Unhealthy Food and Beverage Marketing to Children in the Digital Age: Global Research and Policy Challenges and Priorities.

Food and nonalcoholic beverage marketing is implicated in poor diet and obesity in children. The rapid growth and proliferation of digital marketing has resulted in dramatic changes to advertising practices and children's exposure. The constantly evolving and data-driven nature of digital food marketing presents substantial challenges for researchers seeking to quantify the impact on children and for policymakers tasked with designing and implementing restrictive policies. We outline the latest evidence on children's experience of the contemporary digital food marketing ecosystem, conceptual frameworks guiding digital food marketing research, the impact of digital food marketing on dietary outcomes, and the methods used to determine impact, and we consider the key research and policy challenges and priorities for the field. Recent methodological and policy developments represent opportunities to apply novel and innovative solutions to address this complex issue, which could drive meaningful improvements in children's dietary health.

From the laboratory to the consumer: Innovation, supply chain, and adoption with applications to natural resources.

We analyze the transition from innovative ideas to final marketed products. This transition occurs through two synergetic supply chains for innovation and products. Basic concepts are developed, tested, upscaled, and introduced to commercial use in the innovation supply chain. Then, the products are produced and delivered to the consumer through the product supply chain. We argue that product markets trace their birth to product innovations. These markets tend to start as noncompetitive, which rewards innovators. Credit access and risk determine the reliance on contracting and product diffusion over space and time. The innovation and product supply chains are encouraged and facilitated by public policies, such as support for research and education, intellectual property rights protection, low barriers to trade, science-based regulation, and well-functioning capital markets. We argue for multidisciplinary research incorporating knowledge from economics, business, and engineering to better understand the evolution of innovative companies and supply chains. This understanding will help the development of policies to address challenges of climate change and food security among others.

Preventing liver disease with policy measures to tackle alcohol consumption and obesity: The HEPAHEALTH II study.

BACKGROUND & AIMS: Chronic liver disease (CLD) causes 1.8% of all deaths in Europe, many of them from liver cancer. We estimated the impact of several policy interventions in France, the Netherlands, and Romania. METHODS: We used a validated microsimulation model to assess seven different policy scenarios in 2022-2030: a minimum unit price (MUP) of alcohol of €0.70 or €1, a volumetric alcohol tax, a sugar-sweetened beverage (SSB) tax, food marketing restrictions, plus two different combinations of these policies compared against current policies (the 'inaction' scenario). RESULTS: All policies reduced the burden of CLD and liver cancer. The largest impact was observed for a MUP of €1, which by 2030 would reduce the cumulative incidence of CLD by between 7.1% to 7.3% in France, the Netherlands, and Romania compared with inaction. For liver cancer, the corresponding reductions in cumulative incidence were between 4.8% to 5.8%. Implementing a package containing a MUP of €0.70, a volumetric alcohol tax, and an SSB tax would reduce the cumulative incidence of CLD by between 4.29% to 4.71% and of liver cancer by between 3.47% to 3.95% in France, the Netherlands, and Romania. The total predicted reduction in healthcare costs by 2030 was greatest with the €1 MUP scenario, with a reduction for liver cancer costs of €8.18M and €612.49M in the Netherlands and France, respectively. CONCLUSIONS: Policy measures tackling primary risk factors for CLD and liver cancer, such as the implementation of a MUP of €1 and/or a MUP of €0.70 plus SSB tax could markedly reduce the number of Europeans with CLD or liver cancer. IMPACT AND IMPLICATIONS: Policymakers must be aware that alcohol and obesity are the two leading risk factors for chronic liver disease and liver cancer in Europe and both are expected to increase in the future if no policy interventions are made. This study assessed the potential of different public health policy measures to mitigate the impact of alcohol consumption and obesity on the general population in three European countries: France, the Netherlands, and Romania. The findings support introducing a €1 minimum unit price for alcohol to reduce the burden of chronic liver disease. In addition, the study shows the importance of targeting multiple drivers of alcohol consumption and obesogenic products simultaneously via a harmonized fiscal policy framework, to complement efforts being made within health systems. These findings should encourage policymakers to introduce such policy measures across Europe to reduce the burden of liver disease. The modeling methods used in this study can assist in structuring similar modeling in other regions to expand on this study's findings.

More than a Nuisance: Implications of Food Marketing for Public Health Efforts to Curb Childhood Obesity.

