Author: Taco Tuinstra

  • A Widening Gap

    A Widening Gap

    Image: WindyNight

    Tobacco harm reduction for people with mental health needs

    By Cheryl K. Olson

    “I firmly believe a lot of us, people like me, are self-medicating, pure and simple,” says Skip Murray. A Minnesota-based tobacco harm reduction specialist, Murray began smoking at age 10. She was diagnosed initially with autism and attention deficit/hyperactivity disorder (ADHD) and later with depression, anxiety and post-traumatic stress disorder (PTSD) as well. She vapes to manage her symptoms.

    Brian King, director of the U.S. Food and Drug Administration’s Center for Tobacco Products, has called for greater focus on health equity. One group he cited as disproportionately affected by smoking is people living with mental health conditions. If you’re among this crowd, you are more likely to smoke (and smoke heavily) and less likely to quit compared to the general population.

    Plenty of research details this serious disparity. Among U.S. adults scored as having serious psychological distress (SPD) in the National Health Interview Survey, nearly 40 percent smoked. That’s compared to 13 percent of people without SPD. Of all cigarettes consumed by U.S. adults, nearly one-third are smoked by someone with a mental illness.

    A new analysis of Population Assessment of Tobacco and Health survey data found that among adults ever diagnosed with psychosis, 41 percent had used any kind of tobacco in the past month, and 31 percent had smoked. Having multiple mental health conditions is linked to higher smoking rates.

    The disparity is growing. U.S. national surveys find that smoking rates for those with mental health diagnoses are either stagnant or are declining more slowly compared to the general population. In particular, smoking rates for black and Hispanic adults experiencing serious psychological distress have not budged in years.

    What stands in the way? How can we better support tobacco harm reduction for people with mental health needs and persuade mental health professionals to take smoking seriously?

    A Culture of Smoking

    Historically, mental health care systems tolerated or even encouraged a smoking culture. Smoking breaks helped build relationships between patients and providers. Cigarettes were used as rewards for “good” behavior or for complying with treatment.  

    Studies find that mental health professionals frequently believe that their patients who smoke aren’t interested in quitting. Or that giving up cigarettes is too much to take on when also dealing with mental illness. Many therapists view smoking as not part of their turf but belonging to the physical health side of things.

    Amid the stresses and crises of mental health practice, granting lower priority to smoking cessation may seem practical. But ignoring cigarettes costs their patients years, even decades, of life. A recent editorial in the British Journal of General Practice called smoking the single biggest contributor to the seven-year to 25-year reduced life expectancy for people with mental health conditions.

    “To ignore their smoking, and only focus on their mental health, in the long run harms their overall health,” says Murray. “Why aren’t we looking at why they smoke? Do they not have healthcare, a home, enough food?”

    “I’m more than my mental illness,” she continues. “We need to treat the whole person.”

    Another barrier to encouraging smoking cessation has been lack of research on, and provider knowledge about, effective interventions. People with schizophrenia are at highest risk for earlier death, and their rates of smoking are especially high. Randomized trials suggest that smoking cessation medications are not risky for them to use. The issue is not safety but effectiveness.

    For example, a large Canadian community-based smoking cessation study found that many people with schizophrenia who smoke want to stop. They were as able as others to reduce their smoking but much less successful at quitting altogether.

    For people living with mental health conditions, as with the general population of people who smoke, there is an urgent need for more effective cessation approaches. A 2002 commentary titled “Smokers with Schizophrenia Will Benefit From More Flexible Treatment Approaches” put it this way: “New and creative NRTs [nicotine-replacement therapies] and pharmacological and psychosocial interventions are needed to compete with the high reinforcement value of smoking.”

    Today, we have nicotine alternatives undreamed of in 2002, including e-cigarettes.

    A Role for Vaping?

    In a 2017 review on Smoking, Mental Illness and Public Health, Stanford researchers wrote that “Additional data are needed to more fully understand the long-term potential of [e-cigarettes] for harm/harm reduction, particularly in vulnerable groups of smokers, including those with mental illness.”

    Six years later, many in public health are unfortunately still on the fence about whether vaping causes or reduces harm. We now have high-certainty evidence from a respected Cochrane review of research that vaping works better than NRT to help people quit smoking.

    But what evidence do we have for persons with mental illness in particular? The studies summarized in the Cochrane review either didn’t mention mental health or specifically excluded people with conditions such as depression, anxiety and psychosis from participating.

