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The Advisory Council on Alzheimer’s Research, Care, and Services presented updates on Alzheimer Disease (AD) and AD and related dementias (ADRD) treatments and ongoing AD research in a virtual meeting held in January. 

Representatives from the National Alzheimer Project Act (NAPA) research committee, Washington University School of Medicine (WashU), and the Alzheimer’s Association reported on the developments in disease modifying therapies (DMTs), funding, resources for dementia caregivers, and the connection between AD and Down syndrome.1

DMTs for AD

From 2016 to 2023, researchers have observed advancements in AD treatment. Most recently, the US Food and Drug Administration (FDA) approved Leqembi (lecanemab), an amyloid beta-targeting antibody for patients with AD and those in the mild cognitive impairment (MCI) or mild dementia stage of the disease. The FDA’s decision on donanemab, also an amyloid beta-targeting antibody, for the treatment of patients with early AD, is anticipated in the first quarter of 2024. 

The approved route of administration for lecanemab is intravenous (IV). Eisai Pharmaceuticals is testing a subcutaneous route of administration. Compared with the IV route, initial reports suggest that subcutaneous formulations clear 14% more plaque, have an 11% higher area under the curve (AUC), and have lower systemic injection reaction rates.2

On January 31, 2024, Biogen Inc. decided to discontinue Aduhelm (aducanumab-avwa) production, sales, and the affiliated clinical study. Instead, they will allocate their resources to the development of other treatment methods for AD and prioritize moving forward with lecanemab.3

Growing Resources for Dementia Caregivers

With recent progress in AD treatments, progress has also been made in the availability of resources for dementia caregivers. The Alzheimer's Association collaborated with the Centers for Disease Control and Prevention (CDC), Building Our Largest Dementia (BOLD) Public Health Center of Excellence on Dementia Caregiving, and Emory University to initiate a free interactive public health curriculum for clinicians, students, and educators. The goal is to increase awareness and knowledge about the importance of dementia caregiving and how public health may affect it. 

Representatives of the advisory board addressed further initiatives concerning racial/ethnic diversity needs between patients and caregivers and demanded an increase in caregiver wage. Although a resolution has not been reached, caregiving networks are optimistic to find ways to implement changes in the near future.4 

"
The research and the investments that have been made over the past decades led to these advancements in understanding the disease, how it starts and progresses, and figuring out ways to intervene in it.

Revisions and Updates to Funding AD Research

Various extensions and reauthorizations have been made to continue AD research. There is bipartisan agreement that AD research needs more attention. The National Institutes of Health (NIH) and the CDC are looking to: 

  • Extend and reauthorize NAPA
  • Continue advising the Centers for Medicare and Medicaid Services (CMS) to implement a dementia care management model

In the senate budget requests for the 2024 fiscal year, the NIH requested a $321 million increase and the CDC requested $35 million for the BOLD infrastructure for the Alzheimer Act. The Act focuses on AD diagnosis, treatment, and dementia caregiving.5

Increases in federal funding have advanced AD research and the progression of clinical trials. “It’s research that changes the cookbook of medicine ... The research and the investments that have been made over the past decades led to these advancements in understanding the disease, how it starts and progresses, and figuring out ways to intervene in it,” Randall Bateman, MD, Charlotte and Paul Hagemann distinguished professor of neurology at WashU in St. Louis, said at the meeting.6

https://infogram.com/na_feature_advisory_council_ad-1hnq41ok39dlp23?live

Challenges in AD Research

Researchers at WashU have identified challenges that have limited treatment objectives.7  

Overall Barriers to AD Research 
Racial & Ethnic Disparity- Racial and ethnic groups are excluded from testing
- Overall lack of research about patients with AD who belong to racial and ethnic groups
Accessibility to Infusion Centers- Patients who live in rural areas have difficulty accessing infusion centers
- Infusion treatments are time consuming. Patients often miss due to vacation, travel, and other illnesses.
- 6–8-month waitlist for treatment
- Small window for treatment 
Cost of treatment - Treatment costs $50,000 per year
- Medicare finances only 80% of treatment expenses, which could leave patients with ~$10,000 bill out of pocket
- AD biomarker testing is not offered insurance coverage
Effectiveness of DMTs- Need for precision medicine for an individual's unique disease profile
- Dosage and duration vary per patient
- Some patients need to switch medications 

Although limitations are presented in the infrastructure for AD/ADRD treatment, the researchers highlight initiatives for AD prevention. These include the early administration of lecanemab and the implementation of the combination of DMTs.8 

The Connection Between AD and Down Syndrome

In highlighting the existing challenges with AD treatments, Elizabeth Head, MA, PhD, professor at the University of California, spoke about the connection between AD and Down syndrome (DS). By age 40, patients with DS have sufficient plaque and tangle pathology for an AD diagnosis. Dr Head mentioned that it is widespread for older patients with DS to develop AD, and it is one of the leading causes of death for this patient population.