Fifteen years ago, public health experts urged industry, governments, and advocates to take action to dramatically improve the unhealthy food-marketing environment surrounding children in order to address the global childhood obesity crisis. Since then, research has confirmed that food marketing to children has far-reaching negative effects on their diets and health, takes advantage of adolescent vulnerabilities, and contributes to health disparities. In addition, digital marketing has profoundly changed young people's engagement with brands. Moreover, reliance on industry self-regulation as a solution has proven ineffective. Government-led policies have been more successful, but they remain limited in scope and challenging to adopt and implement. New approaches are necessary to increase public and policy maker awareness that food marketing is more than a nuisance, that it threatens the long-term health of children and adolescents worldwide, and that meaningful governmental action is urgently required to curtail industry's negative impact on young people's well-being.

The science and practice of current environmental risk assessment for gene therapy: a review.

Gene therapy is a fast-growing field showing great potential to treat genetic diseases and cancer. With accelerating gene therapy development and approval, their environment risk assessment (ERA) becomes increasingly important. An ERA is an assessment of the risks to human health and the environment upon exposure to a medicinal product as the result of its release during clinical development or after entering the market. Because ERA is an important component of regulatory submission, drug developers must perform a robust assessment to ensure the safety of unintended persons, animal, plants, microorganisms and environment at large. Global regulations on gene therapy ERA continue to evolve. Gene therapy ERAs are carried out according to general principles as provided in regulatory guidelines for application of clinical trials and marketing authorizations. The current review intends to summarize regulations and content requirements on gene therapy ERA in European Union, the USA and Japan. The approved gene therapy products by EMA and US Food and Drug Administration are analyzed for the critical aspects of their ERAs to provide the current status and practice of gene therapy ERAs by drug developers. For this purpose, the main contents of these gene therapy ERAs are summarized. Critical safety factors of gene therapy ERAs are described. With more experience and knowledge to be accumulated, gene therapy ERAs are expected to be less challenging with commonly used viral vectors.

Safety of recombinant activated factor VII for treatment of breakthrough bleeds in patients with congenital haemophilia A and inhibitors receiving emicizumab prophylaxis: Review of the real-world evidence.

BACKGROUND: Emicizumab is used as a subcutaneous prophylaxis for prevention of bleeding episodes in patients with haemophilia A (HA) with and without inhibitors. While low bleeding rates were observed in clinical trials, patients still experience breakthrough bleeds (BTBs) with emicizumab in the real-world. Current guidelines recommend use of recombinant activated factor VII (rFVIIa) for treatment of BTBs in patients with inhibitors. Due to thrombotic events observed in the HAVEN 1 study, activated prothrombin complex concentrate (aPCC) should be used with caution. OBJECTIVES: The objective of this review is to identify and discuss real-world data on the frequency of BTBs and the safety of concomitant rFVIIa use in patients with inhibitors on emicizumab prophylaxis. METHODS: A search of the following databases was conducted on 15 July 2022: BIOSIS Previews® , Current Contents Search® , Embase® , MEDLINE® . Search terms included 'real world', 'haemophilia A', and 'emicizumab'. RESULTS AND CONCLUSIONS: Eleven relevant publications were identified (seven original research articles and four congress abstracts). The frequency of BTBs specifically for HA patients with inhibitors was described in three publications with 5%-56% patients on emicizumab reporting ≥1 bleeding episode. Treatment of these BTBs appeared to be managed according to relevant guidelines. Importantly, no thrombotic complications occurred during concomitant rFVIIa use. Due to the nature of real-world studies, direct comparison of the results between studies is limited. However, real-world data show that BTBs in inhibitor patients during emicizumab prophylaxis can be safely treated with rFVIIa.

Using Eye tracking to Examine Young Adults' Visual Attention to E-cigarette Advertising Features and Associated Positive E-cigarette Perceptions.

BACKGROUND: Little is known about the influence of e-cigarette marketing features on the antecedents of e-cigarette use. PURPOSE: Using an eye-tracking experiment, we examined visual attention to common features in e-cigarette ads and its associations with positive e-cigarette perceptions among young adults. METHODS: Young adults (ages 18-29) who smoke cigarettes (n = 40) or do not use tobacco (n = 71) viewed 30 e-cigarette ads on a computer screen. Eye-tracking technology measured dwell time (fixation duration) and entry time (time to first fixation) for 14 pre-defined ad features. Participants then completed a survey about perceptions of e-cigarettes shown in the ads. We used regression models to examine the associations between ad features and standardized attention metrics among all participants and by tobacco-use status and person-aggregated standardized attention for each ad feature and positive e-cigarette perceptions. RESULTS: Dwell time was the longest for smoker-targeted claims, positive experience claims, and price promotions. Entry time was the shortest for multiple flavor descriptions, nicotine warnings, and people. Those who do not use tobacco had a longer dwell time for minor sales restrictions and longer entry time for purchasing information than those who smoke. Longer dwell time for multiple flavor descriptions was associated with e-cigarette appeal. A shorter entry time for fruit flavor description was associated with positive e-cigarette-use expectancies. CONCLUSIONS: Young adults allocated attention differently to various e-cigarette ad features, and such viewing patterns were largely similar by tobacco-use statuses. Multiple or fruit flavors may be the features that contribute to the positive influence of e-cigarette marketing among young adults.

