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.

Direct to Consumer Telemedicine: Is Healthcare From Home Best?

Direct-to-consumer (DTC) telemedicine is increasingly popular and enables patients to obtain medical advice and treatment via electronic media (e.g., computer, telephone, or smartphone) without a prior doctor-patient relationship. Convenience, accessibility, and home delivery make DTC telemedicine attractive to patients. Concerns about DTC telemedicine include: a lack of regulation, transparency, and an established patient-provider relationship (physician and pharmacist). In future, researchers, providers, and insurers need to better understand the concerns and challenges that this new form of healthcare poses.

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.

The direct-to-consumer market for stem cell-based interventions in Australia: exploring the experiences of patients.

The prevalence of businesses selling autologous stem cell-based interventions to patients in Australia has raised serious concerns about how weaknesses in regulation have enabled the emergence of an industry that engages in aggressive marketing of unproven treatments to patients. Little is known about how patients experience this marketing and their subsequent interactions with practitioners. This paper reports results from 15 semistructured interviews with patients and carers, and also draws upon discussion conducted with patients, carers and family members (22 participants) in a workshop setting. We explore how Australian patients and carers understand and experience these interventions, and how their presumptions about the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments.

Nutri-Score: el logotipo frontal de información nutricional útil para la salud pública de España que se apoya sobre bases científicas / Nutri-Score: front-of-pack nutrition label useful for public heath in Spain which is supported by as strong scientific background

El Ministerio de Sanidad de España, en noviembre de 2018, notificó oficialmente la adopción del etiquetado nutricional frontal Nutri-Score que permitirá a los consumidores juzgar fácilmente la calidad nutricional de los alimentos en el momento de la compra e incitar a los industriales a mejorar la composición nutricional de sus productos alimentarios. Este artículo sintetiza los trabajos científicos realizados que ponen en relieve la validación del perfil nutricional que subyace al cálculo de Nutri-Score, y los trabajos que demuestran su eficacia y superioridad con respecto a otros logotipos existentes o propuestos por agentes económicos. Asimismo, se hace un balance de su desarrollo en España y en el seno de la Unión Europea y se responde a las fake-news transmitidas por sus detractores. Se presenta también la Iniciativa Ciudadana Europea para que este etiquetado frontal sea obligatorio en Europa

The Spanish Ministry of Health, in November 2018, notified the officially adoption of the front-of-pack nutrition label Nutri-Score which will allow consumers to easily judge the nutritional quality of food at the time of purchase and to encourage industrialists to improve the nutritional composition of food. This article synthesizes the scientific work pertaining to the validation of the nutritional profile that underlies the computation of Nutri-Score and works that demonstrate its effectiveness and superiority in comparison to other existing logos or proposed by food companies. Likewise, it highlights its development in Spain and within the European Union and responds to the fake-news raised by its detractors. It also introduces the European Citizens' Initiative to make it compulsory in Europe

Self-Regulation in the Pharmaceutical Industry: The Exposure of Children and Adolescents to Erectile Dysfunction Commercials.

CONTEXT: Spending on direct-to-consumer advertising (DTCA) for prescription pharmaceuticals has risen to record levels, five times as much as in 1996 in inflation-adjusted dollars. Major health care provider organizations have called for additional regulation of DTCA. These organizations argue that the negative impact of such advertising outweighs the informational value claimed by the pharmaceutical industry. The industry maintains that further restrictions on DTCA are not warranted because it is successfully self-regulating via "guiding principles" for DTCA as certified by firm executives. METHODS: The authors measured recent industry spending on DTCA and used regression models of Nielsen Monitor-Plus data to assess pharmaceutical firm self-regulation after the public disclosure of noncompliance with industry self-regulatory principles, specifically regarding the exposure of children and adolescents to broadcast advertisements for erectile dysfunction drugs. FINDINGS: Public disclosure of noncompliance with self-regulatory DTCA standards did not bring advertising into compliance. Results demonstrate that firms failed to meet the industry standard during every quarter of the six-year period of this study. CONCLUSIONS: Results support previous research findings that pharmaceutical self-regulation is a deceptive blocking strategy rather than a means for the industry to police itself. Policy recommendations include broadcast restrictions on adult content and deincentivizing DTCA via tax reform.

