Looking ahead at the potential benefits of biotechnology-derived allergen therapeutics

While biotechnology-derived allergen therapeutics show promise in improving the safety of immunotherapy, they may prove to have additional benefits in comparison to conventional allergenic extracts that deserve commentary. These issues range from product stability and compatibility to medical practice issues, which will be the focus of this article.     

Medical education must make room for student-specific ethical dilemmas

Most contemporary undergraduate courses in medical ethics leave a critical gap unfilled because they fail to address student-specific issues, says third-year student Joye St. Onge. In this article, which won third prize in CMAJs 1996 Dr. William Logie Medical Ethics Essay Contest, St. Onge outlines the importance of discussing student-specific ethical dilemmas and suggests ways to introduce such teaching in medical schools.     

"Post-residency disease" and the medical self: identity, work, and health care among doctors who become patients

Doctors who become patients due to serious illnesses face many challenges related to issues of identity, work, and professionalism. In-depth interviews with such doctors reveal the complex ways in which illness threatens identity in these professionals. In comparison with "medical student's disease," these doctors now exhibit "post-residency disease"-minimizing physical symptoms that are in fact present, leading to decreases in care sought. Doctors often feel they are somehow invulnerable to disease and have to remain strong, not burdening others. Many describe themselves as "workaholics," which can prove to be a double-edged sword, posing problems as well as providing benefits. This professional commitment could interfere with preventive health behaviors and with "practicing what they preach." Some view their illness with their "medical self" - as if they were a physician observing another patient rather than themselves. These doctors often support their approach by choosing a colleague as a doctor who will not challenge them, thereby establishing a "denial system" as opposed to a support system. These doctor-patients confront difficult issues of how much their physicianhood is an identity or an activity, illustrating the intricate relationships and tensions between work, identity, professionalism, and health in contemporary medicine.     

FPs can play important role in treatment of infertile patients,counsellors say.

Family physicians can do a great deal more to help patients face infertility assessment and treatment, but they must first recognize how their patients may be emotionally and physically affected by the diagnosis, a therapist told a recent workshop in Toronto. Strategies used by medical counsellors can be adapted by FPs and specialists to help patients address infertility issues.     

STEMI time delays: a clinical perspective: Editorial comment on the article by Verweij et al.

STEMI time delays have been introduced as a performance indicator or marker of quality of care. As they are only one part of a very complex medical process, one should be aware of concomitant issues that may be overlooked or even be more important with regard to clinical outcome of STEMI patients. In this overview we try to summarise the most important ones.     

Volunteering in Nha Trang, Vietnam: senior medical students' perspectives of a surgical mission trip

Vietnam has had a long history of international mission teams that volunteer needed surgical care to underserved populations for various medical problems. As senior medical students, we joined a non-profit organization's surgical mission trip led by a community practice surgeon and staffed by 32 health care professionals to provide cleft lip and palate reconstructions for 75 patients at a local hospital in Nha Trang, Vietnam. As a surgical mission team in a resource-poor country, we intended to fill gaps and unmet areas of need by offering care that patients would otherwise not receive. But in doing so, we encountered other gaps in health care for which we did not have adequate preparation or solutions: insufficient primary care, lack of understanding of others' cultural contexts, absence of knowledge of patients' socioeconomic contexts, and problems in other countries' health care systems. Although the purpose of our mission was to provide a specific service, we felt it is important to examine the service in the context of these broader issues. We considered these concerns from two different perspectives: what a medical mission gives and what it does not. In this article, we present several issues that our medical mission confronted and how they were both addressed and overlooked.     

Human genetic banking: altruism, benefit and consent

This article considers how we should frame the ethical issues raised by current proposals for large-scale genebanks with on-going links to medical and lifestyle data, such as the Wellcome Trust and Medical Research Council's 'UK Biobank'. As recent scandals such as Alder Hey have emphasised, there are complex issues concerning the informed consent of donors that need to be carefully considered. However, we believe that a preoccupation with informed consent obscures important questions about the purposes to which such collections are put, not least that they may be only haphazardly used for research (especially that of commercial interest)--an end that would not fairly reflect the original altruistic motivation of donors, and the trust they must invest. We therefore argue that custodians of such databases take on a weighty pro-active duty, to encourage public debate about the ends of such collections and to sponsor research that reflects publicly agreed priorities and provides public benefits.     

Publication: an ethical imperative.

Publication of medical research is both a monitor of the researcher''s ethics and an audit of the local or regional ethics committee that approved it. Selectivity of publication or of the intention to publish lessens this audit. Opinions differ about what is ethically allowable in clinical and benchtop medical research. Ethical permission and ethical monitoring of medical research are subject to a hierarchy of pyramidal controls, starting in hospital and ending with the local, institutional, or regional ethics committee. Currently, such committees function with widely varying degrees of efficiency and quality of output, and with differing viewpoints on many ethical issues. Without an a priori insistence by institutional ethics committees that there be an intention to publish all medical research involving human subjects, ethics committees cannot routinely be subject to the scrutiny or audit which they themselves demand of researchers.     

