Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or 'preapproval', access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients' best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee (CompAC). Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice.
Nowadays, clinicians are faced with multifaceted ethical concerns, and it is often argued that students of medicine should be well trained in clinical ethics and have a minimum level of ethical sensitivity and critical analysis. Consequently, most medical colleges have introduced programs in biomedical ethics. It is often pointed out that there is a gap separating ethical theories from concrete moral dilemmas. This problem became less pervasive as case-studies started being used. Nevertheless, vignettes are mostly presented as an addendum to a unit and often engage the students only "temporarily." It is my contention that this can be remedied if students were given a venue that will allow them to appreciate as many particulars of the situation as possible, to engage in the case not merely as inactive spectators, rather to get entangled in the case just enough to be involved yet remain sufficiently detached to be able to exercise critical analysis. This is possible through medical drama which, I will argue, is a narrative genre that enhances emotional engagement, cognitive development, and moral imagination allowing for a more ethically sensitive student in training. To do that, reference will be made to the medical drama "House MD."
The majority of surveyed physicians consider infants at gestational age less than or equal to 25 weeks gestation or 800 g at birth as non-viable, and therefore would not attempt their resuscitation. Factors influencing threshold of viability in developing countries need to be addressed and explored further.
Objective: The American University of Beirut Faculty of Medicine follows the American model of medical education. In 2013-2014, a carefully designed new curriculum replaced the previous, largely traditional curriculum, and aimed to improve student wellbeing, upgrade the learning environment, enhance student empathy, and counter the negative influences of the hidden curriculum. This longitudinal study assessed the effectiveness of the new curriculum in those domains over a period of 7 years. Methods: Three cohorts of medical students anonymously filled a paper-based survey at the end of years 1, 2, 3, and 4 of the 4-year curriculum. These included the Class of 2016, the last batch of students who followed the old curriculum, and 2 cohorts that followed the new curriculum (Class of 2017 and Class of 2019). The perceived learning environment was assessed by the Dundee Ready Education Environment Measurement survey; the student’s empathy was assessed by the Jefferson Scale of Physician Empathy-Student version; and the hidden curriculum was examined using a locally developed survey. Results: The scores on the learning environment survey were significantly higher among the cohorts following the new curriculum relative to those following the old curriculum. Similar significant results appeared when looking at each of the subscales for the learning environment. The students’ empathy scores were also significantly higher in both cohorts of the new curriculum when compared with the old curriculum. Nevertheless, there was a significant decrease in empathy in both third and fourth years relative to second year. The new curriculum also improved aspects of the students’ perceptions and responses to the hidden curriculum. Conclusion: In conclusion, a well-planned and well-researched curricular intervention, based on sound educational theories, practices, and standards can indeed transform the learning environment, as well as the attitudes, values, and experiences of medical students.
Go Wish cards can be used to help illustrate the variability in priorities of patients. They can be used as an effective to teach medical students about the importance of considering patient preferences when illness progresses.
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