Category: Harm Reduction

  • A Tale of Two COPs

    A Tale of Two COPs

    Image: Tobacco Reporter archive

    This year, the first two weeks of November will witness two COPs (Conference of Parties), large policy gatherings aimed at moving the needle on ratified global U.N.-related conventions. Both have to do with health—individual, population and the planet’s health. Yet, one COP is attracting the leaders of the developed world as well as developing worlds in Glasgow, United Kingdom, along with another 20,000-odd stakeholders. The other COP will be held virtually and quietly from its secretariat in Geneva, Switzerland.

    The United Nations Framework Convention on Climate Change (UNFCCC) secretariat is tasked with supporting the global response to the threat from climate change. With 197 members, the UNFCCC has a near universal coverage. The 26th Conference of the Parties (COP26) Glasgow was kicked off on Oct. 31 with great fanfare, high expectations and drama befitting a Hollywood premiere—e.g., Greta Thunberg arrived on a “climate train,” a test in patience and endurance for Greta, her 150 fellow passengers, the media and the climate activists’ mob at Glasgow Central.

    Throughout the course of these two weeks of negotiations, haggling and posturing, the best possible outcome from COP26 could be that all countries commit to keeping global warming limited to 1.5 degrees Celsius. That calls for some serious re-engineering of human behavior and entire societies. Millions of conventional jobs and livelihoods will be lost, millions more potentially created in the new green economy. Some would argue (and justify): Desperate times call for desperate action. Green economy advocates and solution providers, including transforming oil companies and automobile manufacturers, are in full attendance at the summit and are missing no photo-op to burnish their green credentials.

    The UN climate change conference will consider the input of the manufacturers it seeks to regulate, many of which are eager to show how they can be part of the solution. (Photo: adrian_ilie825)

    The other COP, of the Framework Convention on Tobacco Control (FCTC), created by the U.N.’s World Health Organization and run by the FCTC secretariat, follows a completely different tack. It is notionally intended for addressing the harms to society and the world due to risky forms of smoked (cigarettes, bidis, cigars) and smokeless (khaini, gutkha, zarda, etc.) tobacco products that over a billion people consume today. The FCTC is ratified by most of the countries in the world (the USA and Indonesia being notable exceptions), and the ninth Conference of Parties from Nov. 8–13 will see yet another biannual get together making decisions that affect 1.3 billion tobacco users, their families and millions from the tobacco supply chain globally. However, it is held behind closed doors, driven by health activists that simply see the tobacco industry as the problem and tobacco users as AstroTurf for the tobacco industry. Neither are allowed anywhere near the meeting nor are the lay media.

    The FCTC, in its simplest form, is a demand and supply reduction treaty, underpinned by tobacco harm reduction principles. Broadly, what this could mean in policy as well as practice is that those not currently using risky forms of tobacco products, especially children and young adults, should be disincentivized from initiation, and those currently using risky forms of tobacco should get the necessary help to quit. This may take the form of providing nicotine-replacement therapy, prescription medications and behavioral support. It could also mean that those involved in the supply chain, such as farmers and bidi worker women, should be given support to switch to alternative livelihoods.

    Sixteen years on from the ratification of the FCTC, great progress has been made in adopting parts of the treaty that relate to demand reduction by prevention of initiation into national regulations. Advertising campaigns, tax hikes, health warnings and packaging and sale restrictions have led to significant reductions in initiation, especially among youth. On the other hand, support to current users of risky forms of tobacco remains wanting, lacking innovation and largely under-funded.

    The nicotine in these products makes consumers dependent. The cancers, however, are caused by the toxic chemical mix in the smokeless products and from the smoke itself—but not the nicotine. Pharmaceutically licensed nicotine-replacement therapy products, in the form of gums and patches, are on the WHO’s model essential medicines list for tobacco dependence treatment. It is scientifically proven: Quitting risky forms of tobacco (cessation) is not easy; relapse is very common. The high retail price of the cessation products, poor availability and inadequate training of doctors in prescribing these cessation treatments means that current tobacco users miss out on any meaningful access and support.

    It is easy to point to the tobacco industry’s morally and ethically unacceptable behavior for most of the 20th century that led to the smoking epidemic globally, and even today, to the manufacturers of gutkha and pan masala in India who are fueling an oral cancer epidemic. Based on this historical context, the COP organizers exclude this industry from their deliberations. Sadly, that exclusion extends to consumers, effectively the current and future patients suffering from tobacco dependence.

