Competition And Vulnerabilities In The Global Supply Chain For US Generic Active Pharmaceutical Ingredients.

The US supply of generic drugs is heavily dependent on the global supply chain for sources of generic active pharmaceutical ingredients (APIs) for the US pharmaceutical market. Data from Clarivate Analytics' Cortellis Generics Intelligence database were analyzed to perform a systematic examination of generic APIs produced globally for the US market during 2020-21. We identified a total of 565 facilities producing 1,379 unique generic APIs across forty-two countries. India, China, and Italy were the top producers; 14 percent of APIs were manufactured in the US. About a third of APIs were manufactured by a single facility, and another third were manufactured by two or three facilities. More than one in every five APIs reflected markets in which current Food and Drug Administration standards would have failed to detect low competition because there were three or fewer API manufacturers despite there being four or more manufacturers of finished generic drugs. Monitoring the API supply is crucial to identifying vulnerabilities in the US pharmaceutical supply chain and identifying drugs that could represent potential priorities for domestic production. Incentives in the US may be needed to support API production to safeguard against supply-chain disruptions.

A medical student scholarly concentrations program: scholarly self-efficacy and impact on future research activities.

BACKGROUND: The Scholarly Concentrations program was established at Johns Hopkins University School of Medicine in 2009 with the aim of instilling passion for scholarship. OBJECTIVE: Our study aimed to determine whether the Scholarly Concentrations program achieves positive changes in medical student self-efficacy in conducting research and, if so, whether this results in future career aspirations toward scholarship. DESIGN: We used the Clinical Research Appraisal Inventory-Short Form (CRAI-SF) to assess changes in self-efficacy among students completing the Scholarly Concentrations program between 2014 and 2017. We calculated composite mean scores of six domains. We included outcomes on whether students published a manuscript, overall program perceptions, and likelihood of future research careers. We analyzed relationships between CRAI-SF scores and outcomes using paired t-tests and multivariable-adjusted logistic regression. RESULTS: A total of 419 students completed the Scholarly Concentrations program. All 6 CRAI domain scores showed significant improvements in self-efficacy between the pre-Scholarly Concentrations and post-Scholarly Concentrations ratings (range of changes 0.76-1.39, p < 0.05 for all). We found significant associations between post-Scholarly Concentrations self-efficacy ratings and course satisfaction (adjusted OR 1.57 [95% CI 1.20, 2.07]) and mentor satisfaction (OR 1.46 [1.15, 1.86]), as well as students' intent to conduct future research (OR 1.46 [1.15, 1.86]). These results were robust to sensitivity analyses, and pronounced in the group of students without prior research experience. CONCLUSIONS: Our findings suggest that a Scholarly Concentrations program is associated with an increased self-efficacy for research, and these changes in self-efficacy are associated with higher satisfaction in the scholarly experience and increased likelihood of pursuing scholarly work. Other medical schools could use such a tool of self-efficacy to both investigate the overall Scholarly Concentrations experience and understand factors that may increase interest in future physician-scientist pathways.

Transforming a U.S. scholarly concentrations program internationally: lessons learned.

