Naturally leading: a content analysis of terms, themes and word associations in Natural American Spirit advertising, 2000–2020

BackgroundNatural American Spirit (NAS) is a cigarette brand distinguished by supposed ‘natural’, ‘additive-free’ characteristics, marketing of which is tied to misperceptions of reduced harm. In 2017, NAS’s manufacturer agreed (with the Food and Drug Administration) to remove ‘natural’/‘additive-free’ from US marketing. Prior research has explored NAS marketing immediately post-agreement. This study sought to identify prominent post-agreement terms and themes and analyse how they had been used in pre-agreement ads.MethodsWe conducted a content analysis of NAS ads from 2000 to 2020 (N=176), documenting prominent pre-agreement and post-agreement terms/themes and examining how they are used in NAS ads. We coded for descriptors, themes, imagery and promotions, and extended prior research by analysing how leading post-agreement terms were used in conjunction and thematically associated with ‘additive-free’ and ‘natural’ before the agreement.ResultsResults indicated ‘tobacco and water’ and ‘Real. Simple. Different.’ increased post-agreement, as did environmental imagery. ‘Organic’ was prominent pre-agreement and post-agreement. The descriptors used most often in post-agreement ads almost always appeared in conjunction with (and were thematically linked to) ‘natural’ and ‘additive-free’ in pre-agreement ads.ConclusionsIn the years since the agreement, NAS ads have heavily relied on still-allowable descriptors that may invite reduced risk misperceptions. Notably, these descriptors were consistently used alongside the banned terminology before the agreement and presented as if affiliated conceptually, possibly prompting similar connotations. Findings indicate a continuing need for research into NAS advertising effects and a potential role for additional regulatory action.

Diverse psychotropic substances detected in drug and drug administration equipment samples submitted to drug checking services in Toronto, Ontario, Canada, October 2019–April 2020

Background The overdose crisis has generated innovative harm reduction and drug market monitoring strategies. In Toronto, Ontario, Canada, a multi-site drug checking service (DCS) pilot project was launched in October 2019. The project provides people who use drugs with information on the chemical composition of their substances, thereby increasing their capacity to make more informed decisions about their drug use and avoid overdose. DCS also provides real-time market monitoring to identify trends in the unregulated drug supply. Methods Sample data were obtained through analyses of drug and used drug administration equipment samples submitted anonymously and free of charge to DCS in downtown Toronto from October 10, 2019, to April 9, 2020, representing the first six months of DCS implementation. Analyses were conducted in clinical laboratories using liquid chromatography- and/or gas chromatography-mass spectrometry (LC–MS, GC–MS) techniques. Results Overall, 555 samples were submitted, with 49% (271) of samples that were found to contain high-potency opioids, of which 87% (235) also contained stimulants. Benzodiazepine-type drugs were found in 21% (116) of all samples, and synthetic cannabinoids in 1% (7) of all samples. Negative effects (including overdose, adverse health events, and extreme sedation) were reported for 11% (59) of samples submitted for analysis. Conclusions Toronto’s DCS identified a range of high-potency opioids with stimulants, benzodiazepine-type drugs, and a synthetic cannabinoid, AMB-FUBINACA. This information can inform a range of evidence-informed overdose prevention efforts.

Flavour spectrum of the Puff family of disposable e-cigarettes

BackgroundIn January 2020, the US Food and Drug Administration prohibited the sale of flavours (except for menthol and tobacco) in prefilled pod devices such as JUUL to decrease youth vaping. Excluded from the prohibition were disposable devices.ObjectivesTo determine the scope and scale of flavours marketed by Puff Bar, a leading disposable brand, and related products.MethodsDisposable e-cigarette flavours were identified via online searches encompassing vendor websites, wholesale distributors, manufacturers (eg, made-in-china.com), and social media channel, Instagram, between June and August 2020.ResultsThe ‘Puff’ brand name and iconic cloud logo appear on a variety of products of differing sizes and nicotine e-liquid volumes. Among Puff Bar and its copycats (Puff-a-Likes), 139 flavours were identified. Fruit flavours predominated comprising 82.2% of the flavour varieties (fruit 50%, fruit and menthol/mint 23.6%, and fruity drinks 8.6%). A prevalent new flavour category which combines fruit with menthol/mint (Ice) was offered in 33 varieties such as Lychee Ice, Lush Ice and Banana Ice. Disposable e-cigarette brands are undertaking measures to escape tobacco regulation (eg, non-tobacco-sourced nicotine) and flavour limitations via post-market flavour additions to unflavoured nicotine e-liquid.ConclusionsThe proliferation of flavoured disposable e-cigarette products, many of which are designed to emulate popular pod devices, illustrates that narrowly limited flavour regulations covering only a single category are destined to fail. To be effective in youth protection, flavour regulations need to apply to all recreational nicotine-containing products and need to include measures to counter post-market flavour addition.

Impact of azithromycin mass drug administration on the antibiotic-resistant gut microbiome in children: a randomized, controlled trial

Background Mass drug administration (MDA) with azithromycin is the primary strategy for global trachoma control efforts. Numerous studies have reported secondary effects of MDA with azithromycin, including reductions in childhood mortality, diarrhoeal disease and malaria. Most recently, the MORDOR clinical trial demonstrated that MDA led to an overall reduction in all-cause childhood mortality in targeted communities. There is however concern about the potential of increased antimicrobial resistance in treated communities. This study evaluated the impact of azithromycin MDA on the prevalence of gastrointestinal carriage of macrolide-resistant bacteria in communities within the MORDOR Malawi study, additionally profiling changes in the gut microbiome after treatment. For faecal metagenomics, 60 children were sampled prior to treatment and 122 children after four rounds of MDA, half receiving azithromycin and half placebo. Results The proportion of bacteria carrying macrolide resistance increased after azithromycin treatment. Diversity and global community structure of the gut was minimally impacted by treatment, however abundance of several species was altered by treatment. Notably, the putative human enteropathogen Escherichia albertii was more abundant after treatment. Conclusions MDA with azithromycin increased carriage of macrolide-resistant bacteria, but had limited impact on clinically relevant bacteria. However, increased abundance of enteropathogenic Escherichia species after treatment requires further, higher resolution investigation. Future studies should focus on the number of treatments and administration schedule to ensure clinical benefits continue to outweigh costs in antimicrobial resistance carriage. Trial registration ClinicalTrial.gov, NCT02047981. Registered January 29th 2014, https://clinicaltrials.gov/ct2/show/NCT02047981

Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018

Background Information about the specific regulatory environment of orphan drugs is scarce and inconsistent. Uncertainties surrounding the postmarketing long-term safety of orphan drugs remain. This study aimed to evaluate the labelling changes of orphan drugs and to identify postmarketing safety-associated approval factors. Methods This retrospective cohort study includes all drugs with orphan drug designation approved by the Center for Drug Evaluation and Research of the US Food and Drug Administration between 1999 and 2018. Main outcomes are safety-related labelling changes up to 31 December 2019. We defined any safety-related labelling changes as postmarketing safety events (PMSE). Safety-related withdrawals, suspensions, and boxed warnings were further categorised as severe postmarketing safety events (SPSE). Outcome measurements include frequencies of PMSE, SPSE, and association between approval factors and the occurrence of safety events. Results Amongst the 214 drugs identified with orphan drug designation (25.7% biologics), 83.6% were approved through at least one expedited programme, and 29.4% were approved with boxed warnings. During a median follow-up of 6.74 years since approval, 69.2% and 14.5% of the analysed orphan drugs had PMSE and SPSE, respectively. Safety-related withdrawal (0%, 0/214), suspended marketing (0.46%, 1/214) and new boxed warnings are uncommon (3.7%, 8/214). The safety-related labelling changes were more frequent in the drugs approved with boxed warnings [Incidence rate ratio (IRR): 1.95 (1.02–3.73)] and approved for long-term use [IRR: 2.76 (1.52–5.00)]. Conclusions and Relevance In this long-term postmarketing analysis, approximately 70% of FDA-approved orphan drugs had safety-related labelling changes although severe safety events were rare. While maintaining early access to orphan drugs, the drug regulatory body has taken timely regulatory action with postmarketing surveillance to ensure patient safety.

The attitude of patients with progressive ataxias towards clinical trials

Background The development of new therapies may rely on the conduct of human experimentation as well as later clinical trials of therapeutic interventions. Ethical considerations seek to protect the patient from risk but few have sought to ascertain the attitude to such risk of patients with progressive debilitating or terminal conditions, for which no mitigating or curative therapies exist. Such understanding is also important if recruitment is to be maximized. We therefore sought to define the motivations for and barriers to trial participation amongst patients with progressive ataxias, as well as their condition-specific trial preferences. Methods We conducted an online survey consisting of 29 questions covering four key domains (demographics, personal motivation, drug therapy and study design) relating to the design of clinical trials. Two major ataxia charities, Ataxia UK and the Friedreich’s Ataxia Research Alliance (FARA) sent the survey to their members. Responses were analysed by disease and by ambulatory status. Results Of 342 respondents, 204 reported a diagnosis of Friedreich’s ataxia (FRDA), 55 inherited cerebellar ataxia (CA) and 70 idiopathic CA. The most important symptoms to be addressed by a trial were considered to be balance problems and ambulation, although these were superseded by speech problems in wheelchair users. Common motivations for participation were potential benefits to self and others. Reasons for non-participation included concerns about side effects, and the burden and cost of travel. Financial reimbursement for expenses was reported to be likely to increase trial engagement, Phase two trials were the most popular to participate in, and the use of a placebo arm was seen as a disincentive. Across all disease subgroups, drug repurposing trials proved popular and just under 70% of participants would be prepared to undergo intrathecal drug administration. Conclusions Knowledge of motivations for and barriers to trial participation as well as the acceptability of investigations, time commitments and routes of drug administration should inform better, more patient focused trial design. This in turn may improve recruitment and retention of participants to future trials.

Las vacunas contra la COVID-19, ¿cuál es mejor?

Desde el comienzo de la pandemia por SARS-CoV-2 las vacunas se plantearon como una de las principales estrategias para hacerle frente, debido a esto se inició una carrera en el desarrollo de una vacuna contra la COVID-19. Dicho proceso implica el conocer al agente patógeno de interés, así como el proceso mediante el cual causa enfermedad. Durante el proceso de desarrollo se ponen a prueba las diferentes vacunas en múltiples escenarios pero solo un porcentaje pequeño logra finalizar las diversas etapas. Existen diversos tipos de vacunas, cada una tiene una forma diferente de transportar hacia dentro de la célula al antígeno, o a las partes de este, para inducir una respuesta inmune, y precisamente un dato sorprendente respecto a las vacunas contra COVID-19 es que se están desarrollando bajo una cantidad nunca antes vista de plataformas y tipos de vacunas. Actualmente se desarrollan más de 200 vacunas, pero solo 21 de ellas se encuentran en ensayos clínicos de fase III, cinco de las cuales han sido aprobadas por la COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), tan solo tres por la FDA (Food and Drug Administration) y tres por la EMA (European Medicines Agency). En el presente trabajo se evidencian los resultados de una revisión de la literatura publicada hasta el momento en la base de datos en línea PubMed y el motor de búsqueda Google Academico, todo con el objetivo que fue responder la pregunta ¿Cuál de las vacunas ya aprobadas contra la COVID-19 es la mejor opción?