    This raises a sticky question: Are the global public health community, led by the WHO’s FCTC signatories who meet every two years formally at the COP, simply giving up on the 1.3 billion current users of cigarettes, bidis, khaini and gutkha-like products, letting them die preventable premature deaths, for the want of adequate cessation products and support? Would public health not benefit from a wider range of innovative nicotine-replacement products, manufactured to high standards, regulated appropriately and specifically available as cessation aids for current adult users of risky tobacco products?

    In stark contrast to the climate change COP26, at this tobacco-related COP9, manufacturers of cleaner nicotine products (the “solution providers” to the problem) and consumers (the victims of the problem) will be glaringly absent. (Photo: lezinav)

    This COP season, it may be time to draw parallels between two very similar gatherings with diametrically opposite profiles and approaches. Climate change and tobacco-related harms—both are urgent issues facing humankind. Both are being addressed by global treaties and conventions. For both problems, a wide range of solutions are coming from old and new industries.

    In the case of climate change, the Teslas of the world lead the rally. Conventional fossil fuel giants such as BP (of the Gulf of Mexico spill fame) and Shell are not far behind either, showcasing their renewables’ commitment in every ESG communication. The Volkswagen emissions scandal (from less than five years ago) is distant memory, and the automobile industry is at the table, providing cleaner cars by “electrifying” their offerings.

    In tobacco cessation, underpinned by tobacco harm reduction principles, innovation came from a wide range of inventors and manufacturers globally: e-cigarettes from China, heated-tobacco products from Switzerland and the U.K., nicotine pouches from Sweden and cessation apps from the USA. Pharmaceutical manufacturers of conventional nicotine-replacement products and prescription medications are either withdrawing from the markets or not innovating any more. They have not made any visible effort to make their products available at affordable prices in the developing world—and there was never a huge hue and cry about that from public health.

    None of the new innovative products are a silver bullet but promise to provide cleaner, safer nicotine to the billion-plus current consumers of risky forms of tobacco. In countries such as the U.K. and USA, where regulators are informed by scientific evidence and risk assessment, these products are regulated and allowed. Slowly but surely, this will transform the nicotine use profile in these countries, no doubt saving millions of lives and billions of dollars in future health costs from tobacco-related diseases. In Japan, previously known for its high smoking incidence among men, nearly 30 percent of the cigarette market has been replaced by heated-tobacco devices. These devices are increasingly acknowledged for their reduced toxicant exposure vis-a-vis cigarettes. The U.S. Food and Drug Administration has authorized the sale of a specific brand of heated device, an e-cigarette and a Swedish snus-style smokeless tobacco product for their reduced toxicant exposure and potential to reduce tobacco-related harms. In the U.K., e-cigarettes are one of the many options of quitting tools supported by national health bodies.

    In stark contrast to the climate change COP26, at this tobacco-related COP9, manufacturers of cleaner nicotine products (the “solution providers” to the problem) and consumers (the victims of the problem) will be glaringly absent. In countries where regulators do not need the WHO’s blessings to make their own policies (the U.S., U.K. and increasingly the EU), innovation and better regulation will lead to a reversal of harms from risky 20th century tobacco products. In the developing world, including South Asia, the harms from tobacco will remain unabated in the absence of strong regulatory leadership and industry transformation.

    Whether or not we can manage to curb the global temperature rises to a maximum of 1.5 degrees Celsius by 2050, today’s direction of tobacco control as symbolized by COP9 will hinder access to safer nicotine alternatives to over 1.3 billion current users, 80 percent of whom live in developing countries, accounting for millions of preventable deaths in the next three decades.

  • PMI Applauds Plan to Simplify E-Cig Licensing

    PMI Applauds Plan to Simplify E-Cig Licensing

    Photo: DW labs Incorporated

    Philip Morris International announced its support of the U.K. government’s plan to simplify the pathway to license electronic cigarettes and other inhaled nicotine-containing products as medicines in England.

    “The U.K. already has one of Europe’s lowest smoking rates, supported by a high rate of smokers who have switched to better alternatives,” the company wrote in a press note. “This proposal makes the U.K. the first country in the world to encourage the medical licensing of e-cigarettes via prescription as a route to further lower smoking rates, particularly among low-income smokers.”

