Sofía P Salas

Transitory T-lymphoblastic leukemoid reaction in a neonate with Down syndrome

A transient leukemoid reaction in a neonate with Down syndrome is reported. The blastic proliferation was identified as T lymphoblastic in an early stage of maturation (prethymocytes) using morphological, cytochemical, and immunological methods. A spontaneous complete remission occurred in 8 weeks. No additional cytogenetic alterations were found, except for those concerning chromosome 21. Other cases reported in the literature reveal that cytogenetic studies may be useful to distinguish these transient leukemic reactions from true leukemias in newborns with Down syndrome. The in vitro growth pattern of peripheral blood and bone marrow may also be useful for this purpose.

Transparencia en la investigación biomédica: A propósito de los riesgos asociados al uso de Avandia

The question of how and when to communicate potential risks associated with new drugs has remained an important focus of tension between the pharmaceutical industry and regulatory entities, such as the American Food and Drug Administration. Recently there has been widespread concern related to the cardiovascular risks associated with the use of Avandia, a rosiglitazone produced by Glaxo Smith Kline. In fact, several metaanalyses involving rosiglitazone provided a relatively consistent message that rosiglitazone increases the risk of myocardial ischemic events. In the present article, we review the controversy regarding the way the pharmaceutical company handled this issue, and we describe examples of inappropriate conduct regarding an industry-sponsored clinical trial with this drug. We raise several important ethical questions related to the way researchers handle conflicts of interest when they are employees of the pharmaceutical industry. Finally, we discuss the requirements to conduct biomedical research funded by the pharmaceutical industry in Chile.

Análisis de los principales conflictos éticos entre la Declaración de Helsinki 2008 y su propuesta de cambio

The Declaration of Helsinki (DoH) of the World Medical Association is the basis of the rules governing research on human beings. The latest version (enacted in Korea, 2008) has been a source of ethical discussions, particularly regarding the use of placebos, the measures to assure the access of study subjects to interventions identified as beneficial once the study has ended, and the need of a better protection of potentially vulnerable groups. These issues led to draft a revised version, that was approved in 2013. In this paper, we present an ethical analysis of the main changes contained in the DoH, including the proposed changes in the new version, referring, when appropriate, to relevant Chilean laws governing research on human subjects. In our opinion, the 2008 DoH contains significant imprecisions on some of these issues, making a new version of the declaration necessary to fully protect subjects participating in biomedical research, as stated by the new version approved in 2013.The Declaration of Helsinki (DoH) of the World Medical Association is the basis of the rules governing research on human beings. The latest version (enacted in Korea, 2008) has been a source of ethical discussions, particularly regarding the use of placebos, the measures to assure the access of study subjects to interventions identified as beneficial once the study has ended, and the need of a better protection of potentially vulnerable groups. These issues led to draft a revised version, that was approved in 2013. In this paper, we present an ethical analysis of the main changes contained in the DoH, including the proposed changes in the new version, referring, when appropriate, to relevant Chilean laws governing research on human subjects. In our opinion, the 2008 DoH contains significant imprecisions on some of these issues, making a new version of the declaration necessary to fully protect subjects participating in biomedical research, as stated by the new version approved in 2013.

Encuesta de opinión pública sobre reproducción humana y usos de tecnología de reproducción asistida en habitantes de Santiago, Chile

BACKGROUND Advances in reproductive medicine and the use of assisted reproductive technologies (ART) have a great impact in the lives of people and the conformation of their families. AIM To report the results of an opinion survey applied to inhabitants of Santiago, Chile about the use of ART to conceive. MATERIAL AND METHODS A survey was designed and applied to a random representative sample of 1.500 people between the ages of 18 and 65 in the 34 municipalities of Santiago. RESULTS Eighty eight percent of respondents support the use of medical assistance to conceive children. Wide approval exists for the use of in vitro fertilization (IVF) by heterosexual couples, even when not married (85.9%) and by single women (70.4%), by both mole and female participants of every socioeconomic level, age group and religious affiliation. Support decreases significantly when the use of IVF is considered for post-menopausal women (35.1 %) and by same-sex couples (26.6%). CONCLUSIONS Results of this survey indicate that the majority of inhabitants in Santiago favor the use of ART, including IVF. This support decreases significantly for elderly women and homosexual couples.

Dilemas éticos acerca de la revelación de errores médicos a los pacientes

Since the publication of the Institute of Medicine’s report “To Err is Human: Building a Safer Health System” awareness of the importance of medical errors has increased. These are a major cause of morbidity and mortality and recent studies suggest that they can be the third leading cause of death in the Unites States. Difficulties have been identified by health personnel to prevent, detect and disclose to patients the occurrence of a medical error, an also to report them to the appropriate authorities. Although human error cannot be eliminated, it is possible to design safety systems to mitigate their frequency and consequences. Our goal is to provide an update on the major concepts related to medical errors, a review of Chilean legislation on the subject, and a bioethical analysis on the principles involved, along with a management proposal. We propose mandatory reporting of errors to the health institution where they occur, to serve as a measure of personal and team learning, and to disclose the error to patients, depending on their own preferences.

Recomendaciones del Comité de Ética de la Sociedad Chilena de Nefrología para el manejo de los problemas ético-clínicos de pacientes adultos con enfermedad renal crónica terminal

There are different approaches to treat patients with End Stage Renal Disease (ESRD): hemodialysis, peritoneal dialysis, renal transplantation and conservative medical management. The choice of the best therapy for each patient, needs both clinical and ethical skills. The Ethics Committee of the Chilean Society of Nephrology has elaborated recommendations to help health workers to deal with the ethical and clinical problems related to patients suffering ESRD. Its goal is to guide, at a national level, the effective use of minimal standards in the treatment and care of patients with ESRD, including appropriate care and information for patients, therapy selection, management of difficult cases and potential conflicts.

