One hundred tobacco harm reduction (THR) experts have published a joint letter challenging the World Health Organization’s (WHO) approach to tobacco science and policy. The group is urging members of the Ninth Session of the Conference of the Parties (COP-9) of the Framework Convention on Tobacco Control (FCTC), a global intergovernmental treaty in which the WHO plays a major role, to encourage the WHO to support and promote the inclusion of tobacco harm reduction into its regulatory advisements.
Credit: Igor Golovnev.
“Smoke-free nicotine products offer a promising route to reducing the harms arising from smoking. There is compelling evidence that smoke-free products are much less harmful than cigarettes and that they can displace smoking for individuals and at the population level,” the letter states. “Regrettably, [the] WHO has been dismissive of the potential to transform the tobacco market from high-risk to low-risk products. [The] WHO is rejecting a public health strategy that could avoid millions of smoking-related deaths.”
The letter was published on Oct. 18 and will be sent to COP-9 delegates. In a joint statement, Ruth Bonita, former director of WHO Department of NCD Surveillance, and Robert Beaglehole, former director of the WHO Department of Chronic Disease Prevention and Health Promotion, stated that they were “extremely disappointed by WHO’s illogical and perverse approach” to reduced-harm nicotine delivery products, such as vaping.
“A key challenge in global tobacco control is to assist cigarette smokers to transition from burnt tobacco products to much less harmful options that provide the nicotine without the toxic smoke,” the statement reads. “[The] WHO’s continuing disregard of the wealth of evidence on the value of these products is condemning millions of smokers to preventable disease and premature death.”
The letter goes on to make seven points about the current vaping regulatory environment, such as the value of vaping in THR and the unintended consequences of poor regulatory policies. The authors then go on to make six suggestions for the WHO to consider:
Make tobacco harm reduction a component of the global strategy to meet the Sustainable Development Goals for health, notably SDG 3.4 on non-communicable diseases.
Insist that any WHO policy analysis makes a proper assessment of benefits to smokers or would-be smokers, including adolescents, as well as risks to users and non-users of these products.
Require any policy proposals, particularly prohibitions, to reflect the risks of unintended consequences, including potential increases in smoking and other adverse responses.
Properly apply Article 5.3 of the FCTC to address genuine tobacco industry malpractice, but not to create a counterproductive barrier to reduced-risk products that have public health benefits or to prevent critical assessment of industry data strictly on its scientific merits.
Make the FCTC negotiations more open to stakeholders with harm-reduction perspectives, including consumers, public health experts, and some businesses with significant specialised knowledge not held within the traditional tobacco control community.
Initiate an independent review of WHO and the FCTC approach to tobacco policy in the context of the SDGs. Such a review could address the interpretation and use of science, the quality of policy advice, stakeholder engagement, and accountability and governance. The Independent Panel for Pandemic Preparedness and Response (IPPPR), initiated to evaluate the response to the COVID-19 pandemic, offers such a model.
Another signatory, David Sweanor, adjunct professor of law, chair of the Advisory Board of the Centre for Health Law, Policy and Ethics University of Ottawa, Canada, in a separate statement, said that effective public health efforts need to be based on science, reason and humanism. Instead, the WHO is aligning itself against all three when dealing with nicotine.
“The result is that one of the greatest opportunities to improve global health, separating nicotine use from smoke inhalation, is being squandered. Global trust in health authorities, and the WHO in particular, has never been so important,” the statement reads. “Yet the WHO is abandoning science, rationality and humanism on nicotine and instead apparently pursuing the moralistic abstinence-only agenda of external funders. This is a public health tragedy that extends well beyond the unnecessary sickening of the billion-plus people who smoke cigarettes.”
The suite of new GSTHR publications aim to draw attention to, and challenge the direction of travel of, the Framework Convention on Tobacco Control (FCTC) Conference of the Parties 9 (COP9), a major global meeting on tackling smoking. The meeting is being held virtually in early November. According to the GSTHR, the FCTC agenda and briefing papers indicate the FCTC Secretariat and leadership are continuing to urge parties against the adoption of tobacco harm reduction approaches that could help save millions of lives.
The GSTHR briefing papers offer analyses, commentaries or explainers on topics related to tobacco harm reduction and its role in combating the death and disease caused by smoking.
The first paper provides a brief overview of both the FCTC and the Conference of the Parties biennial meetings, explaining their role in global tobacco and nicotine policy, as well as highlighting some of the problematic elements of their current operation. A deeper analysis of these issues will be revealed when Fighting The Last War is published later in the month.
The second GSTHR briefing paper focuses on the U.K.’s potential leadership role at COP9. According to the GSTHR, the U.K. has successfully implemented important aspects of a domestic tobacco harm reduction policy, while retaining a strong tobacco control record. Currently, the FCTC project does not reflect the U.K. approach–yet the U.K. is one of the most consistent and generous financial backers of both the FCTC and the WHO. At COP9, the paper argues, the U.K. must be prepared to take a strong line and advocate for policies it has enacted that are demonstrably increasing the numbers of people successfully quitting smoking.
These issues and more will be explored in depth in the GSTHR’s forthcoming report, to be published on Oct. 27 at a hybrid launch event, free to attend online. In Fighting The Last War: The WHO and International Tobacco Control the report’s author, Harry Shapiro, takes a close look at the history, development and often secretive processes of the FCTC COP, its early battles with the tobacco industry – and the range of influences shaping international tobacco control’s response to safer nicotine products in 2021.
