Effective regulatory responses to predatory stem cell markets in Australia and Canada.

The rapid proliferation of businesses engaged in direct-to-consumer advertising of unproven stem cell interventions has raised troubling questions about whether government bodies can regulate this health market effectively. Recent developments in Australia and Canada suggest that such fears are unfounded and that targeted regulatory action can have meaningful effects.

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.

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

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

The Frequency and Healthfulness of Food and Beverage Advertising in Movie Theatres: A Pilot Study Conducted in the United States and Canada.

The marketing of unhealthy foods and beverages contributes to childhood obesity. In Canada and the United States, these promotions are self-regulated by industry. However, these regulations do not apply to movie theatres, which are frequently visited by children. This pilot study examined the frequency and healthfulness of food advertising in movie theatres in the United States and Canada. A convenience sample of seven movie theatres in both Virginia (US) and Ontario (Canada) were visited once per month for a four-month period. Each month, ads in the movie theatre environment and before the screening of children's movies were assessed. Food ads were categorized as permissible or not permissible for marketing to children using the World Health Organization's European Nutrient Profile Model. There were 1999 food ads in the movie theatre environment in Ontario and 43 food ads identified in the movie theatre environment in Virginia. On average, 8.6 (SD = 3.3) and 2.2 (SD = 0.9) food ads were displayed before children's movies in Ontario and Virginia, respectively. Most or all (97%-100%) food ads identified in Virginia and Ontario were considered not permissible for marketing to children. The results suggest that movie theatre environments should be considered for inclusion in statutory food marketing restrictions in order to protect children's health.

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.

Consumer alcohol exposure in supermarkets: legislatively adherent, but a societal problem.

OBJECTIVE: The Sale and Supply of Alcohol Act 2012 came into force to promote the safe and responsible sale, supply, and consumption of alcohol in New Zealand. The Act was intended to minimise harm caused by excessive consumption of alcohol and reduce exposure to alcohol promotion. This study assessed supermarket adherence to sections 112-114 of the Act related to the display and advertisement of alcohol. It also assessed consumer exposure to alcohol marketing in these businesses. METHODS: This paper reports on an audit of nine supermarkets in a major New Zealand city. RESULTS: Supermarkets exhibited high average adherence with the Act (86% adherence across audit fields); despite this, exposure to alcohol displays, promotions and advertisements remained an issue regardless of supermarket geographic location, size or chain affiliation. CONCLUSIONS: Supermarkets are an increasingly popular source of off-licence alcohol sales. Exposure to alcohol marketing in these businesses will likely influence consumer purchasing behaviour. Implications for public health: As an important public health challenge, based on this study, it would appear that supermarkets mostly meet the provisions of the Sale and Supply of Alcohol Act 2012, but not the intent. Additional work is required to strengthen their response to the Act.

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.

Online Direct-to-Consumer Advertising of Stem Cell Therapy for Musculoskeletal Injury and Disease: Misinformation and Violation of Ethical and Legal Advertising Parameters.

BACKGROUND: There has been a recent surge in health-care providers offering stem cell therapy (SCT) to patients with musculoskeletal disease. The purpose of this study was to identify and quantify the misinformation present in online direct-to-consumer (DTC) advertising of SCT targeting patients with musculoskeletal disease in the U.S. It was hypothesized that DTC advertising of SCT contains substantial misinformation. METHODS: A list of keywords was used to identify web sites of practices advertising SCT directly to patients with musculoskeletal disease. Web sites were evaluated to determine the specialties of providers offering SCT, types of SCT being advertised, and misinformation presented. Categories of misinformation included false general claims, inaccurate statements regarding mechanism of action, unfounded results, and scare tactics. RESULTS: Of the 896 practice web sites included in the analysis, 95.9% contained at least 1 statement of misinformation, with a mean of 4.65 ± 3.66 statements of misinformation among the sites. Practices associated with an orthopaedic surgeon provided 22% fewer statements of misinformation than practices without an orthopaedic surgeon when we controlled for the effects of other specialties. Practices associated with a podiatrist also provided 22% fewer statements of misinformation. CONCLUSIONS: Nearly all practices failed to accurately represent the clinical efficacy of SCT in DTC advertising. While practices associated with an orthopaedic surgeon were less likely to provide misinformation, the majority of all web sites contained some type of misinformation, ranging from errors in the basic science of stem cells to outright false and misleading claims of their clinical effectiveness.

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.