"A passion to change the landscape and drive a renaissance": The mRNA Hub at Afrigen as decolonial aspiration.

In global conversations about COVID-19 vaccine access, Africa has overwhelmingly been characterized as a site of lack. However, the successful reverse engineering of the Moderna vaccine by Afrigen at the mRNA Hub in Cape Town marks a more hopeful path forward. This paper introduces the mRNA Hub and puts it into context of broader decolonial aspirations for African futures in the face of rich countries' disregard. Highlighting ways in which Afrigen's Managing Director's articulations of the endeavor resonate with historical and contemporary calls to dismantle the unequal global order, we argue that the mRNA Hub provides an example of the potential for decolonial solidarity in the post/pandemic period.

Translational research will fail without surgical leadership: SCOTRRCC a successful surgeon-led Nationwide translational research infrastructure in renal cancer.

BACKGROUND: High quality human biosamples with associated high quality clinical data are essential for successful translational research. Despite this, the traditional approach is for the surgeon to act as a technician in the tissue collection act. Biomarker research presents multiple challenges and the field is littered with failures. Tissue quality, poor clinical information, small sample numbers and lack of validation cohorts are just a few reasons for failure. It is clear that the surgeon involved in tissue acquisition must be fully engaged in the process of biosampling for a specific condition, as this will negate many of the issues for translational research failure due to an inadequate bioresource. APPROACH: In this Matter for Debate paper, the Scottish Collaboration On Translational Research into Renal Cell Cancer (SCOTRRCC) is discussed as an example of a urological surgery lead bioresource which has resulted in a National collection of renal cancer tissue and blood (from over 900 patients to date), negating all of the traditional issues with biobanks because of close enagagement and acknowledgement of urologists and uropathologists from seven centres around Scotland. SCOTRRCC has leveraged renal cancer research in Scotland resulting in several high impact publications and providing a springboard for future research in this disease in Scotland and beyond. CONCLUSIONS: The SCOTRRCC model presented here can be transferred to other surgical disciplines for success in translational research.

Competency Guidelines for Public Health Laboratory Professionals: CDC and the Association of Public Health Laboratories.

These competency guidelines outline the knowledge, skills, and abilities necessary for public health laboratory (PHL) professionals to deliver the core services of PHLs efficiently and effectively. As part of a 2-year workforce project sponsored in 2012 by CDC and the Association of Public Health Laboratories (APHL), competencies for 15 domain areas were developed by experts representing state and local PHLs, clinical laboratories, academic institutions, laboratory professional organizations, CDC, and APHL. The competencies were developed and reviewed by approximately 170 subject matter experts with diverse backgrounds and experiences in laboratory science and public health. The guidelines comprise general, cross-cutting, and specialized domain areas and are divided into four levels of proficiency: beginner, competent, proficient, and expert. The 15 domain areas are 1) Quality Management System, 2) Ethics, 3) Management and Leadership, 4) Communication, 5) Security, 6) Emergency Management and Response, 7) Workforce Training, 8) General Laboratory Practice, 9) Safety, 10) Surveillance, 11) Informatics, 12) Microbiology, 13) Chemistry, 14) Bioinformatics, and 15) Research. These competency guidelines are targeted to scientists working in PHLs, defined as governmental public health, environmental, and agricultural laboratories that provide analytic biological and/or chemical testing and testing-related services that protect human populations against infectious diseases, foodborne and waterborne diseases, environmental hazards, treatable hereditary disorders, and natural and human-made public health emergencies. The competencies support certain PHL workforce needs such as identifying job responsibilities, assessing individual performance, and providing a guiding framework for producing education and training programs. Although these competencies were developed specifically for the PHL community, this does not preclude their broader application to other professionals in a variety of different work settings.

Coronary artery disease and the contours of pharmaceuticalization.