The report launch will be broadcast on Oct. 27 from the Kia Oval in London. Two roundtable sessions will be livestreamed from 11 am British Summer Time, with time allowed for questions from those watching in the room and from afar. Will Godfrey of Filter will host the first session, “The FCTC: past, present and future,” which features Harry Shapiro, KAC, report author; Derek Yach, Foundation for a Smoke-Free World, former WHO cabinet director and executive director for noncommunicable diseases and mental health; and Tom Gleeson of the New Nicotine Alliance Ireland.
The second session will be hosted by Jeannie Cameron of JCIC Consulting and will be centered on the “Challenges to making the FCTC an inclusive international framework convention.” Audience members will hear from Ethan Nadelmann, founder, Drug Policy Alliance; Nataliia Toropova, Healthy Initiatives and Professor Gerry Stimson, director, KAC.
Parties to the FCTC must seize the opportunity to consider evidence from countries where tobacco harm reduction is succeeding, including the U.K., New Zealand, Sweden, Norway and Japan.
“We’re gravely concerned by the WHO’s continued rejection of tobacco harm reduction,” said Stimson. “It already accepts harm reduction as a valid, evidence-based public health intervention for drug use and HIV/AIDS. Harm reduction is explicitly named as one of three tobacco control strategies in the opening lines of the Framework Convention on Tobacco Control. Adoption could hasten the end of the public health crisis caused by smoking.
“Instead the WHO rejects and, worse, repeatedly misinforms the public about safer nicotine products, demonstrating a disregard both for the lives of over one billion adult smokers and the eight million deaths each year due to smoking. Parties to the FCTC must seize the opportunity at COP9 to consider evidence from countries where tobacco harm reduction is succeeding, including the U.K., New Zealand, Sweden, Norway and Japan—and ask why the WHO and its influential financial backers are refusing to do the same.”
The evidence is in. For the first time, the U.S. Food and Drug Administration has authorized the marketing of an e-cigarette in the country because it determined the help it offers adult smokers outweighs the attraction such products may hold for youth.
The decision to allow the sale of British American Tobacco’s Vuse Solo closed electronic nicotine-delivery system, along with three tobacco-flavored cartridges, marks the third time in less than two years that the agency, despite vociferous, emotion-driven opposition from politicians and interest groups, has used peer-reviewed scientific evidence to approve tobacco harm reduction (THR) products.
With this latest move, the FDA has signaled a distinct turn in the oft-contentious debate surrounding e-cigarettes, in which opponents claim little is known about what toxic chemicals they contain and that the tobacco industry has a terrible track record when it comes to being forthcoming about its products.
That was not the case here, indicated Mitch Zeller, the director of the agency’s Center for Tobacco Products. “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust scientific premarket evaluation,” he said in a statement. “The manufacturer’s data demonstrates its tobacco-flavored products could benefit adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals.”
We have said it before, and we’ll continue to say it again (and again and again) in the face of all this misinformed vitriol and distrust: THR products are effective tools to help smokers lessen their risk of developing diseases such as lung cancer and COPD. So says one study after the next, including a recent measured, sober look at the risks and benefits of e-cigarettes that is signed by no less than 15 former presidents of the Society for Research into Nicotine and Tobacco, a leading international proponent of evidence-based science.
The key word here is “evidence.” Although e-cigarettes are not risk-free, they have been found to be up to 95 percent less harmful than combustible cigarettes because they contain no tar and significantly fewer chemicals that make up the toxic stew of smoke in combustible cigarettes.
Evidence, carefully compiled, weighed and debated, is how the FDA reached its earlier decisions to provisionally authorize the sale of Swedish Match’s snus and Philip Morris International’s IQOS heat-not-burn sticks as modified-risk tobacco products (MRTPs), subject to regular review. And “evidence” is how it made its first decision to approve the marketing of Vuse.
It reached its decision through dispassionate, rigorous diligence—a risk-proportionate, microscopic gauging of the potential harm e-cigarettes pose for young people versus their potential therapeutic uses for adults who smoke combustible cigarettes and would like a less damaging alternative. Indeed, the FDA’s approval process is so thorough, it is accepted as the international gold standard for vaccines, pharmaceuticals and medical devices. As Adam I. Muchmore, a Pennsylvania State University law professor, explained last month [August] in an interview with Newsweek about the wait for Covid-19 vaccine approval, “There are a lot of ‘i’s’ to be dotted and ‘t’s’ to be crossed, and these are not simple bureaucratic requirements. Both producing this data, and reviewing it, requires the work of multiple experts in a wide range of scientific fields.”
We hope the FDA will continue to use scientific evidence to approve the sale of menthol-flavored e-cigarettes so that combustible menthol cigarette users, among them the majority of African-American smokers, also have the opportunity to reduce their health risk. And we hope it will consider that nicotine-replacement therapy gums and sprays are already marketed in menthol and other flavors, all to help smokers quit.
One does not need to look far to see the effects of FDA decisions: Following its full approval last August of Pfizer-BioNTech’s Covid-19 vaccine, a “tidal wave” of people were expected to line up for their jabs, spurred by employers and businesses that have been waiting for the green light and at least some doubters who needed more reassurance it is safe.
And the National Institutes of Health’s Anthony Fauci aptly summed up the FDA’s influence in a comment earlier this year about its approval for Aimmune Therapeutics’ Palforzia, the first drug to treat peanut allergy for children. “Science is showing us the path to a future in which new therapeutic options may provide both solutions as well as peace of mind that individuals with food allergies and their families deserve,” he said.
