This comes from OLIVER KERSHAW
/ NOVEMBER 24, 2017 / COMMENT, NEWS & MEDIA / We encourage you to go to the original post HERE and show some love!
The fifth E-Cigarette Summit took place at London’s Royal Society last Friday. For those interested in the true state of global science and regulations on vaping products (and, increasingly, other alternative nicotine products), the Summit is the calendar-event of note.
The following is my personal take on the overall themes, and I’ll start off with a TLDR listicle:
- Vaping typically produces well under 5% of the HPHCs of smoking, likely even under 1%…..
- With the important caveat that cloud-chasing type exposures have not been studied widely.
- Regardless, it’s always possible that there’s an as-yet-unidentified interaction between those small quantities of HPHC that are present and which causes a problem…
- But the world’s first study of long-term vaping never-smokers has shown no negative physiological changes over 3.5 years.
- Formaldehyde is present in cigarettes, vaping products and HTPs, but the exposure is less than those from, er, being indoors.
- Junk science is endemic in the field, although junk PR is a more insidious problem and likely the lever that creates the issue.
- Something radical now needs to be done the continuous erosion in public confidence in vapor products. The UK, despite having the most supportive public health community in the world, has yet again seen another annual decline.
- The Cochrane organization, the world’s most respected arbiter of medical science data, absolutely destroyed the methodology used by Stanton Glantz and colleagues in their efficacy meta-analysis. In what other field could a scientist’s credibility remain intact?
- Heated Tobacco Products (HTPs – PMI’s iQOS and BAT’s Glo) appear to reliably output around ten times less HPHC than cigarettes. See again point 3
- PMI’s Foundation is a political hot potato. PMI need to do more to convince the world of it’s independence although there will always be people who will never engage due to its provenance.
On to the meat, which I’ll serve over three dishes named, arbitrarily, “safety”, “science” and “politics”. I say “arbitrarily”, because in reality they all overlap and intertwine at every level.
Safety and efficacy
This year’s event might best be remembered as the Safety Summit. Or “the one where we felt we got a lot closer to calling vape safe”.
Before the Summit-proper began, Prof Riccardo Polosa held a press conference on his study of never-smoker vapers. This groundbreaking work was published in Nature last week and, for a study that many thought impossible to conduct, Riccardo has sure pulled off a doozy.
He and his colleagues tracked nine never-smoking vapers (and controls) over three and a half years and, reassuringly, found no physiological impact on their respiratory systems. Indeed, one of his slides showed a CT-scanned transverse section of a participant’s lungs: “This image is very boring,” commented Prof Polosa wryly, “because it shows nothing.”
Other presenters echoed the findings, albeit from different perspectives. Dr. Lion “It’s pronounced ”Leon” Shahab and Dr. Ed Stephens gave full summaries of the research on toxicology. What’s absolutely clear is that the data can only ever be understood in context, and that the remaining unanswered questions relate to unknown-unknowns of potentially interacting effects. Dr. Farsalinos was at pains to point that this kind of scrutiny is unheard of in any other product, even in medicine where the full impact of a new pharmacological compound can only ever be understood once it has gone to market.
The highest exposures seen in the current literature are approximately equivalent to iQOS, but vapers can typically expect to be exposed to something around 1/100th of the HPHCs compared with cigarettes.
Dr. Farsalinos presented entirely on his recent work on HPHCs in PMI’s iQOS system, a product that he prefers to call a “Heated Tobacco Product” (“HTP”, as opposed to industry’s favoured “Heat-Not-Burn”: I’m not generally a fan of the continual introduction of new phraseology, but on this, he’s justified). Konstantinos has replicated PMI’s own work with some methodological improvements such as varying the puff intensity. Overall his findings are broadly consistent with PMI’s: exposures of harmful compounds from iQOS are approximately 1/10th of that from cigarettes.
Dr. Farsalinos was also at pains to point out that the risk associated with exposure is nonlinear: that the “safety distance” between a cigarette and iQOS is far larger than between iQOS and vaping, despite vape delivering 1/10th of the exposure of iQOS. In some respects (and I dislike this analogy even as it forms in my mind), it’s like the difference crashing a car into a brick wall at 100mph, 10mph and 1mph.
This Summit was notable for its robust push back against the continuing drip-drip of negative science publicity. Robert West and others railed against the general (and structural) problem of poor science and poor science media. For a slice of the particular, Jamie Hartmann-Boyce
of the Cochrane Tobacco Addiction Group gave delegates a very smart exposition of the state-of-things-meta.
There is little argument that Cochrane is the world’s pre-eminent arbiter of medical science. Their meta-analyses are unimpeachable, if reliant on the existence of relevant literature. With respect to vaping there isn’t an awful lot, but the situation improves each year and Cochrane’s latest work demonstrates a modest efficaciousness for vaping in smoking cessation.
