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] 


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.


Wednesday, March 31, 2021

For Smokers With Schizophrenia: The JUUL in the Crown


The vast majority of people with mental illness also smoke – a lot.  In fact smoking, which delivers to tortured brains the soothing drug nicotine, is considered by many sufferers, and their doctors, as not optional.

More than 60 percent of schizophrenia patients are current smokers (here), but hope may be found in a small open-label Italian clinical trial, reported by Pasquale Caponnetto at the University of Catania and his colleagues.

Caponnetto et al. recruited 40 people with schizophrenia who did not intend to reduce or quit smoking; they were given JUUL e-cigarettes and pods for 12 weeks.  Caponnetto found that 16 subjects had quit smoking over that period, and 21 others had reduced their cigarette consumption from a median of 25 before the trial, to 10.  At the final six-month follow-up visit, when all participants had been purchasing their own tobacco products for three months, 14 had quit smoking.

This study demonstrates that e-cigarettes can be an aid to cessation or reduced consumption for people with schizophrenia who don’t intend to give cigarettes up.  There is one caveat.

Caponnetto used full-strength JUUL pods – also sold in the U.S. – which contain 59 milligrams of nicotine per milliliter of e-liquid.  The researchers probably obtained special permission from regulatory authorities as the European Union limits e-liquids to only 20 mg of nicotine per ml.  It is likely that smokers with mental illness require higher doses of nicotine in cigarette substitutes.

I am reminded of a short article published in the American Journal of Psychiatry in 2005 (reference here):

“Ms. A, a 52-year-old woman with schizoaffective disorder, bipolar type, started smoking shortly after her first psychotic episode at age 19 and, on average, smoked about 1½ packs per day for 33 years. She had attempted to quit using pharmacotherapy, nicotine gum, or patches in combination with cessation classes. Both gum and patch treatments were ineffective since they did not control her craving for cigarettes.

“Her motivation to quit was strong because of the sequelae of smoking: bronchitis, isolation from others, and destabilization of her psychiatric illness from frequently awakening to smoke. Her brother with a bipolar disorder had experienced severe burns over most of his body and died secondary to a fire caused by his smoking. For her, smoking had become a constant reminder of his suffering, which led to nightmares and further isolation. She was afraid to jeopardize the health and safety of others.

“One year ago, she was cross-titrated over a 1-week period to oral pouches. Since that time, she has not resumed smoking, and her psychiatric and medical symptoms have stabilized. Before her cessation of smoking, she lived an isolated existence. Now she resides with and cares for her parents. For Ms. A, ceasing to smoke was a life-changing event.”

Doctors in 2005 successfully switched a patient with severe mental problems from cigarettes to smokeless tobacco, citing two of my studies (here and here) as the scientific basis for their humane and “life-changing” guidance.   

Now, doctors in Italy have produced life changing evidence that patients with schizophrenia can successfully switch to JUUL.





Wednesday, March 24, 2021

A World-Class Case of Corporate Self-Cannibalization May Save Millions of Lives


Heat-not-burn (HNB) tobacco products – mainly IQOS from Philip Morris (PMI) – are eroding cigarette sales in Japan, as I recently noted.  Prevalence estimates from the Japanese Health and Nutrition Survey confirm the consumption numbers. 

Because the Japanese survey only began tracking new products in 2018, no trend can yet be discerned, but HNB product use is impressive, as shown in the chart at left.  Depending on how dual users are counted, HNB accounted for 20 to 27 percent of all tobacco use in 2019.   

The highly credible Japanese Health and Nutrition Survey is the world’s oldest nutrition survey, implemented by Allied Forces after World War II.  Participants include adults age 20+ years; questions on smoking and HNB use are included in the lifestyle section. 

The HNB-driven Japanese harm reduction miracle has been ignored by most of the world, but Motley Fool just published an intriguing article, “Is It Time to Stop Thinking of Philip Morris International as a Cigarette Company?”

The answer is a resounding “Yes!”

There are two standout quotes in the article.

“Philip Morris' annual report shows that cigarette shipment volumes last year tumbled over 11%, with its most important brand Marlboro, which accounts for 37% of all cigarette shipments, down by a like amount.”

PMI risked its core cigarette business when the company launched the multi-year, multi-billion-dollar IQOS research and development effort.  Five years ago, it rolled the dice again when it marketed the products in Japan.  Leadership had no guarantee that IQOS would preferentially erode only other companies’ cigarette sales.  This may end up as a world-class example of self-cannibalization that ultimately saves millions of lives that would otherwise be cut short by smoking.  

“Philip Morris generated $6.8 billion in revenue last year from IQOS, or almost 25% of its total $28.7 billion in net revenue. [PMI CEO Andre] Calantzopoulos says if you just look at the three regions where IQOS is most prevalent -- Asia, Eastern Europe, and the European Union -- it represents 35% of the total.”

Naysayers have dismissed the Japanese miracle because there is no e-cigarette/vapor market there.  However, there is no doubt about the success of IQOS across 67 countries around the world.  IQOS might now find similar public health success in the U.S.  As Altria broadens distribution here, tobacco prohibitionists should give smoke-free tobacco products the opportunity to cancel smoking and advance public health.