Drug Promotions Between Ethics, Regulations, and Financial Interests.

BACKGROUND: The promotion of the latest medicines produced by the pharmaceutical industry is an important issue both from an ethical point of view (the level of accessibility, the way research is carried out) and from the point of view of marketing and especially from the lobbying issues raised. AREAS OF UNCERTAINTY: The ethical dilemmas raised by the promotion of new drugs revolve between the need to discover new molecules important for treating a wide range of diseases and the need to establish a battery of ethical rules, absolutely necessary for regulations in the field to be compliant with all ethical principles. DATA SOURCES: A literature search was conducted through PubMed, MEDLINE, Plus, Scopus, and Web of Science (2015-2023) using combinations of keywords, including drugs, medical publicity, and pharma marketing plus ethical dilemma. ETHICS AND THERAPEUTIC ADVANCES: The promotion of medicines is governed by advertising laws and regulations in many countries, including at EU level, based on the need for countries to ensure that the promotion and advertising of medicines is truthful, based on information understood by consumers. The ethical analysis of the issues raised is more necessary and complex as the channels used for promotion are more accessible to the population, and the information, easier to obtain, can be the cause of increased self-medication and overeating. Large amounts of money invested in the development of new molecules, but also the risk of scientific fraud through manipulation of data during clinical trials, selective or biased publication of information can have repercussions on the health of the population. CONCLUSIONS: The development of new pharmaceutical molecules is necessary to intervene and treat as many conditions as possible, but marketing must not neglect the observance of ethical principles. The promotion of medicines should be the attribute especially of the medical staff, which should also be a mandatory part of the mechanism for approving the marketing methods and means used by the pharmaceutical companies.

Reducing Student Exposure to Digital Food and Beverage Marketing: Policy and Practice Recommendations.

Digital marketing of unhealthy foods and beverages to children and adolescents is pervasive, highly effective, undermines healthy eating, and contributes to health inequities. Expanded use of electronic devices and remote learning during the COVID-19 pandemic has increased the urgency for policy interventions to limit digital food marketing in schools and on school-issued devices. The US Department of Agriculture provides little guidance to schools for how to address digital food marketing. Federal and state privacy protections for children are inadequate. Considering these policy gaps, state and local education authorities can incorporate strategies to reduce digital food marketing into school policies for: content filtering on school networks and on school-issued devices; digital instructional materials; student-owned device use during lunch; and school use of social media to communicate with parents and students. Model policy language is provided. These policy approaches can leverage existing policy mechanisms to address digital food marketing from a variety of sources.

Changes in household food and drink purchases following restrictions on the advertisement of high fat, salt, and sugar products across the Transport for London network: A controlled interrupted time series analysis.

BACKGROUND: Restricting the advertisement of products with high fat, salt, and sugar (HFSS) content has been recommended as a policy tool to improve diet and tackle obesity, but the impact on HFSS purchasing is unknown. This study aimed to evaluate the impact of HFSS advertising restrictions, implemented across the London (UK) transport network in February 2019, on HFSS purchases. METHODS AND FINDINGS: Over 5 million take-home food and drink purchases were recorded by 1,970 households (London [intervention], n = 977; North of England [control], n = 993) randomly selected from the Kantar Fast Moving Consumer Goods panel. The intervention and control samples were similar in household characteristics but had small differences in main food shopper sex, socioeconomic position, and body mass index. Using a controlled interrupted time series design, we estimated average weekly household purchases of energy and nutrients from HFSS products in the post-intervention period (44 weeks) compared to a counterfactual constructed from the control and pre-intervention (36 weeks) series. Energy purchased from HFSS products was 6.7% (1,001.0 kcal, 95% CI 456.0 to 1,546.0) lower among intervention households compared to the counterfactual. Relative reductions in purchases of fat (57.9 g, 95% CI 22.1 to 93.7), saturated fat (26.4 g, 95% CI 12.4 to 40.4), and sugar (80.7 g, 95% CI 41.4 to 120.1) from HFSS products were also observed. Energy from chocolate and confectionery purchases was 19.4% (317.9 kcal, 95% CI 200.0 to 435.8) lower among intervention households than for the counterfactual, with corresponding relative reductions in fat (13.1 g, 95% CI 7.5 to 18.8), saturated fat (8.7 g, 95% CI 5.7 to 11.7), sugar (41.4 g, 95% CI 27.4 to 55.4), and salt (0.2 g, 95% CI 0.1 to 0.2) purchased from chocolate and confectionery. Relative reductions are in the context of secular increases in HFSS purchases in both the intervention and control areas, so the policy was associated with attenuated growth of HFSS purchases rather than absolute reduction in HFSS purchases. Study limitations include the lack of out-of-home purchases in our analyses and not being able to assess the sustainability of observed changes beyond 44 weeks. CONCLUSIONS: This study finds an association between the implementation of restrictions on outdoor HFSS advertising and relative reductions in energy, sugar, and fat purchased from HFSS products. These findings provide support for policies that restrict HFSS advertising as a tool to reduce purchases of HFSS products.

