Sentiment Analysis of Review Data Using Blockchain and LSTM to Improve Regulation for a Sustainable Market

E-commerce has developed greatly in recent years, as such, its regulations have become one of the most important research areas in order to implement a sustainable market. The analysis of a large amount of reviews data generated in the shopping process can be used to facilitate regulation: since the review data is short text and it is easy to extract the features through deep learning methods. Through these features, the sentiment analysis of the review data can be carried out to obtain the users’ emotional tendency for a specific product. Regulators can formulate reasonable regulation strategies based on the analysis results. However, the data has many issues such as poor reliability and easy tampering at present, which greatly affects the outcome and can lead regulators to make some unreasonable regulatory decisions according to these results. Blockchain provides the possibility of solving these problems due to its trustfulness, transparency and unmodifiable features. Based on these, the blockchain can be applied for data storage, and the Long short-term memory (LSTM) network can be employed to mine reviews data for emotional tendencies analysis. In order to improve the accuracy of the results, we designed a method to make LSTM better understand text data such as reviews containing idioms. In order to prove the effectiveness of the proposed method, different experiments were used for verification, with all results showing that the proposed method can achieve a good outcome in the sentiment analysis leading to regulators making better decisions.

Assessing the Endocrine Disrupting Effects of Chemicals on Invertebrates in the European Union

Evidence from both laboratory and field studies has shown that currently used synthetic and naturally occurring chemical substances may potentially disrupt invertebrate endocrine systems, although the extent of this in field populations remains unclear. Translating concerns about potential endocrine disrupting chemicals (EDCs) into practical and effective regulatory action is currently hampered by the breadth of invertebrate endocrinology when compared to the better understood vertebrate systems, a lack of fundamental knowledge about the endocrinology of many invertebrate groups, and the resulting uncertainty when making regulatory decisions. This paper i) outlines the breadth of invertebrate endocrine pathways for which European Union regulation of potential EDCs may be relevant, ii) reviews the extent to which current knowledge meets regulatory requirements for invertebrates, including an assessment of the suitability of current invertebrate test guidelines for detecting endocrine modes of action; and iii) proposes a roadmap towards the regulation of potential EDCs with greater confidence, based on the Adverse Outcome Pathway (AOP) concept and a focus on identifying Molecular Initiating Events (MIEs) within AOPs. We propose that the most important research need is compilation of a comprehensive list of endocrine-related MIEs across invertebrate taxa via use of high throughput ‘omics in combination with bioinformatics reverse engineered analyses. Although tractable, such an approach would require significant resource investment for development and implementation.

Pollution in the Arctic Ocean: An overview of multiple pressures and implications for ecosystem services

The Arctic is undergoing unprecedented change. Observations and models demonstrate significant perturbations to the physical and biological systems. Arctic species and ecosystems, particularly in the marine environment, are subject to a wide range of pressures from human activities, including exposure to a complex mixture of pollutants, climate change and fishing activity. These pressures affect the ecosystem services that the Arctic provides. Current international policies are attempting to support sustainable exploitation of Arctic resources with a view to balancing human wellbeing and environmental protection. However, assessments of the potential combined impacts of human activities are limited by data, particularly related to pollutants, a limited understanding of physical and biological processes, and single policies that are limited to ecosystem-level actions. This manuscript considers how, when combined, a suite of existing tools can be used to assess the impacts of pollutants in combination with other anthropogenic pressures on Arctic ecosystems, and on the services that these ecosystems provide. Recommendations are made for the advancement of targeted Arctic research to inform environmental practices and regulatory decisions.

Pesticides Burden in Neotropical Rivers: Costa Rica as a Case Study

Neotropical ecosystems are highly biodiverse; however, the excessive use of pesticides has polluted freshwaters, with deleterious effects on aquatic biota. This study aims to analyze concentrations of active ingredients (a.i) of pesticides and the risks posed to freshwater Neotropical ecosystems. We compiled information from 1036 superficial water samples taken in Costa Rica between 2009 and 2019. We calculated the detection frequency for 85 a.i. and compared the concentrations with international regulations. The most frequently detected pesticides were diuron, ametryn, pyrimethanil, flutolanil, diazinon, azoxystrobin, buprofezin, and epoxiconazole, with presence in >20% of the samples. We observed 32 pesticides with concentrations that exceeded international regulations, and the ecological risk to aquatic biota (assessed using the multi-substance potentially affected fraction model (msPAF)) revealed that 5% and 13% of the samples from Costa Rica pose a high or moderate acute risk, especially to primary producers and arthropods. Other Neotropical countries are experiencing the same trend with high loads of pesticides and consequent high risk to aquatic ecosystems. This information is highly valuable for authorities dealing with prospective and retrospective risk assessments for regulatory decisions in tropical countries. At the same time, this study highlights the need for systematic pesticide residue monitoring of fresh waters in the Neotropical region.

