Public Concern About Immigration and Customer Complaints Against Minority Financial Advisors

We examine the relation between public concern about immigration and customer complaints against minority financial advisors in the United States. We find that minority advisors are more likely to receive complaints in periods of high public concern about immigration than in other periods, relative to their white colleagues from the same firm, at the same office location, and at the same point in time. This result holds for both complaints with merit and dismissed complaints and is more pronounced in counties where residents likely hold stronger anti-immigration views. We also find that minority advisors are more likely to face regulatory actions or leave their firms after customer allegations in periods of high public concern about immigration than in other periods. Overall, our study provides descriptive evidence of a positive relation between public concern about immigration and customer dissatisfaction with minority advisors. This paper was accepted by Suraj Srinivasan, accounting.

Exploring Indicators of Hepatotoxicity-Related Post-Marketing Regulatory Actions: A Retrospective Analysis of Drug Approval Data

<b><i>Background:</i></b> Hepatotoxicity is a major reason for medication withdrawal from the markets. Unfortunately, serious adverse hepatic effects can occur after marketing with limited indicators during clinical development. Therefore, finding possible predictors for hepatotoxicity might guide the monitoring program of various stakeholders such as drug regulatory authorities. <b><i>Objective:</i></b> To explore the potential of drugs, pre-approval regulatory factors as predictors for the occurrence of hepatotoxicity-related post-marketing regulatory actions. Pre-approval factors were specified as: (a) Hy’s Law hepatotoxicity grade ≥3, (b) accelerated approval status, and (c) labeled hepatic adverse effects and regulatory actions at approval. <b><i>Methods:</i></b> Using publicly accessible FDA data, we examined clinical review documents for drugs approved in the USA during the period from 2011 to 2016 to evaluate their hepatic safety profile, identifying the 3 specified indicators for analysis. <b><i>Predictors (Covariates):</i></b> We assessed whether these medications meet: (a) Hy’s Law hepatotoxicity grade ≥3, (b) accelerated approval status, and (c) labeled hepatic adverse effects and regulatory actions at approval. <b><i>Outcome (Dependent Variable):</i></b> Post-marketing regulatory action related to hepatotoxicity including products withdrawal and updates to either warning, precaution or adverse effects sections. <b><i>Statistical Analysis:</i></b> Drugs that were approved between 2011 and 2016 were included in the analysis with follow-up time from the date of approval until end of December 2019 or the date of first post-marketing regulatory action related to hepatotoxicity, whichever occurred first. The hazard ratio (HR) was estimated using Cox-regression analysis. <b><i>Results:</i></b> A total of 192 medications were included in the study. We classified 48 drugs with grade ≥3 hepatotoxicity, 43 with accelerated approval status, and 74 with labeled information about hepatotoxicity prior to marketing. The adjusted HRs for post-marketing regulatory action for products with grade ≥3 hepatotoxicity was 0.61 (95% confidence interval [CI], 0.17–2.23), 0.92 (95% CI, 0.29–2.93) for drug approved via accelerated approval program, and 0.91 (95% CI, 0.33–2.56) for drugs with labeled hepatotoxicity information at approval time. <b><i>Conclusion:</i></b> Hy’s Law with hepatotoxicity grade ≥3, accelerated approval, and label information on hepatotoxicity were not identified as predictors for post-marketing additional regulatory actions concerning liver adverse effects. However, the evidence is inconclusive due to small sample size and potential channeling bias.

Climate Adaption for Energy Utilities: Lessons Learned From California's Pioneering Regulatory Actions

This Policy Brief provides lessons learned from regulation of climate adaptation by energy utilities. The regulatory bodies responsible for oversight of investor-owned energy utilities are ill-equipped to regulate climate adaptation in the energy sector; but they may be the only institutions with authority to do so. In 2018, the California Public Utilities Commission initiated the first quasi-legislative procedure to regulate investor owned energy utilities' climate adaptation activities. The Commission's new rules for climate adaptation offer some general guidance on climate adaptation, and require investor owned utilities to conduct and submit climate vulnerability studies. Structural limitations, including conflicting interest, capacity of staff, and scope of the problem hampered the success of adaptation regulation, which failed to address fundamental questions about what constitutes adaptive measures.

Correspondence regarding the Perspective article “Addressing the importance of microplastic particles as vectors for long‐range transport of chemical contaminants: perspective in relation to prioritizing research and regulatory actions”

Important clarifictions regarding the long-range environmental transport of chemical additives contained in floating plastic debris are presented.