E-cigarette marketing exposure is associated with e-cigarette use among young adults. However, little is known about the influence of e-cigarette marketing features among this population. This study used eye-tracking technology to objectively measure dwell time and entry time for 14 pre-defined e-cigarette ad features. Young adults (ages 18­29) who smoke cigarettes (n = 40) or do not use tobacco (n = 71) viewed 30 e-cigarette ads on a computer screen and completed an online survey about positive e-cigarette perceptions. The study found that dwell time was the longest for smoker-targeted claims, positive experience claims, and price promotions. Entry time was the shortest for multiple flavor descriptions, nicotine warnings, and people. Those who do not use tobacco had a longer dwell time for minor sales restrictions and longer entry time for purchasing information than those who smoke. Longer dwell time for multiple flavor descriptions was associated with e-cigarette appeal. A shorter entry time for fruit flavor description was associated with positive e-cigarette-use expectancies. The results suggest that young adults allocated attention differently to various e-cigarette ad features, and such viewing patterns were largely similar by tobacco-use statuses. Multiple or fruit flavors may be the features that contribute to the positive influence of e-cigarette marketing among young adults.

The Use of Social Marketing in Community-Wide Physical Activity Programs: A Scoping Review.

BACKGROUND: Previous community-wide physical activity trials have been criticized for methodological limitations, lack of population-level changes, and insufficient reach among underserved communities. Social marketing is an effective technique for community-wide behavior change and can coincide with principles of community-based participatory research (CBPR). PURPOSE: A systematic scoping review of community-wide interventions (system-level) targeting physical activity and/or weight loss was conducted to (i) describe and critically discuss how social marketing strategies are implemented; (ii) identify which populations have been targeted, including underserved communities; (iii) evaluate the use of CBPR frameworks; (iv) assess retention rates; and (v) identify gaps in the literature and formulate future recommendations. METHODS: Eligible studies included those that: aimed to improve physical activity and/or weight loss on a community-wide level, used social marketing strategies, and were published between 2007 and 2022. RESULTS: Approximately 56% of the studies reported a positive impact on physical activity. All studies described social marketing details in alignment with the five principles of social marketing (product, promotion, place, price, and people). Only two studies explicitly identified CBPR as a guiding framework, but most studies used one (k = 8, 32%) or two (k = 12, 48%) community engagement strategies. Few studies included at least 50% representation of African American (k = 2) or Hispanic (k = 3) participants. CONCLUSIONS: This review highlights key gaps in the literature (e.g., lack of fully-developed CBPR frameworks, reach among underserved communities, randomized designs, use of theory), highlights examples of successful interventions, and opportunities for refining community-wide interventions using social marketing strategies.

The purpose of this study was to conduct a systematic scoping review of community-wide interventions targeting physical activity and/or weight loss to describe how social marketing strategies have been implemented, identify which populations have been targeted, evaluate the use of Community-Based Participatory Research (CBPR) frameworks, assess retention rates and identify gaps in the literature and formulate future recommendations. Over half of the studies reported a positive impact on physical activity. All studies described social marketing details in alignment with the five principles of social marketing (product, promotion, place, price, and people). Only two studies explicitly identified CBPR as a guiding framework, but most studies used one or two community engagement strategies. Few studies included at least 50% representation of African American or Hispanic participants. Many of the programs provided health information on the benefits of being active (e.g., educational lessons), behavioral strategies (e.g., walking with friends and family), or opportunities to increase walking and physical activity (e.g., community activities, walking clubs, maps for walking or biking, gardening). A number of the programs also addressed environmental facilitators for walking such as utilizing signage for stair use, accessing parks, or participating in community walking groups. Overall this review highlights key gaps in the literature (e.g., lack of fully-developed CBPR frameworks, reach among underserved communities, randomized designs, use of theory), and highlights examples of successful interventions, and opportunities for refining community-wide interventions using social marketing strategies.

Effects of marketing claims on toddler food products on parents' product preferences, perceptions and purchasing intentions: an online experiment.