Though there is a connection between AD and DS, patients with DS are often excluded from AD trials, presenting a barrier in research. Ultimately, there is a lack of racial and ethnic diversity in trials; only White patients have a higher survival rate.

Since there is still a limited amount of evidence, it is difficult to identify pharmacologic intervention effectiveness for cognitive decline in patients with DS. Dr Head urged that researchers should begin to expand AD studies to this patient population. The inclusion of patients with DS in cohort trials would result in advanced AD research and a better understanding of DS.9

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As the global population becomes older, physicians are increasingly navigating the complexities of geriatric medicine. Older adults often have multiple chronic conditions that require ongoing treatment, which frequently results in the practice of polypharmacy — typically defined as the concurrent use of 5 or more medications.1

Although polypharmacy begins as a well-intentioned effort to manage cooccurring conditions, the interaction of these different medications can become a health hazard instead of an optimal solution. Given the increased risks for adverse drug interactions, medication errors, and cognitive impairment, addressing polypharmacy and developing a nuanced approach to geriatric care is crucial to safeguarding the health of older adults.

Increasing Prevalence of Polypharmacy in Older Adults

In a chapter on polypharmacy published in Geriatric Rehabilitation, co-authors Parulekar and Rogers noted that while only 13% of the United States population was aged 65 years and older, this age group accounted for 33% of total prescription medications.2 More than 50% of older adults with multimorbid conditions receive 5 or more medications, with the rate varying between 10% and 55% globally.3 Furthermore, a study of survey data from the Centers for Disease Control and Prevention (CDC) found that the majority of older adults in the US had major polypharmacy and nonsteroidal anti-inflammatory drugs (NSAIDs) were the most common medication type.4

The prevalence of polypharmacy is even higher among women. Research suggests that women are more likely than men to require more than 1 or more specialized medications,1 and older women have higher rates of multimorbidity relative to men — with a consequently higher prevalence of polypharmacy.5

"
Managing polypharmacy requires careful monitoring and coordination by health care providers to deprescribe, optimize medication regimens, and minimize risks for patients.

Erika Ramsdale, MD, an associate professor at the Department of Medicine, Hematology/Oncology at the University of Rochester Medicine, has studied the effects of polypharmacy on older adults initiating cancer treatment6 and spoke about this issue. “Polypharmacy and potentially inappropriate medications are very, very common in older adults, and especially within certain populations, such as older adults with cancer. [However], there is not an easy way to estimate the burden of medication-related adverse effects on patients and the health care system as a whole,” she remarked.

Risk factors for polypharmacy include both patient-level factors (eg, increased age, difficulty self-managing medications, multimorbidity, disabilities) as well as health care system-level components, such as poor continuity of care, prescribing cascades, the use of multiple pharmacies, and inadequately updated medical records.7,8

While polypharmacy is often deemed necessary to treat multimorbidity, the concurrent use of medications has been shown to cause harm in and of itself. In a retrospective cohort study published in 2023, older adults who received multiple medications experienced significantly higher rates of severe comorbidity relative to those who did not experience polypharmacy. Patients with polypharmacy also had a greater rate of all-cause hospitalizations and emergency department (ED) visits.9

Polypharmacy also carries specific neurologic and psychiatric risks. Older adults with polypharmacy and multimorbidity demonstrate greater levels of cognitive impairment, relative to their peers with fewer comorbidities and medications,10 and has been associated with worse self-reported health and depression in older adults.11

Given the risks associated with multiple medications in older adults, many experts have called into question the “appropriate” vs “inappropriate” use of polypharmacy.2 To this aim, Mohamed and colleagues conducted a study to examine the associations between polypharmacy, potentially inappropriate medications, and adverse treatment outcomes in a large national cohort of older adults with advanced cancer. They found that 67% of patients received 1 or more inappropriate medications, and the use of inappropriate medications increased the odds of unplanned treatment-related hospitalization. Additionally, polypharmacy overall was associated with increased risk for postoperative complications, hospitalizations, and mortality risk.8

Dr Ramsdale emphasized the importance of not just the number of medications prescribed to a patient, but also their appropriateness. “Some patients have polypharmacy by number, but all their medications are needed and appropriate.”

