MENINGOCOCCAL AND TRAVELLERS’ VACCINATIONS

The increase in international tourism has created demandfor vaccination to protect against travel-associatedillness. The decision to vaccinate travellers involvesrisk-benefit assessment. Most currently used travelvaccines include the meningococcal vaccine, yellow fevervaccine, typhoid vaccine, and Japanese encephalitisvaccine.This review addresses the limitations posed by themeningococcal polysaccharide vaccine, the differentquadrivalent meningococcal conjugate vaccines available,the current recommendations in children and adults andthe development of new meningococcal B vaccines.This review also addresses the current recommendationsfor yellow fever vaccines, new typhoid conjugate vaccines,changing epidemiology of Japanese encephalitis (JE), andnew recommendations for the JE vaccines.

Ethical issues on the "synthetic" phosphoethanolamine clinical trial / Questões éticas sobre o ensaio clínico da fosfoetanolamina "sintética"

Summary Notwithstanding its approval by the National Committee for Ethics in Research (Conep) on April 19, 2016, a trial of the so-called "synthetic" phosphoethanolamine (syn-phospho) pill in cancer patients raises ethical concerns. An analysis by a laboratory contracted by the Ministry of Science, Technology and Innovation (MCTI) revealed that syn-phospho contained a great amount of impurities and did not meet standards of pharmaceutical quality required for an investigational drug. Cytotoxicity against human tumor cell lines and in vivo rodent xenograft tumor assays consistently failed to demonstrate a potential anticancer activity of syn-phospho. Preclinical safety studies of syn-phospho were also insufficient to support a trial of this investigational drug in cancer patients. Moreover, the ethical approval decision apparently overlooked two previous findings that suggested a possible enhancement of mammary carcinoma cell proliferation by phosphoethanolamine, and an apparent increase in lung metastases (rat implanted tumor assay) by syn-phospho. The syn-phospho risk-benefit ratio is clearly unfavorable and, thus, this trial in cancer patients does not fulfill a key requirement to make a clinical research ethical. There are also concerns regarding whether the study design is robust enough (scientific validity), and the social value of the trial of syn-phospho in cancer patients is questionable.

Resumo Não obstante a sua aprovação pela Comissão Nacional de Ética em Pesquisa (Conep) em 19 de abril de 2016, um ensaio da pílula de fosfoetanolamina "sintética" (sin-fosfo) em pacientes com câncer levanta preocupações éticas. Uma análise feita por um laboratório contratado pelo Ministério da Ciência, Tecnologia e Inovação (MCTI) revelou que a sin-fosfo continha grande quantidade de impurezas e não satisfazia os padrões de qualidade farmacêutica exigidos para um medicamento experimental. Os ensaios de citotoxicidade com linhagens de células originárias de tumores humanos e testes in vivo em roedores com tumores xeno-enxertados falharam consistentemente em demonstrar uma potencial atividade anticâncer da sin-fosfo. Os estudos pré-clínicos de segurança da sin-fosfo também foram insuficientes para apoiar a realização de um ensaio desse medicamento experimental em pacientes com câncer. Além disso, a aprovação ética aparentemente desconsiderou dois achados anteriores, sugerindo uma possível exacerbação da proliferação de células de carcinoma de mama pela fosfoetanolamina, e um aparente aumento de metástases pulmonares (ensaio de tumores implantados em ratos) pela sin-fosfo. A relação risco-benefício é claramente desfavorável para a sin-fosfo e, portanto, esse ensaio em pacientes com câncer não atende um requisito essencial para que uma pesquisa clínica seja ética. Há também preocupações quanto ao delineamento do estudo ser suficientemente robusto (validade interna), e o valor social do ensaio da sin-fosfo em pacientes com câncer é questionável.

Precision Medicine: Ethical and Regulatory Challenges / 中国医学伦理学

This article describes the definition of precision medicine and the American and Chinese precision medicine initiatives.It then discussed ethical and regulatory challenges raised by precision medicine.These challenges include cost-effectiveness ratio evaluation for precision medicine initiatives,risk-benefit ratio in precision medicine,valid informed consent for research participants,independent ethical review of precise prevention and treatment protocols,protection of individual privacy data,mass data sharing and equitable access of research results.