Great Expectations: Teaching Ethics to Medical Students in South Africa

Many academic philosophers and ethicists are appointed to teach ethics to medical students. We explore exactly what this task entails. In South Africa the Health Professions Council's curriculum for training medical practitioners requires not only that students be taught to apply ethical theory to issues and be made aware of the legal and regulatory requirements of their profession, it also expects moral formation and the inculcation of professional virtue in students. We explore whether such expectations are reasonable. We defend the claim that physicians ought to be persons of virtuous character, on the grounds of the social contract between society and the profession. We further argue that since the expectations of virtue of health care professionals are reasonable, it is also sound reasoning to expect ethics teachers to try to inculcate such virtues in their students, so far as this is possible. Furthermore, this requires of such teachers that they be suitable role models of ethical practice and virtue, themselves. We claim that this applies to ethics teachers who are themselves not members of the medical profession, too, even though they are not bound by the same social contract as doctors. We conclude that those who accept employment as teachers of ethics to medical students, where as part of their contractual obligation they are expected to inculcate moral values in their students, ought to be prepared to accept their responsibility to be professionally ethical, themselves.     

Are the costs of employer-sponsored health insurance passed on to workers at the individual level?

Because employer-sponsored health insurance (ESI) is experience rated, employers have an incentive to try to offset its cost by paying lower wages to employees who have greater medical expenditures. The existing evidence on this topic, however, illustrates only that ESI is associated with lower wages for groups of workers who are costlier to cover. In contrast, I use the variation provided by the Affordable Care Act's employer mandate to examine if differences in medical expenditures are passed on to workers at the individual level. My estimates rely on Medical Expenditure Panel Survey data in a dose response difference-in-difference framework that examines how wages change for workers with varying medical expenditures when they must soon be offered ESI. I find that each $1 difference in medical expenditures is associated with a $0.35 to $0.51 wage offset after the employer mandate's announcement wherever ESI must soon be offered to workers. Placebo analyses, focusing on workers whose employers are not affected by the mandate, provide support for a causal interpretation. I also show that my findings are not sensitive to sample selection or data reliability issues and that they cannot be explained by the effects of the Great Recession, demographic characteristics that correlate with medical expenditures, or location- or industry-specific idiosyncratic shocks.     

Human genetic banking: altruism,benefit and consent

This article considers how we should frame the ethical issues raised by current proposals for large‐scale genebanks with on‐going links to medical and lifestyle data, such as the Wellcome Trust and Medical Research Council's ‘UK Biobank’. As recent scandals such as Alder Hey have emphasised, there are complex issues concerning the informed consent of donors that need to be carefully considered. However, we believe that a preoccupation with informed consent obscures important questions about the purposes to which such collections are put, not least that they may be only haphazardly used for research (especially that of commercial interest)—an end that would not fairly reflect the original altruistic motivation of donors, and the trust they must invest. We therefore argue that custodians of such databases take on a weighty pro‐active duty, to encourage public debate about the ends of such collections and to sponsor research that reflects publicly agreed priorities and provides public benefits.     

Compelled organ donation

Along with ethical considerations, compelling an individual to donate organs, tissues, or bodily fluids brings several legal doctrines into conflict. The privacy of one's body is generally considered sacrosanct by American courts, which have upheld a competent adult's right to refuse medical procedures, even in cases when they are necessary to save the life of another. Although medical and legal communities stress “respect for the individual” as being paramount under American jurisprudential principles, the doctrine of “substituted judgment” permits a court to act (for example, by consenting to organ donation) on behalf of an incompetent individual or child. Parents also have the right to cause a child to “donate” an organ, and although a means exists by which the child can refuse, this may not be realistically feasible for young children. The revised Uniform Anatomical Gift Act of 2006, while clarifying issues of who may make organ donation decisions, does not resolve all the practical issues of compelled organ donation for minors.     

Topics to ponder: Part-time practice and pay parity

Background: The medical profession has undergone a significant demographic change, with a dramatic increase in the number of women applying to medical school and practicing medicine.Objectives: In recognition of the changing demographics in the medical profession, the American Medical Association's Women Physicians Congress (AMA-WPC) conducted a members' survey to identify the issues affecting women physicians and to ascertain certain practice characteristics.Methods: In 2008, an e-mail survey link was sent to a randomly selected nationwide sample of 4992 WPC members, and a second, identical survey was sent to 596 female AMA members, utilizing the Epocrates database (Epocrates, Inc., San Mateo, California). Two e-mail reminders were sent for the first survey, which had a 15% response rate. A quota of 148 physicians was received within 4 days and was utilized to interpret results from the second survey.Results: Achieving work-life balance was a significant concern for 91% of the respondents (n = 884). Half of the respondents believed that pay is gender neutral, and 28% indicated that they were “somewhat or very concerned about sexual harassment”. When queried regarding practice patterns, 29% of respondents indicated that they had worked part-time at some point during their careers.Conclusions: In this survey, women physicians indicated that gender pay disparity and sexual harassment remain important issues in the medical profession. Less than a third of respondents had ever worked part-time, which should be a consideration for physician workforce studies. Barriers to part-time practice may exist.     

