scholarly journals Medical Affairs in Pharmaceutical Companies and Related Pharmaceutical Regulations in Japan

2021 ◽  
Vol 8 ◽  
Author(s):  
Hideki Maeda
Keyword(s):  
Clinical Trials ◽  
Scientific Evidence ◽  
The United States ◽  
Current Status ◽  
Pharmaceutical Companies ◽  
Medical Needs ◽  
Long Time ◽  
Post Marketing ◽  
History Of ◽  
Scientific Value

Medical affairs has received a lot of attention in recent years in Japan, but it is also often misunderstood or poorly understood in the healthcare industry in Japan. In the United States, the function of medical affairs has been established for a long time, whereas its history in Japan is relatively short. Many scandals in clinical trials occurred with inappropriate relationship between medical doctors and the sales departments of pharmaceutical companies from 2012. These incidents undermined confidence in clinical trials in Japan and triggered the enforced separation of sales departments from the conduct of post-marketing clinical trials and evidence generation. There have been growing compliance issues identified in marketing and sales practices, and off-label promotion is also becoming an issue in Japan. These issues resulted in the establishment of independent medical affairs departments from sales departments in pharmaceutical companies operating in Japan. Due to the short history of medical affairs in Japan, the roles and responsibilities vary between companies in Japan. Medical affairs departments aim to fulfill unmet medical needs through the generation of scientific evidence and to deliver scientific value to key stakeholders and patients. People working in medical affairs need to engage in scientific exchange activities with key opinion leaders independent of sales departments. Through these activities, medical affairs ensures that patients receive optimal medical care. Medical affairs in Japan is still developing, and its roles, responsibilities, and functions are improving. This article covers the history of medical affairs in Japan and the current status and future perspectives of medical affairs in Japan.

The Chemical Imbalance Hypothesis: An Evaluation of the Evidence

2015 ◽  
Vol 17 (1) ◽  
pp. 60-75 ◽  
Author(s):  
William Schultz
Keyword(s):  
United States ◽  
Mental Illness ◽  
Popular Culture ◽  
Scientific Evidence ◽  
Antidepressant Medication ◽  
The United States ◽  
Pharmaceutical Companies ◽  
Alternative Approach ◽  
History Of ◽  
Chemical Imbalance

Powered by philosophic argument, scientific evidence, and multibillion dollar pharmaceutical companies sponsoring multimillion dollar advertising campaigns, the chemical imbalance hypothesis has saturated our academic and popular culture. This saturation is, at least partially, responsible for the more than 10 billion dollars annually spent on antidepressant medication in the United States. But what is the “chemical imbalance” hypothesis? And what evidence supports it? This article will provide an account of the chemical imbalance hypothesis, a history of its development, and the evidence provided for its justification. This article will show that the evidence for the chemical imbalance hypothesis is unconvincing. It will discuss why, despite the unconvincing evidence, the hypothesis lingers. And, finally, it will suggest an alternative approach to mental illness that avoids some of the pitfalls of a biological reductionistic account of mind.

Medical Uses of Marijuana—Fact or Fantasy?

2018 ◽  
Author(s):  
Leslie Iversen
Keyword(s):  
United States ◽  
Multiple Sclerosis ◽  
Quality Control ◽  
Clinical Trials ◽  
Placebo Effect ◽  
Scientific Evidence ◽  
The United States ◽  
Controlled Clinical Trials ◽  
History Of ◽  
Medical Indications

Marijuana has a long history of medical use. This chapter discusses the modern revival of interest in marijuana in the United States, Europe, and elsewhere. The fully licensed cannabinoid medicines dronabinol (Marinol), nabilone (Cesamet), and nabiximols (Sativex) and their uses are discusses. Medical indications include multiple sclerosis, pain, nausea and vomiting, epilepsy, appetite stimulation, mood, sleep, and migraine. Apart from the treatment of spasticity and pain in multiple sclerosis, there is little or no scientific evidence of efficacy because of the lack of controlled clinical trials; nevertheless, there may be a significant placebo effect. The supply of cannabis to medical pharmacies is poorly controlled. The Dutch and Canadian models provide good quality control, but in the United States supplies are of patchy quality from state to state.