    “The U.K. is a global leader in medicine, science and public health,” said PMI’s senior vice president, of external affairs, Gregoire Verdeaux. “Expert scientific reviews in the U.K. and U.S. are clear that smoke-free alternatives—such as e-cigarettes—offer adults who would otherwise continue to smoke cigarettes a better alternative. We welcome the U.K. government’s continued recognition that regulated e-cigarettes and other inhaled nicotine-containing products, while not risk-free, are less harmful than smoking and can significantly benefit public health.”

    PMI said regulators can decisively accelerate the decline of smoking through risk-proportionate regulations for all nicotine-containing consumer products. A growing number of countries—including the U.S., New Zealand, Italy, Portugal, Greece and Bulgaria—have recognized this approach and implemented differentiated regulation for noncombustible alternatives, according to the company.

  • Harm Reduction Rally Ahead of COP9

    Harm Reduction Rally Ahead of COP9

    Delegates from some of the International Network of Nicotine Consumer Organizations’ (INNCO) 37 member organizations in North and South America, Europe, Africa and Asia will gather in London on Nov. 8 to applaud the U.K. government’s evidence-based support for tobacco harm reduction and to highlight the importance of the ninth Conference of Parties of the World Health Organization’s Framework Convention on Tobacco Control, which begins that day.

    “We are ex-smokers who use safer nicotine to save our own lives,” said Charles Gardner, INNCO’s executive director, in a statement. “Many of us around the world face stigma for using nicotine, a drug that is no more harmful to health than caffeine. A global ‘misinfodemic’ is now spreading worldwide, and the only cure is to embrace evidence and evidence-based policies such as those in the United Kingdom.”

  • Doctors Reluctant to Prescribe E-Cigarettes

    Doctors Reluctant to Prescribe E-Cigarettes

    Photo: omphoto

    Not all doctors and nurses are enthusiastic about England’s intention to let physicians prescribe e-cigarettes to smokers, reports Daily Mail.

    A yet-to-be-published study, involving the University of Oxford, which interviewed 11 medical staff, found most struggled to advise long-term use of e-cigarettes because of concerns about unknown long-term effects.

    A survey commissioned by Cancer Research UK two years ago indicates that two in five English nurses and doctors would feel uncomfortable recommending e-cigarettes to smokers and one in six would never do so.

    General practitioners “find it difficult handing patients something which may cause them harm, even where e-cigarettes are far safer than cigarettes… They struggle to give people devices which may not be entirely safe or may perpetuate addiction to nicotine,” said Paul Aveyard, professor of behavioral medicine at the University of Oxford, who was involved in both pieces of research.

    Martin Marshall of the Royal College of general practitioners urged more investment in community smoking cessation centers. “’Vaping should only be seen as a way to give up smoking, with the intention to then give up vaping,” he said.

    Simon Capewell, professor of clinical epidemiology at Liverpool University, called the Department of Health plan for prescription e-cigarettes deeply worrying.

    “England is out on a dangerous limb,” he said. “Officials here have fallen for the exaggerated claims of the pro-vaping lobby, and are ignoring the health risks. The main claim, that e-cigarettes are a major aid to quitting, is wrong. If that were true, why would the multinational tobacco corporations be pushing vaping so hard?”

  • England Paves Way for E-Cig Prescriptions

    England Paves Way for E-Cig Prescriptions

    Photo: goodmanphoto

    Doctors in England may soon be prescribing e-cigarettes to help people stop smoking tobacco, according to a news story published by the Department of Health Social Care and the Office for Health Improvement and Disparities. The Medicines and Healthcare products Regulatory Agency (MHRA) is publishing updated guidance that paves the way for medicinally licensed e-cigarette products to be prescribed for smoking cessation.

    Manufacturers can approach the MHRA to submit their products to go through the same regulatory approvals process as other medicines available on the health service.

    This could mean England becomes the first country in the world to prescribe e-cigarettes licensed as a medical product.

    If a product receives MHRA approval, clinicians could then decide on a case-by-case basis whether it would be appropriate to prescribe an e-cigarette to NHS patients to help them quit smoking. It remains the case that non-smokers and children are strongly advised against using e-cigarettes.

