Is exposure to pharmaceutical direct-to-consumer advertising for heart disease and diabetes associated with physical activity and dietary behavior?

CONTEXT: Scholars have suggested that direct-to-consumer advertising (DTCA) of prescription drugs may discourage or encourage changes in lifestyle to improve health. The current paper informs this debate by examining associations between estimated exposure to DTCA for drugs focused on heart disease/cholesterol and diabetes and self-reported exercise and consumption of a variety of unhealthy foods (candy, sugary drinks, alcohol, and fast food). METHODS: We estimated exposure to DTCA by combining data from Kantar Media Intelligence (Kantar) on televised pharmaceutical DTCA airings in the U.S. from January 2003 to August 2016 (n = 7,696,851 airings) with thirteen years of data from the Simmons National Consumer Survey (Simmons), a mailed survey on television viewing patterns. We estimated associations between exposure to advertising (both overall and for advertisements with specific content) and self-reported physical activity and dietary behavior using Simmons data from January 2004 to December 2016 (n = 288,483 respondents from n = 157,621 unique households in the U.S.). Our analysis controls for many potential confounders including respondent demographics, temporal trends, and program placement to account for purposeful ad targeting to higher-risk adults. FINDINGS: Higher estimated exposure to DTCA for heart disease and diabetes drugs were not consistently associated with meaningful differences in the frequency of engaging in regular physical activity. Greater estimated exposure to DTCA for both diseases were, linked to small but consistently higher volume of consumption of candy, sugar-sweetened beverages, alcohol, and fast food. Specific DTCA message content about diet and exercise explained very little of the observed association between overall DTCA exposure volume and study outcomes. CONCLUSIONS: Many Americans were regularly exposed to pharmaceutical DTCA for heart disease and diabetes from 2003 to 2016. Widespread exposure to such DTCA is associated with higher levels (though small in magnitude) of consuming alcohol, fast food, candy, and sugar-sweetened beverages.

Patient Understanding of Oncology Clinical Trial Endpoints in Direct-to-Consumer Television Advertising.

BACKGROUND: This study examined how people interpret overall survival (OS), overall response rate (ORR), and progression-free survival (PFS) endpoints in the context of direct-to-consumer television ads. Although there is little research on this topic, initial evidence suggests that people can misinterpret these endpoints. We hypothesized that understanding of ORR and PFS would be improved by adding a disclosure ("We currently do not know if [Drug] helps patients live longer") to ORR and PFS claims. METHODS: We conducted 2 online studies with US adults examining television ads for fictional prescription drugs indicated to treat lung cancer (N = 385) or multiple myeloma (N = 406). The ads included claims about OS, ORR with and without a disclosure, or PFS with and without a disclosure. In each experiment, we randomized participants to view 1 of 5 versions of a television ad. After viewing the ad twice, participants completed a questionnaire that measured understanding, perceptions, and other outcomes. RESULTS: In both studies, participants correctly differentiated between OS, ORR, and PFS via open-ended responses; however, participants in the PFS conditions (versus ORR conditions) were more likely to make incorrect inferences about OS. Supporting the hypothesis, adding a disclosure made expectations around living longer and quality-of-life improvements more accurate. CONCLUSION: Disclosures could help reduce the extent to which people misinterpret endpoints like ORR and PFS. More research is needed to establish best-practice recommendations for using disclosures to improve patient understanding of drug efficacy without changing their perception of the drug in unintended ways.

Association Between Drug Characteristics and Manufacturer Spending on Direct-to-Consumer Advertising.