scholarly journals Multicenter point prevalence evaluation of the utilization and safety of drug therapies for COVID-19 at the onset of the pandemic timeline in the United States

2021 ◽  
Author(s):  
Nathaniel J Rhodes ◽  
Atheer Dairem ◽  
William J Moore ◽  
Anooj Shah ◽  
Michael J Postelnick ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Therapy ◽  
Supportive Care ◽  
The United States ◽  
Primary Objective ◽  
Point Prevalence ◽  
Medical Centers ◽  
Academic Medical ◽  
History Of ◽  
Secondary Objective

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose There are currently no FDA-approved medications for the treatment of coronavirus disease 2019 (COVID-19). At the onset of the pandemic, off-label medication use was supported by limited or no clinical data. We sought to characterize experimental COVID-19 therapies and identify safety signals during this period. Methods We conducted a non-interventional, multicenter, point prevalence study of patients hospitalized with suspected/confirmed COVID-19. Clinical and treatment characteristics within a 24-hour window were evaluated in a random sample of up to 30 patients per site. The primary objective was to describe COVID-19–targeted therapies. The secondary objective was to describe adverse drug reactions (ADRs). Results A total of 352 patients treated for COVID-19 at 15 US hospitals From April 18 to May 8, 2020, were included in the study. Most patients were treated at academic medical centers (53.4%) or community hospitals (42.6%). Sixty-seven patients (19%) were receiving drug therapy in addition to supportive care. Drug therapies used included hydroxychloroquine (69%), remdesivir (10%), and interleukin-6 antagonists (9%). Five patients (7.5%) were receiving combination therapy. The rate of use of COVID-19–directed drug therapy was higher in patients with vs patients without a history of asthma (14.9% vs 7%, P = 0.037) and in patients enrolled in clinical trials (26.9% vs 3.2%, P < 0.001). Among those receiving drug therapy, 8 patients (12%) experienced an ADR, and ADRs were recognized at a higher rate in patients enrolled in clinical trials (62.5% vs 22%; odds ratio, 5.9; P = 0.028). Conclusion While we observed high rates of supportive care for patients with COVID-19, we also found that ADRs were common among patients receiving drug therapy, including those enrolled in clinical trials. Comprehensive systems are needed to identify and mitigate ADRs associated with experimental COVID-19 treatments.

Power Lies in the Barrel of a Gun: Diplomacy Without Strategic Military Capability Is Futile

2021 ◽  
Vol 20 (1-2) ◽  
pp. 77-99
Author(s):  
Moorosi Leshoele
Keyword(s):  
The United States ◽  
United Nations Security Council ◽  
African Countries ◽  
Military Capability ◽  
Black Africa ◽  
Mineral Wealth ◽  
The World ◽  
Long Time ◽  
History Of ◽  
Pipe Dream

Abstract The United States of America invests heavily on their military capability and it is estimated that it spends, alone, approximately 40 per cent of what the whole world spends on military. Four of the other super powers that make up the five permanent members of the United Nations Security Council (UN-SC) also spend a significant percentage of their national budgets on military. Chinweizu has for a long time argued that Africa needs a well-resourced African Standby Force (or the Black Africa League) that will protect the interests of the continent so as to prevent the history of Africans enslavement and colonialism repeating itself. This article seeks to analyse Africa’s investment on its military defense capability vis-à-vis the five permanent members of the UN-SC and North Korea, by critiquing two case studies of two of the continent’s economic giants – South Africa and Egypt. Realist and Sankofa perspectives are used as the prisms through which the article was researched. In line with Chinweizu’s observation, the article argues that without serious political will and dedication to building Africa’s nuclear weapons capability and ensuring that Africa is economically self-reliant, diplomatic engagements with the rest of the world as (un)equal partners will remain a pipe dream and the looting of Africa’s mineral wealth will continue unabated. It is clear that given the reality of the African Holocust if African countries fail to collectively defend themselves, Africa will continue to be a political football for the rest of the world.

scholarly journals Educating Technical Communication Teachers: The Origins, Development, and Present Status of the Course, “Teaching Technical Writing” at Illinois State University

