Corporate political activity in the context of unhealthy food advertising restrictions across Transport for London: A qualitative case study.

BACKGROUND: Diets with high proportions of foods high in fat, sugar, and/or salt (HFSS) contribute to malnutrition and rising rates of childhood obesity, with effects throughout the life course. Given compelling evidence on the detrimental impact HFSS advertising has on children's diets, the World Health Organization unequivocally supports the adoption of restrictions on HFSS marketing and advertising. In February 2019, the Greater London Authority introduced novel restrictions on HFSS advertising across Transport for London (TfL), one of the most valuable out-of-home advertising estates. In this study, we examined whether and how commercial actors attempted to influence the development of these advertising restrictions. METHODS AND FINDINGS: Using requests under the Freedom of Information Act, we obtained industry responses to the London Food Strategy consultation, correspondence between officials and key industry actors, and information on meetings. We used an existing model of corporate political activity, the Policy Dystopia Model, to systematically analyse arguments and activities used to counter the policy. The majority of food and advertising industry consultation respondents opposed the proposed advertising restrictions, many promoting voluntary approaches instead. Industry actors who supported the policy were predominantly smaller businesses. To oppose the policy, industry respondents deployed a range of strategies. They exaggerated potential costs and underplayed potential benefits of the policy, for instance, warning of negative economic consequences and questioning the evidence underlying the proposal. Despite challenging the evidence for the policy, they offered little evidence in support of their own claims. Commercial actors had significant access to the policy process and officials through the consultation and numerous meetings, yet attempted to increase access, for example, in applying to join the London Child Obesity Taskforce and inviting its members to events. They also employed coalition management, engaging directly and through business associations to amplify their arguments. Some advertising industry actors also raised the potential of legal challenges. The key limitation of this study is that our data focused on industry-policymaker interactions; thus, our findings are unable to present a comprehensive picture of political activity. CONCLUSIONS: In this study, we identified substantial opposition from food and advertising industry actors to the TfL advertising restrictions. We mapped arguments and activities used to oppose the policy, which might help other public authorities anticipate industry efforts to prevent similar restrictions in HFSS advertising. Given the potential consequences of commercial influence in these kinds of policy spaces, public bodies should consider how they engage with industry actors.

Marketing of healthcare services in Denmark: the concept of misleading advertising.

As severe ill and incurable patients can be easy victims of misleading advertising activities for dangerous and non-effective healthcare treatments, the marketing of healthcare services are in many jurisdictions legislations tightly regulated. This article reviews the Danish regulation on marketing of healthcare services to identify which types of advertising activities that are legal. As the legislation only allows healthcare authorities to control the marketing and not the content and quality of the marketed healthcare services, their ability to intervene in serious cases of misleading advertising is limited. Misleading advertising are statements with the purpose to exaggerate or underestimate the effects and risks of healthcare services or to prevent patients from seeking conventional medical treatments. From a public health perspective, there is a need for a common EU legislation for regulation of the marketing of healthcare services as the increasing use of information technologies makes it possible for the providers to access consumers and patients directly across countries and legal systems.

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.

Direct-To-Consumer Advertising of Over-the-Counter Sinonasal Remedies: A History of Mixed Messages.

Sinus, cold, and allergy remedies comprise the most widely used sector of the over-the-counter (OTC) drug market. Direct-to-consumer advertising (DTCA) of pharmaceutical products has increased over the past 30 years, including the promotion of OTC drugs. The influence of DTCA on OTC sinonasal remedies comprises several positive and negative effects. Favorable aspects of this influence include empowerment and promotion of autonomy among patients, avoidance of low-value clinical encounters, self-directed education, and decreased healthcare expenditures. This is balanced by potential concerns, including the lack of rigorous regulation of OTC drugs, the burden of self-diagnosis, the risk of unsupervised use resulting in adverse effects or drug interactions, and redistribution of pharmacy costs to the consumer. Despite the proliferation of product options and consumer-directed information, healthcare utilization and cost of treating sinonasal disease remains high. Moreover, the availability of OTC sinonasal remedies and exposure to DTCA has had mixed effects without apparent overall benefit to patient and consumer health. Laryngoscope, 130:2114-2119, 2020.

Nutritional Content According to the Presence of Front of Package Marketing Strategies: The Case of Ultra-Processed Snack Food Products Purchased in Costa Rica.