Those words could well apply to the field of THR too, although the FDA’s policy of placing the onus solely on individual companies to prove they contribute to public health (to wit, the 2.3 million pages of evidence PMI submitted on behalf of its IQOS application) has already left some smaller, streamlined companies out in the cold.
That said, governments in lower and middle income countries (LMICs), where the vast majority of the world’s 1.14 billion smokers live, would do well to study all three of the FDA decisions regarding THR products as they work to strengthen their own national research and regulatory capabilities and to take note of the careful steps the agency continues to take as it examines the applications of other companies that manufacture e-cigarettes, including Juul.
These governments and their public health authorities need to review the statistics from places such as the United Kingdom, which has supported e-cigarette use as an effective way to lessen health risks and even quit combustible smoking altogether. Or, conversely, they could take two minutes and 42 seconds to watch a graphic Public Health England demonstration of the viscous, oozing, sticky dark brown residue left in the lungs from the smoke from 16 packages of cigarettes over the period of one month compared to the barely discernible trace of vapor left by the equivalent number of e-cigarettes over the same period.
Right now, a huge gap exists between research output in tobacco control by a few developed countries and LMICs, and when it comes to reduced-risk products, the gap is even greater, a reflection of both the lack of support for homegrown scientific research and a concomitant reliance on advanced industrialized countries for regulatory scientific advice and support. The Foundation is committed to playing its role in closing this gap to allow LMICs to have the scientists able to fully inform their policymakers about the potential benefits of THR.
There appears to be no interest in tobacco harm reduction as a principle or a tendency to unquestioningly accept the warnings by bodies such as the World Health Organization, which itself is mired in a past overtaken by technological advancements and sounds like the proverbial Greek chorus as it points to the lack of long-term testing and the perils such products pose to youth.
The most extreme example of this governmental attitude is in India, where, despite 1.3 million people dying each year from tobacco-related diseases, e-cigarettes were banned in haste by the government, which was urged to do so by The Union, a Bloomberg-funded NGO based in Paris that recommends such extreme measures for LMICs on the supposed grounds that youth in these countries are particularly vulnerable. In turn, this has led to a burgeoning black market that prices these products out of reach of many of the disadvantaged communities who could use them most.
The fact is, the most favored tobacco control measure in India is tax increases, which only serves to exacerbate the difference between the rich and the poor, for the latter group must turn to cheaper, even more dangerous products such as bidis, thin cigarettes composed of unprocessed tobacco that are hand-rolled in leaves and contain higher concentrations of nicotine, tar and carbon monoxide than conventional cigarettes sold in the United States.
In Indonesia, where more than a quarter of the population smokes, including 19.4 percent of young people between the ages of 13 to 15, the local—and significantly cheaper—cigarette of choice is the unfiltered kretek, made from a blend of tobacco, cloves and other additives. Yet, there is little government oversight, with children even exposed to lengthy tobacco advertisements before blockbuster Hollywood films.
Still, the WHO refuses to apply the consequences of harm reduction always being part of the definition of tobacco control in the Framework Convention on Tobacco Control. A good start would be for the WHO to consider recent peer-reviewed research by leading scientists that underpins the FDA submission and not reject it simply because it has been funded by the tobacco industry. In its Report on the Global Tobacco Epidemic—2021, it does not waver from its position, stating that new and emerging products simply chart a “new threat to tobacco control.”
“As they emerge and rapidly evolve, these products can be difficult to characterize and therefore bring with them many regulatory challenges,” it states. “At the same time, the tobacco and related industries behind these newer products pedal misinformation campaigns, marketing them as ‘clean,’ ‘smoke-free’ or ‘safer,’ and claim they are effective cessation aids. By doing so, these industries attempt to appear part of the solution to the tobacco epidemic as opposed to instigators and perpetrators of the epidemic.”
How disheartening! Yes, the tobacco industry has acted unconscionably in the past, lying about the toxicity of cigarettes and shamelessly professing its primordial dedication to the health and welfare of smokers. But, to paraphrase the old saying, change—real change—starts from within. We are seeing signs of that in the tobacco industry, with the results recognized by the FDA, leading health experts and authorities in countries such as the U.K.
It is time for all of us to move on—together.
To stop treating all nicotine products as the same.
To acknowledge that we all have a stake in people’s health and well-being and in a healthy future for our children, their children and for generations to come.
And to start saving up to 4 million lives a year in the interim as the battle—our battle—continues to eradicate combustible tobacco for good.
It could be some time before the U.S. Food and Drug Administration issues marketing orders for flavored vapor products.
By Chris Howard
For the past 10 years, we have ridden a rollercoaster together. We have experienced the same highs and lows and shared the hope that harm reduction will prevail in the end. Then, over the course of the past several weeks, the journey ended abruptly with marketing denial orders (MDOs) for so many. Not surprisingly, several question whether the vapor industry can ever recover.
The FDA’s Recent Actions
For what it’s worth, the recent actions of the U.S. Food and Drug Administration should not have been a surprise to anyone in the vapor industry. We have known for several years that being part of a highly regulated segment would not be easy. In fact, the FDA made its expectations clear in its 2016 Draft Guidance entitled Premarket Tobacco Product Applications for Electronic Nicotine-Delivery Systems (ENDS). In sum, this document revealed that obtaining a marketing order for vapor products would require scientific expertise, extensive data development and very deep pockets.
That said, the FDA’s rationale for such broad-based denials has raised questions among many. More specifically, the FDA provided the following rationale in its Aug. 26, 2021, news release:
In light of the public health threat posed by the well-documented, alarming levels of youth use of flavored ENDS, the agency has reviewed the applications subject to this action to determine whether there is sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth. Based on existing scientific evidence and the agency’s experience conducting premarket reviews, the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable.