2013 ◽  
Vol 2 (2) ◽  
pp. 3
Author(s):  
Gerald Savage
Keyword(s):  
Technical Communication ◽  
Technical Writing ◽  
The United States ◽  
Current Status ◽  
State University ◽  
Graduate Course ◽  
Communication Program ◽  
Illinois State University ◽  
History Of ◽  
Communication Pedagogy

Since the early 1980s, Illinois State University’s English Department has educated numerous technical communication practitioners as well as dozens of teachers of technical communication throughout the United States. Today, the program’s faculty members are nationally recognized for their contributions to scholarship and education and its Ph.D. and M.A. students are sought after to teach in the technical communication programs of other universities. A critical component of this success was the development of the graduate course, Teaching Technical Writing in 1990. This essay situates the development of that course in the history not only of the technical communication program at Illinois State University but in the history of the technical communication field, particularly since 1950. Although the essay focuses on one course in one midsized, Midwestern U.S. University, it is, I believe, exemplary of the development and current status of technical communication pedagogy throughout the U.S.

The Amistad Saga: A Transatlantic Dialogue

2021 ◽  
Author(s):  
Jorge Felipe-Gonzalez ◽  
Gibril R. Cole ◽  
Benjamin N. Lawrance
Keyword(s):  
Slave Trade ◽  
The United States ◽  
Historical Drama ◽  
Multiple Points ◽  
The Us ◽  
Us Supreme Court ◽  
Long Time ◽  
History Of ◽  
Triangular Trade ◽  
New Framework

The story of the slave ship La Amistad is one of the most celebrated and narrated 19th-century stories of the transatlantic slave trade. To fully appreciate the significance and impact of the events and circumstances of this fateful episode, it is important to examine its legacy from multiple points of the Atlantic world—vestiges of the triangular trade bequeathed by the Columbian Exchange. For a long time, the Amistad saga has been viewed from a very US-centric perspective because the dispute over the lives of the Africans rose to the US Supreme Court in 1840–1841. New archival and oral research in West Africa, Europe, and the Caribbean is rebalancing the narrative and revising the historical drama. Today, the Amistad story is widely recognized as a quintessentially Atlantic story, a story of mobility that moves back and forth across the Atlantic in multiple directions over many decades. The deployment of the phrase “Amistad saga” provides a vehicle with which to critique the socio-legal battles about transatlantic slave trading in Caribbean, North American, and West African history. The Amistad story is often described as pre-incidental to the US Civil War. The victory of African defendants is often framed as a self-congratulatory vindication of the successful resistance of enslaved Africans. The celebrated figure of “Joseph Cinqué” or Sengbe Pieh, the self-appointed leader of the Africans, and a replica of the ship itself are part of an Amistad memory industry that attempts to narrate the slave trade and its abolition. A new framework for teaching and understanding the history of the Amistad saga and its memory and forgetting through an Atlantic lens must combine historical and contemporary perspectives from the United States, Europe, Cuba, and Sierra Leone.

Strengthening and performance assessing historical cinema hall balcony according to new Turkish Earthquake Code

2021 ◽  
Vol 7 (1) ◽  
pp. 27
Author(s):  
Memduh Karalar ◽  
Murat Çavuşli
Keyword(s):  
Performance Analysis ◽  
Three Dimensional ◽  
Performance Evaluations ◽  
Current Status ◽  
Current State ◽  
Long Time ◽  
History Of ◽  
And Performance ◽  
Special Computer Program ◽  
Study Performance

Strengthening historical buildings and evaluating their performances make great contributions to both the history of the country and the tourism of the country. In this study, performance analysis and evaluations of the historical cinema hall balcony, which was built in 1933 by a French company and served to Zonguldak province for a long time, are presented in detail. This cinema hall was frequently used by local people between 1933 and 1999 and hosted many Yeşilçam movies. Firstly, examinations were performed in the historical cinema hall and the areas (columns, beams and floors) that were damaged in time were identified. According to the obtained information, it was determined that there were significant damages in the carrier system of the building and there were visible cracks and damages in the columns of the cinema hall. It was also observed that explosions occurred in one of the main carrier columns of the balcony. After the core samples taken from the balcony were tested in the laboratory, the current status of the carrier elements and reinforcements were determined with the help of an x-ray rebar scanner. After all these processes, the structure was modeled as three dimensional (3D) using a special computer program and performance evaluations were performed regarding the current state of the structure. As a result of the performance evaluation, it was determined that the balcony of the historical cinema hall could not survive anymore and would collapse over time. It was concluded that there were great damages especially on the balcony columns and a reinforcement should be made on a total of 6 columns. Strengthening was made to 4 different main columns and a performance analysis was performed again in strengthened structure. After strengthening, it was understood that the columns of the balcony of the cinema hall could survive for a long time.