    More often than not, even the newest studies on helping people with mental illness quit smoking ignore the existence of vaping and other non-NRT nicotine options. However, evidence from recent population surveys that give results for people with mental health conditions suggests that vaping merits a closer look.

    A 2023 report analyzed data on people reporting depression and anxiety from the 2018 and 2020 Four Country Smoking and Vaping Surveys. The authors state, “It appears that smokers with depression are motivated to quit smoking but were less likely to manage to stay quit and more likely to be vaping if successfully quit.”

    A 2020 English population survey report by Brose and colleagues found that smokers with mental health problems were just as likely as others to successfully quit smoking if they tried. People who had ever had a mental health diagnosis were nearly four times more likely to choose vaping over nonprescription NRT (37 percent versus 9.8 percent) when making quit attempts—more than the sample overall. The authors suggest that “e-cigarettes used in quit attempts currently are more likely to positively affect inequalities than other smoking cessation interventions,” especially if their reach among people with mental health problems can be increased.

    Wanted: Better Studies

    Caponnetto and Polosa have summarized the results of some small but promising studies, involving first-generation or second-generation e-cigarettes, to help people with schizophrenia spectrum disorders stop smoking. Vaping showed potential as an acceptable substitute even among people with severe mental illness who don’t intend to quit smoking. Are larger studies in the research pipeline?

    A 2021 research letter in JAMA Psychiatry describes registered clinical trials looking at e-cigarettes to reduce or stop smoking. Just eight of the 66 ongoing or completed trials recruited individuals who smoke who have a psychiatric condition. The authors note that very few studies (and no completed ones) tested “newer e-cigarette devices that are designed to deliver nicotine more similarly to cigarettes.” They call for more, higher quality studies. We’ll keep an eye out.

    Ways to encourage harm reduction after inpatient mental health treatment also need more study. A 2023 U.K. study by Shoesmith and colleagues in Nicotine & Tobacco Research describes the development of a complex behavior change intervention to follow discharge from a smoke-free mental health stay. You have to dig into the supplemental material to find that mental healthcare worker training in use of e-cigarettes is part of the recommended intervention.

    We need more research to better understand what may block or encourage people with mental health conditions from trying and switching to vaping. A 2017 study analyzed discussions on Reddit by people with mental illness about motivations and limitations associated with vaping. Self-medication was a common theme.

    One person who reported PTSD and anxiety wrote, “For me, vaping is pretty much the same as smoking, in terms of how it helps me calm down and handle stress.”

    Many wrote on Reddit about the importance of education about and support for vaping from friends, family and online communities. Informed mental health professionals could likely play a critical role in saving lives. A U.K. study found that among people who have used tobacco, those with serious mental distress are more likely to have inaccurate harm perceptions of nicotine and nicotine products, including vaping.

    “A Clear and Definite Message”

    A U.K. government-funded community interest company, the National Centre for Smoking Cessation and Training, just released a much-needed guide to vaping for health and social care professionals. The guide states that “some people from disadvantaged groups may vape for temporary abstinence (e.g., at work or while in a mental health inpatient setting) before deciding to switch completely.” Also, “it is important that people from disadvantaged groups receive a clear and definite message that vaping is much less harmful than smoking.”

    Some mental health professional associations have endorsed vaping, however grudgingly or conditionally. For example, the Royal Australian and New Zealand College of Psychiatrists issued a sensible e-cigarette position statement in 2018 (due for updating soon). Acknowledging the high smoking prevalence and low quit rates among people who live with mental illness, they say that “e-cigarettes and vaping devices may provide a less harmful way to deliver nicotine to those who are unable or unwilling to stop smoking tobacco.”

    The college would like more data on vaping’s long-term health effects and on switching success. However, “This does not justify withholding what is, on the current evidence, a lower-risk product from existing smokers while such data is collected.”

    The position of the U.K. Royal College of Psychiatrists is similarly pragmatic. Vaping devices, they note, have become the most popular real-world quit-smoking aid. Although using neither is preferable, “using an EC [electronic cigarette] is always better than smoking a cigarette.”

    By contrast, a 2022 position statement on vaping products from the American Psychiatric Association does not mention harm reduction. They focus only on potential risks to youth.