Chris Howard
The primary question we are left to ponder is whether this balancing of interests exceeds the FDA’s standard for assessing whether a product is appropriate for the protection of public health. Based on Section 910 of the Tobacco Control Act, which describes the appropriate standard of review, it appears that this balancing is one of many facets of an application that the FDA is required to consider.
Appropriate for the Protection of Public Health
Section 910 of the Tobacco Control Act provides the FDA’s standard of review for new tobacco products:
…whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—
(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and
(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.
So clearly, the risk of initiation of flavored ENDS products by youth is relevant as is the likelihood of ceasing use by smokers generally. Without a doubt, the FDA has determined that evidence related to part (A)—cessation—must outweigh part (B), initiation. This risk balancing, in the FDA’s own words, is reflected in data from clinical studies or longitudinal studies demonstrating that adult use of flavored ENDS leads to cessation (or switching) outcomes that exceed the risk of youth initiation of tobacco product use. And yet, despite this seeming clarity, many questions surround this analysis. For example, by how much must adult cessation exceed youth initiation? What if both tobacco varieties and flavored varieties show the same or similar cessation rates? Has the FDA considered the reduction in use by youth resulting from the recent change in the age to purchase tobacco products to 21 when examining the balancing of risks versus benefits?
These questions are likely to remain unanswered for quite some time. Many committed companies are already beginning efforts to satisfy the FDA’s outstanding requests for clinical studies and/or longitudinal data, but the development of data will take several months. Obviously, this is likely to do significant damage to an already fractured market—and even more potential damage to smokers seeking an alternative to combustible cigarettes.
Flavors Are Critical for Harm Reduction
Despite these tumultuous past few weeks, the FDA is arguably the biggest advocate for harm reduction. Given the agency’s desire to provide options to adult smokers to move away from traditional combustible cigarettes, it seems clear that a pathway for flavors to return does indeed exist.
Along with the rest of the industry and many public health researchers, I believe that the removal of all flavored products would negatively impact harm reduction efforts in the United States. Some vapers will undoubtedly return to smoking combustible cigarettes. And smokers who might have transitioned to ENDS products may now elect not to do so. In the studies conducted at my company, E-Alternative Solutions, we demonstrated that adults prefer flavors and that flavors assist adults in transitioning from combustible cigarettes to potentially less harmful alternatives. Existing literature documenting the research conducted by others also supports this proposition. Moreover, anecdotal reports are easy to find on Twitter and multiple other social media forums.
While it may not be apparent from the FDA’s recent actions, I do not believe that flavored ENDS are finished in the United States. While the bar appears high, I hope and expect, for the sake of adult smokers in this country, that we will see flavored ENDS on the U.S. market again. That said, it could take time until the agency issues market orders for flavored vapor products.
What’s Next?
The FDA’s recent decisions will likely prompt many to appeal and some to resort to litigation [at least two suits are known to have been filed already]. The FDA appears prepared to address these initiatives and is prioritizing enforcement of those failing to comply with MDOs and/or who are selling vapor products that have not undergone premarket review. While these activities are ongoing, many will begin longitudinal studies and the hard work to identify alternative methods to show the FDA that flavors are determinative in adult smokers’ efforts to switch from combustible cigarettes.
Ultimately, we will have to wait while the remainder of the story unfolds. Hopefully, the FDA will be prepared to work directly with sophisticated manufacturers to ensure that flavored ENDS can continue to play a role for adult smokers seeking alternatives.
Chris Howard is the vice president, general counsel and chief compliance officer of E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.
The U.K. Vaping Industry Association (UKVIA) has joined forces with the stop-smoking app Smoke Free to encourage more smokers to give up their habit by using a range of evidence-based alternatives to conventional cigarettes.
As part of the collaboration, the UKVIA and Smoke Free have agreed to work on a number of joint campaigns and initiatives that both promote vaping as a successful method to quit smoking and increase access to the app among those smokers looking to kick their habit.
The joint initiatives include a campaign in January, when smokers will be making New Year’s resolutions to quit. Collaborations are also planned during VApril, the UKVIA’s annual vaping awareness month and on a specific initiative supporting hospital patients with smoking-related conditions and the healthcare professionals that care for them.
This is an exciting collaboration, which is focused on getting smokers to quit completely
“This is an exciting collaboration, which is focused on getting smokers to quit completely,” said John Dunne, director-general of the UKVIA, in a statement. “Some 2.4 million former smokers have successfully done this in the U.K. to date, but there are still 1.2 million dual vape/cigarette users and another 6.9 million smokers who have not quit to date.
“By coming together, we want to significantly ramp up support for smokers who are looking to quit.”
“Vapes make quitting easy because they’re a great replacement for cigarettes,” said David Crane, founder of the app. “But habits still need to be changed, which is where the support we provide comes in. We are proud to work with the UKVIA because they share our mission to create a smoke-free world. Together, we stand a great chance of helping people stop smoking for good.”
Umberto Roccatti, president of National Association of Electronic Smoke Manufacturers (ANAFE) in Italy and vice president of the Independent European Vape Alliance, is biking 700 km to protest a planned vapor tax hike in Italy.
Italian vapor taxes are set to increase from Jan. 1, 2022. “The gradual increase, every year for three years, of the taxation on electronic cigarettes is pure absurdity, that risks bringing to its knees a sector already severely affected by the pandemic and which today counts about 45,000 employees,” said Rocatti in a statement.