Gambling marketing bans in professional sports neglect the risks posed by financial trading apps and cryptocurrencies

Professional sports have in recent years become increasingly intertwined with gambling marketing, especially in countries such as Australia, Spain, and the UK. Even Formula 1 racing, which used to be closely associated with tobacco sponsorship, announced in 2021 an agreement to have an official betting sponsor. However, as happened previously with tobacco sponsorship, some policymakers and regulators have started to take legal action with gambling marketing restrictions. In Italy, gambling advertising and sponsorship are now prohibited. In Spain, gambling sponsorship of sports teams is prohibited, whilst advertising is prohibited except between 1:00AM–5:00AM, thus effectively banning commercially viable gambling marketing through sports. The UK is currently considering a sponsorship ban in sports. Although these regulatory actions may have improved consumer protection against gambling harms, a closer examination of recent developments in the top men’s soccer leagues of these three countries reveals an emerging trend toward sponsorship from two gambling-like industries that are unaffected by these legal bans: financial trading apps and cryptocurrencies. Consumers are becoming increasingly exposed to the marketing of these gambling-like products through sports contexts, and these products could pose similar risks to gambling or even additional, unique risks.

Gambling marketing bans in professional sports neglect the risks posed by financial trading apps and cryptocurrencies

Professional sports have in recent years become increasingly intertwined with gambling marketing, especially in countries such as Australia, Spain, and the UK. Even Formula 1 racing, which used to be closely associated with tobacco sponsorship, announced in 2021 an agreement to have an official betting sponsor. However, as happened previously with tobacco sponsorship, some policymakers and regulators have started to take legal action with gambling marketing restrictions. In Italy, gambling advertising and sponsorship are now prohibited. In Spain, gambling sponsorship of sports teams is prohibited, whilst advertising is prohibited except between 1:00AM–5:00AM, thus effectively banning commercially viable gambling marketing through sports. The UK is currently considering a sponsorship ban in sports. Although these regulatory actions may have improved consumer protection against gambling harms, a closer examination of recent developments in the top men’s soccer leagues of these three countries reveals an emerging trend toward sponsorship from two gambling-like industries that are unaffected by these legal bans: financial trading apps and cryptocurrencies. Consumers are becoming increasingly exposed to the marketing of these gambling-like products through sports contexts, and these products could pose similar risks to gambling or even additional, unique risks.

Implications of TGFβ Signaling and CDK Inhibition for the Treatment of Breast Cancer

TGFβ signaling enacts tumor-suppressive functions in normal cells through promotion of several cell regulatory actions including cell-cycle control and apoptosis. Canonical TGFβ signaling proceeds through phosphorylation of the transcription factor, SMAD3, at the C-terminus of the protein. During oncogenic progression, this tumor suppressant phosphorylation of SMAD3 can be inhibited. Overexpression of cyclins D and E, and subsequent hyperactivation of cyclin-dependent kinases 2/4 (CDKs), are often observed in breast cancer, and have been associated with poor prognosis. The noncanonical phosphorylation of SMAD3 by CDKs 2 and 4 leads to the inhibition of tumor-suppressive function of SMAD3. As a result, CDK overactivation drives oncogenic progression, and can be targeted to improve clinical outcomes. This review focuses on breast cancer, and highlights advances in the understanding of CDK-mediated noncanonical SMAD3 phosphorylation. Specifically, the role of aberrant TGFβ signaling in oncogenic progression and treatment response will be examined to illustrate the potential for therapeutic discovery in the context of cyclins/CDKs and SMAD3.

Sex Differences and Regulatory Actions of Estrogen in Cardiovascular System

Great progress has been made in the understanding of the pathophysiology of cardiovascular diseases (CVDs), and this has improved the prevention and prognosis of CVDs. However, while sex differences in CVDs have been well documented and studied for decades, their full extent remains unclear. Results of the latest clinical studies provide strong evidence of sex differences in the efficacy of drug treatment for heart failure, thereby possibly providing new mechanistic insights into sex differences in CVDs. In this review, we discuss the significance of sex differences, as rediscovered by recent studies, in the pathogenesis of CVDs. First, we provide an overview of the results of clinical trials to date regarding sex differences and hormone replacement therapy. Then, we discuss the role of sex differences in the maintenance and disruption of cardiovascular tissue homeostasis.