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.

Should tobacco sales be restricted to state-run alcohol outlets? Perspectives from 10 US alcohol control states.

BACKGROUND AND AIMS: The ubiquity of tobacco retailers helps to sustain the tobacco epidemic. A tobacco retail reduction approach that has not been tried is transitioning tobacco sales to state-controlled alcohol stores (TTS), which are limited in number and operate under some restrictions, e.g. regarding opening hours or marketing materials. This study summarizes policy experts' and advocates' views of TTS, including (1) advantages and disadvantages; (2) feasibility; and (3) potential implementation obstacles. DESIGN: This study was a qualitative content analysis of semi-structured interviews. SETTING: Ten US states with alcoholic beverage control systems were included. PARTICIPANTS: The participants comprised a total of 103 tobacco control advocates and professionals, public health officials, alcohol policy experts and alcohol control system representatives, including two tribal community representatives. MEASUREMENTS: Interviewees' perspectives on their state's alcoholic beverage control agency (ABC, the agency that oversees or operates a state alcohol monopoly) and on TTS were assessed. FINDINGS: Interviewees thought TTS offered potential advantages, including reduced access to tobacco products, less exposure to tobacco advertising and a greater likelihood of successful smoking cessation. Some saw potential long-term health benefits for communities of color, due to the smaller number of state alcohol stores in those communities. Interviewees also raised concerns regarding TTS, including ABCs' limited focus on public health and emphasis on revenue generation, which could conflict with tobacco use reduction efforts. Some interviewees thought TTS could enhance the power of the tobacco and alcohol industries, increase calls for alcohol system privatization or create difficulties for those in recovery. CONCLUSIONS: In the United States, transitioning tobacco sales to state-controlled alcohol stores (TTS) could have a positive public health impact by reducing tobacco availability, marketing exposure and, ultimately, tobacco use. However, tensions exist between alcohol control system goals of providing revenue to the state and protecting public health. Should a state decide to pursue TTS, several guardrails should be established, including building into the legislation an explicit goal of reducing tobacco consumption.

Fruto do trabalho da IBFAN, Brasil propõe na OMS a regulamentação do marketing digital de SLM

O marketing digital de substitutos do leite materno (SLM) está em crescimento exponencial e descontrolado, levando mães a desacreditarem da amamentação. É urgente regular essas práticas que visam o lucro das empresas produtoras e distribuidoras de produtos que interferem na amamentação. O Brasil está à frente nesse processo e propõe uma Resolução à OMS que será levada à votação na próxima Assembleia Mundial da Saúde (AMS), que acontecerá em maio de 2024.

O marketing digital de produtos para alimentação infantil está fora de controle

O ano de 2024 é um ano de relatório na Assembleia Mundial de Saúde (AMS) sobre Nutrição Materna, Infantil e de Crianças Pequenas. Como parte disso, o Marketing Digital de substitutos do leite materno será discutido dentro da agenda “Populações mais saudáveis”. Em um contexto marcado por tantas emergências sérias causadas por conflitos e eventos climáticos em nosso dia-a-dia, é fácil esquecer a importância de proteger e apoiar as mulheres que desejam amamentar. Amamentar é uma questão de sobrevivência para tantos bebês, pois significa alimento, cuidado e apoio imunológico.

Five-Year Sales for Newly Marketed Prescription Drugs With and Without Initial Orphan Drug Act Designation.

This study evaluates sales revenue earned in the first 5 years for newly marketed brand-name drugs with and without an initial orphan drug designation.

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.

Differences in child and adolescent exposure to unhealthy food and beverage advertising on television in a self-regulatory environment.

