Patent protection creates an encouraging environment for innovation, but it can be a hindrance to the availability of new medications. There are many countries that still harbor this competition while ensuring that all citizens have access to these medications. There are downsides to certain patent systems, but with a few modifications they can be remedied to achieve the highest level of access, quality of care, and best cost for the insured. In most of the countries reviewed, the patent system is thoroughly regulated with the consumers in mind. There are opportunities for manufacturers to create generic and cost effective medications within the typical patent protection timeline to ensure access to new medications. The systems that are in place encourage innovation with medical devices and medication by providing incentives for the researchers.

Antibiotic resistance is a growing crisis across the globe. With the use of antibiotics in heathcare settings in an ever-growing population, the growth of antibiotic resistance has been named a top 10 global public health threat by the World Health Organization. Through an analysis of 6 countries; Mexico, China, the United States, India, Saudi Arabia, and Ethiopia, I look at the current implementation of policy and contributing factors to the use and abuse of antibiotics within the country. Through my research, I was able to find knowledge, behaviors, and a lack of enforcement to be the main contributors to the growing antibiotic crisis. Based on the evidence, I suggested three policies that focused on treatment, prevention, or economic assistance in an effort to combat the antibiotic crisis on a global scale. With socio-economic factors in mind as well as sustainability of policy, the evidence pointed in the direction of a three-pronged approach on prevention with education, policy enforcement, and a global database to minimize the growth of antibiotic resistance as well as improve public health at a global level.

COVID-19 has been challenging for nearly everyone in different ways. Healthcare organizations have had to quickly change policy, modify operations, reorganize facilities, hire, and train staff to overcome COVID-19 related challenges to be able to still provide care for patients, all while being mindful of the protection of their staff. Some healthcare organizations have responded particularly well, perhaps due to preparedness, planning, or exceptional leadership in times of crisis. To explore this, we invited seven healthcare system leaders from three different organizations in Arizona to talk about how they overcame challenges at the beginning of this pandemic with effective strategies and any leadership tips they had for the future. After the interviews were conducted, the interviews were transcribed, coded qualitatively, and separated into themes and categories to analyze their answers to the questions asked. The results and conclusions included strategies such as having open and honest communication, teamwork, rapidly developing communicating policies, and widely adopting new work practices like Telemedicine, Zoom, and working at home as crucial. This report is designed to assist in aiding and inspiring future or other leaders to be better prepared for solving various challenges with other emergencies that arise in the future.

As much as SARS-CoV-2 has altered the way humans live since the beginning of 2020, this virus's deadly nature has required clinical testing to meet 2020's demands of higher throughput, higher accuracy and higher efficiency. Information technology has allowed institutions, like Arizona State University (ASU), to make strategic and operational changes to combat the SARS-CoV-2 pandemic. At ASU, information technology was one of the six facets identified in the ongoing review of the ASU Biodesign Clinical Testing Laboratory (ABCTL) among business, communications, management/training, law, and clinical analysis. The first chapter of this manuscript covers the background of clinical laboratory automation and details the automated laboratory workflow to perform ABCTL’s COVID-19 diagnostic testing. The second chapter discusses the usability and efficiency of key information technology systems of the ABCTL. The third chapter explains the role of quality control and data management within ABCTL’s use of information technology. The fourth chapter highlights the importance of data modeling and 10 best practices when responding to future public health emergencies.

Developing a vaccine during the midst of a pandemic requires a careful balance between <br/>speed, safety, and efficacy. For the COVID-19 pandemic, the U.S. implemented Operation Warp Speed to accelerate the timeline for vaccine development. The FDA also imposed specific guidelines for granting Emergency Use Authorization (EUA). As of April 1st, 2021, Operation Warp Speed resulted in three different vaccines receiving EUA, all of which are currently being administered to the public. However, the rapid production and changes in the approval process intensified public scrutiny on the safety and efficacy of the vaccine. This thesis analyzes the differences in fast-tracking a vaccine, which consolidated the authorization process into months rather than years, and delineates the main concerns of the public regarding the COVID-19 vaccine through a media analysis. Although the EUA raised questions about the safety of the vaccine, polls indicate that most Americans would still be willing to receive the vaccine.

Chronic diseases place a financial burden on the United States and claim the lives of nearly 2 million Americans every year. Among the chronic diseases that plague American people, type 2 diabetes is particularly prevalent and injurious. Thus, action is warranted to improve prevention and management of this disease. Nutrition plays a significant role in prevention and management of type 2 diabetes and other chronic diseases. Registered dietitians, as nutrition experts, are qualified to use medical nutrition therapy as a method of prevention and treatment for chronic diseases using a nutritional approach. However, there is no consensus as to which eating pattern is the most efficacious. The aim of this review of research was to examine how plant-based eating patterns impact chronic disease conditions, with an emphasis on type 2 diabetes mellitus, as compared to omnivorous eating patterns. A literature search was conducted through the ASU Library, PubMed, and CINAHL using terms related to plant-based diets and chronic diseases, such as type 2 diabetes. The results revealed that a plant-based eating pattern may be beneficial in the prevention and treatment of certain chronic diseases, such as type 2 diabetes. Specifically, adults who have type 2 diabetes and consume a plant-based diet may exhibit enhanced glycemic control as evidenced by less insulin resistance, increased incretin and insulin secretion, greater insulin sensitivity, and improved HbA1c levels. There is sufficient evidence for registered dietitians to recommend a plant-based approach to patients with type 2 diabetes who would like to achieve enhanced glycemic control.

