ROCKY ROAD AHEAD FOR NEW FDA CHIEF CALIFF

Final Senate approval by a historically narrow 50-46 vote came only after the White House and Califf's supporters lobbied hard to gain sufficient support, a success that is very different from Califf's 89-4 approval back in 2016. Pressure to help control the high cost of prescription drugs will continue to drive FDA support for developing complex generic drugs and biosimilars. There is pressure to clarify rules governing e-cigarettes;a need to address serious health problems arising from contaminated food and seafood, including significant volumes of imported products;and the safety of cosmetic products, dietary supplements, sunscreens, and other non-prescription products raise additional complex issues.

Corporate social responsibility within a global pandemic: a qualitative analysis of the population's perception of sport organizations

The purpose of this study was to examine the population's perception of corporate social responsibility of three (inter)national sport organizations during the first wave of the Covid-19 pandemic. Within an online survey in Germany, 389 open statements were gathered and analyzed using thematic analysis. Drawing on Carroll's CSR conceptualization, the identified themes were assigned to the economic, legal, ethical and discretionary responsibility of sport organizations. The analysis revealed a fifth dimension of responsibility referring to organizations' communication and transparency. Most answers were concerned with the economic and ethical theme, highlighting the importance of financial modesty and contributing to the health of others during the pandemic. This study stresses the importance for sport organizations to meet ethical and moral expectations of society during times of crisis to maintain mutually beneficial relationships with core stakeholders such as the resident population. © 2023 Informa UK Limited, trading as Taylor & Francis Group.

The Elephant (or Donkey) in the Room

With the United States presidential election merely days away (set to take place on 3 Nov. 2020), the world's gaze has shifted to the race for the White House and whether there will be a Republican or Democrat taking office. [...]if this circumstance were to change, there would be potential consequences for European pharma companies that have a presence in or deal with the US. If the Democrats win the presidency and have control over Congress, it is expected that foreign and generic-drug manufacturers would benefit as a result of lower market entrance barriers.

The Spectrum of Pulmonary Histomorphology Changes in COVID-19 Cases

Introduction/Objective Pulmonary specimens following COVID-19 virus infection demonstrate a spectrum of pulmonary histomorphology. Six patients with a history of COVID-19 infection are summarized in this review. The purpose of our study is to elucidate any possible correlations between clinical, laboratory, radiographic, and pathologic findings in COVID-19 patients. Further, we aim to characterize both non-specific and specific histomorphology and cytomorphology in COVID-19 patients. Methods/Case Report Six patients with known COVID-19 infection and lung biopsies/resections are identified. A chart review is performed to collect clinical histories, the results of COVID-19 PCR testing, radiographic impressions, pathologic interpretations of histology, and clinical outcomes. Information is summarized and tabulated. Results (if a Case Study enter NA) The most common, non-specific histological findings are focal/diffuse acute lung injury, organizing lung injury, or a combination of both patterns. Unique features of COVID-19 infection are identified in three cases, which illustrate viral cytopathic changes within hyperplastic pneumocytes. These include basophilic, vacuolated, granular cytoplasm and variably sized cytoplasmic/nuclear inclusions. Virus-loaded pneumocytes are typically identified in the organizing phase, and rarely in the acute lung injury phase. Immunohistochemical staining of anti-nuclear capsule antibody with appropriate controls shows focal positive staining in one case. SARS-CoV-2 PCR is positive in formalin-fixed paraffin-embedded (FFPE) tissue, while a serum PCR assay is negative. Conclusion The severity of clinical symptoms and clinical outcome are unrelated to the degree of lung involvement. Viral cytopathic changes are identified in three cases, with these specific findings associated with the organizing phase of lung injury, and either concurrent PCR positivity or positive immunohistochemical staining.