Further complicating this medication management issue, Dr Ramsdale addressed the challenge of differentiating between patients who develop symptoms from polypharmacy vs a root cause issue, such as comorbidities/disease. “Often, there is not one ‘root cause’ for a symptom or adverse effect in older adults. There are generally multiple contributing factors and you have to look at all of them and also how the factors interact with each other. One thing you can say is that medications are very often contributing and need to be considered each time something happens.”

Concerns & Barriers in the Management of Polypharmacy in Clinical Practice

Although a wealth of evidence has demonstrated the adverse health risks associated with polypharmacy, the question remains as to how health care systems should best manage this issue. Researchers conducted a study across 14 countries, including the US and UK, to identify the barriers associated with addressing polypharmacy in primary care. They found the most common barriers were a lack of evidence-based guidance, a lack of communication and decision-making systems, and gaps in support.12

From a clinician’s perspective, Dr Ramsdale stated,

Older adults tend to have many doctors who are all prescribing [medications], sometimes in different health systems, leading to fragmentation of care. Providers also may not want to alter [a medication] that another provider has prescribed.

In-depth review of medications takes a lot of time and thought, as each patient’s situation is unique and everyone has different goals and preferences. In addition, clinicians often do not have the time or resources to accomplish this for all patients because of the way our health care system is set up and [the type] of care it prioritizes.

Because one of the major concerns regarding polypharmacy is the increased risk for drug-to-drug interactions that are associated with adverse events and even death,13 there is a critical need to support physicians in these complicated — but increasingly common — cases of medication management.

How Can Providers Manage Polypharmacy in Older Adults?

Researchers have agreed that screening and interventional tools to optimize medication usage for improved outcomes may be beneficial.9 However, the frequency of prescribing multiple medications needs to be evaluated to reduce adverse events and medication burden in this patient population.4 Clinical studies have shown that one of the ways of reducing exposure to polypharmacy is through the practice of “deprescribing” medications.12

Deprescribing medications involves the identification of inappropriate or unnecessary medications to ultimately taper or discontinue their use. In 2019, the American Academy of Family Physicians (AAFP) developed recommendations for clinicians to help in deprescribing medications and reducing the risks for polypharmacy.7 Some of the key guidelines include the identification and prioritization of medications to discontinue, conducting informed decision-making with the patient, ensuring routine follow-up visits, and considering the risks vs benefits when refilling medications.

“Patients and their caregivers can be excellent advocates. All older adults should be [encouraged to] ask questions about the [safety] of their medications. The US Deprescribing Research Network and the Canadian Medication Appropriateness and Deprescribing Network have excellent patient resources available,” Dr Ramsdale recommended.

One of the key aspects in reducing polypharmacy is medication reconciliation, which can be more effectively achieved by improving the communication between provider and patient and the process of discharge from hospitalization. With the increased use of artificial intelligence and clinical decision support systems, the risks for polypharmacy may be minimized.14

Given that many older patients experience some degree of polypharmacy, pharmacists, specialist nurses, and physician assistants play a vital role in medication management, quality prescribing practices, and safety monitoring.4 Managing polypharmacy requires careful monitoring and coordination by health care providers to deprescribe, optimize medication regimens, and minimize risks for patients. Overall, polypharmacy in older adults is directly related to health care service outcomes,9 which warrants the need for a multidisciplinary, holistic approach to address and evaluate its use among patients.

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In the demanding and emotionally-charged field of health care, physicians often find themselves at the forefront of providing care and support to patients and their loved ones. While empathy and compassion are essential qualities in this profession, the constant exposure to suffering and the pressure to deliver optimal care can take a toll on the emotional well-being of health care professionals. These concerns are particularly true in certain environments like palliative care settings.1 In addition, intense workloads and limited resources during the COVID-19 pandemic further highlighted the mental health crisis facing many health care workers.2

A specific form of psychological distress known as compassion fatigue has emerged as an important topic in need of further research and attention. Compassion fatigue is a state of emotional exhaustion that can reduce your capacity for empathy,1 ultimately putting patient care at risk. To remain effective, health care professionals need strategies to identify the signs of compassion fatigue and alleviate its symptoms before the cumulative stress of work takes over.