The new tax regime, he added, will not only cripple a supply chain comprising small and medium enterprises, but also encourage black market sales. According to Rocatti, the tax hikes would make some vapor products more expensive than some cigarette brands, encouraging vapers to return to smoking.
Rocatti’s “Ride4Vape” left Bolzano Sept. 20 and will pass through Abano Terme, Santarcangelo di Romagna and Sangemini before finishing in Rome. Along the way, Roccatti will explain on Facebook the disastrous effects of the fiscal policy call on lawmakers to reverse their plan.
“What the whole sector hopes for, is a revision of the current tax burden—which turns out to be particularly excessive,” says Roccatti. “Moreover, it should be noted that the revenue–referred to the first months when the tax came into force before it was suspended by the new government—was not what expected, but quite the opposite, thus confirming the fact that raising taxes, especially in the midst of a pandemic, does not contribute positively to state revenues. We therefore ask for stability and fiscal balance on a sector which already underwent four tax increases in the last six years.”
Ireland has made progress toward its goal of being smoke-free by 2025, according to the republic’s department of health, reports Joe.
The announcement follows the publication of the Tobacco Free Ireland 2020 Annual Report, which outlines “several key achievements” in 2020, despite Covid-19 disruptions. These achievements consist of the inclusion of information on the dangers of tobacco use in Healthy Choices 1, the first substance misuse module of Junior Cycle Social, Personal and Health Education; the launch of a new quit marketing campaign called The Last Stop; the completion of three comprehensive evidence reviews on electronic cigarettes and heated-tobacco products by the Health Research Board; and an increase of $0.50 per pack of cigarettes with pro-rata increases on other tobacco products included in Budget 2021.
“By working to remove smoking from daily life in Ireland and educating young people on the dangers of tobacco while making cessation assistance as widely available as possible, we can continue to build on the promising results we have seen in recent years,” said Health Minister Stephen Donnelly. “I urge anyone that is thinking of quitting to act now. Stopping smoking remains one of the best decisions a person can make for their health. The last 18 months has further highlighted the importance of being proactive about our own health and the health of those around us. The HSE quit service remains available to anyone that needs it.”
Tobacco companies should be allowed to transition to harm reduction products, but under history’s watchful eye.
By George Gay
I don’t go along with the oft-repeated idea that, if we don’t remember the past, we are condemned to repeat it. This is not to say that particular versions of the past, whether real or invented, are not repeated, just that mostly it is impossible to know whether an event is an original or a repeat. For one thing, memories of the past are mostly not the result of direct experiences and so are not fixed and generally agreed. History, into which the past is roughly sieved, is never objective. It is most often weighted, open to interpretation and subject to disagreements.
I would be happy to consign all versions of history to oblivion, but then, as somebody famously said, there would be no point. In saying that we consign something to oblivion, we suggest that it is simultaneously forgotten and preserved. We are incapable, it seems, of letting go of favorite versions of the past, which get stuck to our shoes like carelessly discarded chewing gum.
Specifically, it concerns me that history, or versions of it, are being allowed to act as a drag on advances that could be being made in reducing the health consequences of cigarette smoking. I recently attended a nicotine conference and, as part of one generally good presentation, a still of a video was shown in which CEOs from U.S. tobacco companies told a Congressional oversight committee sitting a quarter of a century ago that they did not believe nicotine was addictive. I have seen this still, or similar ones, on more occasions than I care to remember, often presented as shorthand for how heinous the tobacco industry was or even is.
But one problem in my view is that what is presented here is a version of history directed by the enemies of the tobacco industry who feel they won the moral war. In other words, a history presented by the victors. It implies that those CEOs were willing to lie about something that everyone knew to be true—that nicotine was and is addictive. There is no time for nuance in a single still. There is no room for other interpretations.
Credit: Sky Next
For instance, were all the CEOs referencing the same, agreed version of addiction? And if, as generally supposed, they were all referencing the same definition of addiction, were they acting in bad faith, or were they, or at least some of them, not informed or badly informed by the scientists working in their companies who did believe that nicotine was addictive? Is it possible the CEOs were right and everybody else was wrong? Was one or more of them delusional and in need of help?
I ask above whether all of the CEOs were referencing the same definition of addiction and, frankly, I have no idea what the answer to that question is. I tend to the view, however, that they were, because I find it difficult to believe their legal teams would have allowed them to give the answers they did without knowing exactly what they were signing up for.
But I have one troublesome doubt in this regard. As far as I am aware, five of the seven CEOs who testified in 1994 said they believed that nicotine was not addictive; one said he believed that neither nicotine nor his company’s products were addictive while another said he believed cigarettes and nicotine clearly did not meet the classic definition of addiction because there was no intoxication.
The reference to “the classical definition” surely suggests that it was admitted there was more than one definition, which possibly means the answers need to be interpreted individually. Additionally, it cannot be ruled out that even if a CEO knew that his company’s scientists believed nicotine to be addictive, his personal view might have been different. We all become fed up with experts at one time or another.
The oversight committee’s hearings later revealed that all sorts of skulduggery had gone on; for instance, at least some of the people within these companies knew or believed that nicotine was addictive and that some had manipulated their products to try to make them more addictive, whatever that means in the context of whatever definition you are using.
But where did this information come from? It came in part from documents voluntarily handed over to the committee at the behest of the CEOs. This seems to suggest that the CEOs were either not aware of what was in those documents or that they were not aware of all that was in them.