The danger of inappropriate use of personal protective equipment

The coronavirus pandemic is a global health emergency which has had widespread unforeseen mental health consequences. Those with borderline personality disorder are predisposed to poor coping strategies to manage such stress and require intense psychological input which was not widely available during the peak of the pandemic. It is likely that the coronavirus outbreak has had a significant impact on the mental stability of such patients aggravating deliberate self-harm behaviours. A 20-year old psychiatric in-patient with borderline personality disorder, held under Section III of the mental health act, presented to the adult plastic surgery team in Bristol with localised infection of her right forearm. Foreign bodies were easily palpable and imaging revealed linear metal objects. The patient reported that she had removed metal strips from her collection of face masks and inserted them into her forearm as an act of deliberate self-harm. The patient was taken to operating theatre for removal of these foreign bodies under general anaesthetic. After twenty-four hours of antibiotics she was discharged safely back to the psychiatric ward. Despite the epilogue of the COVID-19 pandemic facemasks are still mandatory within the hospital setting. Clinicians need to be aware of these unusual circumstances where a form of protective equipment was deconstructed to cause actual bodily harm. The purpose of this report is to promote awareness of this type of injury especially in those suffering from mental illness. The authors would suggest an alternative mask without any form of metal.

Research on the 6XS6 of the SARS-CoV-2 Spike Protein

The 6XS6 is the structure of the SARS-CoV-2 spike protein. The physiological role of the spike protein is relative to the respiratory syndrome coronavirus and has a stronger infect on the human body than the ancestor virus. The purification of the 6XS6 is in the homo sapiens cell by the affinity chromatography, PBS supplemented and Size Exclusion chromatography. At last, using the Cryo-Electron Microscopy to see the structure. This paper is using the D614G mutation to illustrate the structure of the 6XS6. The N-terminal domain and C-terminal domain of the 6XS6 protein are ALA27 and VAL1137. Furthermore, the mutation doesn't have the hydrogen bond because the Asp614 is substituted by the Gly614, and the molecule that interacts with the Ala 647 may occur. While the 6XS6 structure has lots of non-covalent and disulfide bonds. Comparing the structure of the 6XS6 and 6VXX, both are glycoproteins, have three monomers, have two subunits, and have the same category of expression and classification. The different conformations of the two structures can affect the binding ability with the ACE2. This paper can help the researchers to further understand the structure and function of the 6XS6 which can be used in future experiments. © 2023 SPIE.

Feminist Governance in the European Parliament: The Political Struggle over the Inclusion of Gender in the EU's COVID-19 Response

The research objective of this article is to analyze the European Parliament's response to the COVID-19 pandemic from the perspective of feminist governance. Feminist governance can either play a role in ensuring the inclusion of a gender perspective in crisis responses, or, quite the opposite, crises may weaken or sideline feminist governance. The empirical analysis focuses on two aspects of feminist governance: (1) a dedicated gender equality body and (2) gender mainstreaming. In addition to assessing the effectiveness of feminist governance, the analysis sheds light on the political struggles behind the policy positions. The article argues that feminist governance in the European Parliament was successful in inserting a gender perspective into the COVID-19 response. The article pinpoints the effects of the achievements of the European Parliament's Women's Rights and Gender Equality Committee and gender mainstreaming on gendering the pandemic crisis response.

Black Poetics of Affect: Intimate Public Encounters with Strangers in Claudia Rankine's Just Us (2020)