Emerging technologies and their impact on regulatory science

There is an evolution and increasing need for the utilization of emerging cellular, molecular and in silico technologies and novel approaches for safety assessment of food, drugs, and personal care products. Convergence of these emerging technologies is also enabling rapid advances and approaches that may impact regulatory decisions and approvals. Although the development of emerging technologies may allow rapid advances in regulatory decision making, there is concern that these new technologies have not been thoroughly evaluated to determine if they are ready for regulatory application, singularly or in combinations. The magnitude of these combined technical advances may outpace the ability to assess fit for purpose and to allow routine application of these new methods for regulatory purposes. There is a need to develop strategies to evaluate the new technologies to determine which ones are ready for regulatory use. The opportunity to apply these potentially faster, more accurate, and cost-effective approaches remains an important goal to facilitate their incorporation into regulatory use. However, without a clear strategy to evaluate emerging technologies rapidly and appropriately, the value of these efforts may go unrecognized or may take longer. It is important for the regulatory science field to keep up with the research in these technically advanced areas and to understand the science behind these new approaches. The regulatory field must understand the critical quality attributes of these novel approaches and learn from each other's experience so that workforces can be trained to prepare for emerging global regulatory challenges. Moreover, it is essential that the regulatory community must work with the technology developers to harness collective capabilities towards developing a strategy for evaluation of these new and novel assessment tools.

Unexpected Interacting Effects of Physical (Radiation) and Chemical (Bisphenol A) Treatments on Male Reproductive Functions in Mice

For decades, numerous chemical pollutants have been described to interfere with endogenous hormone metabolism/signaling altering reproductive functions. Among these endocrine disrupting substances, Bisphenol A (BPA), a widely used compound, is known to negatively impact germ and somatic cells in the testis. Physical agents, such as ionizing radiation, were also described to perturb spermatogenesis. Despite the fact that we are constantly exposed to numerous environmental chemical and physical compounds, very few studies explore the impact of combined exposure to chemical and physical pollutants on reproductive health. The aim of this study was to describe the impact of fetal co-exposure to BPA and IR on testicular function in mice. We exposed pregnant mice to 10 µM BPA (corresponding to 0.5 mg/kg/day) in drinking water from 10.5 dpc until birth, and we irradiated mice with 0.2 Gy (γ-ray, RAD) at 12.5 days post-conception. Co-exposure to BPA and γ-ray induces DNA damage in fetal germ cells in an additive manner, leading to a long-lasting decrease in germ cell abundance. We also observed significant alteration of adult steroidogenesis by RAD exposure independently of the BPA exposure. This is illustrated by the downregulation of steroidogenic genes and the decrease of the number of adult Leydig cells. As a consequence, courtship behavior is modified, and male ultrasonic vocalizations associated with courtship decreased. In conclusion, this study provides evidence for the importance of broadening the concept of endocrine disruptors to include physical agents, leading to a reevaluation of risk management and regulatory decisions.

A comparison of the Food and Drug Administration’s and Health Canada’s regulatory decisions about failed confirmatory trials for oncology drugs: an observational study

Background Oncology drugs are frequently approved on the basis of surrogate outcomes that require further trials to confirm the benefits, but at times these trials fail and regulators need to decide whether to withdraw approval for the indication and/or to remove the drug from the market. This study compares decisions by the Food and Drug Administration and Health Canada about oncology drugs that were approved using either Accelerated Approval (FDA) or Notice of Compliance with conditions (NOC/c, Health Canada) and that failed confirmatory trials. Methods Drug/indications approved by the FDA through its Accelerated Approval Pathway and that later failed confirmatory studies were identified from a published study and additional information on these drugs was collected from Drugs@FDA. Health Canada websites were searched on September 11, 2021 for the same group of drugs to determine if they were approved in Canada under the NOC/c pathway for the same indication as in the US. Information from both the FDA and Health Canada about these products was entered into an Excel spreadsheet. Decisions about whether to withdraw the drugs or remove the failed indication for the drug and requirements for confirmatory studies were compared. In addition, the dates of decisions by the two agencies were compared. Results Ten drug/indications were available for comparison. Regulatory decisions were similar in 4 cases, different in 1 case and could not be determined in the remaining 5, in 1 case because decisions were pending in both countries and in the other 4, because the NOC/c had not been fulfilled in Canada. The requirements for the confirmatory studies were similar in both countries. Decisions were made earlier in the United States. Conclusions This study shows that decisions made by Health Canada and the FDA about whether to withdraw a drug or remove a failed indication when drug/indications fail a confirmatory trial are usually similar, although the sample size on which this conclusion is made is small. The clinical implications of these similarities and differences should be explored.