<b>4．Evaluation of the Risk Minimization Plan of the Drugs such as Thalidomide </b> / 薬剤疫学

<p>If mother use drugs during pregnancy, the risk to the fetus is concerned. So the management of the drug is important. Previously, we have experienced The Thalidomide Disaster, the drug has not been used for many years since then. However, since thalidomide is found to have an effect on multiple myeloma, its management method is problematic. In the patients who use thalidomide, there are few women with the possibility of pregnancy. And by strict management, it has been concerned about the problem of the things that is difficult to use in patients not related to pregnancy. Isotretinoin is currently being used in the United States as the drug for acne therapy. Although there is no adaptation in Japan, the physician personally import the drug and administer to the patients. Because a lot of childbearing women are included in the patient who use the drug, strict management is necessary. Because the drug is not marketed in Japan, the offer of the information is not enough. Valproic acid has both adaptation the prevention of the migraine headache other than epilepsy. The control of epilepsy is very important, there are patients that use the drug after consideration of risk benefit balance. On the other hand, benefit was relatively small when use it for the prevention of the migraine headache. FDA prohibited the use during pregnancy for this purpose. In Japan, it is the same regulation regardless of adaptation, and balance of the risk benefit is not clear. It was thought that different attention awakening should be carried out by adaptation in future.</p><p></p>

4．Evaluation of the Risk Minimization Plan of the Drugs such as Thalidomide / 薬剤疫学

If mother use drugs during pregnancy, the risk to the fetus is concerned. So the management of the drug is important. Previously, we have experienced The Thalidomide Disaster, the drug has not been used for many years since then. However, since thalidomide is found to have an effect on multiple myeloma, its management method is problematic. In the patients who use thalidomide, there are few women with the possibility of pregnancy. And by strict management, it has been concerned about the problem of the things that is difficult to use in patients not related to pregnancy. Isotretinoin is currently being used in the United States as the drug for acne therapy. Although there is no adaptation in Japan, the physician personally import the drug and administer to the patients. Because a lot of childbearing women are included in the patient who use the drug, strict management is necessary. Because the drug is not marketed in Japan, the offer of the information is not enough. Valproic acid has both adaptation the prevention of the migraine headache other than epilepsy. The control of epilepsy is very important, there are patients that use the drug after consideration of risk benefit balance. On the other hand, benefit was relatively small when use it for the prevention of the migraine headache. FDA prohibited the use during pregnancy for this purpose. In Japan, it is the same regulation regardless of adaptation, and balance of the risk benefit is not clear. It was thought that different attention awakening should be carried out by adaptation in future.

Risk-benefit Assessment of Foods in Sweden - Developing a Working Procedure.