This article aims to explore how Jamaican-born writer Claudia Rankine displays the ways in which, as a black woman and a first-generation migrant settled in the United States, she 'regularly has to negotiate conscious and unconscious dismissal, erasure, disrespect, and abuse' (Rankine [2020] Just Us: An American Conversation, New York: Penguin, p. 23). Just Us: An American Conversation is a genre-defying work that includes poems, essays, photography, visual art, posts from social media, and academic and journalistic sources that tackle the discursive constructions of whiteness in cultural and political life in the United States. In this volume, the private and the public merge through conversations with white strangers and friends at the airport and the train station, in the classroom, in the backyard, in the street and in social distancing interactions via Zoom. Berlant ([2011] Cruel Optimism, Durham: Duke UP.) writes about public spheres as 'affect worlds', where emotions precede rational or deliberative thought, attaching strangers to each other and defining the terms of the state-civil society relation. I also use Sara Ahmed's idea of 'encounter' (2000, 2012), defined as a meeting with others that surprises and involves conflict, because it shifts the boundaries of the familiar or assumed knowledge. In this sense, Rankine creatively looks for traces of racialized and gendered experiences in encounters that involve bodies or texts, including the devastating effects of Covid-19 on marginalized black communities. The volume completes a vital trilogy that includes the hybrid book-length poems Don't Let Me Be Lonely (2004) and Citizen (2014). This lyrical series conform what I call 'a black poetics of affect', shaped by intimate public encounters with racism and sexism that disrupt the fantasy of a post-racial society. Rankine's sustained reflections on 'the affective dimensions of Black life' (Palmer [2017] '"What Feels More Than Feeling?": Theorizing the Unthinkability of Black Affect', Critical Ethnic Studies 3:2, pp. 31-56.) provide new and situated insights on affect theories and feminist studies.

Anesthesia for penetrating injury of the oropharynx in a child: a case report

BackgroundPenetrating injury of the oropharynx occurs frequently in children, however, anesthetic management is seldom described in such cases.Case presentationA 2-year old child came to the emergency room with a toothbrush impacted in the gingivobuccal sulcus making airway management difficult. We used a simple yet unique approach to secure the airway safely given the lack of pediatric size fibreoptic and videolaryngoscopes in our emergency operation theatre. The patient was kept in Pediatric ICU and watched for any complications and discharged on the 4th postoperative day.ConclusionsThus, ingenious non-invasive techniques to secure the airway can prevent the patient from undergoing surgical tracheostomy.

Chaos, expansion, and contraction: The information worlds of depression patients during the COVID-19 pandemic lockdown

Although there have been several studies of people's information behaviors during the COVID-19 epidemic, the information practices of a specific group of people-those with depression-have been neglected. This study reports on qualitative interviews with 24 participants to explore the information practices of people living with depression during the pandemic lockdown. We use the theory of information worlds and the concept of transition to understand the phases of chaos, expansion, and contraction that the information worlds of this group present during the lockdown, and examine the interrelationship between the information worlds and the individual's transition experiences during specific periods. Our results show that, first, emotion, body, and embodiment play key roles in the individual's information worlds, while individuals' information practices are regulated by the economic environment, group norms, and other social circumstances. Second, government-level information, the volunteer community, social media, and nonhuman objects further impact participants' information practices. We suggest that health management strategies need to have different priorities at different stages of the transition, and attention should be paid to the provision of emotional information support systems during the pandemic lockdown.

COVID-19 Geopolitics in Southeast Asia: Regional and National Health (in)Securities in Times of Pandemic

COVID-19 is a nonhuman threat that has thrust disease to the center of discourses about geopolitics, security, and national sovereignty. This chapter examines the multilateral, regional, and national dimensions of COVID-19 as the pandemic has played out in Southeast Asia. National vignettes are utilized to reveal different geopolitical dimensions of COVID-19 responses and influences. COVID-19 has had enormous implications for migrant workers worldwide, which may reinforce preexisting prejudices and practices of exclusion. In Singapore's case, migrant infection clusters have generated a growing state and public recognition of the nation's dependence on foreign workers as part of its political economic drive for growth and survival. The use of "war metaphors” as national propaganda against the disease and as a means for state-nation-building are explored in the case of Vietnam. Even a force as deadly as a global pandemic cannot prevent humanmade geopolitical rifts from becoming deeper. The chapter explores how the military in Myanmar have exploited the timing of pandemic and targeted public health workers in order to strengthen a hold over the country following a military coup. Finally, the chapter considers "ways forward, " and suggests that we draw inspiration from frontline workers, everyday struggles, and the realm of public health in order to seek sustainable meanings of justice and security. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.