Importance: Some drugs are heavily marketed through direct-to-consumer advertising. Objective: To identify drug characteristics associated with a greater share of promotional spending on advertising directly to consumers. Design, Setting, and Participants: Exploratory cross-sectional analysis of drug characteristics and promotional spending for the 150 top-selling branded prescription drugs in the US in 2020 as identified from IQVIA National Sales Perspectives data. Promotional spending data were provided by IQVIA ChannelDynamics. Exposures: Drug characteristics (total 2020 sales; total 2020 promotional spending; clinical benefit ratings; number of indications, off-label use; molecule type; nature of condition treated; administration type; generic availability; US Food and Drug Administration [FDA] approval year, World Health Organization anatomical therapeutic chemical classification; Medicare annual mean spending per beneficiary; percent sales attributable to the drug; market size; market competitiveness) assessed from health technology assessment agencies (France's Haute Autorité de Santé and Canada's Patented Medicine Prices Review Board) and drug data sources (Drugs@FDA, the FDA Purple Book, Lexicomp, Merative Marketscan Research Databases, and Medicare Spending by Drug data). Main Outcomes and Measures: Proportion of total promotional spending allocated to direct-to-consumer-advertising for each drug. Results: The 2020 median proportion of promotional spending allocated to direct-to-consumer advertising was 13.5% (IQR, 1.96%-36.6%); median promotional spending, $20.9 million (IQR, $2.72-$131 million); and median total sales, $1.51 billion (IQR, $0.97-$2.26 billion). Of the 150 best-selling drugs, 16 were missing data and key covariates; therefore, the primary study sample comprised 134 drugs. After adjustment for multiple drug characteristics, the mean proportion of total promotional spending allocated to direct-to-consumer advertising for the remaining 134 drugs was an absolute 14.3% (95% CI, 1.43%-27.2%; P = .03) higher for those with low added clinical benefit than for those with high added clinical benefit and an absolute 1.5% (95% CI, 0.44%-2.56%; P = .005) higher for each 10% increase in total sales. Conclusions and Relevance: Among top-selling US drugs in 2020, a rating of lower added benefit and higher total drug sales were associated with a higher proportion of manufacturer total promotional spending allocated to direct-to-consumer advertising. Further research is needed to understand the implications of these findings.

Sunscreen Secondary Claims: Market Differentiation or Market Confusion?

This chapter is focused on those products that are sold primarily as sun protection products and considers the additional claims made for these that are intended to differentiate and imply additional benefits. It is essentially an overview, as each claim would require an individual chapter to deal with in detail. We do not consider products with another intended primary use, such as moisturizer or colour comments, which are, in themselves "secondary sunscreens," defined specifically in Australia [AS/NZS 2604:2012 Sunscreen products - Evaluation and classification] or Canada. Primarily, the chapter serves as a reference guide. An argument is presented for the potential negative impact on the credibility of the whole product category brought about by the marketing strategy of attempting to segment on the basis of either criticism of competitor products and/or targeting niche groups of consumers. The European Union (EU) Regulation 655/2013 [Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products] states 6 criteria for representation of products. These are Legal Compliance, Truthfulness, Evidential Support, Honesty, Fairness and Informed Decision Making. More specifically to sunscreens, the EU Synthesis Document makes recommendation on efficacy and related claims [European Union Synthesis Document - Commission recommendation on the efficacy of sunscreen products and claims related thereto]. This chapter does not consider or test these criteria but does include a table of claims and suggested ways to substantiate these.

Impact of Direct-to-Consumer Advertising of Cosmetic Procedures on Consumers.

BACKGROUND: Direct-to-consumer (DTC) advertising is a prominent type of health care communication. OBJECTIVE: This study aims to determine the impact of DTC advertisements on consumer opinion. METHODS: A total of 203 participants were recruited from dermatology clinics at an urban academic center. Participants viewed 2 cosmetically oriented DTC advertisements, and prequestionnaires and postquestionnaires were administered to assess consumer opinion. RESULTS: Postquestionnaire data highlight a 18.8% and 24.6% increase in participants reporting using commercials as an information source (p < .001) and seeking out additional medical knowledge (p < .001), respectively. After watching the advertisements, there was a 14.4% increase in participants who believed advertisements facilitate better discussions between patients and physicians (p < .001) and a 33% increase in patients reporting they would discuss the procedures with their doctors (p < .001). Of the participants, 60% believed the advertisements did not provide enough information about the possible risks of the product and 39.4% believed a physician was not required to perform cosmetic procedures. CONCLUSION: Direct-to-consumer advertisements instill meaningful information to patients and promote patient-physician communication. They also seem to exaggerate the benefits while making the procedures seem simple and without risks, suggesting trained medical professionals are not needed for administration.