But let’s say for the sake of argument that the CEOs, or at least some of them, told the committee they believed nicotine was not addictive, knowing that all this skulduggery had been going on—would they not have been acting in exactly the way they would have been expected to act—perfectly in line with business and societal norms? After all, they were CEOs charged with maximizing company profits at a time when greed was good, so there was some collateral damage. But then, starting only with the “A’s,” look at the alcohol, arms and automobile industries.
I don’t want to defend what the CEOs said during that committee hearing or what the tobacco industry got up to because I don’t know enough about this stuff. But it seems a little odd to me that, at a time when the U.S. was deep in the grip of neoliberal dogma, these men (they were all men) were condemned for following the logic of the market and maximizing profits.
But the committee seemed to want to set itself above all of this tacky business stuff, somewhere on the moral high ground. This is, in part, what the chairman on April 14, 1994, said in opening the hearing: “For decades, the tobacco companies have been exempt from the standards of responsibility and accountability that apply to all other American corporations. … This hearing marks the beginning of a new relationship between Congress and the tobacco companies. The old rules are out; the standards that apply to every other company are in.”
I would imagine that what a lot of people took away from this, whether it was meant or not, is that there goes the wicked tobacco industry again, avoiding its responsibilities for decades. But, if the finger is to be pointed anywhere, it should surely be pointed at Congress, which, as is more or less admitted by the chairman, allowed this situation to exist and to continue. It cannot be expected that businesses will, in the normal course of things, lobby Congress to saddle themselves with additional regulations.
I thought the opening remarks strange in another way also. The chairman at one point says: “Nearly a half million Americans die every year as a result of tobacco. This is an astounding, almost incomprehensible statistic. Imagine our nation’s outrage if two fully loaded jumbo jets crashed each day, killing all aboard. Yet that is the same number of Americans that cigarettes kill every 24 hours.”
As I see it, the chairman is making a comparison as part of what I suppose was meant to be a moral argument, but that comparison does not stand up to even basic scrutiny. As human beings, we take risks every day, balancing those risks, either consciously or unconsciously, against perceived benefits. Smoking and drinking alcohol are two obvious everyday examples of this. And so, too, for a lot of people (though perhaps not recently) is getting on an airplane. As things stand, people get on airplanes because they are overwhelmingly safe to use, so the benefit-to-risk ratio is hugely positive.
But it is inconceivable that if two jumbo jets crashed each day in the U.S. alone, people would still board them. The chairman was ignoring the fact that people make risk assessments so as to conjure up a situation that would never occur. People understand that smoking might cause them to die in 40 years to 50 years, and they understand that falling from 30,000 feet brings on death a lot quicker.
The idea of risk can be manipulated, and often is, as in the story about the therapist with a patient who is still nervous of flying even after being told that the chances of a bomb being on board a plane is a billion to one; the therapist advises her to take her own bomb on board next time she flies because the chances of there being two bombs on board are a trillion to one.
I need to emphasize that I am not trying to defend the past behavior of the tobacco industry or the CEOs in question. What concerns me here is that a single picture is being regularly presented as telling a story that is far simpler than it really is. What has passed into history—what I would imagine most people would “remember” from the picture of the subcommittee hearing—was that all of the CEOs lied in saying that nicotine was not addictive. I doubt that many people would realize that what they said was they believed nicotine was not addictive, let alone the back story to this event.
This is the problem with the versions of history we drag around with us. In the end, what did the hearings bring about? Reputational damage to tobacco companies for sure. But they are still operating in one form or another, and part of their business is largely unchanged. It is said that the number of smokers fell after the hearings, but who knows whether the hearings were a causal factor in this.
It is more interesting to examine what continued: taxes. Local, state and federal agencies continued to benefit from people smoking through the taxes they paid, and later was added the proceeds of the Master Settlement Agreement, very little of which is ever spent on ameliorating the toll of tobacco smoking; so who gets to stand on the moral high ground?
Credit: Gawriloff
Well, the answer to that question might seem strange. I say above that it is not usual for businesses to lobby Congress to try to saddle themselves with additional regulations. But, in fact, odd as it might seem, this is exactly what many nicotine and tobacco companies have been doing in recent times.
I’m not saying they are perfect and that part of this new way of thinking hasn’t to do with competition, but in part it is a genuine attempt to ensure that the new generation products that are being developed and offered to help people transition to safer forms of nicotine consumption are not causing, and can be seen not to be causing, unintended consequences.
And for those people who tend still to be wedded to the idea portrayed by the still of the tobacco CEOs, it is worth noting that, importantly, in the recent past the major tobacco companies have found a way of offering reduced-risk products while roughly maintaining the sorts of business models that were so successful for them in the past. Does this put them on the moral high ground? Of course not, but it has mapped out a route to that ground.
Times are changing, and we desperately need to stop slowing the transition into a new world of nicotine consumption by constantly dragging behind us a little-examined history of what went on 20 years to 30 years ago—a time that few working in the nicotine and tobacco industries could probably remember.
There was a furor just after I started to write this piece about a proposed takeover by Philip Morris International of the pharmaceutical company Vectura, which in news reports was said to be developing inhaled treatments for respiratory diseases. Why the furor? Well, it’s all about history, of course. PMI has in the past sold traditional cigarettes and still does; so, the detractors claimed, we cannot let it near a pharmaceutical company.
There seems to be no way such people can accept that, in order to move ahead with the transition from smoking to other forms of nicotine consumption, we have to look at innovative, even daring ways of doing things.
I have no insights into what PMI is up to beyond what has been reported in the general press, but it doesn’t take a genius to figure out that it might be looking, in part, to benefit from some cross fertilization of ideas in respect of inhalation technologies—ideas that just might allow it to make a breakthrough in respect of reduced-risk, next-generation nicotine products.