The industry uses nutrition and health claims, premium offers, and promotional characters as marketing strategies (MS). The inclusion of these MS on ultra-processed products may influence child and adolescent purchase behavior. This study determined the proportion of foods carrying claims and marketing strategies, also the proportion of products with critical nutrients declaration, and nutritional profile differences between products that carry or not claims and MS on the front-of-package (FoP) of ultra-processed food products sold in Costa Rica. Data were obtained from 2423 photographs of seven food groups consumed as snacks that were sold in one of the most widespread and popular hypermarket chains in Costa Rica in 2015. Ten percent of products lacked a nutrition facts panel. Sodium was the least reported critical nutrient. Energy and critical nutrients were significantly highest in products that did not include any nutrition or health claim and in products that included at least one MS. Forty-four percent and 10% of all products displayed at least one nutrition or at least one health claim, respectively, and 23% displayed at least one MS. In conclusion, regulations are needed to restrict claims and marketing on ultra-processed food packages to generate healthier food environments and contribute to the prevention of childhood and adolescent obesity in Costa Rica.

The opioid crisis: Origins, trends, policies, and the roles of pharmacists.

PURPOSE: The purpose of this review is to (1) provide information concerning the opioid crisis including origins, trends, and some important related laws/policies; and (2) summarize the current involvement and impact of pharmacists in helping to address the crisis, as well as examine practices in other healthcare disciplines from which pharmacists might derive guidance and strategies. SUMMARY: Contributors to the opioid crisis included campaigns to treat pain as a fifth vital sign and to use opioids in treatment of non-cancer-related pain, as well as aggressive marketing of opioid analgesics by pharmaceutical companies. To address the crisis, numerous strategies have been implemented at the policy/legislative, health-system, and patient levels, such as prescription drug monitoring programs (PDMPs), increased regulation of pain clinics, and expanded use of naloxone. Pharmacists have a critical role to play in interventions to address opioid misuse and reduce harm resulting from misuse. Such interventions include patient screening and risk stratification, patient and community education and outreach concerning appropriate pain management, medication reviews/medication therapy management, education on safe storage and disposal, distribution of naloxone/opioid rescue kits and training on their proper use, and referral of patients to addiction treatment, among other strategies. CONCLUSION: Pharmacists have multiple, complex roles in addressing the opioid crisis. Outcomes of several studies provide substantial evidence that pharmacists can make an impact through appropriate pain management, use of PDMPs, opioid overdose prevention training, and medication reviews and counseling, among other interventions.

Can direct-to-consumer advertising of prescription drugs be effectively regulated?

The government of New Zealand is currently considering a new Therapeutic Products Regulatory Scheme that includes how direct-to-consumer advertising (DTCA) of prescription drugs should be regulated. This article reviews three different types of possible regulation of DTCA: government regulation, industry self-regulation and a mixture of the two. Recent studies demonstrate that DTC ads in the US continue to be misleading and contain minimal if any educational value, despite governmental regulatory efforts by the Food and Drug Administration. Other regulatory models are equally unsuccessful at controlling DTCA. Available evidence suggests that DTC ads are commonly misinterpreted as trusted public health messages and are more likely to affect vulnerable subgroups of New Zealanders. Taken together with the international evidence that regulation has consistently failed to prevent the inappropriate promotion of prescription medicines, these findings suggest that DTCA is more likely to cause harm than benefit and should be banned.

Medical Marketing in the United States, 1997-2016.