BACKGROUND: The retail market for toddler-specific packaged foods is growing. Many of these products are ultra-processed and high in nutrients of concern for health, yet marketed in ways that may make them appear wholesome. This study aims to assess parents' responses to claims on unhealthy, ultra-processed toddler food products and test whether removing such claims promotes more accurate product perceptions and healthier product preferences. METHODS: Parents of toddlers aged 12 to < 36 months (N = 838) were recruited for an online experiment testing four on-pack claim conditions: control (no claim); 'contains "good" ingredient'; 'free from "bad" ingredient'; and unregulated 'child-related' claim. Participants were randomly assigned to one condition, then viewed images of toddler food products that varied in nutrition content and the claims displayed. Participants completed tasks assessing product preferences (unhealthy product displaying claim vs. a healthier option with no claim, across four food categories (banana bars, strawberry snacks, blueberry yogurt snacks and veggie snacks)), purchase intentions and product perceptions. Poisson regression (count variable) and linear regression (continuous outcomes) analyses were employed to test for mean differences by marketing claim conditions. RESULTS: For the overall sample, brief exposure to 'free from "bad" ingredient' claims increased participant's intentions to purchase unhealthy food products for their toddlers, but there was no clear evidence that 'contains "good" ingredient' claims and 'child-related' claims significantly impacted parent's preferences, purchase intentions and perceptions of toddler foods. However, certain claims influenced particular parent subgroups. Notably, parents with three or more children chose more unhealthy products when these products displayed 'contains "good" ingredient' or 'free from "bad" ingredient' claims; the latter claims also promoted stronger purchase intentions and enhanced product perceptions among this subgroup. CONCLUSIONS: Findings indicate that 'free from "bad" ingredient' claims on unhealthy toddler foods are of most concern, as they boost the appeal of these products to parents. 'Contains "good" ingredient' claims and 'child-related' claims showed limited effects in this study. Considering available evidence, we recommend claims should not be permitted on child-oriented foods, as they may promote inaccurate product perceptions and unhealthy product choices by parents, that can detract from their children's diets and health.

#junkfluenced: the marketing of unhealthy food and beverages by social media influencers popular with Canadian children on YouTube, Instagram and TikTok.

BACKGROUND: Marketing of unhealthy foods to children on digital media significantly impacts their dietary preferences and contributes to diet-related noncommunicable diseases. Canadian children spend a significant amount of time on digital devices and are frequently exposed to unhealthy food marketing on social media, including by influencers with celebrity status who endorse products. This study aimed to examine the frequency, healthfulness, and power of unhealthy food marketing in posts by influencers popular with Canadian children on YouTube, Instagram and TikTok. METHODS: The top 9 influencers popular amongst Canadian children aged 10-12 years were identified from the 2021 International Food Policy Study Youth Survey. A total of 2,232 Instagram, YouTube and TikTok posts made by these influencers between June 1st 2021 and May 31st 2022 were examined for instances of food marketing. Food products/brands were identified and frequencies were calculated for the number of posts promoting food products/brands, posts promoting products/brands classified as less healthy according to Health Canada's Nutrient Profile Model (2018) and marketing techniques utilized. RESULTS: YouTube had the highest average rate of food marketing instances per post, at a rate of 1 food marketing instance every 0.7 posts, while TikTok and Instagram had instances every 10.2 posts and 19.3 posts, respectively. Overall, fast food restaurants was the most promoted food category (21%), followed by regular soft drinks (13%), snacks (11%), candy and chocolate (11%) and water (8%). The most frequently used marketing techniques were appeals to fun/cool (37%), the use of songs or music (28%) and the product being consumed (25%). In terms of healthfulness, 83% of the products/brands (87% of brands and 82% of products) promoted were classified as less healthy. CONCLUSIONS: Social media influencers play a substantial role in promoting unhealthy food products to children, primarily fast food items. Given the significant impact of such marketing on children, there is a need for ongoing government-led monitoring, and it is crucial to include social media and influencer marketing in marketing restrictions targeting children in Canada to safeguard this vulnerable demographic.

Food environment research in Canada: a rapid review of methodologies and measures deployed between 2010 and 2021.

Numerous research methodologies have been used to examine food environments. Existing reviews synthesizing food environment measures have examined a limited number of domains or settings and none have specifically targeted Canada. This rapid review aimed to 1) map research methodologies and measures that have been used to assess food environments; 2) examine what food environment dimensions and equity related-factors have been assessed; and 3) identify research gaps and priorities to guide future research. A systematic search of primary articles evaluating the Canadian food environment in a real-world setting was conducted. Publications in English or French published in peer-reviewed journals between January 1 2010 and June 17 2021 and indexed in Web of Science, CAB Abstracts and Ovid MEDLINE were considered. The search strategy adapted an internationally-adopted food environment monitoring framework covering 7 domains (Food Marketing; Labelling; Prices; Provision; Composition; Retail; and Trade and Investment). The final sample included 220 articles. Overall, Trade and Investment (1%, n = 2), Labelling (7%, n = 15) and, to a lesser extent, Prices (14%, n = 30) were the least studied domains in Canada. Among Provision articles, healthcare (2%, n = 1) settings were underrepresented compared to school (67%, n = 28) and recreation and sport (24%, n = 10) settings, as was the food service industry (14%, n = 6) compared to grocery stores (86%, n = 36) in the Composition domain. The study identified a vast selection of measures employed in Canada overall and within single domains. Equity-related factors were only examined in half of articles (n = 108), mostly related to Retail (n = 81). A number of gaps remain that prevent a holistic and systems-level analysis of food environments in Canada. As Canada continues to implement policies to improve the quality of food environments in order to improve dietary patterns, targeted research to address identified gaps and harmonize methods across studies will help evaluate policy impact over time.