Viral Entanglements Biosecurity, Sexuality, and HIV/AIDS in South Korea

This article explores the treatment of queer people as biosecurity threats during the 2015 outbreak of the Middle East Respiratory Syndrome coronavirus (MERS-CoV) in South Korea. The making of corporeal threats pivoted on the common biosecurity techniques of isolation and containment, of both virus and (potentially) infected, and mirrors the protracted treatment of people living with HIV/AIDS. However, in the aftermath of the MERS-CoV outbreak, queer and HIV/AIDS activists critiqued the methods of isolation that make people into threats and reify structural violence, articulating a radical form of relationality that draws infected and noninfected, humans and viruses, together. I argue that inviting relationality, activists mobilize the same biosecurity relations thought to be dangerous. The problem of proximity becomes not only the solution but also an activist tool of social justice. The MERS-CoV outbreak became an opportunity to illustrate a different kind of living, one predicated on what I call the human-virus hybrid: the social and microbial relationships between humans and viruses. Moving through the fields of biosecurity, human-microbe relations, sexuality, and HIV/AIDS, I proffer that the human-virus hybrid provides nuanced understandings of how people considered threats live during public health crises and find innovative methods of endurance.

Best practices for pediatricians in diagnosing and treating asthma

Additionally, they can treat atopic comorbidities such as atopic dermatitis, chronic urticaria, nasal polyps, eosinophilic esophagitis, and hypereosinophilic syndrome, resulting in improved quality of life for our patients. Parents should be made aware of its updated black box warning for possible effects on mental health and behavior changes,3 including but not limited to suicidal ideation. FDA requires boxed warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair);advises restricting use for allergic rhinitis.

Mistakes and complications in the diagnosis and treatment of children with organic foreign body aspiration

The reason for the publication of this article was the increase in the number of children with long-standing organic foreign bodies in the respiratory tract, the late diagnosis of which causes severe complications. The article presents the three most significant cases from the general series, when the diagnosis and treatment tactics at the stages of treatment were associated with errors both at the prehospital stage and in the hospital. In the first clinical case, as it turned out, the child had aspired multiple foreign bodies. The first bronchoscopy revealed one solid foreign body. Due to severe fibrinous-purulent endobronchitis and contact bleeding, the bronchoscopy procedure was aborted. However, after 10 days, the child independently coughed up the second seed, which was a surprise to us. Control bronchoscopy after 3 weeks revealed no foreign bodies. In the second clinical observation, a child developed bronchiectasis due to a long stay of a foreign body in the respiratory tract. The third case demonstrates the diagnosis and treatment tactics in a child with a foreign body against the background of a coronavirus infection. In the first and third cases, the results of treatment were satisfactory. In the second case, a long stay of peanuts in the respiratory tract led to bronchiectasis in the lower lobe of the left lung, which required its removal. In the follow-up, there are no complaints, the child grows and develops according to age. The study analyzes the mistakes made at the stages of diagnosis and treatment of children with foreign bodies in the respiratory tract. Conclusion. Young children with long-term and atypically current respiratory diseases, dubious and even normal radiological picture with the absence of comprehensive information on the anamnesis of diseases should alert the doctor to the possibility of aspiration of a foreign body in the respiratory tract and serve as the basis for performing bronchoscopy.Copyright © 2023 National Academy of Pediatric Science and Innovation. All rights reserved.