    Knowledge can flow the other way, from patient to mental health professional. Murray received counseling for a year from a therapist who was initially highly skeptical of vaping. “She was one of those who believed that nicotine causes cancer and depression,” Murray recalls.

    After seeing the difference in Murray’s focus when she had forgotten her vape at work and gone without nicotine for hours, the therapist became curious. “That’s when we figured out that nicotine helps my ADHD,” Murray says. Upon request, she shared published studies on nicotine and mental health with her therapist.

    Adds Murray, “It was cool to meet somebody who was willing to look at information and think about if what they believed was actually true.”

  • Filtrona Launches Cannabis Division

    Filtrona Launches Cannabis Division

    Photo: yellowj

    Filtrona has launched Cannatrona, a dedicated division serving the cannabis and hemp market.

    The Cannatrona business supplies filter tips, mouthpieces and pre-roll solutions for cannabis and hemp products, alongside scientific services.

    “The cannabis and hemp industry is seeing rapid expansion, but the regulatory landscape is also shifting at speed,” said Filtrona CEO Robert Pye in a statement. “What businesses in this field need is a partner with a proven track record of quality, innovation, brand development and compliance, and that’s exactly what Cannatrona offers. With the company’s launch, we’re looking to propel the sector to even greater heights in a transformative and meaningful way.”

    “In any growing market, new businesses can be found all along the supply chain,” said Jeni Sperry, head of new business development at Cannatrona. “However, Cannatrona has something that the rest don’t, and that’s the century-long experience of Filtrona, one of the world’s leading special filter brands. For cannabis and hemp product innovators, we’re not just introducing filter tip and mouthpiece products to the market, we’re bringing expertise, innovation and a very bright future.”

  • France Unveils Plans to Curb Smoking

    France Unveils Plans to Curb Smoking

    Photo: Richard-Villalon

    France will increase tobacco taxes, ban disposable vapes and further restrict outdoor smoking as part of an ambitious plan to reduce the health impact of tobacco consumption and create a “tobacco-free” generation by 2032, a term that is usually defined as a situation in which less than 5 percent of the population smokes.

    Smoking rates in France have remained roughly unchanged since 2019 after decades of regularly declining, according to French public health authorities. Nearly a quarter of French adults, or about 12 million people, still smoke daily. Smoking is the leading cause of avoidable mortality in France, causing about 75,000 deaths per year.

    Some 15 percent of teenagers have vaped, and 47 percent of them started their nicotine consumption through e-cigarettes, according to an ACT Alliance Contre Le Tabac survey published in November.

    The government plan bans smoking on beaches, near public buildings like schools and in public parks and forests next year. Previously, local authorities had already barred people from smoking at more than 7,000 outdoor locations, including at beaches, forests and parks across the country, but there was no nationwide ban.

    The government also wants to extend the plain packaging requirement for cigarette packs to vaping products and set a minimum tobacco price of €13 ($14) per pack.

    Health Minister Aurelien Rousseau said the government will enact most measures by degree early next year. The ban on disposable vapes, however, will require legislation that is expected to go to Parliament in December.

    While welcoming France’s ambition to end smoking, tobacco harm reduction activists expressed concern about the planned ban on single-use vapes, which they described as a step backward in the fight against smoking.

    “Such prohibitions only serve to drive consumers either back to smoking or to black markets,” said Michael Landl, director of the World Vapers Alliance, in a statement.

    “We’ve seen time and again that prohibition doesn’t work. France should look to countries like Sweden, where a balanced approach to harm reduction has led to significant public health gains. The French government must recognize the importance of offering a variety of less harmful alternatives to smokers.”

  • Malaysia Passes Watered-Down Bill

    Malaysia Passes Watered-Down Bill

    Image: PX Media

    Malaysia’s lower house of Parliament has passed the Control of Smoking Products and Public Health Bill without the controversial generational endgame (GEG) clause, reports the New Straits Times.

    The legislation regulates advertisements, packaging and smoke-free places but excludes a provision that would have made it illegal for Malaysians born after 2007 to buy or consume nicotine products.

    Health Minister Zaliha Mustafa said the GEG was dropped due to constitutional concerns. The Attorneys General Chambers had warned that the proposal contravenes Article 8 of Malaysia’s constitution, as it creates unequal treatment before the law between persons born before Jan. 1, 2007, and individuals born after the date.