IMPORTANCE: Manufacturers, companies, and health care professionals and organizations use an array of promotional activities to sell and increase market share of their products and services. These activities seek to shape public and clinician beliefs about laboratory testing, the benefits and harms of prescription drugs, and some disease definitions. OBJECTIVE: To review the marketing of prescription drugs, disease awareness campaigns, health services, and laboratory tests and the related consequences and regulation in the United States over a 20-year period (1997-2016). EVIDENCE: Analysis (1997-2016) of consumer advertising (Kantar Media data for spending and number of ads); professional marketing (IQVIA Institute for Human Data Science, Open Payments Data [Centers for Medicare & Medicaid Services]); regulations and legal actions of the US Food and Drug Administration (FDA), Federal Trade Commission (FTC), state attorneys general, and US Department of Justice; and searches (1975-2018) of peer-reviewed medical literature (PubMed), business journals (Business Source Ultimate), and news media (Lexis Nexis) for articles about expenditures, content, and consequences and regulation of consumer and professional medical marketing. Spending is reported in 2016 dollars. FINDINGS: From 1997 through 2016, spending on medical marketing of drugs, disease awareness campaigns, health services, and laboratory testing increased from $17.7 to $29.9 billion. The most rapid increase was in direct-to-consumer (DTC) advertising, which increased from $2.1 billion (11.9%) of total spending in 1997 to $9.6 billion (32.0%) of total spending in 2016. DTC prescription drug advertising increased from $1.3 billion (79 000 ads) to $6 billion (4.6 million ads [including 663 000 TV commercials]), with a shift toward advertising high-cost biologics and cancer immunotherapies. Pharmaceutical companies increased DTC marketing about diseases treated by their drugs with increases in disease awareness campaigns from 44 to 401 and in spending from $177 million to $430 million. DTC advertising for health services increased from $542 million to $2.9 billion, with the largest spending increases by hospitals, dental centers, cancer centers, mental health and addiction clinics, and medical services (eg, home health). DTC spending on advertising for laboratory tests (such as genetic testing) increased from $75.4 million to $82.6 million, although the number of ads increased more substantially (from 14 100 to 255 300), reflecting an increase in less expensive electronic media advertising. Marketing to health care professionals by pharmaceutical companies accounted for most promotional spending and increased from $15.6 billion to $20.3 billion, including $5.6 billion for prescriber detailing, $13.5 billion for free samples, $979 million for direct physician payments (eg, speaking fees, meals) related to specific drugs, and $59 million for disease education. Manufacturers of FDA-approved laboratory tests paid $12.9 million to professionals in 2016. From 1997 through 2016, the number of consumer and professional drug promotional materials that companies submitted for FDA review increased from 34 182 to 97 252, while FDA violation letters for misleading drug marketing decreased from 156 to 11. Since 1997, 103 financial settlements between drug companies and federal and state governments resulted in more than $11 billion in fines for off-label or deceptive marketing practices. The FTC has acted against misleading marketing by a single for-profit cancer center. CONCLUSIONS AND RELEVANCE: Medical marketing increased substantially from 1997 through 2016, especially DTC advertising for prescription drugs and health services. Pharmaceutical marketing to health professionals accounted for most spending and remains high even with new policies to limit industry influence. Despite the increase in marketing over 20 years, regulatory oversight remains limited.

Testimonials within health advertising in Australia: an analysis of current policy.

The advertising of regulated health services to consumers is strictly regulated in Australia. The advertising prohibitions within the National Law that ban the use of testimonials relating to services provided by health practitioners have caused controversy, garnering mixed reactions from the health professions, health consumers and other stakeholders. Advertising that misleads health consumers may promote unnecessary and inappropriate engagement in health services and may therefore negatively affect consumers' ability to exercise autonomous decisions relating to their care. This article considers policy implications relating to advertising with a focus on the use of testimonials, particularly those that are online. Although there would seem to be appetite for amending the current legislative framework, there is uncertainty as to the form change may take and the effect this could have.

The effectiveness of voluntary policies and commitments in restricting unhealthy food marketing to Canadian children on food company websites.

Marketing unhealthy foods and beverages to children (M2K) fosters poor dietary patterns, increasing obesity and noncommunicable disease risk. Federal restrictions on M2K have been under development in Canada since 2016; however, at present, M2K is mostly self-regulated by food companies. This study aimed to compare M2K on Canadian websites of food companies with and without voluntary policies or commitments in this area. A systematic content analysis of company websites was conducted in spring/summer 2017 for major packaged food (n = 16), beverage (n = 12), and restaurant chain (n = 13) companies in Canada. M2K policies were sourced from company websites and published corporate documents. Sixteen companies (43%) reported national and/or global M2K policies, while 21 companies (57%) had no published policies. The websites of Canadian companies (n = 154) were scanned for child-directed products and marketing; type and frequency of marketing techniques were recorded. Child-directed marketing appeared on 19 websites of 12 companies (32%), including 9 companies with M2K policies. Websites featured products with unconventional flavours, colours, shapes, or child-oriented packaging, and used promotional characters, contests, games, activities, or lettering and graphics appealing to children. The nutritional quality of products marketed to children was evaluated using a nutrient profile model developed by Health Canada for proposed M2K regulations. Of the 217 products marketed to children, 97% exceeded Health Canada's proposed ∼5% Daily Value threshold for saturated fat, sodium, and/or sugars, 73% of which were products from 9 companies with policies. These findings highlight the limitations of self-regulation in restricting M2K on food company websites, reinforcing the need for government regulations.

Complaints addressed by regulatory authorities in drug advertising targeted at consumers: Cases across three, different countries.