Countering online marketing and user endorsements with enhanced cannabis warning labels: An online experiment among at-risk youth and young adults.

As cannabis legalization expands and online marketing intensifies, this study examines whether online social cues can amplify youth-targeted cannabis advertising and whether cannabis warning labels (CWLs) can counteract these influences. A U.S. online sample of 970 adolescents and 1776 young adults susceptible to cannabis use were recruited from Qualtrics in summer 2022. Each participant was randomly assigned to one of the 3 (CWLs: none vs. textual vs. pictorial) by 3 (comments: none vs. anti-cannabis vs. pro-cannabis) conditions in an online experiment. Participants were exposed to three online marketing posts promoting marijuana edibles (randomly selected from a large pool, N = 1260), each with either no warning label, a textual warning, or a pictorial warning (text and picture), and with either five comments (pro- or anti-cannabis in valence) or none. Results showed that among adolescents, pro-cannabis comments increased product appeal (vs. anti-cannabis comments: b = 0.18, p = .025; vs. no comments: b = 0.21, p = .021), and did so more than young adults. For adolescents, only pictorial warnings reduced product appeal (b = -0.20, p = .028). For young adults, both pictorial (b = -0.18, p = .002) and textual warnings (b = -0.12, p = .029) reduced product appeal. Furthermore, both textual (adolescents: b = -0.20, p = .004; young adults: b = -0.15, p = .005) and pictorial (adolescents: b = -0.30, p < .001; young adults: b = -0.18, p = .001) warnings reduced cannabis use intentions. Findings support requiring enhanced CWLs accompany online marketing ads.

Analytical Methods for Comparing Uncontrolled Trials with External Controls from Real-World Data: a Systematic Literature Review and Comparison to European Regulatory and Health Technology Assessment Practice.

OBJECTIVES: To provide an overview of analytical methods in scientific literature for comparing uncontrolled medicine trials to external controls from individual patient-level real-world data (IPD-RWD). In addition, to compare these methods with recommendations made in guidelines from European regulatory and health technology assessment (HTA) organizations and with their evaluations described in assessment reports. METHODS: A systematic literature review (until March 1st 2023) in PubMed and Connected Papers was performed to identify analytical methods for comparing uncontrolled trials with external controls from IPD-RWD. These methods were compared descriptively to methods recommended in method guidelines and encountered in assessment reports of the European Medicines Agency (2015-2020) and four European HTA organizations (2015-2023). RESULTS: Thirty-four identified scientific articles described analytical methods for comparing uncontrolled trial data to IPD-RWD-based external controls. The various methods covered controlling for confounding and/or dependent censoring, correction for missing data; and analytical comparative modelling methods. Seven guidelines also focused on research design, RWD quality and transparency aspects, and four of those recommended analytical methods for comparisons with IPD-RWD. The methods discussed in regulatory (n=15) and HTA (n=35) assessment reports were often based on aggregate data and lacked transparency due to the few details provided. CONCLUSION: Literature and guidelines suggest a methodological approach to comparing uncontrolled trials with external controls from IPD-RWD similar to target trial emulation, using state-of-the-art methods. External controls supporting regulatory and HTA decision-making were rarely in line with this approach. Twelve recommendations are proposed to improve the quality and acceptability of these methods.

Impact on species' online attention when named after celebrities.