Formas de Revisión Ética de Proyectos de Investigación Biomédica

Ten years after the approval of the Chilean bill that regulates scientific research in humans (Law Nº 20.120), and considering the current status of accreditation and training of many Research Ethics Committee (REC), it is necessary to analyze their performance. We analyzed the Chilean experience with REC aiming to propose a differential type of review, considering the risks to research participants. To improve the quality of the review and the efficiency of these committees, we propose to differentiate the revisions depending on the type of project, its methods and its risks. Initially, the types of review should be classified as exempt from review, expedited review and full review by the committee. In this proposal the type of review is confirmed or can be modified by a designated member of the committee after an initial review of the project. Thus, the deliberation and review times of the committee could be optimized avoiding delays in their revision.Ten years after the approval of the Chilean bill that regulates scientific research in humans (Law No 20.120), and considering the current status of accreditation and training of many Research Ethics Committee (REC), it is necessary to analyze their performance. We analyzed the Chilean experience with REC aiming to propose a differential type of review, considering the risks to research participants. To improve the quality of the review and the efficiency of these committees, we propose to differentiate the revisions depending on the type of project, its methods and its risks. Initially, the types of review should be classified as exempt from review, expedited review and full review by the committee. In this proposal the type of review is confirmed or can be modified by a designated member of the committee after an initial review of the project. Thus, the deliberation and review times of the committee could be optimized avoiding delays in their revision.

Ethical challenges posed by clinical trials in preterm labor: a case study

This paper explores the ethical implications of a randomized double-blind clinical trial aimed to determine effectiveness and safety of an oxytocin receptor antagonist versus a betamimetic in the treatment of preterm labor, presented to a teaching hospital affiliated with a private university in Santiago, Chile. Though this trial protocol fulfills one of the conditions under which pregnant women could be enrolled in a clinical trial—the intervention has the potential to benefit the pregnant woman (by reducing adverse effects associated to salbutamol administration) and her fetus (if the new drug prolongs pregnancy)—there are some specific ethical issues raised. First, when to obtain consent is an important issue for clinical trials involving acute and unforeseen conditions that affect pregnant woman, e.g. preterm labor. Second, research must address the risk/benefit ratio for these two interdependent individuals, providing a good prospect of low risk and adequate benefit for both of them. Thirdly, specifically when a study is sponsored by a high-income country and conducted in a low- or middle-income country, decisions regarding ancillary care provisions for research participants should be made in advance. Lastly, researchers must consider the requirements for paternal consent based on cultural contexts.

Problemas éticos y de salud planteados por la reciente epidemia de Ébola: ¿Qué debemos aprender?

The recent Ebola epidemic that affected several countries in Africa, with very high mortality and a pandemic threat, posed problems of justice, public health, prevention, treatment and research, each of which has relevant ethical issues. Despite severe initial difficulties, an effective international response was achieved, whose outcome has left significant teachings to be considered in order to deal with future epidemics or pandemics. In this article, the authors analyze the main problems faced during the Ebola epidemic, including the unequal distribution of health resources between countries, the need for international collaboration, the requirement for a review of the ethical standards of clinical trials in emergencies, and the necessity of an organized global system of prevention and timely response to these outbreaks. Authors conclude that at the present time health is a global issue without borders, that insufficient healthcare resources in some countries poses risks and affects all countries and that the confrontation of the threats of epidemics requires a solution based in universal solidarity. At the same time, a moral duty to investigate should be acknowledged, seeking a balance between sense of urgency, scientific rigor and involvement of local communities.The recent Ebola epidemic that affected several countries in Africa, with very high mortality and a pandemic threat, posed problems of justice, public health, prevention, treatment and research, each of which has relevant ethical issues. Despite severe initial difficulties, an effective international response was achieved, whose outcome has left significant teachings to be considered in order to deal with future epidemics or pandemics. In this article, the authors analyze the main problems faced during the Ebola epidemic, including the unequal distribution of health resources between countries, the need for international collaboration, the requirement for a review of the ethical standards of clinical trials in emergencies, and the necessity of an organized global system of prevention and timely response to these outbreaks. Authors conclude that at the present time health is a global issue without borders, that insufficient healthcare resources in some countries poses risks and affects all countries and that the confrontation of the threats of epidemics requires a solution based in universal solidarity. At the same time, a moral duty to investigate should be acknowledged, seeking a balance between sense of urgency, scientific rigor and involvement of local communities.

Conflictos éticos en las autorías de trabajos científicos

The frequency of conflicts about authorship of publications has increased along with the increase in the number of people involved in scientific work. Some of the factors that strongly influence the generation of conflicts and malpractices in authorship definition of scientific publications are the pressure of academia, economic incentives from the pharmaceutical industry in the field of biomedicine and authors’ wishes and expectations of recognition, among other factors. The article analyzes this problem, increasingly common in the field of medicine and related areas. Special attention is devoted to the prevailing laws in our country and international guidelines related to intellectual property and authorship of scientific publications, respectively. However, the ethical commitment, intellectual honesty and truthfulness of each of the authors about what is reported seems to be the decisive factor for the solution to these authorship conflicts.