At least we should allow companies to try such things—while keeping an eye on them, of course. We should not let history stand in the way.
Considerable evidence suggests that e-cigarettes are an effective smoking cessation tool for adults in the United States, where hundreds of thousands of people die of smoking-related illness each year.
Kenneth Warner, dean emeritus and the Avedis Donabedian Distinguished University Professor Emeritus at the University of Michigan’s School of Public Health, says, however, that the potential of vaping to increase smoking cessation has been largely overshadowed by media coverage and policies that focus on the potential risk vaping represents for teens.
Warner and 14 other past presidents of the Society for Research on Nicotine and Tobacco co-authored an article that argues that the media, legislators and the general public have developed a negative view of e-cigarettes because of the heavy emphasis public health organizations have placed on protecting kids from vaping while ignoring the potentially substantial benefits of e-cigarettes in helping adults quit smoking. The article is published online in the American Journal of Public Health.
In an interview with Michigan News of the University of Michigan, Warner discusses why the group, all of whom have presided over the top tobacco research society in the world, decided to take on this issue.
What prompted this group to write this article?
In my 45 years in the field of tobacco control research, I’ve never seen an issue that is as divisive as this one, and maybe none that is as important to public health. We have a large group within public health who are very much opposed to vaping because they see it as imposing huge risks on kids. On the other end of the spectrum, we see a number of researchers and members of the vaping community who believe that vaping is a great tool for helping people to quit smoking and that it is far less hazardous than smoking. These polar opposite views have created much of the contention within the tobacco control community.
Our goal in this paper is to try to inject some sense of balance, to get public health organizations, the media and legislators to recognize that their appropriate but singular desire to keep e-cigarettes out of the hands of kids may actually be harming public health. Policies oriented exclusively toward protecting kids may be responsible for more adults smoking than would be if we had policies that also emphasized helping adults to quit with vaping, and frankly, if we had honest characterizations of the risks of vaping.
Exaggerations of the risk have led a majority of Americans, including a majority of smokers, to the erroneous belief that vaping is as dangerous as, or more dangerous than, smoking. The National Academies of Science, Engineering and Medicine has determined that vaping is likely substantially less dangerous.
What do you want people to take away from the AJPH article?
We call for a rebalancing of society’s consideration of vaping and specifically for more attention being paid to its potential to increase smoking cessation. We should continue working to decrease young people’s use of e-cigarettes—of all nicotine products, for that matter—but we must increase our focus on adult smokers.
In the article, my colleagues and I express concern that we have forgotten about the adults who are going to die as a consequence of smoking. We lose 480,000 Americans every year as a result of smoking. Understandably and justifiably, all Americans were enormously concerned by the toll of Covid-19 this past year. Consider that we have a Covid-level disaster created by smoking every year, year after year after year.
How would you characterize the risks associated with e-cigarettes? What are the potential benefits of vaping for adult smokers?
Vaping is clearly not risk-free, but it is also substantially less dangerous than cigarette smoking. Inhaling combusted tobacco smoke, which includes over 7,000 chemicals, is what causes the disease and death associated with tobacco use.
Multiple types of evidence, identified in our article, demonstrate that vaping can increase smoking cessation. The highly respected Cochrane Review has concluded that it is likely that vaping is more effective than FDA-approved nicotine-replacement products like gum and patches. The CDC has also found that more smokers use e-cigarettes than other aids in attempts to quit smoking—and with a higher self-reported success rate.
Still, the public is largely unaware of the potential vaping has to aid in smoking cessation. As I mentioned previously, a majority of adults, including a majority of smokers, believe that vaping is as dangerous as, or more dangerous than, cigarette smoking. This misunderstanding has actually worsened over time. That reflects, in part, the media’s coverage of vaping.
A recent study cited in our article found that 70 percent of U.S. news coverage on vaping mentioned vaping’s risks to kids while only 37 percent noted the potential benefits for adult smokers. As such, it’s likely that fewer smokers are trying e-cigarettes as a method of quitting smoking than would be the case if they were accurately informed about its potential to help them quit and its smaller health risk compared to smoking. That means fewer people are quitting smoking.
Put simply, research shows that the potential benefits of vaping for adult smokers are substantial. Those benefits are not being fully realized in today’s environment of misinformation and a singular focus on the welfare of kids, to the detriment of the health of adults who smoke.
What is known about the risks of youth e-cigarette use?
Vaping does have risks for kids, including the potential of addicting some to nicotine. But in our article, we point to evidence that the percentage of kids being addicted to nicotine by vaping is much smaller than popularly believed.
We also note that while prospective studies have found that vaping by kids who had never smoked increases their risk of trying cigarettes 6–24 months later, much of this may be explained by what is called “common liability,” meaning that kids who try e-cigarettes are more prone to risk-taking than are kids who don’t vape, so the former may be more likely to try cigarettes anyway, even if e-cigarettes had never existed.
Further—and very importantly—even if there is an increased risk, doing the math indicates that this factor would increase overall smoking initiation by kids by only a very small amount. However, even that seems unlikely since we’ve seen smoking rates fall among young people (both adolescents and young adults) at unprecedented rates precisely during the period of vaping’s ascendancy. That certainly is not consistent with the idea that vaping increases smoking.
Why has e-cigarette use in adults not been a focus in policy or the media?