Celebrities can generate substantial attention and influence public interest in species. Using a large-scale examination of publicly available data, we assessed whether species across 6 taxonomic groups received more page views on Wikipedia when the species was named after a celebrity than when it was not. We conducted our analysis for 4 increasingly strict thresholds of how many average daily Wikipedia page views a celebrity had (1, 10, 100, or 1000 views). Overall, we found a high probability (0.96-0.98) that species named after celebrities had more page views than their closest relatives that were not named after celebrities, irrespective of the celebrity threshold. The multiplicative effect on species' page views was larger but more uncertain as celebrity page-view thresholds increased. The range for thresholds of 1 to 1000 was 1.08 (95% credible interval [CI] 1.00-1.18) to 1.76 (95% CI 0.96-2.80), respectively. The hierarchical estimates for the taxa tended to be positive. The strongest effects were for invertebrates, followed by amphibians, reptiles, fish, and mammals, whereas the weakest effect was for birds at lower page-view thresholds. Our results suggest that naming species after celebrities could be particularly significant for those belonging to taxonomic groups that are generally less popular than others (e.g., invertebrates). Celebrities may further influence the effectiveness of this marketing strategy, depending on their likability and connection to the species named after them. Eponyms may serve as a reminder of the disproportionate power dynamics between populations and some namesakes' untenable actions. However, they also provide an opportunity to recognize remarkable individuals and promote equity, inclusivity, and diversity in taxonomic practice. We encourage taxonomists to examine whether naming threatened species after celebrities could affect conservation support, especially for species that are otherwise typically overlooked by the public.

Impacto sobre la atención virtual de una especie si lleva el nombre de una celebridad Resumen Las celebridades pueden generar atención considerable e influir sobre el interés público por las especies. Usamos un análisis a gran escala de datos con disponibilidad pública para evaluar si las especies de seis grupos taxonómicos recibían más visitas en Wikipedia cuando el nombre de la especie provenía del de una celebridad que cuando no. Realizamos nuestro análisis en cuatro umbrales cada vez más estrictos de cuántas visitas diarias en promedio tenía la página de Wikipedia de una celebridad (1, 10, 100 or 1000 visitas). En general, descubrimos una probabilidad alta (0.96­0.98) de que las especies con nombres de celebridades tuvieran más visitas que sus parientes más cercanos que no tenían un nombre así, sin importar el umbral de la celebridad. El efecto multiplicativo sobre las visitas a la página de la especie fue mayor pero más incierto si incrementaba el umbral de visitas de la celebridad. El rango para los umbrales de 1 a 1000 fue de 1.08 (95% intervalo creíble [IC] 1.00­1.18) a 1.76 (95% IC 0.96­2.80) respectivamente. Los estimados jerárquicos para los taxones tuvieron una tendencia positiva. Los efectos más fuertes se presentaron en los invertebrados, seguidos de los anfibios, reptiles, peces y mamíferos, mientras que el efecto más débil fue para las aves en los umbrales de menor número de visitas. Nuestros resultados sugieren que nombrar a una especie con el nombre de una celebridad podría ser particularmente importante para aquellas que pertenecen a grupos taxonómicos que generalmente suelen ser menos populares que otros (invertebrados). Las celebridades podrían influir todavía más en la efectividad de esta estrategia de marketing, dependiendo de su popularidad y la conexión con la especie que lleva su nombre. Los epónimos pueden funcionar como recordatorios de las dinámicas disparejas de poder entre las poblaciones y las acciones indefendibles de algunos homónimos. Sin embargo, los epónimos también proporcionan la oportunidad para reconocer individuos destacados y promover la equidad, inclusividad y diversidad en la práctica taxonómica. Alentamos a que los taxónomos analicen si nombrar a una especie amenazada con el nombre de una celebridad podría afectar el apoyo a su conservación, especialmente para las especies que de otra manera suelen ser ignoradas por el público.

Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis: post-marketing surveillance study.

BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We aimed to identify the safety and effectiveness of tofacitinib in patients with UC in routine clinical settings in Korea. METHODS: This open-label, observational, prospective, post-marketing surveillance study was conducted at 22 hospitals in the Republic of Korea. Patients with moderate to severe active UC who received tofacitinib were included and followed up for up to 52 weeks. Tofacitinib was administered at a dosage of 10 mg twice daily for at least 8 weeks, followed by 5 or 10 mg twice daily at the investigator's discretion based on clinical evaluation according to the approved Korean label. Safety including adverse events (AEs) and effectiveness including clinical remission, clinical response, and endoscopic mucosal healing were evaluated. Safety analysis set was defined as all patients registered for this study who received at least one dose of tofacitinib according to the approved Korean label and followed up for safety data. Effectiveness analysis set included patients in the safety analysis set who were evaluated for overall effectiveness assessment and excluded patients who had received tofacitinib less than 8 weeks. RESULTS: A total of 110 patients were enrolled, of whom 106 patients were included in the safety population. The median duration of treatment was 370 days and the treatment duration ranged from 16 to 684 days for the safety population. AEs occurred in 42 patients (39.6%). Serious AEs (SAEs) occurred in 7 patients (6.6%) and of them, there were 2 cases of serious infections. These serious infections were reported as Adverse Event of Special Interest (AESI) in this study and no other AESI were reported. There were no cases of death during the study period. Clinical remission rates were 40.0%, 46.7%, 57.6%, and 55.1% at 8, 16, 24, and 52 weeks, and clinical response rates were 77.8%, 87.9%, 56.6%, and 81.4% at each visit, respectively. Endoscopic mucosal healing rates were 58.7% at 16 weeks and 46.2% at 52 weeks. CONCLUSION: Tofacitinib was effective in Korean patients with moderate to severe active UC and the safety findings were consistent with the known safety profile of tofacitinib. This study confirmed the safety and effectiveness of tofacitinib in Korean patients with moderate to severe active UC in routine clinical settings. TRIAL REGISTRATION: This study is registered in the ClinicalTrials.gov under the identifier NCT04071405, registered on 28 August 2019.