Background: Assessments of food-related health risks and benefits performed by national or international experts are still to a large extent separate processes. Diets, foods, and even single food ingredients, may potentially be associated with both beneficial and adverse health effects. Therefore in some cases it is important to consider both health risks and benefits, by assessing the balance between potential risks and benefits, ideally by expressing risk and benefit on the same scale. In Sweden risk-benefit assessments in the food sector are the responsibility of the Risk and Benefit Assessment Department at the National Food Agency (NFA), which brings together the scientific disciplines toxicology, nutrition and microbiology and related fields. In 2012 a project was initiated to develop a general procedure for risk-benefit assessments at the NFA. The results of this project, and an in-house working procedure, have been published in a governmental report [1] and presented at the Scientific conference “Shaping the Future of Food Safety Together” hosted by the European Food Safety Authority (EFSA) in Milan, Italy, in October 2015 (http://www.efsaexpo2015.eu/). The objectives of the project were to: • Summarize previous national and international experiences in the field of risk-benefit assessment • Develop a working procedure for practical use at the NFA • Test the procedure in a case study Principles of Risk-benefit Assessment From the overview and evaluation of the risk and benefit assessment literature it was concluded that no international consensus on the general principles or approaches for conducting risk-benefit assessment of foods and food components has so far been reached. The workflow suggested by EFSA [2] was used as a starting point for the development of the proposed NFA procedure for risk-benefit assessment. Tiered, stepwise approaches have been the preferred procedure in the majority of published risk-benefit assessments. In such an approach the nature of the question and the availability and type of data on for example food composition, exposure and health consequences determine at what tier the assessment can be stopped. The advantage of a stepwise methodology is that it is conceptually easy to use by the assessors and promotes transparency of the process. The NFA Procedure for Risk-benefit Assessment The developed risk-benefit assessment procedure contains three steps, from a qualitative assessment of risks and benefits separately to a quantitative assessment expressing risks and benefits on the same scale: 1) Initial assessment of risks and benefits separately 2) Enhanced assessment where different metrics for risks and benefits are weighted 3) Expressing risks and benefits on the same scale, for example mortality or DALYs (Disability Adjusted Life Years). Fig. 1. The relation between the three different steps in the NFA working procedure (1). Dialogue between the risk-benefit assessor and the risk-benefit manager is crucial after each step Case Study of the Risk-benefit Assessment Procedure The procedure was applied in a case study to assess the risk and benefits with a decreased content of nitrite and salt in processed meat, when done in combination with a decreased maximum storage temperature [3]. The potential health benefits for the general population, in terms of lower risk of exceeding ADI and lower risk of high blood pressure of decreased nitrite and salt intake was weighed against an increased risk of Clostridium botulinum and Listeria monocytogenes infections. The two first steps of the procedure could be applied, and it was concluded that the reduction of salt and nitrite levels would only have marginal effects on public health. Moreover, this reduction would not result in increased growth of microorganisms. The reduction of storage temperature from 8°C to 5°C would however result in a positive effect due to a reduction of growth of L. monocytogenes, but no effect on growth of C. botulinum. Future Activities at NFA Considering the complexity and the continuous development of the risk-benefit assessment area there is a need for national and international collaboration. At NFA we have initiated collaborative work with the Karolinska Institutet in Stockholm in order to increase the awareness of risk-benefit assessment in the academic environment, as well as to acquire valuable input from other experts. To promote cooperation on this subject in a Nordic setting we aim to host a workshop on risk-benefit assessment methods for Nordic countries during 2016. We are also open for collaboration in the risk-benefit assessment area within the EU. Conclusions The described working procedure is based on current best practices on how to perform risk-benefit assessments. The NFA working procedure share many features with for example the BEPRARIBEAN [4], BRAFO [5] and EFSA procedures [2]. Thus, our intention has been to incorporate experience and knowledge from previously published assessments and suggested procedures into a suitable in-house method. Our risk-benefit procedure is applied to relevant risk assessment questions at NFA. The case study regarding reduction of salt and nitrite content of processed meat helped us to identify critical points in the working procedure since it covered various aspects in microbiology, nutrition and toxicology. In our work and report we have identified several challenges associated with risk-benefit assessments. This emphasizes the need to develop a commonly accepted and feasible working procedure within the EU. The complete report can be downloaded free from: http://www.livsmedelsverket.se/globalassets/rapporter/2014/2014_livsmedelsverket_24_risk_benefit_assessment_procedures.pdf

Broader Transparency on Risk-benefit Assessment of the Bial Trial in France.

On 11 January 2016, a Phase I trial of an experimental fatty acid amide hydrolase inhibitor for pain developed by Bial-Portela was halted after six healthy volunteers were admitted to the University of Rennes Hospital in France. One volunteer died and four suffered severe neurological injuries. It is a dreadful reminder of the Tenegero trial that also hospitalized six volunteers in 2006. Three major similarities were observed between the Tegenero and Bial trials. The first similarity is related to the dosing interval protocol. There is a lack of information about whether the multiple-dose regimen included adequate time intervals between individuals receiving the drug. The second similarity is on the dosing calculation that was based on the ‘no adverse effect level’ (NOAEL). The third similarity is observed in terms of how there was no prior publication of preclinical findings in the public domain before the start of both trials. There have been calls for the full release of the Investigation Medicinal Product Dossier and the Investigator’s Brochure, as these data are critical to maximize patient safety in the future and should outweigh considerations of commercial confidentiality. Likewise, it is necessary for the Brest Regional Ethics Committee to release its documents, which captured the risk-benefit assessment in approving the Bial trial, for external scrutiny.

Symposium Report: Effective and Safe Micronutrient Interventions, Weighing the Risks against the Benefits.