Meta-analyses are critical in human sciences for a number of reasons. Different research groups have different resources available to them (intellectual, financial, and human-participation). They have different reasons for conducting the research and, following this, different biases that are introduced in the process of carrying it out. Each recruited sample has variables, known and unknown, for which even the most rigorous methodology cannot control.
So the meta-analysis process standardizes data from a number of eligible studies. In this way, the truth-burden of experimenter bias and population effects is reduced, if not eliminated. The meta-analysis then becomes the reference point for anyone wishing to understand, as closely as the available science allows, the effect of an intervention. It’s a matter of considerable importance, therefore, that the analysis itself be conducted in as rigorous and dispassionate a way as is possible.
With respect to the question “does vaping help people stop smoking?” therefore, it’s arguable that the very last people that should be addressing it are those with a lifetime involvement in anti-tobacco research.
At the conclusion of her slot, Jamie signed off with a short “meta-meta-analysis” that readers may consider to be somewhat of a buried lede: Of the four meta-analyses published on the same topic, only one stands out showing a negative relationship between vaping and successful smoking cessation: the 2014 meta-analysis by Stanton Glantz and colleagues.
This analysis has been analyzed forensically by Clive Bates and others previously, but it continues to be circulated despite its absolutely critical flaws. Seen side by side with the others in a simple grid matrix outlining the methodological differences it’s just not possible to credit the UCSF team with the notion that they are conducting this research properly.
Charitably, Mr. Glantz is not sufficiently well versed in the appropriate methodology to be conducting this sort of research.
This brings us neatly to the more general point that was raised, first by Robert West, as to the current state of tobacco-related science.
In a particularly candid panel discussion, Robert West said (I paraphrase): “We have long tolerated poorly conducted science, perhaps because we liked the conclusions”. The inference being that poor science is rubber-stamped by Journal editors having been reviewed by peers that are not sufficiently critical, or prepared to be so.
It is now, I believe, a well-accepted truth that the peer review process is flawed (although perhaps, like democracy, it’s the best system we’ve got). Academic psychology, for example, has been forced into accepting that a great number of its research findings are erroneous or overstated, and into a process rewriting the methodological book (I wonder if Stanton – or his grad students – will rewrite this?).
As a side note, this tumult within the field has had little impact outside of academia in the real-world of “applied psychology”. Anyone that has been assigned a four-letter personality moniker courtesy of the MBTI can attest to this (ENTP here!).
Most relevantly to US tobacco control, the continued use of the “Stages of Change Model” by the occupiers of “evidence based” practice is truly awful. As a first year psych undergrad I was taught its parent model (the Transtheoretical Model) as an example of voguish psychological theories that are now only slightly embarrassing to psychologists as ever having been part of the canon. So, it was a shock to learn from Amelia Howard that the stages of change model is fundamental to mainstream smoking cessation guidelines from reputable organizations and government agencies in the United States
The UK lacks the structural problems that come with an entrenched tobacco control community. As Amelia Howard has notes in personal correspondence, Tobacco Control is part of the healthcare system in any country, and it serves the interests of that particular system. In the USA, political entrenchment serves industry interests well, and carriers of those politics don’t even need to care about the industry or know what industry interests actually are to help them. Indeed, they can even act in a way that appears totally anti-industry.
The difference between the US and UK in this respect is that the UK’s healthcare system is a public service, so UK tobacco control is accordingly more likely to serve the public.
As significantly, though, the UK also has the legacy of Sir Michael Russell. His scions include researchers that have contributed strongly to the UK’s pro-vape position, not via ideology, but through careful and measured interpretation of the evidence. So, can the UK be the “shining city on the hill” (my apologies) for smokers globally? It’s hard to know, although the recent Australian recalcitrance suggests there’s a way to go.
In this context, PMI’s Foundation Foundation for a Smokefree Future can be seen as an important confounder: its research agenda will influence the direction of travel here in no small way…
The Summit has always been inwrought with a political thread, although this year it came woven from a different fibre: Heat not Burn/Heated Tobacco Products and PMI’s Foundation for a Smoke Free Future.
iQOS has stolen an extraordinary market share in Japan, occupying 14% of the market in just two years. It is, by any measure, an extraordinary disruption, and the product is being rolled out globally. In February this year PMI announced a dramatic corporate renaissance, rebranding itself as the company that can realize a world without smoking (but not, of course, tobacco). For its efforts PMI saw a corresponding $30billion added to its market cap (!).
They followed up in September with the announcement of the, er, foundation of the Foundation, endowed with $1bn over 12 years and a mandate to promote rigorous science into safer nicotine technologies.
Professor Etter’s speech, “the good, bad and ugly of the Foundation” was, in this context, always going to be the most eagerly anticipated of the day. It seemed to me to be a fair exposition of the range of the controversy that necessarily accompanies the move, although it lacked some of the more speculative arguments I’ve heard for it’s raison d’être.