Antibiotic Prescribing During Pediatric Direct-to-Consumer Telemedicine Visits.

BACKGROUND AND OBJECTIVES: Use of commercial direct-to-consumer (DTC) telemedicine outside of the pediatric medical home is increasing among children, and acute respiratory infections (ARIs) are the most commonly diagnosed condition at DTC telemedicine visits. Our objective was to compare the quality of antibiotic prescribing for ARIs among children across 3 settings: DTC telemedicine, urgent care, and the primary care provider (PCP) office. METHODS: In a retrospective cohort study using 2015-2016 claims data from a large national commercial health plan, we identified ARI visits by children (0-17 years old), excluding visits with comorbidities that could affect antibiotic decisions. Visits were matched on age, sex, chronic medical complexity, state, rurality, health plan type, and ARI diagnosis category. Within the matched sample, we compared the percentage of ARI visits with any antibiotic prescribing and the percentage of ARI visits with guideline-concordant antibiotic management. RESULTS: There were 4604 DTC telemedicine, 38 408 urgent care, and 485 201 PCP visits for ARIs in the matched sample. Antibiotic prescribing was higher for DTC telemedicine visits than for other settings (52% of DTC telemedicine visits versus 42% urgent care and 31% PCP visits; P < .001 for both comparisons). Guideline-concordant antibiotic management was lower at DTC telemedicine visits than at other settings (59% of DTC telemedicine visits versus 67% urgent care and 78% PCP visits; P < .001 for both comparisons). CONCLUSIONS: At DTC telemedicine visits, children with ARIs were more likely to receive antibiotics and less likely to receive guideline-concordant antibiotic management compared to children at PCP visits and urgent care visits.

Online advertising and marketing claims by providers of proton beam therapy: are they guideline-based?

BACKGROUND: Cancer patients frequently search the Internet for treatment options, and hospital websites are seen as reliable sources of knowledge. Guidelines support the use of proton radiotherapy in specific disease sites or on clinical trials. This study aims to evaluate direct-to-consumer advertising content and claims made by proton therapy centre (PTC) websites worldwide. METHODS: Operational PTC websites in English were identified through the Particle Therapy Co-Operative Group website. Data abstraction of website content was performed independently by two investigators. Eight international guidelines were consulted to determine guideline-based indications for proton radiotherapy. Univariate and multivariate logistic regression models were used to determine the characteristics of PTC websites that indicated proton radiotherapy offered greater disease control or cure rates. RESULTS: Forty-eight PTCs with 46 English websites were identified. 60·9% of PTC websites claimed proton therapy provided improved disease control or cure. U.S. websites listed more indications than international websites (15·5 ± 5·4 vs. 10·4 ± 5·8, p = 0·004). The most common disease sites advertised were prostate (87·0%), head and neck (87·0%) and pediatrics (82·6%), all of which were indicated in least one international guideline. Several disease sites advertised were not present in any consensus guidelines, including pancreatobiliary (52·2%), breast (50·0%), and esophageal (43·5%) cancers. Multivariate analysis found increasing number of disease sites and claiming their centre was a local or regional leader in proton radiotherapy was associated with indicating proton radiotherapy offers greater disease control or cure. CONCLUSIONS: Information from PTC websites often differs from recommendations found in international consensus guidelines. As online marketing information may have significant influence on patient decision-making, alignment of such information with accepted guidelines and consensus opinion should be adopted by PTC providers.

Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines.

BACKGROUND: Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. METHODS: All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. RESULTS: Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. CONCLUSIONS: Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.

Industry Responsibilities in Tackling Direct-to-Consumer Marketing of Unproven Stem Cell Treatments.

The direct-to-consumer marketing of unproven stem cell interventions (SCIs) is a serious public health concern. Regulations and education have had modest impact, indicating that different actors must play a role to stop this unfettered market. We consider the role of the biotech industry in tackling unproven SCIs. Grounded in the concept of corporate social responsibility, we argue that biotech companies should screen consumers to ensure that products and services are being used appropriately and educate employees about unproven SCIs.