Ausência de raça e gênero no enfrentamento da pandemia no Brasil / Absence of race and gender in the fight against the pandemic in Brazil / Falta de raza y género en el enfrentamiento a la pandemia en Brasil

Esta nota discute a ausência dos quesitos cor/raça e gênero nos boletins epidemiológicos da Covid-19 e como essa omissão está articulada ao modo como se operacionaliza o racismo no Brasil. Coloca-se em evidência a apropriação da identidade racial e de gênero por alguns estados brasileiros que ganharam visibilidade midiática, como sendo solidários, ao iniciarem a campanha de vacinação com mulheres negras, grupo social mais vulnerável. É o jogo da dissimulação, em que se evidencia a raça/gênero na aparência, embora essas variáveis não sejam consideradas no enfrentamento da pandemia.

This note discusses the non-inclusion of information about color/race and gender in Covid-19 epidemiological reports and how this omission is related to the way that the racism is operated in Brazil. It highlights the racial and gender identity appropriation by some Brazilian states, which have gained media visibility as sympathetic governments to Black women, by starting the vaccination campaign with them, an extremely vulnerable social group. It is like a confidence trick, in which race and gender are in the spotlight, although these features are not considered in the fight against the pandemic.

Esta nota discute la ausencia de las informaciones sobre cor/raza y género en los boletines epidemiológicos de la Covid-19 y como esa omisión se encuentra articulada al modo en que se opera el racismo en Brasil. Destaca la apropiación de la identidad racial y de género por parte de algunos estados brasileños que han ganado visibilidad mediática, vistos como solidarios, puesto que han iniciado la campaña de vacunación con algunas mujeres negras, el grupo social más vulnerable. Es el juego del disimulo, por lo cual es evidenciada la raza/género en la apariencia, sin embargo esas variables no sean tenidas en cuenta en el enfrentamiento a la pandemia.

Análise da propaganda de medicamentos isentos de prescrição em TV aberta / Analysis of advertising of over-the-counter medicines on open TV

O objetivo deste estudo foi analisar as irregularidades da publicidade de medicamentos isentos de prescrição veiculada em mídia televisiva aberta. Trata-se de um estudo descritivo transversal, no qual duas emissoras da televisão aberta do Rio de Janeiro foram monitoradas durante sete meses. As 90 peças publicitárias coletadas foram transcritas e, posteriormente, analisadas frente à legislação vigente. Todas apresentavam alguma infração, com média de 3,6 infrações por peça. Os grupos farmacológicos mais frequentes foram os analgésicos, anti-inflamatórios, antigripais e antiácidos. Como observado por outros autores, os resultados evidenciam a deficiência no cumprimento da regulamentação e a fragilidade da fiscalização acerca da publicidade de medicamentos isentos de prescrição no Brasil, apontando para a necessidade de mudanças que priorizem a promoção do uso racional de medicamentos.

The objective of this study was to analyze the advertising irregularities of over-the-counter medicines in open television media. This is a descriptive cross-sectional study, in which two open television stations in Rio de Janeiro were monitored for seven months. The 90 pieces of advertising collected were transcribed and, later, analyzed under the current legislation. All had some infraction, with an average of 3.6 infractions per piece. The most frequent pharmacological groups were analgesics, anti-inflammatories, antiflu and antacids. As observed by other authors, the results show the deficiency in the compliance with the regulations and the fragility of the supervision regarding the advertising of over-the-counter medicines in Brazil, pointing to the need for changes that prioritize the promotion of rational use of medicines

From the margins to mainstream: How providers of autologous 'stem cell treatments' legitimise their practice in Australia.