    This country continues to be a global leader on healthcare, whether it’s our Covid-19 vaccine rollout saving lives or our innovative public health measures reducing people’s risk of serious illness.

    If a product receives MHRA approval, clinicians could then decide on a case-by-case basis whether it would be appropriate to prescribe an e-cigarette to NHS patients to help them quit smoking. It remains the case that non-smokers and children are strongly advised against using e-cigarettes.

    E-cigarettes contain nicotine and are not risk free, but expert reviews from the U.K. and U.S. have been clear that the regulated e-cigarettes are less harmful than smoking. A medicinally licensed e-cigarette would have to pass even more rigorous safety checks.

    Smoking remains the leading preventable cause of premature death and while rates are at record low levels in the U.K., there are still around 6.1 million smokers in England. There are also stark differences in rates across the country, with smoking rates in Blackpool (23.4 percent) and Kingston upon Hull (22.2 percent) poles apart from rates in wealthier areas such as Richmond upon Thames (8 percent).

    E-cigarettes were the most popular aid used by smokers trying to quit in England in 2020, according to the Department of Health and Social Care. E-cigarettes have been shown to be highly effective in supporting those trying to quit, with 27.2 percent of smokers using them compared with 18.2 percent using nicotine replacement therapy products such as patches and gum.

    Some of the highest success rates of those trying to quit smoking are among people using an e-cigarette to kick their addiction alongside local Stop Smoking services, with up to 68 percent successfully quitting in 2020 -2021.

    We fully welcome the news that the NHS in England is exploring opportunities to prescribe vaping products to help people quit smoking.

    “This country continues to be a global leader on healthcare, whether it’s our Covid-19 vaccine rollout saving lives or our innovative public health measures reducing people’s risk of serious illness,” said Health and Social Care Secretary Sajid Javid.

    “Opening the door to a licensed e-cigarette prescribed on the NHS has the potential to tackle the stark disparities in smoking rates across the country, helping people stop smoking wherever they live and whatever their background.”

    Vapor industry representative welcomed the prospect of e-cigarettes on prescription.

    “We fully welcome the news that the NHS in England is exploring opportunities to prescribe vaping products to help people quit smoking,” said Doug Mutter, director of VPZ, the U.K.’s largest vaping retailer with 157 stores throughout the country.

    “The pandemic has triggered an increase in smoking rates and the public health problem has been compounded by funding cuts for NHS stop smoking services and local support groups.

     “However this progressive and innovative approach being considered by the NHS in England has the potential to reverse this damage and bring new momentum to our ambitions of becoming a smoke free nation by 2030.”

    The government deserves huge praise for taking this bold decision to look more closely at the use of vaping when it comes to smoking cessation and for taking an evidence-based, science-led approach.

    “The government deserves huge praise for taking this bold decision to look more closely at the use of vaping when it comes to smoking cessation and for taking an evidence-based, science-led approach rather than the nonsensical anti-vaping, anti-harm reduction stance of some countries,” said John Dunne, Director General of the U.K. Vaping Industry Association.

    “This announcement by the Department for Health is just the latest in a long line of breakthroughs for those of us who for years have advocated vaping as the best and most effective method for people looking to quit smoking.”

  • WHO Urged to Embrace Harm Reduction

    WHO Urged to Embrace Harm Reduction

    The ninth Conference of the Parties (COP9) to the World Health Organization Framework Convention on Tobacco Control (FCTC) will operate under conditions of secrecy comparable to those of the U.N. Security Council, according to a new report by the Global State of Tobacco Harm Reduction (GSTHR) titled, Fighting the Last War: The WHO and International Tobacco Control.

    The public and media are banned from attending all but one largely ceremonial opening plenary, yet millions will be affected by the decisions taken at COP9, which is scheduled to take place virtually Nov. 8–13.

    The report contends that current implementation of the FCTC is a global public health failure. In force since 2005, when there were 1.1 billion smokers around the world, the FCTC set out the principles of global tobacco control—to reduce the death and disease caused by smoking. In 2021, however, there are still 1.1 billion smokers worldwide and 8 million smoking-related deaths each year. What’s more, the number of smokers is predicted to rise, and the number of smoking-related deaths is set to top 1 billion this century.

    Change is urgently needed, and harm reduction for tobacco offers the opportunity for that change, according to the GSTHR.