First, the concern for young people’s welfare is a compelling one, and the rapid increase in youth vaping in 2018 and 2019 understandably created a great deal of anxiety. The focus on youth drowned out attention to the welfare of adults who smoke. Youth vaping decreased significantly in 2020. We will have to monitor future years’ trends closely.
Second, I think a lot of people may believe that the problem of smoking is pretty much resolved. I’m referring mainly to the higher education, upper socioeconomic status population. They don’t smoke, their friends and colleagues don’t smoke, there’s no smoking in their workplaces, and there’s no smoking in the restaurants and bars that they frequent. They don’t see smoking and thus may believe the problem has largely been solved.
And yet one out of seven adult Americans is a smoker today. When we take a look at who’s smoking, it’s the underprivileged members of our society, those who don’t have a voice in politics. African Americans as a group, although they don’t smoke more, have higher rates of smoking-produced disease and death than do [white individuals]. There are groups like low socioeconomic populations, people with mental health problems and the LGBTQ community that all have higher than average smoking rates.
My fear, frankly, is that many nonsmokers are ignoring smokers because they may not care that much about them. There is a very large life expectancy differential between the rich and the poor in the United States, and perhaps the single most important behavior-related variable is differences in smoking. The data show that low-income, low-education populations smoke at much higher rates than the high-income population, and they die at much younger ages. If we could reduce smoking among these often marginalized populations, we might be able to reduce the gap in life expectancy. This is fundamentally a matter of social justice.
What are some policy changes that might help achieve a more balanced approach to e-cigarettes?
Currently, we have very unbalanced policies that are directed exclusively at trying to reduce youth vaping. Two of the most prominent are eliminating or seriously restricting flavors in e-cigarettes and trying to equalize the taxation of e-cigarettes and cigarettes. Both of these policies can have adverse consequences for adult smokers. Adult smokers like flavors just like kids do, and in fact, they tend to like the same flavors.
Banning flavors would eliminate adult smokers’ access to the flavored e-cigarettes that they prefer in attempts to quit smoking. So that’s a real concern. We propose restricting the sale of e-cigarettes to adult-only establishments, such as vape shops. This is a compromise—flavors are a significant attraction to vaping for kids, and our recommended policy would not eliminate flavors; at the same time, the policy would restrict access for adults, thereby creating an inconvenience for them. But this policy would strongly limit youth access to flavored e-cigarettes while allowing adults to get the flavored e-cigarettes they want to aid in their attempts to quit smoking.
We also suggest a substantial increase in excise taxes on cigarettes and other combusted tobacco products, and a much more modest tax on e-cigarettes. This is the opposite of what is happening now, with states imposing “equalizing” taxes on e-cigarettes without raising taxes on cigarettes. Significantly raising the tax on cigarettes will discourage both adults and kids from smoking. A big differential in price between very expensive cigarettes and less expensive e-cigarettes creates an incentive for adults who don’t quit smoking to switch to e-cigarettes. For kids, a modest tax on e-cigarettes will discourage them from vaping because they’re the most price-sensitive group when it comes to nicotine and tobacco products.
A new paper co-authored by a majority of recognized tobacco control experts in the United Sates endorses the harm reduction benefits of vaping for adult smokers trying to quit combustible cigarettes. The group of experts state that the public image of vaping products must be improved and electronic nicotine-delivery systems (ENDS) should be promoted as a safer alternative to combustible cigarettes.
“Opponents focus on e-cigarettes’ risks for young people, while supporters emphasize the potential for e-cigarettes to assist smokers in quitting smoking. Most US health organizations, media coverage, and policymakers have focused primarily on risks to youths,” the report states. “Because of their messaging, much of the public—including most smokers—now consider e-cigarette use as dangerous as or more dangerous than smoking. By contrast, the National Academies of Science, Engineering, and Medicine concluded that e-cigarette use is likely far less hazardous than smoking. Policies intended to reduce adolescent vaping may also reduce adult smokers’ use of e-cigarettes in quit attempts.”
The paper, published August 19 in The American Journal of Public Health, was led by Kenneth Warner, a professor emeritus of health management and policy at the University of Michigan and a distinguished tobacco control expert. Fifteen former presidents of the Society for Research on Nicotine and Tobacco (SRNT), the leading scientific professional society focused on nicotine and tobacco, co-authored the paper.
The authors present four categories of evidence supporting vaping as a quit aid for combustible tobacco use: the results of randomized trials, which show e-cigarettes outperform other cessation methods like nicotine patches; population studies, the findings of which “are consistent with a near doubling of quit attempt success”; cigarette sales, which decrease rapidly as vaping sales increase; and the unintended consequences of policies restricting vaping, such as bans that unintentionally shot up cigarette smoking.
“The major elements of the public health community that are concerned with tobacco have been singularly focused on the risk to kids,” Warner told Alex Norcia of Filter. “They seem to truly have no interest whatsoever in adult smokers. The other piece is that you’re seeing lots of allegedly scientific papers that are raising health concerns that are unwarranted.” One such paper, which claimed that vaping increased the likelihood of having a heart attack, was later retracted.
The paper also presents “a sensible mix of policies” to boost ENDS use, including taxing traditional cigarettes higher than e-cigarettes to encourage adult smokers to switch, allowing flavored vaping products available only at vape shops, restricting advertising to limit youth initiation and reducing the nicotine levels in cigarettes while ensuring the availability of “consumer-acceptable” reduced-risk nicotine products.
“Because evidence indicates that e-cigarette use can increase the odds of quitting smoking, many scientists, including this essay’s authors, encourage the health community, media, and policymakers to more carefully weigh vaping’s potential to reduce adult smoking-attributable mortality,” the paper states.