    Critics blamed Malaysia’s U-turn on tobacco lobbying.

    Zaliha insisted that any shortcomings in the bill could be improved over time.

  • Butts Pollution Costs $26 Billion: Study

    Butts Pollution Costs $26 Billion: Study

    Photo: Funkenzauber

    The costs of environmental pollution caused by plastics in cigarette butts and packaging amount to an estimated $26 billion every year in waste management and marine ecosystem damage worldwide, according to a data analysis published online in Tobacco Control.

    To gauge the global economic toll of tobacco waste, Deborah K. Sy of the Global Center for Good Governance in Tobacco Control in Bangkok drew on public data sources for cigarette sales, cleanup costs and plastic waste on land and sea.

    The average weight of each plastic filter is 3.4 grams. As cigarette butts are often littered along with plastic packaging, which weighs an average 19 grams for a standard pack size of 20 cigarettes, this was also included in the calculations.

    The researcher estimated the annual projections of the environmental and economic costs of tobacco plastic based on the tonnage. Ten-year projections were included because cigarette butts are reported to take 10 years to degrade.

    The total figure reflects cost estimates of cleanup and disposal (adjusted for inflation) of the total plastic generated by filtered cigarette sales potentially ending up as waste in the sea, landfills or in the environment.

    Sy estimated that the annual economic cost of cigarette plastic waste is around $26 billion, made up of $20.7 billion in marine ecosystem damage and $5 billion in waste management costs, adding up to $186 billion over 10 years.

    The costs of tobacco product plastic pollution are likely highest in China, Indonesia, Japan, Bangladesh and the Philippines, the estimates suggest.

    The research was funded by Bloomberg Philanthropies.

  • Russia to Criminalize E-liquid Trafficking

    Russia to Criminalize E-liquid Trafficking

    Photo: diy7

    Traffickers of illegal vape liquids could face up to seven years in prison in Russia if a proposal by the Committee of the Federation Council on Economic Policy becomes law, reports AIF.

    Lawmakers are concerned about the ingredients in illegal vapes, which evade regulatory scrutiny.

    Anatoly Vyborny, Deputy Chairman of the Committee on Security and Anti-Corruption, supported the provision, saying that the measure would help protect the health of young Russians.

    Currently, in Russia, there is no criminal liability for the illegal import of vaporizers and e-liquids.

  • MRTP Renewal Filed for General Snus

    MRTP Renewal Filed for General Snus

    On Nov. 30, 2023, the U.S. Food and Drug Administration filed for scientific review modified-risk tobacco product (MRTP) renewal applications submitted by Swedish Match USA for General Snus smokeless tobacco products, including:

    • General Loose;
    • General Dry Mint Portion Original Mini;
    • General Portion Original Large;
    • General Classic Blend Portion White Large, 12 count;
    • General Mint Portion White Large;
    • General Nordic Mint Portion White Large, 12 count;
    • General Portion White Large; and
    • General Wintergreen Portion White Large.

    In 2019, the FDA issued modified-risk granted orders for eight smokeless tobacco products made by Swedish Match USA. These orders expire in 2024. To continue marketing the MRTPs after the authorized five-year term, the company submitted an MRTP renewal application to the FDA.

    Starting Dec. 1, the public may submit comments on these applications on regulations.gov.

  • Malawi Approves Tobacco Law

    Malawi Approves Tobacco Law

    Photo: Taco Tuinstra

    Lawmakers in Malawi approved the Tobacco Industry Bill, which stipulates how stakeholders are supposed to operate, reports the Nyasa Times.

    In addition to provisions on child labor and tenancy, the legislation includes clauses on traceability and the use of agrochemicals. Lawmakers hope the new rules will improve compliance and make it easier for Malawi to market its leaf around the world.

    The Tobacco Industry Bill will also regulate contract and noncontract farming, tobacco production and delivery quota, and prices, along with disposal of tobacco stalks.

  • Menthol Ban Risks Alienating Voters: Poll

    Menthol Ban Risks Alienating Voters: Poll

    Photo: New Africa

    A majority of U.S. President Joe Biden’s core voter base opposes the administration’s proposed ban on menthol cigarettes and flavored cigars, reports National Review, citing a poll by Cornell Belcher commissioned by Altria.