Upper Aerodigestive Tract Procedures in COVID-19 Pandemic

Since the late 2019 months' pandemic of Corona Virus Disease-2019 (COVID-19), it has spread globally and claimed abundant lives due to its expeditious interpersonal transmission and high mortality rate. Early studies showed that the upper aerodigestive tract procedures had the highest rates of nosocomial spread due to high viral load in upper respiratory and pharyngeal secretions. Between March 10 and April 10, 2020, a total of 28 rigid endoscopies were performed under general anesthesia for the removal of esophageal foreign bodies at our center. All the patients were screened on admission for symptoms of COVID-19 and a chest CT scan was performed and they were later followed up for further investigations. No patient had symptoms of COVID-19 (fever, cough, and dyspnea) on admission, and only one patient (3.57 %) had a suspicious CT scan for COVID-19. The mean age of 27 asymptomatic cases, including 14 men and 13 women, was 45.2 years old. Their average hospital stay was 0.8 days. all patients were later interviewed, inspected, and closely observed for any upcoming symptoms which would raise suspicion for COVID-19 during isolation. Of the 27 patients who cooperated, none showed COVID-19 symptoms. What makes this experiment prominent is that with suitable plans in a careful and precautionary manner, we can provide first-rate care for patients and meanwhile protect physicians during this pandemic promptly.Copyright © 2023 Tehran University of Medical Sciences.

Government support to Pakistani women entrepreneurs during the COVID-19 pandemic

PurposeUnder the unique context of COVID-19, this paper aims to analyze how the Government of Pakistan (GoP) provides financial and non-financial support to women entrepreneurs in Pakistan. Drawing on the resource-based theory of entrepreneurship (RBTE), the study advances the understanding of resources and grants offered by GoP to women entrepreneurs to help them in business survival.Design/methodology/approachThe study adopts qualitative research method to address the questions: how does the Pakistani government respond to issues faced by women entrepreneurs during the COVID-19 pandemic, and what assistance and initiatives were implemented by GoP? Semi-structured interviews were conducted with twenty on-job government officials related to the entrepreneurial sector in Pakistan.FindingsThe paper reveals that during the pandemic, GoP keenly communicated with women entrepreneurial representatives to comprehend their business challenges. In addition, waivers and incentives were provided to support their business activities. GoP further invited women entrepreneurs to contribute their knowledge and give suggestions in policy making.Originality/valueLots of research have been conducted to identify the issues faced by women entrepreneurs during the pandemic. However, the specific strategies, policies, and support provided by the governments to address these issues have often been overlooked. This paper fills such gap with focus on the governing bodies and policymakers in Pakistan towards women entrepreneurship during the COVID-19 crisis.

Intrinsic factors behind long-COVID: I. Prevalence of the extracellular vesicles.

It can be argued that the severity of COVID-19 has decreased in many countries. This could be a result of the broad coverage of the population by vaccination campaigns, which often reached an almost compulsory status in many places. Furthermore, significant roles were played by the multiple mutations in the body of the virus, which led to the emergence of several new SARS-CoV-2 variants with enhanced infectivity but dramatically reduced pathogenicity. However, the challenges associated with the development of various side effects and their persistence for long periods exceeding 20 months as a result of the SARS-CoV-2 infection, or taking available vaccines against it, are spreading horizontally and vertically in number and repercussions. For example, the World Health Organization announced that there are more than 17 million registered cases of long-COVID (also known as post-COVID syndrome) in the European Union countries alone. Furthermore, by using the PubMed search engine, one can find that more than 10 000 articles have been published focusing exclusively on long-COVID. In light of these enormous and ever-increasing numbers of cases and published articles, most of which are descriptive of the various long-COVID symptoms, the need to know the reasons behind this phenomenon raises several important questions. Is long-COVID caused by the continued presence of the virus or one/several of its components in the recovering individual body for long periods of time, which urges the body to respond in a way that leads to long-COVID development? Or are there some latent and limited reasons related to the recovering patients themselves? Or is it a sum of both? Many observations support a positive answer to the first question, whereas others back the second question but typically without releasing a fundamental reason/signal behind it. Whatever the answer is, it seems that the real reasons behind this widespread phenomenon remain unclear. This report opens a series of articles, in which we will try to shed light on the underlying causes that could be behind the long-COVID phenomenon.

