other countries.”

How will this work in Malawi, Zimbabwe, Brazil, and China or, for that matter, grower states in the United States? Who will pay for this and why would they see it as good value for money?

How many years of the crop would be bought out? What if new cultivations began in response to shortages and higher prices?

Have the authors studied the markets in cannabis, poppy and coca and the efforts to eradicate or buy out these crops? They have not been a conspicuous success.

“Concerns about smuggling would naturally arise. However, large-scale smuggling can be effectively countered.”

This is a very peculiar claim. An easy and enjoyable way to study whether this is true would be to watch the Narcos series on Netflix. But there is also compelling literature on the multiple harms arising from vast illicit trade in drugs [2].

Oddly, the authors do not mention the situation where a ban on cigarettes was tried on sales of cigarettes was introduced as part of the response to COVID-19 - that was in South Africa. A ban on tobacco sales in South Africa did not work, it showed all the effects one might expect and has since been reversed. Reports by the Research Unit on the Economics of Excisable Products (REEP) at the University of Capetown documented the failure: [3][4]

Our findings suggest that the ban on cigarette sales is failing in what it was supposed to do. While the original intention of the ban was to support public health, the current disadvantages of the ban may well outweigh the advantages. Smokers are buying cigarettes in large quantities, despite the lockdown, and unusual brands are becoming prevalent. [...] The current sales ban is feeding an illicit market that will be increasingly difficult to eradicate when the lockdown and the COVID-19 crisis is over. It was an error to continue with the cigarette sales ban into Level 4 lockdown. The government should lift the ban on cigarette sales as soon as possible. [3]

A Better Approach

The authors have misunderstood how a ban on tobacco sales would work in real-world markets and why the extreme measures used in response to COVID-19 do not provide them with a viable precedent for tackling smoking. Probably the biggest issue with this sort of commentary is that "grandiose masterstroke" ideas like this crowd out and distract from more careful and pragmatic approaches to creating pro-health transitions in real-world markets. They distract from viable progress by introducing unviable fantasy policies.

Here is a better way to address this problem, in my view.

Drop the war-on-drugs approach and the misplaced belief that making something illegal makes it go away: it does not. This approach has utterly failed and with terrible consequences.

Recognise that there is likely to be continuing, and probably permanent, demand for nicotine as a mild recreational drug (as with caffeine and modest alcohol consumption) especially if nicotine can be consumed without the health burden of smoking. Be clear that the goal is to reduce harm not to eliminate nicotine use. 

Resolve to migrate the demand for nicotine from smoking products to low-risk, non-combustible products which radically reduce the harms associated with the delivery system - vaping, heated and smokeless tobacco, and oral nicotine instead of smoking products.

Develop a 'risk-proportionate' tax and regulatory regime to incentivise both consumers and the tobacco industry to shift from high-risk to low-risk product.

Back fiscal and regulatory measures with candid communications to encourage (but not force) consumers to switch and providing information on risk to inform consumer choice

Ensure a competitive market that encourages innovation with low barriers to entry to ensure the tobacco industry faces competition to provide low-risk products and does not just establish a self-serving oligopoly

By far the best way to deal with the problem of smoking-related harms is to go with the grain of consumer preferences (most do not want to die an agonising death, but many do like nicotine) and to reshape the market for nicotine to remove the primary vector of harm: the smoke. We need to approach 'the endgame' with some care, with a clear eye on the goals, with a sense of pragmatism about what can be achieved in politics and with the consent of the public and consumers. I have written more about this in an article about "the endgame". [5] 

Disclosure

Clive has no competing interests with respect to tobacco, nicotine or pharmaceutical industries. He has campaigned for many years for a harm-reduction approach to addressing the health consequences of smoking.