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. 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. (shrink)

Termination of pregnancy (TOP) is offered in many countries, for foetuses prenatally diagnosed with congenital malformations that are deemed incompatible with life or that are associated with a high morbidity. In Lebanon, a middle income country where religion plays a focal role, the law prohibits any form of TOP unless it is the only means to save the mother's life. It is the contention of the authors of this article that even if the foetus is a person, if it were (...) medically revealed that there is a substantial risk that the newborn will suffer severe physical abnormalities that will cause it to be seriously handicapped; it is morally acceptable to terminate the pregnancy. Hence, TOP carried out for these indications is justified in the interest of the foetus and the child. Whatever the status of the foetus is, once born, it will become a full-fledged sentient being with all that this entails. When given the option of starting an existence, this person-to-be has the right to a minimum that allows him/her to enjoy a relatively good quality of life. Today, Lebanese obstetricians are confronted with the burden placed on them under the law to refuse TOP, or, when performing them, to forge records or deny having done them. This is why we strongly believe that the Lebanese policy on abortion should be amended. (shrink)

The field of reproductive medicine witnessed a breakthrough in September 2014 with the first successful live birth post uterine transplantation. This success represents the culmination of decades' worth of research on infertility and reproductive medicine. This subject of infertility gathers special attention in the Middle East, as childbearing is given paramount importance in the family unit. And as with any new medical advancement, Middle Eastern people look to their religious authorities for guidance. This paper describes the various ethical quandaries related (...) to uterine transplantation, from a perspective of the religious and societal factors that are unique to the Middle East, and embeds them within the conversation of its alternative solutions. (shrink)

This symposium includes twelve narratives from individuals or groups who have worked to help the sick and injured receive healthcare during armed conflict. Four commentaries on these narratives are also included, authored by experts and scholars in the fields of bioethics, human rights, sexual violence in armed conflict, the forced displacement of civilians, and policy development for resource constrained healthcare. The goal of this symposium is to call attention to the the difficulties and ethical dilemmas of providing healthcare during violent (...) armed conflict. (shrink)

Over the last 80 years, a major goal of medical educators has been to improve the quality of applicants to medical school and, hence, the resulting doctors. To do this, academic standards have been progressively strengthened. The Medical College Admission Test (MCAT) in the United States and the undergraduate science grade point average (GPA) have long been correlated with success in medical school, and graduation rates have been close to 100 percent for many years. Recent studies have noted that some (...) doctors having difficulties in practice were found to have had similar problems while in school. In this essay, we present a brief historical account of attitudes and approaches to admissions requirements, then discuss basic broad areas of accomplishment in clinical practice: academic mastery, clinical acumen, and professionalism. We then review data that suggest that lack of competency can often be detected very early in a student’s career and may or may not be immune to remediation efforts. We end with a recommendation for a course of action that upholds and fulfills the profession’s social responsibility. This will be a moral argument, defending an aggressive but equitable approach to maintaining both public accountability and trust. (shrink)

Opportunities for practical, hospital-based training in those skills demanded by clinical ethics consultation (CEC) have been limited. Given the number of individuals who provide part-time CEC, greater access to condensed, practical training such as the clinical ethics immersion course offered by the Washington Hospital Center, is necessary.Two participants in the initial cohort evaluate their CE training at a busy, urban referral center, exploring prior expectations, perceptions of its utility and suggestions for improvement. Such training will prove valuable not only for (...) bioethicists who lack practical CEC experience “at the bedside” but also for ethics consultants whose ethics services have a low consult volume who wish to sharpen their skills. (shrink)

A physician's lack of humanity is a general complaint in public surveys. The physician-patient relationship is viewed by the public as being reduced to a business relationship where the patient feels that she is merely a 'client' and the physician a healthcare 'practitioner' instead of a 'care giver'. This public perception is not a phenomenon that is peculiar to Lebanon. Yet, the problem has been increasing over the years to the extent that patients feel that physicians are becoming inhumane and (...) business oriented. While this might not characterize all physicians of the 21 st century, this might be true of at least some. Responses were collected from a study that was undertaken based on a questionnaire distributed to a pool of 650 participants from different geographical areas and different social and educational backgrounds in Lebanon. Participants were all older than18 years and mentally competent. None were physicians. The questionnaire was open-ended and initially piloted among a random sample. The physician traits most desired by the public were found to be: moral traits (41%), interpersonal traits (36%), scientific traits (19%) and other (4%). The most unwanted traits/behaviours were a lack of interpersonal traits (57%), a lack of moral traits (40%) and a lack of scientific skills (3%). The physician-patient relationship was perceived, in general, as being a flawed one. What can be done to remedy the image of the Lebanese physician that has been projected in the minds of the patients and the public at large? Nine major recommendations are presented. (shrink)

Bioethics is a relatively new addition to bedside medical care in Arab world which is characterized by a special culture that often makes blind adaptation of western ethics codes and principles; a challenge that has to be faced. To date, the American University of Beirut Medical Center is the only hospital that offers bedside ethics consultations in the Arab Region aiming towards better patient-centered care. This article tackles the role of the bedside clinical ethics consultant as an active member of (...) the medical team and the impact of such consultations on decision-making and patient-centered care. Using the case of a child with multiple medical problems and a futile medical condition, we describe how the collaboration of the medical team and the clinical ethics consultant took a comprehensive approach to accompany and lead the parents and the medical team in their decision-making process and how the consultations allowed several salient issues to be addressed. This approach proved to be effective in the Arab cultural setting and indeed did lead to better patientcentered care. (shrink)

BackgroundBetween the need for transparency in healthcare, widely promoted by patient’s safety campaigns, and the fear of negative consequences and malpractice threats, physicians face challenging decisions on whether or not disclosing medical errors to patients and families is a valid option.We aim to assess the knowledge, attitudes and practices (KAP) of physicians in our center regarding medical error disclosure.MethodsThis is a cross-sectional self-administered questionnaire study. The questionnaire was piloted and no major modifications were made.A day-long training workshop consisting of didactic (...) lectures, short and long case scenarios with role playing and feedback from the instructors, were conducted. Physicians who attended these training workshops were invited to complete the questionnaire at the end of the training, and physicians who did not attend any training were sent a copy of the questionnaire to their offices to complete. To assure anonymity and transparency of responses, we did not query names or departments.Descriptive statistics were used to present demographics and KAP. The differences between response\s of physicians who received the training and those who did not were analyzed with t-test and descriptive statistics. The 0.05 level of significance was used as a cutoff measure for statistical significance.ResultsEighty-eight physicians completed the questionnaire (55 attended training (62.50%), and 33 did not (37.50%)). Sixty Five percent of physicians were males and the mean number of years of experience was 16.5 years. Eighty-Seven percent (n = 73) of physicians were more likely to report major harm, compared to minor harm or no harm. Physicians who attended the workshop were more knowledgeable of articles of Jordan’s Law on Medical and Health Liability (66.7% vs 45.5%,p-value = 0.017) and the Law was more likely to affect their decision on error disclosure (61.8% vs 36.4%,p-value = 0.024).ConclusionFormal training workshops on disclosing medical errors have the power to positively influence physicians’ KAP toward disclosing medical errors to patients and possibly promoting a culture of transparency in the health care system. (shrink)