Coronary artery disease (CAD) has dominated mortality for most of the past century, not just in Europe and North America but worldwide. Treatments for CAD, both pharmaceutical and surgical, have become leading sectors of the healthcare economy. This paper focuses on the therapeutic landscape for CAD in the United States. We hope to add texture to the broader conversation of pharmaceuticalization explored in this issue by situating pharmaceutical therapies as just one element in the broader therapeutic terrain, alongside cardiac surgery and interventional cardiology. Patients with CAD must navigate a therapeutic landscape with three intersecting paths: lifestyle change, pharmaceuticals, and surgery. While pharmaceuticals are often seen as a quick fix, a way of avoiding more difficult lifestyle changes, it is surgery and angioplasty that promise patients the quickest fix of all. There also is another option, often overlooked by analysts but popular among physicians and patients: inaction. The U.S. context is often critiqued as a site of excessive treatment with respect to both drugs and procedures, and yet there is deep stratification within it--over-treatment in many populations and under-treatment in others. People who experience the serious risks of CAD do so in a racialized terrain of durable preoccupations with difference and unequal access to care. While the pharmaceuticalization literature disproportionately attends to lifestyle drugs, which some observers consider to be medically inappropriate or unnecessary, CAD does remain the leading cause of death. Thus, the stakes are high. Examination of the pharmaceuticalization of CAD in light of surgical treatments and racial disparities offers a window into the pervasiveness and persuasiveness of pharmaceuticals in an increasingly consumer-driven medicine, as well as the limits of their appeal and their reach.

Pilonidal abscess in the breast: a case report.

Pilonidal sinus is a common entity, most often occurring in the natal cleft. Pilonidal sinus with abscess formation has also been described in hairdressers in the interdigital space. We report a case of pilonidal abscess of the breast in a hairdresser, a rarely reported site, which requires awareness on the clinician's part of this occupational risk, for appropriate management and post-surgery advice on prevention. It is particularly important to impart such information to the reporting pathologist who is key to making this histological diagnosis.

Primary care physicians' challenges in ordering clinical laboratory tests and interpreting results.

BACKGROUND: The number and complexity of clinical laboratory tests is rapidly expanding, presenting primary care physicians with challenges in accurately, efficiently, and safely ordering and interpreting diagnostic tests. The objective of this study was to identify challenges primary care physicians face related to diagnostic laboratory testing and solutions they believe are helpful and available to them. METHODS: In this study, sponsored by the Centers for Disease Control and Prevention, a random sample of general internal medicine and family medicine physicians from the American Medical Association Masterfile were surveyed in 2011. RESULTS: 1768 physicians (5.6%) responded to the survey. Physicians reported ordering diagnostic laboratory tests for an average of 31.4% of patient encounters per week. They reported uncertainty about ordering tests in 14.7% and uncertainty in interpreting results in 8.3% of these diagnostic encounters. The most common problematic challenges in ordering tests were related to the cost to patients and insurance coverage restrictions. Other challenges included different names for the same test, tests not available except as part of a test panel, and different tests included in panels with the same names. The most common problematic challenges in interpreting and using test results were not receiving the results and confusing report formats. Respondents endorsed a variety of information technology and decision support solutions to improve test selection and results interpretation, but these solutions were not widely available at the time of the survey. Physicians infrequently sought assistance or consultation from laboratory professionals but valued these consultations when they occurred. CONCLUSIONS: Primary care physicians routinely experience uncertainty and challenges in ordering and interpreting diagnostic laboratory tests. With more than 500 million primary care patient visits per year, the level of uncertainty reported in this study potentially affects 23 million patients per year and raises significant concerns about the safe and efficient use of laboratory testing resources. Improvement in information technology and clinical decision support systems and quick access to laboratory consultations may reduce physicians' uncertainty and mitigate these challenges.

Places of pharmaceutical knowledge-making: global health, postcolonial science, and hope in South African drug discovery.

This article draws on ethnographic research at iThemba Pharmaceuticals, a small South African startup pharmaceutical company with an elite international scientific board. The word 'iThemba' is Zulu for 'hope', and so far drug discovery at the company has been essentially aspirational rather than actual. Yet this particular place provides an entry point for exploring how the location of the scientific knowledge component of pharmaceuticals--rather than their production, licensing, or distribution--matters. The article explores why it matters for those interested in global health and postcolonial science, and why it matters for the scientists themselves. Consideration of this case illuminates limitations of global health frameworks that implicitly posit rich countries as the unique site of knowledge production, and thus as the source of unidirectional knowledge flows. It also provides a concrete example for consideration of the contexts and practices of postcolonial science, its constraints, and its promise. Although the world is not easily bifurcated, it still matters who makes knowledge and where.