Psychosocial Concerns and Interventions for Cancer Survivors

2006 ◽  
Vol 24 (32) ◽  
pp. 5132-5137 ◽  
Author(s):  
Annette L. Stanton
Keyword(s):  
Cancer Survivors ◽  
Psychosocial Interventions ◽  
The United States ◽  
Current Status ◽  
Empirical Literature ◽  
Medical Treatments ◽  
Effective Interventions ◽  
History Of ◽  
Intervention Trials ◽  
Meta Analyses

In light of the increasing population living with a history of cancer in the United States, it is important to attend to quality of life and health in this group, and to develop effective interventions to address psychosocial and physical concerns across the course of the cancer trajectory. The goals of this article are to document the need for attention to psychosocial domains; offer a brief overview of the current status of the empirical literature on effects of psychosocial interventions with cancer survivors, relying on systematic reviews and meta-analyses conducted in the last decade; highlight recent examples of randomized, controlled psychosocial intervention trials directed toward cancer survivors after the completion of primary medical treatments (ie, the re-entry phase and beyond); and identify directions for application and research.

Understanding and finding oil over the centuries: The case of the Wallachian Petroleum Company in Romania

2017 ◽  
Vol 36 (1) ◽  
pp. 41-62 ◽  
Author(s):  
Francesco Gerali ◽  
Jenny Gregory
Keyword(s):  
The United States ◽  
Oil Companies ◽  
Study Approach ◽  
Animal Fats ◽  
Oil Markets ◽  
Long Time ◽  
History Of ◽  
Oil Sector ◽  
Petroleum Company ◽  
Oil Company

About four centuries passed between the first appearance of pamphlets in which the medical uses of petroleum were discussed (for example, the Tegernsee (southern Bavaria, 1430), Geneva (Swiss Confederacy, 1480), Nurnberg (northern Bavaria, 1500), and the Antwerp (Duchy of Brabant, today Flanders, 1540–1550) pamphlets), and Michael Faraday's discovery in 1825 of the chemical composition of benzene derived from bituminous oil as a compound of carbon and hydrogen. During this long time span, studies of oil, carried out between alchemy and chemistry, benefited from rapid advances and brilliant insights, much as they had moments of stagnation, and disappointing regressions. In 1855 the chemist Benjamin Silliman Jr., of Yale University, proved that crude oil could be decomposed through a process of fractional distillation into a range of fuels and lubricants cheaper than the oils, greases and waxes rendered by animal fats and vegetal matter (Silliman 1855; Forbes 1948 Forbes 1958). In the course of the early 1860s, oil became the main source of illumination first in North America, then in Europe and Australia. This transformation of oil from a substance of limited use into a commodity of mass consumption radically changed the pattern of oil finding and production. Crude was no longer collected just from natural springs or draining seepages, but was pumped out of the ground from wells drilled by machines using steam power. This was the first step toward the modern oil industry, and a breakthrough in the history of energy: the beginning of an oil society. The first part of this article provides an introduction to the early uses and production of petroleum in Europe, and advances in understanding the nature, the physical properties, and the composition of hydrocarbons. It provides a brief analysis of the interaction between technology, society and the environmental context in northwestern Pennsylvania, where, between 1858 and 1859, a new successful pattern developed to produce oil in commercial quantity. From 1861, that innovative process put the United States in the position to gain increasing shares in the young European mineral oil markets and, subsequently, to jeopardize the position of local oil (vegetal, animal and mineral) producers. The second part, using a national case study approach, explores the history of a British oil company operating in Romania since 1863, the Wallachian Oil Company. This venture by London stockholders—short, difficult, and abortive—is a mirror of the nature of the business implemented by emerging oil companies, not only from Europe, and therefore exemplifies the challenges of setting the modern oil sector in motion in the nineteenth century.

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