How to Recognize Compassion Fatigue

Compassion fatigue is a psychological and physical state that occurs when health care professionals become emotionally drained from their efforts to care for patients. It is often a result of prolonged exposure to patients' suffering, traumatic events, or the inability to alleviate their pain. Experts have defined compassion fatigue as a combination of secondary traumatic stress and burnout.1 It may be viewed as, “the phenomenon of stress resulting from exposure to a traumatized individual rather than from exposure to the trauma itself.”3

As physicians experience increased levels of stress and burnout, they may feel emotionally detached and helpless, losing their sense of purpose. Some warning signs you shouldn't ignore include:

  • Apathy and cynicism: A growing sense of pessimism may develop, affecting interactions with patients, colleagues, family, and friends.
  • Decreased job satisfaction: Compassion fatigue often leads to frustration and dissatisfaction with one's profession, increasing absenteeism and making physicians question their career choices.3
  • Emotional withdrawal: Physicians may emotionally detach themselves from patients and colleagues, leading to numbness or indifference towards their work.
  • Physical exhaustion: Feeling constantly tired, irritable, or experiencing sleep disturbances, along with a lack of enthusiasm for work, are signs of compassion fatigue.
  • Reduced empathy: A once empathetic physician may find it challenging to connect with patients emotionally, leading to a decline in the quality of care provided.

Studies suggest that the greatest mental health concerns for health care providers during the pandemic included insomnia, anxiety, depression, post-traumatic stress disorder, and stress.2 Untreated compassion fatigue and mental health issues can lead to unhealthy coping strategies, including drug and alcohol use disorders.3

Physicians need to remember that their well-being matters. No one is immune to the weight of such significant responsibility. Getting lost in caring for others isn't sustainable. In fact, doing so may compromise patient care, resulting in widespread negative consequences both personally and professionally.2

Preventing Compassion Fatigue

Physicians can use proactive strategies to combat compassion fatigue that promote self-care and emotional resilience. Physicians must prioritize self-care by taking regular breaks, engaging in hobbies, maintaining a healthy work-life balance, and setting boundaries to protect their well-being. Practicing mindfulness and meditation techniques can help physicians stay present and grounded.4

The opposite of compassion fatigue, referred to as “compassion satisfaction” describes pleasure experienced from relieving patient suffering and enjoying a positive work environment.1 Perhaps one of the best ways to avoid compassion fatigue is by focusing on the satisfying aspect of work, taking time to document and reflect on the positive effects of your efforts, even if they seem small in the larger context of a patient’s eventual outcomes.

Seeking professional counseling or therapy can be immensely beneficial in processing emotional challenges and building coping mechanisms. Counseling can be an opportunity to share small wins and talk through traumatizing experiences. In addition, open communication and sharing with colleagues can create a supportive environment where physicians can seek guidance and understanding. Hospitals and medical institutions should provide training and education on compassion fatigue to help combat this increasing problem for physicians around the world.5

More experienced physicians who take time for their mental wellness can positively impact the culture of medicine by setting a healthier example for students and residents entering the field. As research, awareness, and resources related to compassion fatigue increase, the stigma of mental health care should continue to decrease.5

Alleviating Compassion Fatigue

Despite best efforts, compassion fatigue in health care can seem unavoidable. Physicians must first acknowledge and accept that they are experiencing compassion fatigue. Denying or ignoring these feelings can exacerbate the problem.