    Biden’s core voter base is defined as minority voters or nonconservative white voters under the age of 45. Of this group, 54 percent oppose the proposed ban, with each battleground state showing a majority of opposition as well.

    “Candidates risk alienating base supporters in battleground states by taking up a cause that most voters oppose and don’t believe to be important,” according to the poll.

    Based on the poll, tobacco product bans are at the bottom of voters’ priority list when it comes to the U.S. Food and Drug Administration—opioid abuse, prescription medication and food safety are the top concerns.

    “Biden’s core voters are simply not comfortable with the idea of prohibition as a government approach to tobacco,” Belcher’s polling memo says. The majority of voters (74 percent) prefer a harm reduction approach.

    “With so many issues more pressing on voters’ minds—issues that voters actually agree with—these bans represent a very avoidable self-inflicted wound that could alienate base supporters in a battleground state,” the memo said. “Adult use of tobacco is far from a top-tier concern, and voters recognize there are more important matters for the president, Congress and the FDA to address. Candidates should not be taking up a cause that most voters oppose, that voters don’t believe to be important and that can get in the way of a campaign’s ability to mobilize supporters.”

    The poll was conducted from Sept. 17 to Oct. 10 among 3,021 likely voters in Biden’s “core coalition.” Roughly 600 voters per battleground state were included in the poll.

  • Cessation Therapy Validated in Study

    Cessation Therapy Validated in Study

    Image: Qnovia

    Qnovia announced positive results from its first in-human study of QN-01, an inhaled smoking cessation therapy that is currently being evaluated by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA).

    “Today marks a pivotal milestone for Qnovia as we believe this data validates the clinical translation of our platform for the first time in patients,” said Qnovia CEO Brian Quigley.

    “One of the reasons that quitting smoking is so challenging is that cigarettes provide a significant nicotine spike directly into the bloodstream within seconds. The challenge with current nicotine replacement therapies is that they fail to deliver nicotine quickly enough and at concentrations high enough to effectively alleviate a smoker’s withdrawal symptoms. Unfortunately, this leads to smokers relapsing, resulting in a significant unmet need for novel smoking cessation therapies.

     

    We believe our nicotine delivery platform has the potential to solve this complex pharmacokinetic puzzle and could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most

    “We believe our nicotine delivery platform has the potential to solve this complex pharmacokinetic puzzle and could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most,” said Quigley.

    “We are delighted to share that QN-01 demonstrated a superior pharmacokinetic profile compared to an existing inhaled NRT and was well tolerated. We look forward to submitting our IND and CTA for QN-01 and advancing our clinical development program into Phase 1/2 clinical trials next year.”

    The Phase 1 study was an open-label trial evaluating the delivery of QN-01 for three different nicotine dosing regimens to determine the pharmacokinetics and safety profile of Qnovia’s drug delivery platform in 12 healthy adults who currently smoke combustible cigarettes. Each adult received three different doses of treatment delivered on subsequent days after a washout period.

    The study confirmed dose-dependent pharmacokinetics of QN-01 delivered with the Qnovia’s RespiRx device. The mean maximum plasma concentration (Cmax) was higher, and the time to achieve the maximum plasma concentration  (Tmax) was lower for QN-01 across all three dose regimens, demonstrating superior pharmacokinetics compared to an existing inhaled nicotine replacement therapy (NRT). The drug-device combination was well tolerated with no severe adverse events and few minor adverse events typical of inhaled nicotine.

    Highlights of Initial Phase 1 Pharmacokinetic and Safety Data

    “We are pleased to see our platform being utilized for the first time in human clinical trials. We believe these results validate that we have identified an optimal Cmax for QN-01 that is higher than the currently available inhaled NRTs but lower than combustible cigarettes, thus enabling QN-01 to have optimal therapeutic efficacy while mitigating abuse liability potential,” said Mario Danek, Founder and chief technology officer of Qnovia.

    “What makes our platform unique is that the RespiRx device utilizes a vibrating mesh nebulizer aerosol engine with zero heat to create an aerosol that can be inhaled by the smoker. Given our e-liquid drug product is not heated, there is no formation of thermal degradants or other toxicants during the aerosol generation process. As a result, our device platform is uniquely positioned to meet CDER’s safety standards. Looking ahead, we are committed to advancing QN-01 into the next stage of clinical development and will be working closely with FDA and MHRA to bring this treatment option to the millions of smokers who want to quit.”