Governed bodies, discarded bodies: Notes for an analysis of contemporary migrations during Covid-19

This article presents the results of an ethnographic research conducted in the northern border of Mexico from 2019 to 2021, specifically in the city of Tijuana. The objective of this article is to analyse the role of bodies in border and migration management with special emphasis on the time of the Covid-19 pandemic. To do so, I focus on three situations. First is the case of migrants whose bodies are exploited in the precarious work opportunities they find along Mexico's northern border. Second, I look at migrants who experience detention and confinement in Customs and Border Protection (CBP) detention centres in the United States. And third, I analyse the situation of missing migrants whose bodies are sought by family members and numerous collectives in Mexico. Through the analysis of these situations, the article demonstrates that by using ‘bodies' as a productive category for analysing migration and the containment of migratory movements, we can understand both the resulting negative effects on migrants' subjectivity and bodies and how migrants respond to and challenge the global migration system. © The Author(s) 2023.

Mistakes and complications in the diagnosis and treatment of children with organic foreign body aspiration.

The reason for the publication of this article was the increase in the number of children with long-standing organic foreign bodies in the respiratory tract, the late diagnosis of which causes severe complications. The article presents the three most significant cases from the general series, when the diagnosis and treatment tactics at the stages of treatment were associated with errors both at the prehospital stage and in the hospital. In the first clinical case, as it turned out, the child had aspired multiple foreign bodies. The first bronchoscopy revealed one solid foreign body. Due to severe fibrinous-purulent endobronchitis and contact bleeding, the bronchoscopy procedure was aborted. However, after 10 days, the child independently coughed up the second seed, which was a surprise to us. Control bronchoscopy after 3 weeks revealed no foreign bodies. In the second clinical observation, a child developed bronchiectasis due to a long stay of a foreign body in the respiratory tract. The third case demonstrates the diagnosis and treatment tactics in a child with a foreign body against the background of a coronavirus infection. In the first and third cases, the results of treatment were satisfactory. In the second case, a long stay of peanuts in the respiratory tract led to bronchiectasis in the lower lobe of the left lung, which required its removal. In the follow-up, there are no complaints, the child grows and develops according to age. The study analyzes the mistakes made at the stages of diagnosis and treatment of children with foreign bodies in the respiratory tract. Conclusion. Young children with long-term and atypically current respiratory diseases, dubious and even normal radiological picture with the absence of comprehensive information on the anamnesis of diseases should alert the doctor to the possibility of aspiration of a foreign body in the respiratory tract and serve as the basis for performing bronchoscopy.Copyright © 2023 National Academy of Pediatric Science and Innovation. All rights reserved.

An Efficient and Intelligent Systems for Internet of Things Based Health Observance System for Covid 19 Patients

This paper describes how an IoT -based health monitoring system was conceived and built (IoT). With the proliferation of new technologies, doctors nowadays are constantly on the lookout for cutting-edge electronic tools that will make it simpler to detect abnormalities in the human body. The Internet of Things makes it possible to create cutting-edge, non-intrusive healthcare assistance systems. In this article, we introduce the Comprehensive Health Monitoring System, or CHMS. Normal people can't afford to buy separate devices or make frequent trips to hospitals. Our CHMS will monitor a patient's vitals, including temperature, heart rate, and oxygen saturation (OS), and relay that information to a portable device. To make sense of the information gathered by the physical layer's sensors, the logical layer must analyses it. The application layer then makes judgments based on the processed data from the logical layer. The primary goal is to reduce costs for average consumers. Patients will have simple access to individual healthcare, in addition to financial sustainability. This study introduces an IoT -based system that would streamline the operation of a complex medical gadget while reducing its associated cost, allowing its users to do so from the comfort of home. The public's adoption of these gadgets as aids in a given setting might have significant effects on their own lives. © 2023 IEEE.