An evaluation of the evidence submitted to Australian alcohol advertising policy consultations.

BACKGROUND: Industry self-regulation is the dominant approach to managing alcohol advertising in Australia and many other countries. There is a need to explore the barriers to government adoption of more effective regulatory approaches. This study examined relevance and quality features of evidence cited by industry and non-industry actors in their submissions to Australian alcohol advertising policy consultations. METHODS: Submissions to two public consultations with a primary focus on alcohol advertising policy were analysed. Submissions (n = 71) were classified into their actor type (industry or non-industry) and according to their expressed support for, or opposition to, increased regulation of alcohol advertising. Details of cited evidence were extracted and coded against a framework adapted from previous research (primary codes: subject matter relevance, type of publication, time since publication, and independence from industry). Evidence was also classified as featuring indicators of higher quality if it was either published in a peer-reviewed journal or academic source, published within 10 years of the consultation, and/or had no apparent industry connection. RESULTS: Almost two-thirds of submissions were from industry actors (n = 45 submissions from alcohol, advertising, or sporting industries). With few exceptions, industry actor submissions opposed increased regulation of alcohol advertising and non-industry actor submissions supported increased regulation. Industry actors cited substantially less evidence than non-industry actors, both per submission and in total. Only 27% of evidence cited by industry actors was highly relevant and featured at least two indicators of higher quality compared to 58% of evidence cited by non-industry actors. CONCLUSIONS: Evaluation of the value of the evidentiary contribution of industry actors to consultations on alcohol advertising policy appears to be limited. Modifications to consultation processes, such as exclusion of industry actors, quality requirements for submitted evidence, minimum standards for referencing evidence, and requirements to declare potential conflicts, may improve the public health outcomes of policy consultations.

Latin American Considerations for Infant and Young Child Formulae.

Infant formula is the only acceptable substitute for breastmilk from 0 to 6 months old when human milk cannot be provided in sufficient amounts. Manufacturers have developed options that intend to meet the changing needs of the child aged from six to twelve months (follow-on formulae) and after the age of one year (young child formulae). The international code for marketing breast milk substitute stipulates standards for marketing practices of these products. In Latin America there are local variations of marketing practices. Novel marketing strategies such as advertising through social media and influencers pose new threats for breastfeeding success in Latin America. This review aims to examine variations in local regulations for marketing of infant formulae and to analyze the emerging phenomenon of influencer advertising. We reviewed the local norms for Latin American countries and examined differences and possible gaps. Emerging evidence of influencer marketing was explored. The results indicate that national regulations differ among Latin American countries, particularly with respect to product labelling and the requirement to use a local native language, highlighting the cost of the product, and different regulations prohibiting certain messages and illustrations. Regarding new marketing strategies, there is limited evidence on advertising infant formula through social media influencers, where different categories of marketing strategies can be described. More transparent reporting of social marketing by formula providers and more independent research on novel marketing strategies are needed.

Tobacco Advertising, Promotion and Sponsorship in India and Indonesia: Present Regime and the Way Forward.