This article examines how Australian providers of unproven autologous 'stem cell treatments' legitimise these products and their practices. We focus on the strategies employed by providers in their efforts to create and sustain a market for procedures that have yet to be proven safe and clinically efficacious. Drawing on the work of Thomas Gieryn and Pierre Bourdieu and the findings of research involving an analysis of direct-to-consumer online advertising of clinics that sell purported 'stem cell treatments' and interviews with clinicians who provide them, we examine the mechanisms by which medical legitimacy for these products is established and defended. We argue that Australian providers employ a number of strategies in order to create medical legitimacy for the use and sale of scientifically unproven therapies. A key strategy employed by providers of stem cell treatments is to use markers of social distinction, drawing strongly on the symbols of science, to confirm their legitimacy and differentiate their own practices from those of other providers, who are posited as operating outside the boundary of accepted practice and hence illegitimate. We argue there is a paradox at the heart of the autologous stem cell treatment market. Providers aim to create legitimacy for their work by emphasising the potential benefits of their 'treatments', their expertise and the professionalisation of their practices in an environment where regulators are yet to take a firm stance; they are also required to undertake the challenging task of managing patients' hopes and expectations that both enable and potentially jeopardise their operations and revenue. We conclude by suggesting that providers' creation of symbolic capital to establish medical legitimacy is a crucial means by which they seek to bring unproven 'stem cell treatments' from the margins of medicine into the mainstream and to portray themselves as medical pioneers rather than medical cowboys who exploit vulnerable patients.

Saborizantes y caracteres de diseño en cigarrillos y productos de tabaco disponibles próximos a centros educativos en Montevideo, Uruguay / Flavour additives and design lettering in cigarettes and tobacco products available close to educational centers in Montevideo, Uruguay / Sabores e características das embalagens de cigarros e produtos de tabaco disponíveis próximos a de centros educativos em Montevidéu, Uruguai

Resumen: Introducción: los productos de tabaco están diseñados para ser atractivos, introduciéndose últimamente elementos aditivos y saborizantes. En Uruguay existen normativas que evitan la publicidad en cualquiera de sus formas, por esto, la atracción del propio producto de tabaco a través de su sabor y diseño es un factor importante para la elección por parte de los fumadores, en particular, jóvenes. Es relevante conocer qué productos se encuentran disponibles en nuestro medio y cuáles son accesibles cerca de centros educativos. Material y método: se realizó un estudio descriptivo, observacional, prospectivo de corte transversal. El protocolo de trabajo de campo se adaptó del Sistema de Vigilancia de paquetes de Tabaco de la Universidad de Johns Hopkins. Resultados: se identificaron 23 variedades. El 34,78% de los productos fueron saborizados, estando disponibles en 86,67% de los puntos de venta. Todas las cajas de los saborizados tenían alguna referencia que indicaba su condición. En la mitad, la marca sugería la presencia de sabor o su activación. El 87,5% de los filtros se referían a la activación del sabor y 37,5% agregaban caracteres tecnológicos para éste; 75% tenía sabor a menta y 24% doble sabor. Solo 39,1% tenía información de protección al menor. Conclusiones e implicancias: hay una gran disponibilidad de productos de tabaco saborizados, incrementado la variedad en los últimos años, siendo en Uruguay menor que en otros países. En ausencia de regulación específica sobre aditivos y saborizantes, los países podrían disminuir la oferta implementando presentación única por marca y prohibición total de la publicidad.

Summary: Introduction: tobacco products are designed to be attractive, and recently, flavour additives have been introduced in the market. In Uruguay, regulations in force prohibit all forms of publicity for these products. For this reason, attracting consumers to tobacco products by means of flavour and design constitutes an important factor in smokers' choice, in particular the young. Learning about products available in our market and those that are close to educational centers is relevant. Method: descriptive, observational, prospective and transversal study. The field work protocol was adapted from the Johns Hopkins University Tobacco Pack Surveillance System Project. Results: 23 varieties were identified. 34.78% of the products were flavoured, and they were available in 86,67% points of sale. All flavoured products' packs included a reference to its condition. In 50% of them, the brand suggested the presence or activation of flavour. 87.5% of filters referred to flavor activation and 37.5% added technological traits. 75% were mint flavoured and 24% were double-flavoured. Only 39.1% included minor protection information. Conclusions: there is great availability of flavoured tobacco products, the variety being greater in recent years, although lower in Uruguay if compared to other countries. In the absence of specific regulations on additives and flavouring substances, countries could reduce the offer by implementing a single presentation by brand and the complete banning of publicity.