Despite the fact that seizures are commonly associated with autism spectrum disorder (ASD), the effectiveness of treatments for seizures has not been well studied in individuals with ASD. This manuscript reviews both traditional and novel treatments for seizures associated with ASD. Studies were selected by systematically searching major electronic databases and by a panel of experts that treat ASD individuals. Only a few anti-epileptic drugs (AEDs) have undergone carefully controlled trials in ASD, but these trials examined outcomes other than seizures. Several lines of evidence point to valproate, lamotrigine, and levetiracetam as the most effective and tolerable AEDs for individuals with ASD. Limited evidence supports the use of traditional non-AED treatments, such as the ketogenic and modified Atkins diet, multiple subpial transections, immunomodulation, and neurofeedback treatments. Although specific treatments may be more appropriate for specific genetic and metabolic syndromes associated with ASD and seizures, there are few studies which have documented the effectiveness of treatments for seizures for specific syndromes. Limited evidence supports l-carnitine, multivitamins, and N-acetyl-l-cysteine in mitochondrial disease and dysfunction, folinic acid in cerebral folate abnormalities and early treatment with vigabatrin in tuberous sclerosis complex. Finally, there is limited evidence for a number of novel treatments, particularly magnesium with pyridoxine, omega-3 fatty acids, the gluten-free casein-free diet, and low-frequency repetitive transcranial magnetic simulation. Zinc and l-carnosine are potential novel treatments supported by basic research but not clinical studies. This review demonstrates the wide variety of treatments used to treat seizures in individuals with ASD as well as the striking lack of clinical trials performed to support the use of these treatments. Additional studies concerning these treatments for controlling seizures in individuals with ASD are warranted.

There is a growing body of scientific evidence that the health of the microbiome (the trillions of microbes that inhabit the human host) plays an important role in maintaining the health of the host and that disruptions in the microbiome may play a role in certain disease processes. An increasing number of research studies have provided evidence that the composition of the gut (enteric) microbiome (GM) in at least a subset of individuals with autism spectrum disorder (ASD) deviates from what is usually observed in typically developing individuals. There are several lines of research that suggest that specific changes in the GM could be causative or highly associated with driving core and associated ASD symptoms, pathology, and comorbidities which include gastrointestinal symptoms, although it is also a possibility that these changes, in whole or in part, could be a consequence of underlying pathophysiological features associated with ASD. However, if the GM truly plays a causative role in ASD, then the manipulation of the GM could potentially be leveraged as a therapeutic approach to improve ASD symptoms and/or comorbidities, including gastrointestinal symptoms.

One approach to investigating this possibility in greater detail includes a highly controlled clinical trial in which the GM is systematically manipulated to determine its significance in individuals with ASD. To outline the important issues that would be required to design such a study, a group of clinicians, research scientists, and parents of children with ASD participated in an interdisciplinary daylong workshop as an extension of the 1st International Symposium on the Microbiome in Health and Disease with a Special Focus on Autism (www.microbiome-autism.com). The group considered several aspects of designing clinical studies, including clinical trial design, treatments that could potentially be used in a clinical trial, appropriate ASD participants for the clinical trial, behavioral and cognitive assessments, important biomarkers, safety concerns, and ethical considerations. Overall, the group not only felt that this was a promising area of research for the ASD population and a promising avenue for potential treatment but also felt that further basic and translational research was needed to clarify the clinical utility of such treatments and to elucidate possible mechanisms responsible for a clinical response, so that new treatments and approaches may be discovered and/or fostered in the future.

Background: Despite the high prevalence of seizure, epilepsy and abnormal electroencephalograms in individuals with autism spectrum disorder (ASD), there is little information regarding the relative effectiveness of treatments for seizures in the ASD population. In order to determine the effectiveness of traditional and non-traditional treatments for improving seizures and influencing other clinical factor relevant to ASD, we developed a comprehensive on-line seizure survey.

Methods: Announcements (by email and websites) by ASD support groups asked parents of children with ASD to complete the on-line surveys. Survey responders choose one of two surveys to complete: a survey about treatments for individuals with ASD and clinical or subclinical seizures or abnormal electroencephalograms, or a control survey for individuals with ASD without clinical or subclinical seizures or abnormal electroencephalograms. Survey responders rated the perceived effect of traditional antiepileptic drug (AED), non-AED seizure treatments and non-traditional ASD treatments on seizures and other clinical factors (sleep, communication, behavior, attention and mood), and listed up to three treatment side effects.

Results: Responses were obtained concerning 733 children with seizures and 290 controls. In general, AEDs were perceived to improve seizures but worsened other clinical factors for children with clinical seizure. Valproic acid, lamotrigine, levetiracetam and ethosuximide were perceived to improve seizures the most and worsen other clinical factors the least out of all AEDs in children with clinical seizures. Traditional non-AED seizure and non-traditional treatments, as a group, were perceived to improve other clinical factors and seizures but the perceived improvement in seizures was significantly less than that reported for AEDs. Certain traditional non-AED treatments, particularly the ketogenic diet, were perceived to improve both seizures and other clinical factors. For ASD individuals with reported subclinical seizures, other clinical factors were reported to be worsened by AEDs and improved by non-AED traditional seizure and non-traditional treatments. The rate of side effects was reportedly higher for AEDs compared to traditional non-AED treatments.

Conclusion: Although this survey-based method only provides information regarding parental perceptions of effectiveness, this information may be helpful for selecting seizure treatments in individuals with ASD.