Micronutrient fortification of staple foods can be an effective strategy to combat micronutrient malnutrition. When planning on fortification, challenges faced include the collection of essential information on population food and nutrient intake patterns, as well as the use of this information in a method to select appropriate fortification levels. A symposium was organized aimed at discussing the existing approaches to set effective and safe micronutrient fortification levels and to outline the challenges and needs in this area. Two different approaches to establish effective and safe fortification levels for food fortification were presented. In the first approach, the Estimated Average Requirement (EAR) and Tolerable Upper Intake Level (UL) are used as cut-points in the micronutrient intake distribution to evaluate and simulate effective and safe micronutrient intakes. This was exemplified by challenges encountered in Guatemala and Cameroon towards unequal vitamin A intake distribution and the impact of the food vehicle choice. Secondly, the risk-benefit approach was presented as an approach in which risks and benefits of micronutrient intakes can be quantified and balanced in order to optimize fortification benefits with the least risks and to allow decision making. This was illustrated by a case on folic acid fortification in The Netherlands. Irrespective of the approach, food and nutrient intake data are required to identify potential vehicles for fortification, quantify the nutrient gap to be addressed, and set the appropriate level of fortification based on consumption pattern. Such information is rarely available to the quality and extent ideal to set fortification levels and requires regular updating, as exemplified in the case of sugar fortification in Guatemala. While the EAR cut-point method can be used to determine the proportion of the population meeting their required and safe nutrient intakes and set goals, riskbenefit assessment may offer an answer to commonly-asked questions as to whether, and at which levels, the benefits of increasing micronutrient intakes outweigh the risks.

Estudo crítico do princípio de benefício e dano / Critical analysis of the principle of benefit and harm / Estudio crítico del principio de beneficio y daño

Benefício e dano são elementos essenciais em toda ponderação de natureza bioética. A prevenção de danos está presente no juramento de Hipócrates como preocupação central. O objetivo deste artigo é analisar criticamente o princípio de maximizar benefício e minimizar dano, tendo como ponto de partida o artigo da Declaração Universal sobre Bioética e Direitos Humanos (DUBDH) que trata do tema. Propomos, primeiramente, uma abordagem geral, filosófica, a partir de autores clássicos, como Kant e Mill, mas também contemporâneos, como Ruwen Ogien e Edgar Morin, entre outros. Seguimos com algumas abordagens da literatura bioética brasileira e internacional. Nesse ponto, pudemos observar um viés claramente equivocado, na medida em que é proposto um conceito bastante limitado de benefício, por parte de alguns autores norte-americanos. Ao valer-se de argumentos tradicionalmente principialistas para defender suas posições, tais autores reforçam (involuntariamente) a necessidade de outra via de ponderação bioética, a DUBDH.

Benefit and harm are essential elements in any consideration of bioethical nature. Preventing harm is already present in the Hippocratic Oath as a central concern. The purpose of this article is to critically analyze the principle of maximizing benefit and minimizing harm. It takes as its starting point the article of the Universal Declaration on Bioethics and Human Rights (UDBHR) dedicated to this principle. First we propose a more general, philosophical approach grounded in classical authors such as Kant and Mill, but also contemporaries such as Ruwen Ogien and Edgar Morin, among others. We then present several approaches to bioethics in the Brazilian and international literature. At that point we were able to observe a clearly misconceived bias, in that a rather limited concept of benefit is proposed by certain American authors. Using arguments from principalism to defend their positions, these authors (unintentionally) reinforce the need for another standard for bioethical evaluation, the UDBHR.

Beneficios y daños son elementos esenciales de cualquier ponderación de carácter bioético. La prevención de daños ya está presente en el juramento hipocrático como una preocupación central. El propósito de este artículo es analizar críticamente el principio de maximizar el beneficio y minimizar el daño, tomando como punto de partida el artículo de la Declaración Universal sobre Bioética y Derechos Humanos (DUBDH) que se ocupa de la temática. En primer lugar se propone un carácter más general, filosófico, de los autores clásicos, como Kant y Mill, así también como los contemporáneos como Ruwen Ogien y Edgar Morin, entre otros. Seguimos algunos enfoques de la bioética brasileña y la literatura internacional. En este punto se observa un sesgo claramente equivocado, ya que propone un concepto más limitado de beneficio por parte de algunos autores estadunidenses. Al hacer uso de los argumentos tradicionalmente principialistas para defender sus posiciones, estos autores destacan (involuntariamente) la necesidad de otro camino de ponderación bioética, la DUBDH.