    Fighting the Last War notes that while tobacco control policy has remained frozen in time, innovative noncombustible nicotine technology and supporting evidence have moved forward. Vaping devices, snus, nicotine pouches and heated-tobacco products are significantly safer than cigarettes as they deliver nicotine without combustion, according to the report’s authors. This, they argue, enables people who cannot or do not want to stop using nicotine to quit deadly smoking and switch to less risky products.

    “Just as delegates at COP26 will be discussing the world’s urgent need to stop fossil fuel combustion, the technology is now in place to ensure the end of the age of combustion for tobacco as well,” the GSTHR wrote in a press note. “A number of Parties to the FCTC, such as the United Kingdom and New Zealand, have successfully introduced tobacco harm reduction policies alongside their tobacco control regimes and have seen marked decreases in smoking rates.”

    When given accurate information about comparative risk, many smokers switch, the organization notes. Worldwide, the GSTHR estimated in 2020 that 98 million people worldwide were using safer nicotine products.

    The authors also point out that the concept of harm reduction is embedded in the WHO response to drug use and HIV/AIDS. It is explicitly named as the third pillar of tobacco control alongside demand and supply reduction in the FCTC. Yet the WHO has remained implacably opposed to harm reduction for tobacco and is increasingly viewed as having overseen a “mission creep,” which now sees international tobacco control setting its sights on prohibition for nicotine in all its forms.

    “There are concerning signs in published agenda and briefing papers that the FCTC secretariat and leadership continue to urge Parties against increasing access to, or even to prohibit, safer nicotine products,” the GSTHR wrote.

    Fighting the Last War considers the motivations—ideological, financial and historical—that have led to many global tobacco control practitioners becoming so hostile to what others see as the greatest potential public health advance in decades.

    The report argues that Parties to the FCTC need to seize back control of the COP meetings from the FCTC secretariat, which it says has become overly influential with little oversight. FCTC Parties should press for more evidence-based discussions, calling upon the widest breadth of scientific, clinical and epidemiological expertise on safer nicotine products and tobacco harm reduction, according to the authors. “This should include evidence from Parties that have implemented harm reduction policies, those involved in manufacturing safer nicotine products and the lived experience of consumers,” they wrote. “The establishment of a working group on tobacco harm reduction would offer a pragmatic route to move the FCTC toward a tobacco control regime fit for purpose in the 21st century.”

    “As global leaders prepare to make important pledges on climate change under the glare of the media spotlight at COP26, we urge them to demand more from their delegations inside the closed and unscrutinized rooms of COP9,” says Gerry Stimson, director of Knowledge-Action-Change and emeritus professor at Imperial College London. “Every day, more than one billion smokers are being failed by the international tobacco control regime. The age of combustion—for tobacco as for fossil fuels—must end.

    “Tobacco harm reduction offers new routes out for adult smokers. GSTHR estimates suggest that 98 million of them have already switched. At COP9, government delegations must seize back control and prevent the slide into outright nicotine prohibition that would see many return to smoking and many millions more never succeed in quitting.”

    “The fight to reduce eight million smoking-related deaths a year is now being actively undermined by the WHO and the international tobacco control establishment,” said report author Harry Shapiro. “Together, they are fighting the last war against the tobacco industry—to direct attention away from the evidence that safer nicotine products can make a significant contribution to reducing that death toll.”

    “If those who dominate the global tobacco control discourse were truly committed to public health imperatives, harm reduction principles and policies would be front and center,” said Ethan Nadelmann, founder of the Drug Policy Alliance. “This valuable report exposes the ways in which international institutions have turned their backs on scientific evidence and the human and political rights of hundreds of millions of people whose lives might be saved by safer nicotine products.”

    Fighting the Last War provides an insight into the dark arts of the WHO that many would find breathtaking and incomprehensible,” said Jeannie Cameron from JCIC Consulting. “It shows a concerning difference between the world’s preparations for COP26 on climate change and COP9 on tobacco. Governments need to stand up at COP9 to support tobacco harm reduction against the outdated views of the WHO.”

    The fight to reduce eight million smoking-related deaths a year is now being actively undermined by the WHO and the international tobacco control establishment. Together, they are fighting the last war against the tobacco industry—to direct attention away from the evidence that safer nicotine products can make a significant contribution to reducing that death toll.”