医学研究伦理学的发展现状与前景

创新技术的开展和转化医学的注重给医学的发展注入了新的活力,但同时,也带来了一系列社会伦理问题和法律问题。生命医学伦理学的兴起和发展催生了医学研究伦理学分支学科形成,目的在于推进解决涉及人体的医学研究的伦理问题。当前,面临的最突出的伦理问题在于,对医学研究合法性、先进性及伦理性的把握,对医学研究伦理审查必要性的认知,对医学研究方案设计与伦理道德的匹配,对医学研究知情同意的告知,对医学研究风险与受益的平衡。逐步与国际接轨,加强伦理委员会制度建设;提高伦理审查能力建设,形成高水平的伦理审查队伍;学术组织和团体共同努力,推进医学研究伦理学的发展,这将助推医学研究伦理学的发展。     

Aggression and violence: perspectives on integrating animal and human research approaches

Aggression and violence are concerns that engage us across society as moral and cultural issues. They are also critical issues for mental health research--both for survivors and for understanding how such behaviors occur. Interpersonal violence often explodes in deliberate acts of physical force leaving survivors behind with a diminished sense of control that is often shadowed by persistent fear and anxiety. The treatment of the victims is a clear and immediate concern; from their perspectives the medical consequences require effective attention whether they suffered as a result of acts of nature, mental disease, ideology, or combinations of these. At the same time preventing violent behavior from happening in the first place is a compelling challenge for public health research.     

Physician prescribing practices: What do we know? Where do we go? How do we get there?

Although drug prescribing is one of the most important components of medical care, little is known about how prescribing practices are determined and how they can be influenced. Enhancing the quality and effectiveness of drug prescribing requires research and better dissemination of information to physicians and other decision-makers. This requires a collaborative effort and a coordinated action plan. Participants at the Physician Prescribing Practices Workshop, held in Ottawa in October 1995, addressed issues and made recommendations in three areas: current knowledge and issues for research in the field of prescribing practices, and the capacity of Canadian databases to study these issues, strategies for disseminating and implementing knowledge and research findings to enhance the quality of prescribing; and the formation of a network to foster collaboration among stakeholders.     

Non-protein amino acids: plant, soil and ecosystem interactions

Non-protein amino acids are a significant store of organic nitrogen in many ecosystems, but there is a lack of knowledge relating to them. Research has indicated that they play important roles as metabolites, as allelopthic chemicals, in nutrient acquisition, in signalling and in stress response. They are also thought to be responsible for significant medical issues in both invertebrate and vertebrate animals. This review attempts to appraise the literature related to non-protein amino acids, both in terms of their metabolism, plant?Csoil interactions and at the level of the ecosystem, where they are seen as significant drivers of structure and function. Finally, important areas for future research are discussed.     

Characteristics of Pivotal Trials and FDA Review of Innovative Devices

When patients lack sufficient treatment options for serious medical conditions, they rely on the prompt approval and development of new therapeutic alternatives, such as medical devices. Understanding the development of innovative medical devices, including the characteristics of premarket clinical trials and length of Food and Drug Administration (FDA) review, can help identify ways to expedite patient access to novel technologies and inform recent efforts by FDA to more quickly get these products to patients and physicians. We analyzed publicly available information on clinical trials and premarket FDA review for innovative medical devices that fill an unmet medical need. In this first-of-its-kind study focusing on these products, we extracted data on the length of the pivotal trials, primary study endpoint and FDA review; number of patients enrolled in trials; and in what country the device was available first. We identified 27 approved priority review devices from January 2006 through August 2013. The median duration of pivotal clinical trials was 3 years, ranging from 3 months to approximately 7 years. Trials had a median primary outcome measure evaluation time of one year and a median enrollment of 297 patients. The median FDA review time was 1 year and 3 months. Most priority review devices were available abroad before they were approved in the United States. Our study indicates that addressing the length of clinical studies—and contributing factors, such as primary outcome measures and enrollment—could expedite patient access to innovative medical devices. FDA, manufacturers, Congress and other stakeholders should identify the contributing factors to the length of clinical development, and implement appropriate reforms to address those issues.     

The ethics of human gene transfer

Almost 20 years since the first gene-transfer trial was carried out in humans, the field has made significant advances towards clinical application. Nevertheless, it continues to face numerous unresolved ethical challenges--among them are the question of when to initiate human testing, the acceptability of germline modification and whether the technique should be applied to the enhancement of traits. Although such issues have precedents in other medical contexts, they take on a different character in gene transfer, in part because of the scientific uncertainty and the social context of innovation.