One of the important factors contributing to tobacco epidemic is tobacco advertising, promotion, and sponsorship (TAPS). TAPS is employed by tobacco industry to increase demand for its products, often through targeting specific groups or market segments. The World Health Organization Framework Convention on Tobacco Control (WHO FCTC) recommends implementation of comprehensive bans on TAPS as part of an effective set of tobacco control policies. Article 13 of the WHO FCTC and its guidelines mandate a comprehensive ban on all TAPS. Besides, TAPS ban is one of the MPOWER strategy and is included in the 'Best Buys' for effective tobacco control. However, many countries, especially low-income and middle-income countries, primarily implement only partial TAPS bans, allowing the tobacco industry to directly or indirectly advertise and promote its products via multiple media. This review article analyzes the current state of affairs in respect of TAPS in India and Indonesia, the two of the largest countries in the WHO South-East Asia Region of the world, and discusses the way forward to address the identified gaps in TAPS ban policy formulation and implementation focusing on strengthening its compliance and enforcement at the country level.

Opportunities and Challenges of Tobacco Control Policy at District Level in Indonesia: A Qualitative Analysis.

INTRODUCTION: Comprehensive tobacco control policies are lacking in Indonesia where smoking prevalence in males is among the highest in the world. This study aims to explore the knowledge, attitude, opportunities and challenges to tobacco control among local stakeholders. METHODS: This is a qualitative study using in-depth interviews. Four study areas included Bengkulu Province, Bengkulu City, Seluma District, and Kaur District. Eighteen participants interviewed were from policymakers, legislators, and civil societies during November-December 2020. Thematic data analysis was used. RESULTS: While knowledge and support of the existing Smoke Free Policy (SFP) were high, that of other policies such as outdoor tobacco advertising (OTA) ban and tobacco product display ban were low. Among others, one opportunity was there is already SFP regulation in each study area, to which such bans can be added. Among others, three major challenges were: (a) lack of enforcement of the existing SFP, (b) lack of national regulation to ban OTA and product display, and (c) counter actions by the tobacco industry. CONCLUSION: The opportunities and challenges identified could be lessons learnt for more comprehensive tobacco control especially by local governments in Indonesia and other countries with similar settings.

A Legislative/Legal History of Prescription Drug Advertising and Promotion Regulation.

PURPOSE: The communication by pharmaceutical companies of promotional messages about their products has long been controversial, but deemed to be necessary by the pharmaceutical industry so that health care professionals and in some cases patients/consumers can be made aware of the latest developments through the communication vehicles they are accustomed to seeing - in the case of health care professionals, through medical advertising, direct mail, visits by company representatives, and attendance at medical meetings, and in case of patients, through the news media and television advertising. On the other hand, critics argue that such promotion, which sometimes reduces complex medical issues to advertising slogans, is inappropriate for products intended to treat and cure diseases, and that health care professionals should learn about new products from peer-reviewed medical literature.  Consequently, advertising, and promotional programs are heavily regulated by the U.S. Food and Drug Administration (FDA). However, the laws themselves raise constitutional issues of infringement on free speech.  Over the past few years, a number of lawsuits have been decided that help clarify the role of the FDA and the extent of its authority in regulating what companies or their employees say about their products. These court decisions are important because they help define how health care professionals and patients/consumers receive medical information. METHODS: This overview is intended to identify, in non-technical language, some of the more controversial and challenging issues involved in the FDA's efforts to regulate marketing communications by drug companies and how the courts view them. RESULTS: The recent lawsuits often involve complex and far-reaching legal issues.  But when examined in toto, as this paper does, they have reflected a view by the courts that truthful and non-misleading statements by drug companies about their products can be legally communicated even when the medical information is not formally approved by the FDA and included in the FDA-approved labeling.  The lawsuits thus have led to an environment in which the FDA continues to oversee with great fervor the activities of drug companies in communicating medical information but at the same time having some flexibility in keeping health care professionals and patients up to date with th latest information about medical research and new therapeutic products. CONCLUSION: How pharmaceutical products are marketed has been deemed by the U.S. Congress to be important enough to need to be subject to federal regulation.  The issues create a tension between the need for medical information to be accurate and balanced, and the guarantees of free speech.  This review provides an important perspective on how this tension is being resolved, even as dramatic advances in both medical products and technology create new challenges.

Are Australian regulatory codes adequate in scope to protect youth from alcohol advertising?