BACKGROUND: Scholarly Concentrations programs in U.S. medical schools aim to instill passion for critical thinking and promote careers in academic medicine. The rise of these programs has seen variable goals, structure, and outcomes. Transformation of these programs internationally is in its infancy. METHODS: We describe implementation of the Johns Hopkins School of Medicine Scholarly Concentrations program, offering Basic Science, Clinical Science, Medical Ethics/Healing Arts, History of Medicine, and Public Health/Community Service, at Bezmiâlem Vakif University in Istanbul, Turkey. Over six modules in the preclinical years, students develop a faculty-mentored experience which encourages the acquisition of attitudes and skills for self-directed, lifelong learning and scholarship. This culminates in abstract and project presentation. We report program characteristics (context and logistics) and outcomes (student engagement and experiences). RESULTS: The Scholarly Concentrations program at Bezmiâlem began in 2014, with nearly two completed cohorts of students. In comparison to Johns Hopkins, students at Bezmiâlem begin at an earlier age (thus do not have as much prior research experience) and are subsequently evaluated for residency in terms of test scores rather than scholarship and publications, but have a similar level of intellectual curiosity and desire to take ownership of their project. Eighty-two percent of Bezmiâlem students stated the project they pursued was either their own idea or was an idea they formed after meeting with their mentor. Students at Bezmialem were more likely to choose Clinical Science projects (p = 0.009). Only 5% of Bezmiâlem students in end-of-course survey felt dissatisfied with the level of ownership they experienced with their project, a frequency similar to that seen by Johns Hopkins students (2%). CONCLUSIONS: Scholarly Concentrations programs play an important role in U.S. medical schools, and these programs can be successfully implemented internationally. The Scholarly Concentrations program at Johns Hopkins has been transformed to a program at Bezmiâlem in Istanbul, the first program outside North America or the European Union. When designing these programs, one must consider the context, logistics, student engagement, and outcomes. While long-term outcomes are needed, this can serve as a model for implementation elsewhere.

Are the Medical Humanities for Sale? Lessons from a Historical Debate.

In November of 1959, William Bean published in the Archives of Internal Medicine a scathing review of Félix Martí-Ibañez's Centaur: Essays on the History of Medical Ideas. Martí-Ibañez and Bean were two of the leading exponents of the importance of medical humanism during a formative period from the 1950s through the 1970s. But the two physicians differed fundamentally in their views of the ideal relationships among the pharmaceutical industry, the medical profession, and the medical humanities. We situate Bean's review within its historical context, shedding light on the history and diverging uses of the medical humanities.

All Health Is Global Health, All Medicine Is Social Medicine: Integrating the Social Sciences Into the Preclinical Curriculum.

As physicians work to achieve optimal health outcomes for their patients, they often struggle to address the issues that arise outside the clinic. Social, economic, and political factors influence patients' burden of disease, access to treatment, and health outcomes. This challenge has motivated recent calls for increased attention to the social determinants of health. At the same time, advocates have called for increased attention to global health. Each year, more U.S. medical students participate in global health experiences. Yet, the global health training that is available varies widely. The discipline of social medicine, which attends to the social determinants of disease, social meanings of disease, and social responses to disease, offers a solution to both challenges. The analyses and techniques of social medicine provide an invaluable toolkit for providing health care in the United States and abroad.In 2007, Harvard Medical School implemented a new course, required for all first-year students, that teaches social medicine in a way that integrates global health. In this article, the authors argue for the importance of including social medicine and global health in the preclinical curriculum; describe Harvard Medical School's innovative, integrated approach to teaching these disciplines, which can be used at other medical schools; and explore the barriers that educators may face in implementing such a curriculum, including resistance from students. Such a course can equip medical students with the knowledge and tools that they will need to address complex health problems in the United States and abroad.

Locating global health in social medicine.

Global health's goal to address health issues across great sociocultural and socioeconomic gradients worldwide requires a sophisticated approach to the social root causes of disease and the social context of interventions. This is especially true today as the focus of global health work is actively broadened from acute to chronic and from infectious to non-communicable diseases. To respond to these complex biosocial problems, we propose the recent expansion of interest in the field of global health should look to the older field of social medicine, a shared domain of social and medical sciences that offers critical analytic and methodological tools to elucidate who gets sick, why and what we can do about it. Social medicine is a rich and relatively untapped resource for understanding the hybrid biological and social basis of global health problems. Global health can learn much from social medicine to help practitioners understand the social behaviour, social structure, social networks, cultural difference and social context of ethical action central to the success or failure of global health's important agendas. This understanding - of global health as global social medicine - can coalesce global health's unclear identity into a coherent framework effective for addressing the world's most pressing health issues.