It is crucial to lean on support systems, whether it be friends, family, colleagues, or professional counselors. Supervisors can also be a supportive resource. Talking about emotions and seeking understanding can help reduce the burden.1 In addition, therapy can help physicians understand their boundaries and limitations, including the fact that it’s not always possible to change a patient’s outcome or circumstances.1 To shift the focus to compassion satisfaction, physicians must find ways to see the rewards and accomplishments in their work.1

Long shifts and physical exhaustion often make it harder to weather the demands of working in health care. Therefore, time off to rest is vital. Physicians should not hesitate to use their leave entitlements when needed. Time off is critical to staying engaged and should be viewed as a necessary aspect of the job. It should also be used wisely as an active time to rejuvenate. In addition, activities that promote relaxation and joy, such as physical exercise, fun hobbies, or spending time in nature, can help reduce stress levels so you can bring your best self to work.1

Resources for Physician Self-Care

Many health care providers face unrealistic expectations, traumatic experiences, and a challenging work environment. Fortunately, more institutions and organizations recognize and provide resources to address burnout and compassion fatigue. If you're struggling with compassion fatigue (or simply trying to prevent it), you may want to seek out some of the following resources:

  • Employee assistance programs (EAPs): Many health care facilities offer EAPs that provide confidential counseling and support services for employees facing emotional challenges.
  • Peer support groups: Some medical institutions organize support groups for physicians to share their experiences, struggles, and coping strategies in a safe and understanding environment.
  • Therapy: Many medical societies and organizations provide access to professional counseling services specialized in supporting health care professionals.
  • Wellness workshops and retreats: Hospitals and medical associations often conduct workshops and seminars on stress management and promoting physician well-being.

Helping Yourself to Help Others

Compassion fatigue is a significant challenge faced by health care professionals, particularly physicians, who dedicate their lives to caring for others. By recognizing the signs of compassion fatigue, taking preventive measures, and utilizing available resources, physicians can safeguard their emotional well-being and continue providing exceptional patient care.

Acknowledging and addressing compassion fatigue is not a sign of weakness but a demonstration of strength and dedication to your profession and patients. Unfortunately, despite an increased awareness of physician burnout and compassion fatigue, there’s still no official guidelines for treatment.5 More research into this common phenomenon can help promote the development of more effective interventions.3 By promoting a culture of understanding, and support, health care institutions can contribute to a healthier and more resilient workforce, improving physicians’ lives and patient outcomes.

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What’s the best way to curb vaping, especially among adolescents and young adults?

Despite Food and Drug Administration (FDA) regulation, vaping is flourishing, with a steady stream of e-cigarette products finding their way into stores as well as into the hands, lungs, and bloodstreams of America’s youth. Vaping, it seems, is the new smoking for teenagers and young adults.

“E-cigarettes have taken over the youth tobacco use landscape. They are the most commonly used tobacco product,” said Thomas Carr, Director of National Policy at the American Lung Association (ALA), in an exclusive interview.

Although there is not yet data to show whether vaping is as harmful as cigarette smoking, substantial harms have been documented — enough to show that vaping poses a threat to human health, especially to the lungs and the heart.1

Given that February has been designated by the Centers for Disease Control and Prevention (CDC) as heart health month, this report looks at what is being done — and what could be done — to curb youth vaping.

"
Taxation has worked well at reducing use in every other tobacco product, especially among youth. I feel pretty confident in saying it will reduce vaping rates.

“The [American Lung] Association is committed to reducing and eliminating use of e-cigarettes among youth users,” noted Carr. Moving forward, he added, the ALA is hoping to see:

  • better FDA regulation and enforcement with respect to e-cigarettes;
  • high levels of taxation on e-cigarettes;
  • an end to the sale of flavored e-cigarettes (a measure that has been taken by only 5 states thus far);
  • incorporating vaping into existing state tobacco-control programs;
  • more media campaigns against e-cigarette use; and
  • community education in schools about the dangers of vaping.

The American Heart Association (AHA) is similarly dedicated to curbing youth vaping, said Rose Marie Robertson, MD, AHA Science and Medical Officer, in an exclusive interview. “A comprehensive approach is needed to help reduce vaping among young people,” she said.

“We have heard from young people who recognize the dangers of vaping and their own addiction to these products, but don’t feel like they know the proper strategies to quit or even how to say no to e-cigarettes and other dangerous products to begin with,” said Robertson. “Therefore, our efforts focus on significant investments in research, youth engagement efforts, and support for schools to choose restorative rather than punitive approaches to students who vape,” she noted.

The AHA and the ALA are also united in their desire for better regulation and enforcement of vaping by the FDA and states.

Statistics on Youth Vaping

Although there has been “some decline since 2019” in the use of e-cigarettes, said Carr, “e-cigarettes remain the most commonly used tobacco product.”