    “The challenge for lower and middle-income countries while fighting the last war and promoting real tobacco control is about two major issues,” said Nataliia Toropova from Healthy Initiatives. “Firstly, the current provisions of the WHO FCTC have not been properly implemented due to stretched government resources. Thus, smoking cessation programs are nonexistent, and adult smokers feel hopelessly stuck while making their numerous unsuccessful attempts to quit with no medical help or guidance provided. Secondly, the lack of a comprehensive harm reduction strategy is aggravated by a massive misinformation campaign about harm reduction products and a declared war on nicotine. Unless these two issues get tackled, unless the powerful voice of doctors becomes loud and gets heard, unless education and awareness building campaigns take place, no changes will occur, and this last war will be lost.”

  • Update of ‘Clearing the Smoke’ Report Urged

    Update of ‘Clearing the Smoke’ Report Urged

    Forty-two public health leaders have signed onto a letter urging the U.S. Food and Drug Administration Center for Tobacco Products (CTP) to review and update the 20-year old Clearing the Smoke report so that it can address the evolved tobacco and nicotine marketplace.

    Two decades ago, the Institute of Medicine (now the National Academy of Medicine) issued its landmark report Clearing the Smoke—Assessing the Science Base for Tobacco Harm Reduction. The report had been compiled at the request of the FDA as it considered—even before Congress gave it the authority to do so—how best to regulate the growing tobacco and nicotine marketplace.

    The signatories of the letter point out that much has changed in the tobacco and nicotine marketplace since the report was first published. Science, technology and innovation have dramatically advanced over the past two decades. Consumers can now choose from a range of nicotine delivery products spanning the entire continuum of risk—from deadly combustible cigarettes on one hand to less-harmful noncombustible products such as snus, e-cigarettes and tobacco heating products.

    However, a slow product approval process means these products are not being made available to the public at a pace that would help significantly reduce the harms of cigarette smoking. What’s more, a lack of education efforts means consumers remain uninformed about the less-risky product choices available to them.

    The signatories maintain that an update of the Clearing the Smoke report will help put all stakeholders on a track that will collectively advance public health objectives. They believe that the National Academy of Medicine, which produced the original report, is the most appropriate body to undertake such a review on behalf of the CTP.

    The letter’s signatories include Scott Ballin, former vice president and legislative counsel of the American Heart Association; K. Michael Cummings, professor in the department of psychiatry and behavioral sciences at the Medical University of South Carolina; David Abrahams, professor in the department of social and behavioral science, at the College of Global Health at New York University; Aaron Biebert, former president and CEO of Clear Medical Solutions; Allan C. Erickson, former president for public education and tobacco control at the American Cancer Society; Ray Niaura, professor of public health global studies at New York University; and John R. Seffrin.

  • WHO Urged to Adjust its Vapor Stance

    WHO Urged to Adjust its Vapor Stance

    Photo: ekim

    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) to encourage the WHO to support and promote the inclusion of tobacco harm reduction into its regulatory advisements.

    “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, WHO has been dismissive of the potential to transform the tobacco market from high-risk to low-risk products. 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. “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 specialized 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.

    In a separate statement, David Sweanor, adjunct professor of law, chair of the Advisory Board of the Centre for Health Law, Policy and Ethics University of Ottawa, Canada, said that effective public health efforts need to be based on science, reason and humanism. Instead, he noted, 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.”

  • Howard: Will Harm Reduction Prevail?

    Howard: Will Harm Reduction Prevail?

    Photo: Photolia Premium

    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.

    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.

     

  • Experts Challenge WHO Stance on Safer Nicotine

    Experts Challenge WHO Stance on Safer Nicotine

    Photo: Tom

    The Global State of Tobacco Harm Reduction (GSTHR), a Knowledge-Action-Change (KAC) project, launches a new series of briefing papers ahead of the publication of its latest report, Fighting The Last War: The WHO and International Tobacco Control, on Oct. 27.

    The suite of new GSTHR publications aims to draw attention to, and challenge the direction of travel of, the Framework Convention on Tobacco Control (FCTC) ninth Conference of the Parties (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 a.m. 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 of the Drug Policy Alliance; Nataliia Toropova from Healthy Initiatives and Professor Gerry Stimson, director of 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.”