BACKGROUND: Food and beverage promotion is a contributor to children's dietary behaviours, and ultimately, downstream health consequences. Broadcast television remains an important source of such advertising. The objective of this study was to examine and compare children and adolescent's exposure to food advertising on television in Canada over an entire year in a self-regulatory environment. METHODS: Television advertising data for 57 selected food and beverage categories were licensed from Numerator for 36 stations in Toronto, for 2019. The estimated average number of advertisements viewed by children aged 2-11 and adolescents aged 12-17 was determined overall, by food category, and by marketing technique. The healthfulness of advertisements was also assessed using Health Canada's Nutrient Profile Model. RESULTS: Overall in 2019, children viewed 2234.4 food ads/person/yr while adolescents viewed 1631.7 ads, exposure for both groups stemmed primarily from stations with general appeal, and both age groups were exposed to a range of powerful marketing techniques. Exposure to advertising for restaurants, snacks, breakfast food and candy and chocolate was high among both age groups and the healthfulness of most advertised products was considered poor. Adolescents were exposed to 36.4% more food products classified as unhealthy, had higher exposure to all marketing techniques examined, and were exposed to substantially more child-related marketing techniques compared to children. CONCLUSION: Children and adolescents were heavily exposed to food advertisements on television in 2019. Despite current self-regulatory policies, children's exposure to unhealthy food and beverages remains high. Differences in exposure to food advertisements by food category and healthfulness may suggest that adolescents are being disproportionately targeted by food companies as a result of self-regulatory marketing restrictions.

The Impact of Suboxone's Market Exclusivity on Cost of Opioid Use Disorder Treatment.

BACKGROUND: Buprenorphine-naloxone is an essential part of the response to opioid poisoning rates in North America. Manipulating market exclusivity is a strategy manufacturers use to increase profitability, as evidenced by Suboxone in the USA. OBJECTIVE: To investigate excess costs of buprenorphine-naloxone due to unmerited market exclusivity (no legal patent or data protection) in Canada. METHODS: Using controlled interrupted time-series, this study examined changes in the cost of buprenorphine-naloxone before and after the first generics were listed on public formularies. Methadone cost was the control. Public data from the Canadian Institute of Health Information in British Columbia, Manitoba, and Saskatchewan were used. All buprenorphine-naloxone and methadone claims (2010-2019) accepted for payment by the provincial drug plan/programme were collected. Primary outcome was mean cost per mg of buprenorphine-naloxone after the first listing of generics. RESULTS: Mean cost per mg of buprenorphine-naloxone before the first listing of generics was $1.21 CAD in British Columbia, $1.27 CAD in Manitoba, and $0.85 CAD in Saskatchewan. Following the introduction of generics, the cost per mg decreased by $0.22 CAD (95% CI - 0.33 to - 0.10; p = 0.0014) in British Columbia, $0.36 CAD (95% CI - 0.58 to - 0.13; p = 0.004) in Manitoba, and $0.27 CAD (95% CI - 0.50 to - 0.05; p = 0.03) in Saskatchewan. Mean cost per mg decreased by $0.26 CAD (95% CI - 0.38 to - 0.13; p = 0.0004) after a third generic was introduced in British Columbia. Excess costs to public formularies during the 4- to 5-year period prior to the listing of generics were $1,992,558 CAD in British Columbia, $80,876 CAD in Manitoba, and $4130 CAD in Saskatchewan. If buprenorphine-naloxone cost $0.61 CAD (mean cost after the third generic entered) instead of $1.21 CAD per mg during the pre-generics period, public payers in British Columbia could have saved $5,016,220 CAD between 2011 and 2015. CONCLUSIONS: Unmerited 6 years of market exclusivity for brand-name buprenorphine-naloxone in Canada resulted in substantial excess costs. There is an urgent need to implement policies that can help reduce costs for high-priority drugs in Canada.

Regulatory Framework of Fortified Foods and Dietary Supplements for Athletes: An Interpretive Approach.