The Summit witnessed its only frisson of the day in the form of a modestly arcane exchange between Tim Baxter (from UK government’s Department of Health) and the head of the foundation, Derek Yach. Article 5.3 of the W.H.O’s Framework Convention on Tobacco Control (which has been ratified by most governments globally, with the notable exception of the USA) prohibits governmental employees contact with the tobacco industry. Yach took some umbrage with the notion that the foundation itself might be subject to 5.3 and, therefore, unable to communicate research findings.
The science itself is, of course, heavily politicised. No more so than in the context of the tobacco industry’s own inroads into risk-reduced products and its role in producing research into them.
The unanswerable question is as to whether iQOS and Glo really are the “breakthrough” products that will end up being the most significant part of the market. Equally unanswerable, at least to anyone but the cigarette sellers’ boards, is what their strategic considerations are.
Deborah Arnott of ASH UK noted that these products don’t address the health inequalities posed by tobacco (Iqos is at least as expensive to use, on average, than smoking premium cigarettes, whereas vaping can be done very cheaply). She made it clear that her concern is that part of the strategy is to disrupt the existing independent vaping sector, which she said “needs to be protected”.
Any hoping for PMI’s failure on the basis of their having a product that is, say, unappealing to consumers might underestimate the power that comes from being able to put your product anywhere you want, whenever you want. To some extent, if the corporate wish were strong enough, they could succeed with almost any product in the markets they chose to succeed in. The better question is: “what constitutes success (or failure) for a company like PMI?”
In any case, the emergence of PMI as a force in the THR debate is naturally divisive. It’s possible to engage in hours of speculative conversation as to their motivations, but really to do so is quixotic.
What is not quixotic is advocating for good science. There are a bunch of questions to be answered, and the current research focus of the public health/tobacco control world seems incapable of posing many of them. Is the Foundation any better prepared to or adept at doing so, and will it find researchers willing and able to work with it? Also, is the best way to answer a preponderance of bad science on vaping to do so with “more and better science on vaping”? Is it not possible (likely) that many of the important questions were posed and answered well before the market for vape products emerged?
The $1bn endowment is an eye-swiveling sum of cash, but over 12 years it amounts to less than 1% of PMI’s marketing budget and is probably around the same amount spent on iQOS’s research and development. The general concern aired last week was in relation to the Foundation’s independence.
The concern I have is that the Foundation may serve (through design or otherwise) to preserve and entrench the existing medical hegemony (for want of a better phrase) that informs the way these products are understood. As Amelia Howard and I have argued previously, the focus on narrowly defined fields such as “efficacy” and “safety” rather than, say, “processes and diffusion of innovation”, do not explain vaping at all satisfactorily given its emergence as a consumer-led innovation. Nor are they capable of understanding the technology as a still-evolving process.
A true epistemology of new risk-reduced technology needs to be generated across a wide variety of research specialisms. But here’s an important point: The foundation could equally serve to muddy the waters by being seen to generate “new talking points” that serve its interests.
In my view, the only way to address this double-edged sword is by to take the Foundation at its word but to hold it under great scrutiny.
On the Summit and its participants.
This Summit felt for the first time institutional, and I don’t mean this negatively. The event has had its fair share of criticism for having “the same speakers” each year by people who don’t understand the value of, say, Robert West giving a population-level update each year, or of Dr. Farsalinos returning each year to update us on the current state of medico-vape epistemology.
On a personal note, I was particularly glad to see Prof Etter speak for the first time since the inaugural event. Four and a half years ago he and I had a conversation outside the European Commission following their now notorious “E-Cigarette Workshop”. I had it in mind that we needed to see the science on the stage (all of it: “good, bad and ugly”, you might say), and JF encouraged me to pursue this. I was introduced to Amanda and the rest is history.
And, speaking of Amanda, she deserves massive credit. I’ve known many people connected with this chapter of human history for whom the stress and emotional burden of involvement becomes too much. Every time Amanda puts on a Summit she has to sit in the middle of the vortex of contesting forces. It’s fair to say that the Summit has, since its inception, been attacked from every side in this debate in one way or another.
I don’t know if many people consider or can understand what this is like or what it involves? As a perfect example, the day before the Summit, the Verge ran a particularly egregious article attacking the Summit across a range of totally false premises – no effort, as I understand it, was made to contact Amanda. There is a campaign afoot to delegitimize the Summit from various quarters, and Amanda needs support now more than ever.
When she receives applause at the end of each event for pulling off a super slick and ever-fascinating program, some of us are clapping because we know what else she deals with.
I should note here that I have no personal involvement in the Summit except as having been its co-founder. Both Amanda and I were from the first day committed to putting all the available science on stage and the editorial decisions have always been hers.
The Summit concluded with a banger of a keynote from Sarah Jakes. She’s a trustee of the New Nicotine Alliance charity in the UK, and has worked tirelessly and unpaid to build bridges between interested parties. There was much uncomfortable listening there for tobacco controllers and other public health she conjured the sentiments of many vapers and smokers at receiving end of the often-draconian measures to end smoking.