BACKGROUND: Misleading advertisements can affect behavior of both consumers and prescribers and may lead to inappropriate use of medications. OBJECTIVE: To analyze the complaints upheld by regulatory authorities in the United Kingdom, Canada, and Australia regarding pharmaceutical advertising directed at consumers. METHODS: Complaints addressed between January 2014 and June 2017 were retrieved from the websites of regulatory authorities. Complaints addressed by self-regulatory bodies were not included due to the poor availability of data. RESULTS: Sixty complaints, 374 complaints, and 223 complaints from the United Kingdom, Canada, and Australia, respectively, were analyzed. In the United Kingdom, the most frequent type of violation was advertising of prescription drugs (70.5%); most of these violations involved botulinum toxin. In Canada, advertising on online media was more likely to be associated with prescription drugs than that on traditional media (P < 0.001). In Australia, advertising of prescription drugs accounted for less than 10% of complaints, but all were associated with online media. CONCLUSIONS: In countries where direct-to-consumer advertising of prescription drugs is prohibited, regulatory authorities may need to devise further strategies to safeguard the public as this is an unresolved issue and is predicted to become more problematic with the increased use of online media.

Disease awareness campaigns in printed and online media in Latvia: cross-sectional study on consistency with WHO ethical criteria for medicinal drug promotion and European standards.

BACKGROUND: European legislation prohibits direct-to-consumer advertising of prescription medicines, but allows drug manufacturers to provide information to the public on health and diseases. Our aim was to measure the frequency of disease awareness campaigns in Latvian media and assess their compliance with international and European standards. METHODS: Materials on health/disease and treatments were collected between April and September 2015 from 12 newspapers and magazines and six online portals. Disease awareness campaigns were assessed using a previously developed instrument based on the WHO Ethical Criteria for Medicinal Drug promotion and European standards (EU law and pharmaceutical industry self-regulatory guidelines). Collected materials were used to examine the information provided on medical conditions and their diagnosis and treatment. The inter-rater reliability was calculated. RESULTS: We collected 263 materials from print (n = 149) and online media (n = 114); 94 were news items and 169 were disease-awareness advertisements. Cancer, cardiovascular problems, allergies and respiratory diseases were common topics. Of the 157 campaigns assessed, non-compliance was identified in 149 cases (inter-rater reliability 90%), mainly due to misleading or incomplete information, lack of balance and the absence of a listed author/sponsor. Six disease awareness campaigns directly mentioned a pharmaceutical product by brand name and other four included the logo or name of a manufacturer, referred to a condition and indirectly mentioned a treatment, all in contravention with European law. CONCLUSIONS: The compliance of disease awareness campaigns in Latvian media with international and European standards is low. This raises concerns about the nature of information being conveyed. Through lack of balance, missing sponsorship information, and misleading or incomplete information, these campaigns could contribute to inaccurate self-diagnosis and generate demand among those who might not need medical treatment.

Is multi-level marketing of nutrition supplements a legal and an ethical practice?

BACKGROUND: Multi-level marketing (MLM) of nutrition products has experienced dramatic growth in recent decades. 'Wellness' is the second most popular niche in the MLM industry and represents 35% of sales among all the products in 2016. This category includes dietary supplements, weight management and sports nutrition products. The aim of this paper is to analyse whether this practice is legal and ethical. METHODS: An analysis of available documentary information about the legal aspects of Multi-level marketing business was performed. Ethical reflexion was based on the "principlism" approach. RESULTS: We argue that, while being a controversial business model, MLM is not fraudulent from a legal point of view. However, it is an unethical strategy obviating all the principles of beneficence, nonmaleficence and autonomy. What is at stake is the possible economic scam and the potential harm those products could cause due to unproven efficacy, exceeding daily nutrient requirements and potential toxicity. The sale of dietary and nutrition supplements products by physicians and dieticians presents a conflict of interests that can undermine the primary obligation of physicians to serve the interests of their patients before their own. CONCLUSION: While considering that MLM of dietary supplements and other nutrition products are a legal business strategy, we affirm that it is an unethical practice. MLM products that have nutritional value or promoted as remedies may be unnecessary and intended for conditions that are unsuitable for self-prescription as well.