Consumer views on safety of over-the-counter drugs, preferred retailers and information sources in Sweden: after re-regulation of the pharmacy market

Background: The availability of over-the-counter drugs (OTCs) has increased in Sweden since a re-regulation of the pharmacy market in 2009, through which non-pharmacy retailers became permitted to provide certain OTCs. Objective: To examine the adult general public’s views on safety, purchasing and information channels, storage and disposal of OTCs in Sweden, three years after the re-regulation of the pharmacy market. Methods: A questionnaire study in 2012-13 in a stratified, random sample of all inhabitants in Sweden ≥ 18 years old. Results: Totally 8,302 people (42%) answered the questionnaire. Seven percent found OTCs completely harmless regardless of how they are being used, 18% felt they should be used only on health professionals’ recommendation. Differences in how OTCs are perceived were however found with regards to respondents’ country of birth, family type, educational level and income. The pharmacy was still the preferred OTC drug retailer by 83% of the respondents and preferred information source by 80% Reasons for preferred retailers were primarily due to out of habit (45%), counseling provided (35%), the product range (34%) and the confidence in staff (27%). Analgesics are the most common OTCs to have at home (90%). The bathroom cabinet is the primary site for storage (42%) and 16% throw their OTC leftovers in the trash. Conclusions: The study population does not consider OTCs as harmless regardless of how they are used, but on the other hand feels they should not be taken on health professionals’ recommendation only. The pharmacy is still the preferred retailer and information source, and there is room for further improvement in the storage and disposal of OTCs. A return of OTC drug leftovers to the pharmacy should be further encouraged. Due to several limitations, great caution should however be observed when generalizing the results to the adult population of Sweden (AU)

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Correction of misleading information in prescription drug television advertising: The roles of advertisement similarity and time delay.

BACKGROUND: Prescription drug television advertisements containing potentially consequential misinformation sometimes appear in the United States. When that happens, the U.S. Food and Drug Administration can request that companies distribute corrective advertisements to address misinformation and inaccurate claims. Previous research has demonstrated effectiveness in corrective advertising for various products. OBJECTIVES: The present article builds on that work with a randomized experimental study (n = 6454) of corrective advertising investigating the extent to which visual similarity matters between violative and corrective ads and the extent to which time delay matters between violative and corrective advertisement exposure. METHODS: Our study sample included overweight or obese U.S. adults recruited from an existing online consumer panel representative of the U.S. adult population. We created a brand for a fictitious prescription weight-loss drug and produced corresponding direct-to-consumer (DTC) television ads. All participants viewed the same violative ad, but were randomly assigned to view corrective ads with different levels of visual similarity and exposure time delay using a 4 × 4 between-subjects factorial design. RESULTS: Results suggest corrective ad exposure can influence consumer perceptions of drug efficacy, risks, and benefits previously established by violative ads that overstated drug efficacy, broadened drug indication, and omitted important risk information. Corrective ads also can weaken consumer intentions to consider and investigate a drug. However, ad similarity does not appear to affect consumer perceptions and preferences. Although we found that the effects of violative ad exposure tend to diminish over time, the length of the delay between violative and corrective ad exposure has limited influence. An exception to this was observed with regard to recall of drug benefits and risks, where the impact of corrective ad exposure increases with greater time delay. CONCLUSIONS: These results extend previous research to a new health condition and hold implications for regulatory policy.

¿Es tiempo de exigir publicidad basada en la evidencia?

Claims made in current advertising for medical products is not necessarily scientifically proven, yet at the same time clinicians are required to adopt evidence-based practices and undergo periodic certifications. This is a clear contradiction. It is crucial to begin to reflect on the need to regulate information presented in the media and to place greater emphasis on patient well-being and safety instead of on third-party interests. The medical community must demand stricter regulations and evidence-based advertising policies.