A varied and well-planned diet can meet the nutritional needs of an athlete; however, in certain cases, it could be advisable to increase the intake of some vitamins, minerals or other components through the controlled intake of fortified foods or dietary supplements. In the European Union, a high number of sport foods and supplements are marketed; athletes could at times consume them indiscriminately or even choose products that have not been evaluated and approved by scientific evidence. In this sense, it is necessary to know and interpret the specific regulations for these products in order to make adequate use of them. The aim of this manuscript is to describe the current status of the European regulatory framework, focusing on: (1) regulation of the marketing and labelling of both fortified foods and supplements; (2) regulation of the use of substances used as ingredients in fortified foods; and (3) regulation of nutritional claims and/or health properties associated with nutrients, ingredients and other related substances. This review can facilitate knowledgeable decision making by sports nutrition professionals in order to counsel or manage adequate food choices as well as help consumers make better-informed food decisions. Other experts, such as producers who ensure food safety, might also be interested in this review.

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.

Are the Eatwell Guide and Nutrient Profiling Models Consistent in the UK?

A nutrient profiling model (NPM) was developed in 2005 in the UK to regulate the marketing of foods to children. It was revised in 2018, but the new version has not been finalised. The Eatwell Guide (EWG) is the UK's official food-based dietary guidelines. The aim of this study was to evaluate the agreement between the 2005 and 2018 versions of the NPM and the EWG. Using recent National Diet and Nutrition Surveys, we estimated the healthiness of individual diets based on an EWG dietary score and a NPM dietary index. We then compared the percentage of agreement and Cohen's kappa for each combination of the EWG score and NPM index across the range of observed values for the 2005 and 2018 versions. A total of 3028 individual diets were assessed. Individuals with a higher (i.e., healthier) EWG score consumed a diet with, on average, a lower (i.e., healthier) NPM index both for the 2005 and 2018 versions. Overall, there was good agreement between the EWG score and the NPM dietary index at assessing the healthiness of representative diets of the UK population, when a low cut-off for the NPM dietary index was used, irrespective of the version. This suggests that dietary advice to the public is broadly aligned with NPM-based food policies and vice-versa.

Implementation of the Code of Marketing of Breast-Milk Substitutes in Vietnam: Marketing Practices by the Industry and Perceptions of Caregivers and Health Workers.

BACKGROUND: The promotion of breastmilk substitutes (BMS) is an important barrier to successful breastfeeding. OBJECTIVE: To examine the enactment and implementation of the Code of Marketing of Breast-Milk Substitutes (the Code) in Vietnam with a focus on marketing practices by the baby food industry and perceptions of caregivers, health workers, and policy makers. METHODS: From May to July 2020, we conducted a mixed-method, cross-sectional study including a survey of 268 pregnant women and 726 mothers of infants aged 0-11 months and in-depth interviews with a subset of interviewed women (n = 39), policy makers, media executives, and health workers (n = 31). RESULTS: In the previous 30 days, two mothers (out of 726) participating in the quantitative survey reported that health workers had recommended BMS, at private hospitals in both cases. In-depth interviews with health workers showed that hospitals have internal procedures to prevent the promotion of BMS by health workers. However, companies employed representatives to promote products not covered under the Code (e.g., commercial milk formula for pregnant women) at antenatal care visits and by gaining contact information from women and using this information to promote BMS outside the hospital, often on social media. In the 30 days preceding the survey, one-fifth of pregnant women were exposed to promotions of commercial milk formula for pregnant women and 7.1% to promotions of BMS. Among mothers of infants, 7.3% and 10.7% of respondents with infants aged 0-5 and 6-11 months, respectively, were exposed to some form of BMS promotion in the past 30 days. Around the time of birth, parents commonly brought BMS to maternity facilities (52.5%) or purchased it nearby (35.4%). CONCLUSIONS: Although Vietnam has a strong regulatory environment for the protection, promotion, and support of breastfeeding, there are implementation, monitoring, and enforcement gaps. Stronger enforcement of national policies to regulate the presence of BMS industry representatives in health facilities-both public and private-and the promotion of BMS products on digital platforms are needed.