Decoding Vaping: Empowering Youth through Media Literacy Based E-Cigarette Educational Program.

INTRODUCTION: E-cigarette industry's marketing and social media efforts have promoted adolescent vaping. We developed and pilot-tested an anti-vaping media literary program - MediaSense. METHODS: In addition to employing the Community-Based Participatory Research approach for program development, we applied a prospective, interventional, and single-arm design to assess the impact of MediaSense among students from five middle and high schools. Data were collected through REDCap surveys administered before and after the intervention. We performed generalized linear mixed models and median analysis to evaluate changes in vaping media literacy (i.e., Authors and Audiences [vAA], Messages and Meanings [vMM], and Representation and Reality [vRR]), knowledge, harm perception, and susceptibility to e-cigarette use before and after the intervention. RESULTS: A total of 384 students aged 11-18 years completed the pre-post survey assessment. After the intervention, students exhibited significantly improved vaping media literacy across all three domains (vAA,fold change [FC]=150%, p<0.0001; vMM, FC=143%, p<0.0001; vRR, FC=133%, p=0.0007). The intervention was associated with a reduction of vaping susceptibility (adjusted odds ratio [AOR]=0.7, p=0.04) and improvement in harm perception (AOR=1.6, p=0.009), knowledge of flavored e-cigarettes (AOR=4.4, p<0.0001) and Tobacco 21 policy (AOR=6.2, p<0.0001). Further mediation analysis unveiled the pathway of the intervention on reduction of vaping susceptibility through media literacy (ßindirect=-0.03, p=0.003) and harm perception enhancement (ßindirect=-0.02, p=0.03). CONCLUSION: The MediaSense program showed promise in vaping prevention among adolescents by reducing vaping susceptibility. Comprehensive vaping media literacy education, especially interventions aimed at decoding misleading marketing information and addressing emerging marketing themes, provides valuable evidence in curbing adolescent vaping. IMPLICATIONS: MediaSense (Media Education for Sensible Evaluation and Nurturing Substance-free Experiences) represents a promising e-cigarette education program designed for adolescent vaping prevention. The findings of this study highlight the positive impact of the program on media literacy, harm perception, and knowledge of tobacco control policies.

Recognition of online e-cigarette marketing and e-cigarette-related attitudes and behaviors among young adults.

INTRODUCTION: Past research examining the relationship between exposure to online e-cigarette marketing and e-cigarette-related attitudes and behaviors has relied on unaided recall measures that may suffer from self-report bias. To date, few studies have presented participants with e-cigarette marketing stimuli and assessed recognition. This study examined the associations between recognition of online e-cigarette marketing stimuli and e-cigarette-related attitudes and behaviors among young adults in California. METHODS: A non-probability representative sample of young adults (ages 18-24; N=1500) living in California completed an online survey assessing their recognition of online e-cigarette marketing stimuli, including image-based (i.e., Instagram, email) and audiovisual (i.e., YouTube, TikTok) promotions, and positive e-cigarette-related attitudes (e.g., appeal of e-cigarettes) and behaviors (e.g., e-cigarette use). Adjusted and weighted logistic regression analyses were used. RESULTS: 79.0% (n=1185) of young adults, including 78.1% (n=310/397) of participants under 21 years old, recognized online e-cigarette marketing. Participants who reported recognition of stimuli, compared with those who did not, had greater odds of reporting appeal of e-cigarettes (AOR=2.26, 95% CI=1.65-3.09) and e-cigarette purchase intentions (AOR=1.66, 95% CI=1.13-2.43) among all participants, and susceptibility to use e-cigarettes among never users (AOR=2.29, 95% CI=1.59-3.29). CONCLUSIONS: Young adults in California recognized audiovisual and image-based online e-cigarette marketing. Such recognition may lead to positive e-cigarette-related attitudes and behavioral intentions, especially among never users. Future research should examine the causal relationship between the associations found in this study. Findings may inform the development and evaluation of psychometrically valid measures of online e-cigarette marketing exposures. IMPLICATIONS: Recognition of online e-cigarette marketing stimuli was associated with greater odds of reporting appeal and benefits of e-cigarettes, purchase intentions, and lifetime e-cigarette use among all participants, and susceptibility to use e-cigarettes among never users. These findings may motivate the development and evaluation of psychometrically valid measures of online e-cigarette marketing exposures.