The Tip of the Iceberg of Misleading Online Advertising Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

Kim's overview of Food and Drug Administration (FDA) regulatory actions from 2005 to 2014 is a comprehensive analysis of the US regulatory experience with online direct-to-consumer advertising (DTCA) of prescription medicines. This experience is of relevance internationally as online DTCA reaches the English-speaking public globally, despite the illegality of DTCA in most countries. The most common violations were omissions or minimizations of risk information, overstatements of efficacy, unsubstantiated claims, and promotion of unapproved ("off-label") use. Nearly one fourth of violations involved cancer drugs, raising additional concerns about patient vulnerability, limited treatment advance, and high costs. Based on content analyses of online DTCA, these cases likely reflect a small proportion of unbalanced and misleading promotional information available on the web. The FDA is only able to review a small proportion of promotional materials submitted to them, due to limited staffing, and the delay between first posting and regulatory action means that many people may be exposed to messages that are found to be inaccurate and misleading. The sheer volume of online DTCA, combined with the ability for content to shift continually, poses unique regulatory challenges.

Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: Teaching Drug Marketers How to Inform Better or Spin Better? Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

Hyosun Kim's report "Trouble Spots in Online Direct to Consumer Prescription Drug Promotion: A content Analysis of FDA Warning Letters" aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA) guidelines in their online drug promotion. While Kim hopes to minimise the potential for online promotion to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in online drug promotion is more likely to make marketers more adept at spinning information than appropriately balancing it.

Análise dos perfis de clínicas odontológicas e de cirurgiões-dentistas em duas redes sociais quanto aos aspectos éticos, de propaganda e publicidade / Analysis of the profiles of dental clinics and dentists in two social media regarding the ethical issues related to advertising and propaganda

Introdução: O Brasil é o país com o maior número de cirurgiões-dentistas do mundo e, devido à má distribuição deste grande número de profissionais, existe uma grande concorrência entre eles, gerandouma necessidade para o profissional de lançar mão de ferramentas que possam ajudar na busca e manutenção de clientes. Objetivo: Avaliar duas redes sociais (Facebook® e Instagram®) de cirurgiões dentistas e clínicas odontológicas em relação aos cumprimentos dos preceitos do Código de Ética Odontológica (CEO), bem como verificar infrações éticas cometidas nestas redes sociais. Metodologia:Usou-se, para coletada de dados, um questionário composto por 14 itens baseados nas infrações éticascitadas no CEO. Consideraram-se fotografias e legendas nas redes sociais estudadas, Facebook® eInstagram®, num total de 257 páginas, sendo 187 para o Facebook® e 70 para o Instagram®, no períodode agosto a setembro de 2015. As páginas foram coletadas e analisadas pelo mesmo pesquisador. Osdados foram armazenados e analisados no programa Epi Info. Resultados: Foi constatado que 97,28%estavam em desacordo com pelo menos um dos 14 itens investigados. Conclusão: Em virtude dos dadosobservados, percebemos a necessidade de uma maior fiscalização destas redes sociais, visando umrespeito aos usuários dos serviços. Além disso, é notória a necessidade de atualização dos profissionais,credenciados a estas redes, com o Código de Ética Odontológica, uma vez que o mesmo está emconstante atualização.

Introduction: Brazil is the country with the largest number of dentists and due to the bad distribution of this large number of professionals there is a lot of competition between them. This generates a need for newtools of attracting and retaining clients. Objective: Evaluate dentists’s and dental clinics’s use of two socialnetworks (Facebook® and Instagram®) in compliance with the Brazilian Dental Code of Ethics (CEO)using a questionnaire. Materials and methods: The information was collected from pictures and titles in therespective social networks sites from a sample of 257 pages. 187 for Facebook® and 70 for Instagram®by applying a 14 itens questionnaire. The data was collected and analyzed via Epi Info. Results: It was foundthat 97.28% were irregular with at least one of the 14 surveyed items. Conclusions: Looking at thecollected data, a need of a better supervision of those social networks in order to protect customersbecomes clear. Furthermore, it is important for professionals using those networks to keep themselves upto date regarding of the Brazilian CEO and its constant changes.