CDC’s 2023 National Youth Tobacco Survey confirms that e-cigarettes are the most commonly used tobacco product by youth in the US. The 2023 survey found that 10% of high school students and 4.6% of middle school students used e-cigarettes. Notably:2

  • 25.2% of current youth e-cigarette users used an e-cigarette product every day;
  • 34.7% of youth e-cigarette users surveyed reported using e-cigarettes during at least 20 of the previous 30 days;
  • 89.4% of youth users used flavored e-cigarettes; fruit flavors were most popular, followed by candy, desserts/other sweets, mint, and menthol;
  • 57.9% reported using products with “ice” or “iced” in the branding;
  • the most common e-cigarette devices used were disposables (60.7%) followed by prefilled/refillable pods (16.1%); and
  • the most popular brands included Elf Bar (56.7%), Esco Bars (21.6%), Vuse (20.7%), JUUL (16.5%), and Mr. Fog (13.6%).

Taxation

One under-utilized strategy that may effectively curb the use of e-cigarettes by both youths and adults is heavy taxation — meaning taxation at the same level as cigarettes, said Carr.

Currently, there is no federal tax on e-cigarettes, and only 31 states and the District of Columbia have enacted excise taxes on vaping products.3 The level of taxation varies widely, with some surcharges hardly noticeable, said Carr.

According to the Tax Foundation, a nonprofit organization that researches tax policy in the US and elsewhere, methods used to tax vaping vary. “Authorities tax based on manufacturer, wholesale, or retail price (ad valorem), volume (specific), or with a bifurcated system that has different rates for open and closed tank systems,” noted a Tax Foundation blog on vaping taxes. “Of those that tax wholesale values, Minnesota levies the heaviest tax at 95 percent, followed closely by Vermont at 92 percent. On the other end of the spectrum, Connecticut levies a 10 percent wholesale tax and Wyoming applies a 15 percent wholesale tax.”

Other states levy a per mL tax. The states with the lowest per milliliter (mL) taxations are Delaware, Kansas, North Carolina, and Wisconsin, with a rate of $0.05 per mL. Louisiana has the highest rate per mL, after tripling this rate to $0.15 per mL in 2023, the blog noted.3

“Taxation has worked well at reducing use in every other tobacco product, especially among youth. I feel pretty confident in saying it will reduce vaping rates,” said Carr.  “We’re still sorting through what completely works,” he added.

FDA regulation

The FDA is acutely aware of the dangers that e-cigarettes pose to youth. A focused segment of their Comprehensive Plan for Tobacco and Nicotine Regulation aims to prevent youth from accessing e-cigarettes and other tobacco products. The FDA has claimed that “significant regulatory and research efforts related to access, marketing, and education are already underway.”4

Regulation enforcement for e-cigarettes is a stated FDA priority. As former FDA Commissioner Scott Gottlieb, MD, said in a 2019 press release, “As the number of children using e-cigarettes remains at epidemic levels, our enforcement work has been one cornerstone of our efforts to protect youth from the dangers of tobacco products.” Gottlieb noted that the FDA had been involved in “vigorous enforcement efforts.” These included “a number of actions to combat the illegal sales of e-cigarettes to youth at brick-and-mortar and internet storefronts, as well as steps to target companies engaged in kid-friendly marketing that can increase the appeal of these products to youth,” and other actions “focused on both retailers and manufacturers.”5

In its Guidance for Industry issued in April 2020, the FDA laid out its enforcement priorities, announcing its intent to target any electronic nicotine delivery system (ENDS) product being sold after September 9, 2020, “for which the manufacturer has not submitted a premarket application.”6

FDA’s Guidance for Industry also stated that for products marketed “without FDA authorization, FDA intends to prioritize enforcement against: [1] Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product); [2] All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and [3] Any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors.”6

ALA, AHA: More Regulation, Better Enforcement Needed

Although the ALA is pleased that the FDA has not approved any flavored tobacco products to date, the FDA hasn’t yet enforced against any of these products, said Carr, who noted that the ALA would like to see a ban on the sale of all flavored tobacco products.7

https://infogram.com/pulm_feature_vapinglawsinfographic-1hxj48m5re8d52v?live

“The Lung Association has been dismayed at the delay with the FDA, although they have been making more progress recently. In some cases, the companies aren’t following the laws at all and selling products without premarket review. A lot of these products come from overseas so they’re hard to interdict — especially flavored disposable varieties,” said Carr.