Resumo: Introdução: os produtos do tabaco são projetados para serem atraentes, com aditivos e elementos aromatizantes recentemente introduzidos. No Uruguai, existem normas que proíbem a publicidade em qualquer de suas formas, portanto, a atração do próprio produto do tabaco pelo seu sabor e design é um fator importante na escolha dos fumantes, principalmente dos jovens. É importante saber quais produtos estão disponíveis em nosso ambiente e quais estão disponíveis próximos a centros educativos. Material e métodos: foi realizado um estudo transversal descritivo, observacional e prospectivo. O protocolo de trabalho de campo foi adaptado do Sistema de Vigilância de Pacotes de Tabaco da Universidade Johns Hopkins. Resultados: foram identificadas 23 marcas diferentes. 34,78% dos produtos eram aromatizados, estando disponíveis em 86,67% dos pontos de venda. A embalagem de todas as marcas com sabor tinha alguma referência indicando essa característica. A metade delas indicava a presença do sabor ou sua ativação. 87,5% dos filtros referiram-se à ativação do sabor e 37,5% agregaram sus características tecnológicas. 75% tinham sabor mentolado e 24% dois sabores. Apenas 39,1% possuíam informações de proteção à criança. Conclusões e implicações: há uma grande disponibilidade de produtos de tabaco aromatizados, e a variedade tem aumentado nos últimos anos, sendo menor no Uruguai que em outros países. Na ausência de regulamentação específica sobre aditivos e aromatizantes, os países poderiam reduzir a oferta implementando uma apresentação única por marca e a proibição total da publicidade.

XY Gonadal Dysgenesis in a Phenotypic Female Identified by Direct-to-Consumer Genetic Testing.

We report a 16-year-old phenotypic female with 46,XY complete gonadal dysgenesis and metastatic dysgerminoma, unexpectedly discovered through direct-to-consumer (DTC) commercial genetic testing. This case underscores the importance of timely interdisciplinary care, including psychosocial intervention and consideration of gonadectomy, to optimize outcomes for individuals with differences of sex development. Her unique presentation highlights the implications of DTC genetic testing in a new diagnostic era and informs general pediatricians as well as specialists of nongenetic services about the value, capabilities, and limitations of DTC testing.

HPV prevention is not just for girls: an examination of college-age-students' adoption of HPV vaccines.

This study identifies source(s) of information young adults found to be persuasive in choosing/declining HPV vaccines. The results indicate that males are not getting HPV vaccination information from either their physician, parent, or DTC advertising. Females reported that physicians and their mothers were the most influential sources of information. Additionally, females found that risk message frames focusing on empowerment, reduced dread, control and benefit in the DTC HPV vaccine advertisements were persuasive; males did not. With the rapid rise of HPV related cancers found in males, there is a need to inform males and their parents about for HPV vaccines.

Exposure to direct-to-consumer advertising is associated with overestimation of benefits regarding ultrahypofractionated radiation therapy for prostate cancer.

BACKGROUND: While direct-to-consumer (DTC) medical advertising can provide useful information, it also risks oversimplification and being misleading. For an abbreviated prostate cancer treatment regimen called "ultrahypofractionation" (UHF), advertising has been used for CyberKnife (CK), a common delivery system for stereotactic body radiation therapy. We hypothesized that those viewing an advertisement for CK versus factual information would have inaccurate impressions of effectiveness and safety. METHODS: 400 men aged 40-80 were randomly assigned to one of four arms: a de-identified CK advertisement, the same advertisement with disclaimers, scientific information obtained from review of contemporary peer-reviewed literature, and a control. Subjects answered questions regarding risks/benefits of CK and likelihood of pursuing CK versus other treatments. Regression analysis was performed to determine factors associated with CK preference. RESULTS: 400 men were included. Compared to controls, those who viewed any of the three interventions were more likely to pursue CK over other treatments (p < 0.01), with a greater increase in the advertisement groups. Respondents who viewed scientific information were less likely to agree CK is superior regarding impotence and urinary dysfunction. Disclaimers decreased positive impressions of CK's side effects, but not effectiveness. Both advertisement and advertisement with disclaimer respondents were more likely to consider CK superior. CONCLUSIONS: DTC medical advertisements can be misleading and impact laypersons' impressions. In this case, viewing an advertisement created inaccurate impressions regarding effectiveness and safety of UHF for prostate cancer.