ISSUE ADDRESSED: Exposure to alcohol advertising has been found to be associated with more positive attitudes toward alcohol and heavier drinking among youth. Appropriate regulation of alcohol advertising is thus crucial for reducing use among members of this population group. To assist policy makers in their alcohol control efforts, this study explored the scope of Australian alcohol advertising codes and the extent to which they address issues relating to youth exposure. METHODS: Two researchers assessed 628 unique alcohol advertisements against youth-related provisions of the Alcohol Advertising Review Board (AARB) Code and Alcohol Beverages Advertising Code (ABAC). A third researcher resolved discrepancies. The ads sampled were those that had been the subject of formal complaints to the AARB. RESULTS: Most (94%) ads were assessed as violating at least one of the AARB Code provisions relating to youth, while 36% were found to violate at least one of the ABAC youth provisions. The most frequently violated AARB Code provision related to placement, with 88% of ads located in places or broadcast at times where young people were likely to be exposed. The most frequently violated ABAC provision related to appeal to minors (33%). CONCLUSIONS: Results indicate that self-regulation is an ineffective means of protecting youth from alcohol advertising, with the ABAC failing to capture many ads featuring content that appeals to youth. SO WHAT?: Greater efforts are required to protect youth from alcohol advertising. Findings from the present study reinforce calls for mandatory, evidence-based regulation that is administered independently of the alcohol industry. SUMMARY: An analysis of 628 unique alcohol advertisements found that the vast majority were in violation of the AARB Code's youth-related provisions whereas substantially fewer were in violation of the ABAC, supporting arguments that self-regulation is an ineffective means of protecting youth from alcohol advertising.

Truth-in-Advertising Laws: Are They Working? A Cross-Sectional Analysis of a "Plastic Surgeon" Patient Search Simulation.

BACKGROUND: Non-board-certified plastic surgeons performing cosmetic procedures and advertising as plastic surgeons may have an adverse effect on a patient's understanding of their practitioner's medical training and patient safety. The authors aim to assess (1) the impact of city size and locations and (2) the impact of health care transparency acts on the ratio of board-certified and non-American Board of Plastic Surgeons physicians. METHODS: The authors performed a systematic Google search for the term "plastic surgeon [city name]" to simulate a patient search of online providers. Comparisons of board certification status between the top hits for each city were made. Data gathered included city population, regional location, practice setting, and states with the passage of truth-in-advertising laws. RESULTS: One thousand six hundred seventy-seven unique practitioners were extracted. Of these, 1289 practitioners (76.9 percent) were American Board of Plastic Surgery-certified plastic surgeons. When comparing states with truth-in-advertising laws and states without such laws, the authors found no significant differences in board-certification rates among "plastic surgery" practitioners (88.9 percent versus 92.0 percent; p = 0.170). There was a significant difference between board-certified "plastic surgeons" versus out-of-scope practitioners on Google search between large, medium, and small cities (100 percent versus 92.9 percent versus 86.5; p < 0.001). CONCLUSIONS: Non-board-certified providers tend to localize to smaller cities. Truth-in-advertising laws have not yet had an impact on the way a number of non-American Board of Plastic Surgery-certified practitioners market themselves. There may be room to expand the scope of truth-in-advertising laws to the online world and to smaller cities.

Health-related claims in food supplements endorsements: a content analysis from the perspective of EU regulation.

OBJECTIVES: Based on the legal framework regulating the advertisement of food supplements in the EU, the aim of this article is to analyse the relationship between the presence of endorsers, the different types of health-related claims (H-RCs) and product content information. STUDY DESIGN: We applied a quantitative approach based on the content analysis of all radio spots broadcast throughout 2017 on full-service radio stations in Spain. METHODS: A corpus of 10,556 radio spots was obtained of the three radio stations with the highest audience levels (165 without repetitions). We incorporated data on the accumulated broadcast frequencies to supplement the content analysis specific to each radio spot with its weight in relation to the overall advertising discourse. We developed a coding scheme to assess the type of endorser, the types of H-RCs, and the product content information. RESULTS: Results show that European directives are breached in different ways. Healthcare experts prevail in disease claims, although they are prohibited. Celebrities are the most widely used endorsers (25%) in the function and reduction of disease risk claims. In addition, although these types of claims require substantiation by authorised ingredient, 73% of H-RCs lack this information. CONCLUSIONS: The high presence of illicit H-RCs and endorsers, such as physicians, and the omission of compulsory product information suggest that public administrations must apply stricter monitoring and sanctioning mechanisms to dissuade advertisers from further breaches of the law and to protect consumers. Implications for public health policy are made.