Dr Robertson of the AHA echoed this sentiment. “While the FDA has fined retailers for continuing to sell unauthorized tobacco products, the agency must be given the proper resources to not only fund additional research on characterizing flavors, but also strengthen enforcement efforts to remove all illegal e-cigarettes from the marketplace,” she said.

“The [AHA] has continued to urge the Food and Drug Administration to complete its review of all e-cigarette product applications and we are working to ensure that state laws align with the federal minimum age for sale of tobacco products, which is 21,” she added.

E-Cigarette Smuggling

The smuggling of e-cigarettes across the border into the US complicates vaping regulation enforcement.7

“The Lung Association was pleased by the FDA announcement in May 2023 that e-cigarette products from several companies — Elf Bar, Esco Bar and Eon Smoke — were added to an FDA import alert red list with CBP [Customs and Border Protection] in order to be detained at the border without conducting a full inspection at the time of entry. Additional e-cigarette products have been added to the list,” stated the ALA’s State of Tobacco Control 2024 Report.7

“However, Elf Bar, the most popular e-cigarette with kids in 2023, was able to avoid enforcement initially by simply changing the name of its product, a disturbing loophole that needs to be closed. A recent US Department of Health and Human Services Inspector General report looked at FDA enforcement against retailers from 2010 to 2020, and found that FDA did not always follow through with more serious penalties such as civil monetary,” the ALA report continued.7

To date, the FDA and Customs and Border Protection have worked together to seize 1.4 million illegal cigarette products at the border, the report noted.7

The Manufacturers Strike Back

Taking a page from the litigation playbook of big tobacco companies, many e-cigarette manufacturers have filed lawsuits against FDA marketing denial orders for flavored e-cigarettes. The ALA has signed more than 20 amicus briefs with coalition partners in 2022 and 2023 asking courts to uphold these orders. To date, 6 of 8 US circuit courts have upheld these FDA marketing denial orders.7

In addition to leveraging litigation to fight to keep flavored e-cigarettes on retail shelves, manufacturers have kept on top of youth trends and interests when marketing their products to ensure sales. “They have proven expert at getting around regulations whenever they can by innovating their products,” Carr lamented.

Dr Robertson of the AHA agreed. “Big Tobacco and the vaping industry continue to foster addiction in younger generations by developing and marketing new tobacco products that appeal to youth and get them addicted.” This, of course, is nothing new, she added. “For decades, the tobacco industry has modified old products and created new ones to hook new users and keep them addicted, leading to tobacco use as a leading cause of preventable disease and death and a major risk factor in the development of heart disease and stroke.”

Second-Hand Vape

An issue of note that has yet to be talked about is the dangers of second-hand vape, said Carr. “Second-hand aerosol isn’t harmless,” he noted. This problem can be addressed by “adding e-cigarettes to smoke-free workplace laws that exist in a number of states … to prevent vaping in restaurants and other public places.”7

Public and Patient Outreach

Public outreach and education are imperative in the battle against rising rates of e-cigarette use in youth, said Carr. This includes efforts by clinicians, community education in schools, peer education on the dangers of tobacco and smoking, and the use of media campaigns.

One such media campaign is #DoTheVapeTalk.8 The American Lung Association (ALA) recently paired with the nonprofit Ad Council to launch this youth vaping awareness campaign, which involves a public service announcement showing how a dad talks to his teen about the dangers of vaping. #DoTheVapeTalk arms parents with the necessary facts to discuss the dangers of vaping with their kids “while they’re still willing to listen,” according to the ALA State of Tobacco Control 2024 report.7 Unfortunately, there is a paucity of youth-cessation resources like #DoTheVapeTalk, Carr noted.

“It’s vital that the harms and consequences of e-cigarettes and other addictive tobacco products be shared by trusted messengers, such as doctors and other health professionals, teachers, coaches and parents,” said the AHA’s Robertson. “But it is just as important that these influencers in young people’s lives specifically encourage them to quit and refer them to the proper resources and care to do so.”

Carr urged clinicians to take an active role in public and patient outreach. In particular:

  • When seeing kids in the office, physicians should ask about tobacco use and vaping, assess their desire to quit, and refer to counseling.
  • Pediatric pulmonologists can share stories about patients and vaping in the form of letters to the editor or community outreach.
  • Clinicians can support public policy efforts.
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