Marketing of food and beverage in Brazil: scientific literature review on regulation and self-regulation of advertisements / Publicidade de alimentos e bebidas no Brasil: revisão de literatura científica sobre regulação e autorregulação de propagandas / Publicidad de alimentos y bebidas en Brasil: revisión de la literatura científica sobre regulación y auto-regulación de propagandas

The effects of marketing strategies for promotion of foods and beverages have been investigated due to its potential impacts on populations' food choices, particularly among children and adolescents. The paper presents an academic literature review on regulation and self-regulation of food and beverage advertisements in Brazil, based on search performed in electronic databases. Majority of studies were based on law analysis or qualitative study of advertisements. There are sufficient evidences on the need for government regulation of advertisements addressed to children and adolescents complementarily to institutional self-regulation in order to tackle ethical transgressions on food and beverage advertisements identified in Brazil. Additionally, there should be imposition of rigorous penalties for noncompliance to ethical rules and proposition of incentives towards actions encouraging healthy food consumption patterns, in order to comprise an actual system for promotion of public health.

Os efeitos de estratégias de marketing para promoção de alimentos e bebidas têm sido investigados devido aos potenciais impactos sobre escolhas alimentares populacionais, particularmente entre crianças e adolescentes. O artigo apresenta revisão de literatura acadêmica sobre regulação e autorregulação de propagandas de alimentos e bebidas no Brasil, baseada em busca realizada em bases de dados eletrônicas. A maioria dos estudos identificados referia-se a análise de legislação ou estudo qualitativo das propagandas. Há evidências de necessidade de regulação das propagandas direcionadas a crianças e adolescentes em complementação ao sistema de autorregulação institucional para combate às transgressões éticas identificadas em propagandas de alimentos e bebidas no Brasil. Adicionalmente, há necessidade de aplicação de penalidades severas para transgressões éticas, assim como incentivos às ações de apoio à alimentação saudável para compor um sistema efetivo de promoção da saúde pública.

Los efectos de estrategias de marketing para promoción de alimentos y bebidas se han investigado debido a los potenciales impactos sobre elecciones alimenticias poblacionales, particularmente entre niños y adolescentes. El artículo presenta una revisión de la literatura académica sobre regulación y auto-regulación de propagandas de alimentos y bebidas en Brasil, con base en una búsqueda realizada en bases de datos electrónicas. La mayoría de los estudios identificados se refería al análisis de la legislación o estudio cualitativo de las propagandas. Hay evidencias de la necesidad de regulación de las propagandas dirigidas a niños y adolescentes en complementación al sistema de auto-regulación institucional para el combate a las transgresiones éticas identificadas en propaganda de alimentos y bebidas en Brasil. Adicionalmente, hay la necesidad de aplicación de penalidades severas para transgresiones éticas, así como incentivos a las acciones de apoyo a la alimentación saludable para componer un sistema efectivo de promoción de la salud pública.

The possibility of obtaining marketing authorization of orphan pharmaceutical compounding preparations: 3,4-DAP for Lambert-Eaton Myasthenic Syndrome.

BACKGROUND: Pharmaceutical compounding preparations, produced by (hospital) pharmacies, usually do not have marketing authorization. As a consequence, some of these pharmaceutical compounding preparations can be picked-up by a pharmaceutical company to obtain marketing authorization, often leading to price increases. An example is the 3,4-diaminopyridine slow release (3,4-DAP SR) tablets for Lambert-Eaton Myasthenic Syndrome (LEMS). In 2009 marketing authorization was given for the commercial immediate release phosphate salt of the drug, including a fifty-fold price increase compared to the pharmaceutical compounding preparation. Obtaining marketing authorization for 3,4-DAP SR by academia might have been a solution to prevent this price increase. To determine whether the available data of a pharmaceutical compounding preparation with long-term experience in regular care are adequate to obtain marketing authorization, 3,4-DAP SR is used as a case study. METHODS: A retrospective qualitative case-study was performed. Initially, document analysis was executed by collecting the required data for marketing authorization in general and whether data of Firdapse® and 3,4-DAP SR met these requirements. Secondly, the (non-) available data of the two formulations were compared with each other to determine the differences in availability. RESULTS: At the time of approval, almost all data were available for both Firdapse® and 3,4-DAP SR. Conversely, much of the data used for the approval of Firdapse® originated from the 3,4-DAP immediate release (3,4-DAP IR) formulation. Only two bioequivalence studies and one pharmacology safety study was performed with Firdapse® before marketing authorization application. CONCLUSIONS: In conclusion, at time Firdapse® obtained approval, the data available did not differ substantially from 3,4-DAP SR, indicating that approval with 3,4-DAP SR would have been possible. We make a plea for approval of orphan medicinal products developed and manufactured by academic institutions as to keep utilization of these products affordable.