Steroid-responsive polyradiculopathy in association with focal segmental glomerulosclerosis.

An 80-year-old woman presented with simultaneous increasing muscle weakness and nephrotic syndrome. A renal biopsy confirmed focal segmental glomerulosclerosis (FSGS). Her neurological diagnosis best fitted with a Guillain-Barre-like syndrome. There have been several cases of FSGS in combination with both conventional and atypical Guillain-Barre syndrome (GBS). Our patient was treated with high-dose steroids and resolution of both nephrotic syndrome and neurological symptoms occurred over 6 months. This article reviews all previously published presentations of this nature and discusses putative mechanisms for the development of concurrent FSGS and GBS.

Guidelines for safe work practices in human and animal medical diagnostic laboratories. Recommendations of a CDC-convened, Biosafety Blue Ribbon Panel.

Prevention of injuries and occupational infections in U.S. laboratories has been a concern for many years. CDC and the National Institutes of Health addressed the topic in their publication Biosafety in Microbiological and Biomedical Laboratories, now in its 5th edition (BMBL-5). BMBL-5, however, was not designed to address the day-to-day operations of diagnostic laboratories in human and animal medicine. In 2008, CDC convened a Blue Ribbon Panel of laboratory representatives from a variety of agencies, laboratory organizations, and facilities to review laboratory biosafety in diagnostic laboratories. The members of this panel recommended that biosafety guidelines be developed to address the unique operational needs of the diagnostic laboratory community and that they be science based and made available broadly. These guidelines promote a culture of safety and include recommendations that supplement BMBL-5 by addressing the unique needs of the diagnostic laboratory. They are not requirements but recommendations that represent current science and sound judgment that can foster a safe working environment for all laboratorians. Throughout these guidelines, quality laboratory science is reinforced by a common-sense approach to biosafety in day-to-day activities. Because many of the same diagnostic techniques are used in human and animal diagnostic laboratories, the text is presented with this in mind. All functions of the human and animal diagnostic laboratory--microbiology, chemistry, hematology, and pathology with autopsy and necropsy guidance--are addressed. A specific section for veterinary diagnostic laboratories addresses the veterinary issues not shared by other human laboratory departments. Recommendations for all laboratories include use of Class IIA2 biological safety cabinets that are inspected annually; frequent hand washing; use of appropriate disinfectants, including 1:10 dilutions of household bleach; dependence on risk assessments for many activities; development of written safety protocols that address the risks of chemicals in the laboratory; the need for negative airflow into the laboratory; areas of the laboratory in which use of gloves is optional or is recommended; and the national need for a central site for surveillance and nonpunitive reporting of laboratory incidents/exposures, injuries, and infections.

A summary of deliberations on strategic planning for continuous quality improvement in laboratory medicine.

On September 24-26, 2007, the Centers for Disease Control and Prevention convened the 2007 Institute on Critical Issues in Health Laboratory Practice: Managing for Better Health to develop an action plan for change for the immediate and long-term future. A wide variety of stakeholders, including pathologists, pathologist extenders, clinicians, and researchers, examined means to improve laboratory service communication, quality parameters, and potential future laboratory contributions to health care. In this summary document, we present the identified gaps, barriers, and proposed action plans for improvement for laboratory medicine in the 6 quality domains identified by the Institute of Medicine: safety, effectiveness, patient centeredness, timeliness, efficiency, and equity. Five major recommendations emerged from concluding discussions and included focusing on preanalytic and postanalytic processes as areas of potential quality improvement and recruiting a multidisciplinary group of nonlaboratory stakeholders to work with laboratory personnel to achieve improvement goals.

Pharmaceutical meaning-making beyond marketing: racialized subjects of generic thiazide.

In contrast to discussions of BiDil, this paper explores racial meaning-making processes around an old generic hypertension drug. By unpacking a vignette about race and thiazide outside marketing or medicine, it shows that racialization of drugs exceeds those spheres and moves in unpredictable ways.