Direct-to-Consumer Advertising for Cancer Centers and Institutes: Ethical Dilemmas and Practical Implications.

In the United States, many cancer centers advertise their clinical services directly to the public. Although there are potential public benefits from such advertising, including increased patient awareness of treatment options and improved access to care and clinical trials, there is also potential for harm through misinformation, provision of false hope, inappropriate use of health care resources, and disruption in doctor-patient relationships. Although patient education through advertising is appropriate, misleading patients in the name of gaining market share, boosting profits, or even boosting trial accrual is not. It is critical that rigorous ethical guidelines are adopted and that oversight is introduced to ensure that cancer center marketing supports good patient care and public health interests. Patients with cancer have been identified as an especially vulnerable population because of fears and anxiety related to their diagnosis and the very real need to identify optimal sources of care. Cancer organizations have a fiduciary duty and a moral and legal obligation to provide truthful information to avoid deceptive, inaccurate claims associated with treatment success. In this article, actionable recommendations are provided for both the oncologist and the cancer center's marketing team to promote ethical marketing of services to patients with cancer. This tailored guidance for the oncology community includes explicit communication on (1) ensuring fair and balanced promotion of cancer services, (2) avoiding exaggeration of claims in the context of reputational marketing, (3) providing data and statistics to support direct and implied assertions of treatment success, and (4) defining eligible patient groups in the context of marketing for research. These recommendations for cancer centers are designed to promote ethical quality marketing information to patients with cancer.

Análise ético-jurídica da publicidade odontológica no Instagram / Ethical and legal analysis of Odontology-related advertisement on Instagram

A restrição à publicidade odontológica coíbe a mercantilização, resguarda a privacidade do paciente e o protege como consumidor. O objetivo deste estudo foi avaliar a adequação da publicidade na rede Instagram® ao regramento vigente. Numa amostra de 384 perfis profissionais, avaliaram-se postagens públicas à luz da Lei 5.081/1966, Código de Defesa do Consumidor e Código de Ética Odontológica. A identificação adequada não foi feita por 35,4%. Já 3,6% anunciaram especialidades não reconhecidas. A expressão "popular" foi utilizada por 27,1%. Houve publicidade abusiva (16,4%) ou enganosa (8,3%). Serviços gratuitos foram anunciados (9,4%), com divulgação de preços (5,5%). Usando a imagem do paciente (79,4%), constatou-se divulgação de resultados clínicos (72,9%). Houve identificação do paciente em 68,2%, com uso adequado da imagem em apenas 9,1% dos casos. As imagens de antes/depois foram usadas em 76,6% das postagens. As inadequações sem a imagem do paciente orbitam entre infração ética, exercício profissional ilícito e desrespeito ao direito consumerista. Conclui-se que a publicidade odontológica veiculada no Instagram® apresentou condutas ilícitas e antiéticas, com e sem o uso da imagem do paciente o que pode configurar prejuízos ao paciente, ao profissional e à Odontologia como profissão da área de saúde.

Rogue stem cell clinics.

Cell therapies hold significant promise for the treatment of injured or diseased musculoskeletal tissues. However, despite advances in research, there is growing concern about the increasing number of clinical centres around the world that are making unwarranted claims or are performing risky biological procedures. Such providers have been known to recommend, prescribe, or deliver so called 'stem cell' preparations without sufficient data to support their true content and efficacy. In this annotation, we outline the current environment of stem cell-based treatments and the strategies of marketing directly to consumers. We also outline the difficulties in the regulation of these clinics and make recommendations for best practice and the identification and reporting of illegitimate providers. Cite this article: Bone Joint J 2020;102-B(2):148-154.