Harmonizing regulatory market approval of products with high safety requirements: Evidence from the European pharmaceutical market.

We causally analyzed whether being a member of the European Union (EU) and having access to a centralized marketing authorization procedure (centralized procedure [CP]) affects availability and time to launch of new pharmaceuticals. We employed multiple difference-in-differences models, exploiting the eastern enlargement of the EU as well as changes in the indications that fall within the compulsory or voluntary scope of the CP. Results showed that countries experienced a mean decrease in launch delay of 10.9 months (p = 0.004) after joining the EU. Effects were higher among pharmaceuticals that belong to indications that might voluntarily participate in the CP but are not obliged to. These are often financially less attractive to manufacturers than pharmaceuticals within the compulsory scope. Availability of new pharmaceuticals launched remained unaffected. We found signs that the magnitude of the country-specific effect of centralized marketing authorization on launch delay may be influenced by strategic decisions of manufacturers at the national level (e.g., parallel trade or reference pricing).

Safety and effectiveness of clofarabine in Japanese patients with relapsed/refractory acute lymphoblastic leukaemia: a post-marketing surveillance study.

OBJECTIVE: Clofarabine is used to treat acute lymphoblastic leukaemia, but evidence of its safety and effectiveness in Japanese patients is limited. We evaluated the safety and effectiveness of clofarabine in patients with relapsed/refractory acute lymphoblastic leukaemia in real-world clinical practice in Japan. METHODS: An observational, multicenter, post-marketing, all-case surveillance was conducted for safety. Effectiveness analyses were conducted in patients aged ≤21 years and those treated with clofarabine monotherapy and combination therapy (clofarabine plus etoposide and cyclophosphamide). RESULTS: In the all-case survey, 260 of 264 registered patients were eligible for safety analysis. Among the 225 patients eligible for effectiveness analysis, 139 were aged ≤21 years. For monotherapy and combination therapy, 20/31 and 34/88 patients were eligible, respectively. In the all-case survey, the median age was 16.0 years, and 47.7% of patients were <15 years old. Adverse drug reaction incidence was 83.5% and the most common were hematologic toxicities. The best overall response rates in the population aged ≤21 years were complete remission, 29.7%; complete remission without platelet recovery, 7.3% and partial remission, 10.9%. The rest (52.2%) were classified as ineffective. The sum of complete remission, complete remission without platelet recovery and partial remission rates (effectiveness rate) was 47.8% (66/138 patients). The effectiveness rates in the monotherapy and combination therapy surveys were 10.0% (2/20 patients) and 58.8% (20/34 patients), respectively. CONCLUSIONS: These post-marketing surveys provide real-world evidence of the safety and effectiveness of clofarabine regimens, including monotherapy and combination therapy in Japanese patients with relapsed/refractory acute lymphoblastic leukaemia. The safety and effectiveness profiles were comparable with those of previous prospective studies.

Real-world safety of nivolumab in patients with malignant pleural mesothelioma in Japan: post-marketing surveillance study.

OBJECTIVE: This post-marketing surveillance (PMS) was conducted to evaluate the incidence of adverse events with nivolumab in patients with unresectable, advanced or recurrent malignant pleural mesothelioma (MPM) that had progressed after first-line chemotherapy and to identify factors that potentially affected its safety in real-world clinical practice. METHODS: Patients who had not received nivolumab previously were registered between November 2018 and February 2021. Nivolumab was given intravenously 240 mg every 2 weeks or 480 mg every 4 weeks. Patients were followed up for 6 months after treatment initiation. Information on patient characteristics, treatment status, and adverse events was collected. RESULTS: This PMS enrolled 124 patients, involving 48 sites across Japan. At 6 months, nivolumab therapy was ongoing in 35.5% of patients (44/124) and had been discontinued in 64.5% (80/124). The overall incidence of treatment-related adverse events (TRAEs) was 40.3%; the incidence of Grade 3 or higher TRAEs was 12.9%. The pattern of TRAEs based on System Organ Class categories was generally consistent with those seen in the Japanese phase II MERIT study. The most common Grade 3 or higher TRAEs were interstitial lung disease (2.4%), lung disorder, and diarrhea (each 1.6%). The incidence of TRAEs was significantly higher in inpatients or patients who had good PS, high bodyweight, high body mass index, or autoimmune diseases than in those without these characteristics. CONCLUSION: The post-marketing incidence of TRAEs with nivolumab in patients with MPM has been evaluated, and no new safety signals were identified compared to the phase II clinical trial in Japan.