Establishing Auditing Intermediaries to Verify Platform Data

This chapter provides an overview of the main problems associated with basing public regulatory decisions on unverified data, before sketching out some ideas of what a solution might look like. In order to do this, the chapter develops the concept of auditing intermediaries. After discussing which problems the concept of auditing intermediaries is designed to solve, it then discusses some of the main challenges associated with access to data, potential misuse of intermediaries, and the general lack of standards for the provision of data by large online platforms. In conclusion, the chapter suggests that there is an urgent need for an auditing mechanism to ensure the accuracy of transparency data provided by large online platform providers about the content on their services. Transparency data that have been audited would be considered verified data in this context. Without such a transparency verification mechanism, existing public debate is based merely on a whim, and digital dominance is likely to only become more pronounced.

Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent

The US Food and Drug Administration (FDA) has approved two drugs for ‘hypoactive sexual desire disorder’ in women, flibanserin (Addyi) in 2015 and bremelanotide (Vyleesi) in 2019. In this paper we examine the outcome measures and clinical trial data upon which regulatory approval was based. In clinical trials, flibanserin led to an average of only one additional enjoyable sexual experience every two months, bremelanotide to none. Trials for both drugs feature shifts in primary outcomes and a contested indication. A politicised industry-sponsored advocacy campaign and conflicted patient and expert testimony likely influenced flibanserin’s approval at its third attempt. Bremelanotide, with even weaker efficacy, capitalised on the regulatory precedent set by the approval of flibanserin. Reconsideration of regulatory decisions to approve these drugs is in order, as well as a broader examination of how future regulatory decisions can better address conflicts of interest and clinically meaningful benefit.

NIH Tobacco Research and the Emergence of Tobacco Regulatory Science

Introduction This study explores how the emergence of FDA-funded Tobacco Regulatory Science (TRS) research complements and perhaps influenced the direction of tobacco research supported by NIH. Methods New NIH- and FDA-funded tobacco projects awarded in fiscal years (FY) 2011-2020 were identified using internal NIH databases of awarded grants. Project abstracts and research aims were coded by the authors to characterize research domains and tobacco products studied. Results Between FY 2011 and 2020, NIH funded 1032 and FDA funded 322 new tobacco projects. For the years and grant activity codes studied, the number of new NIH tobacco projects declined while FDA’s increased; combined the number of new projects held steady. Much of NIH research included smoking combustibles (43.7%). The most common products in FDA research were cigarettes (74.8%) and e-cigarettes/ENDS (48.1%). Most NIH (58.6%) and FDA (67.7%) projects included research on the determinants of tobacco use. Another area of apparent overlap was health effects (29.5% NIH and 30.1% FDA). Projects unique to NIH included treatment interventions (33.3%), disease pathology/progression (17.8%) and neurobiology (18.9%). A minority of both NIH and FDA projects included populations particularly vulnerable to tobacco product use. Conclusions In total, support for new tobacco research supported by NIH and FDA combined remained steady for the time period covered, though there was a concomitant decline in NIH tobacco projects with the increase in FDA-funded TRS projects for the activity codes studied. Despite apparent overlap in some areas, both NIH and FDA support research that is unique to their respective missions. Implications NIH continues to support tobacco research that falls within and outside of FDA’s regulatory authorities. This research still is needed not only to bolster the evidence base for regulatory decisions at the national and state levels, but also to advance a comprehensive scientific agenda that can inform multiple levels of influence on tobacco control, use and addiction. It will be important to continue monitoring FDA-funded TRS and NIH-funded tobacco research portfolios to ensure that the level of support for and focus of the research is sufficient to address the burden of tobacco-related morbidity and mortality.