The food pyramid meets the regulatory pyramid - responsive regulation of food advertising to children

Obesity poses an urgent threat to children’s health. The causes of obesity are many and varied, but evidence suggests that the food industry makes a significant contribution. Multinational companies use a range of communication channels and marketing techniques to promote unhealthy foods and beverages to children. This promotion has a small but significant effect on children’s food preferences and choices, their consumption patterns and diet-related health. While public health advocates call for statutory regulation of unhealthy food advertising, the food industry has mobilised government support for voluntary action. In Australia, there is significant debate over the success of two self-regulatory codes that address food advertising to children. In this thesis I evaluate the food industry’s initiatives using a new approach. Although I consider evidence of the codes’ outcomes, I focus on whether they establish the building blocks of an effective self-regulatory regime. I use regulatory studies and public health law to create a framework for evaluation, drawing particularly on the idea of responsive regulation. I also compare food, tobacco and alcohol advertising regulation to predict whether statutory regulation of food advertising is practical and politically feasible. I find that food and alcohol advertising codes contain a series of ‘escape clauses’ that permit companies to continue with most of their marketing practices. As a result, the codes do not significantly reduce children’s exposure to food and alcohol advertising, or moderate the persuasive techniques used by marketers. Food industry self-regulation lacks the features of a well-designed voluntary scheme, including clear objectives, independent administration and monitoring, effective enforcement and systematic review. Further, regulatory processes are almost entirely industry based, meaning that the scheme is not accountable to external stakeholders. The difficulty of conducting research in this area underscores this conclusion. Food and alcohol companies report high levels of compliance with the codes, and an ethical commitment to responsible marketing practices. However, the initiatives do not place demanding requirements on participants; they only codify existing best practice in advertising to children. Further, industry initiatives exclude some of the main food and alcohol advertisers. In comparison to tobacco, food and alcohol products are highly varied, making regulation a more complex exercise. More fundamentally, these industries have an economic interest in advertising unhealthy products to a wide range of age groups. Accordingly, they are unlikely to accept any tighter restrictions on advertising to children, which might impact on their communication with adult audiences. One way of strengthening self-regulation is to include external stakeholders in regulatory processes. Public health actors engage with the food and alcohol industry (unlike the tobacco industry), creating the potential for more collaborative arrangements. However, experience with the ‘quasi-regulation’ of alcohol advertising illustrates that public health participation may not create a more transparent and accountable scheme. Also, external participation in industry schemes is highly contentious, and public health actors risk their credibility and reputation in doing so. Accordingly, government action is required to broaden the reach of self-regulation and improve its functioning. Given the strong case for government action, the question becomes what form it should take. There are significant political barriers to legislation, including the power of the food industry, and neo-liberal ideologies that favour minimal regulation. Accordingly, I consider options outside of ‘command-and-control’ regulation. Through co-regulation, the government could set clear objectives for the codes to achieve, establish an independent body for monitoring and enforcement, and formalise its oversight of the scheme. It must also threaten the industry with more intrusive regulation, should the improved scheme fail to reduce children’s exposure to unhealthy food advertising. This strategy implicitly endorses a responsive regulatory approach that begins with voluntary action by the food industry itself. However, it also recognises the central role of the state in regulation, and describes new ways for governments to protect public health

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570