Public Health Risk-benefit Assessment Associated with Food Consumption–A Review.

Background: In the food safety field, risk assessment, including microbial and chemical components, has been applied for many years. However, a whole and integrated public health assessment also depends on the nutritional composition of food. While the fact that foods and diets can be a source of both risks and benefits now appears undisputed, carrying out a risk-benefit assessment (RBA) is still an emerging and challenging scientific subject. Aims: The purpose of the present review was to synthesize RBA studies associated with food consumption and to summarize the current methodological options and/or tendencies carried out in this field. Methods: The different data sources explored included around 20 accessible databases using the main terms “risk”, “benefit” and “food” as keyword enquiries in article title and full-text. The initial research process led to 3293 screened papers, 160 of which were examined in detail. Results: There were 126 articles dealing with RBA studies and 34 with the RBA methodological framework. Most of the available papers dealt with the comparison of nutritional beneficial effects and chemical adverse effects related to fish consumption. The majority of studies undertook a comparison of consumer exposure to risks and benefits with regard to reference safety values. However, more varied studies have emerged during the last 15 years, contributing to the diversification and the development of this issue. Conclusion: RBA appears to be a promising scientific discipline and should be the next step in assessing the overall impact of food on health.

Finding the Optimum Scenario in Risk-benefit Assessment: An Example on Vitamin D.

Background: In risk-benefit assessment of food and nutrients, several studies so far have focused on comparison of two scenarios to weigh the health effect against each other. One obvious next step is finding the optimum scenario that provides maximum net health gains. Aim: This paper aims to show a method for finding the optimum scenario that provides maximum net health gains. Methods: A multiple scenario simulation. The method is presented using vitamin D intake in Denmark as an example. In addition to the reference scenario, several alternative scenarios are simulated to detect the scenario that provides maximum net health gains. As a common health metric, Disability Adjusted Life Years (DALY) has been used to project the net health effect by using the QALIBRA (Quality of Life for Benefit Risk Assessment) software. Results: The method used in the vitamin D example shows that it is feasible to find an optimum scenario that provides maximum net health gain in health risk-benefit assessment of dietary exposure as expressed by serum vitamin D level. With regard to the vitamin D assessment, a considerable health gain is observed due to the reduction of risk of other cause mortality, fall and hip fractures when changing from the reference to the optimum scenario. Conclusion: The method allowed us to find the optimum serum level in the vitamin D example. Additional case studies are needed to further validate the applicability of the approach to other nutrients or foods, especially with regards to the uncertainty that is usually attending the data.

Risk-Benefit Analysis and Assessment in Ethical Review:A Study Based on Literature Review / 中国医学伦理学

The reasonable risk-benefit ratio is one of the most significant criteria in ethical review .However , there is not a well-organized standard for risk -benefit analysis and assessment .Also the commonly used Common Rule and Duty of Personal Care Approach have their own limitations , which revoked the Component Analysis Strate-gy, unfortunately, failed again.Alex John London, as a result, tried to construct a comprehensive approach , in which he clarified reasonable riskbased on the distinction of personal interest and basic interest , as well as brought in the concept of comparator activities .Compare to the theoretical contribution of London ,A seven-step framework for risk-benefit evaluationcreated by Annette Rid and David Wendler concerns more from the practi-cal aspect .

Updates in Psychotropic Medication for Lactating Women / 대한정신약물학회지

The use of psychotropic medications in lactating women is controversial. Despite widely accepted advantages of human milk, patients and professionals hesitate to use medications during breastfeeding. Package inserts written by manufacturers routinely discourage breastfeeding to prevent law suits. Here we conducted a review to help professionals to decide medication for lactating women on an evidence-based risk-benefit analysis. First, we reviewed lactational pharmacology. The relative infant dose (RID) was defined to give an objective measure for infant exposure to medication, and drugs with RID lesser than 10% were considered quite safe. Subsequently, we reviewed each category of psychotropic medications which were commonly used in mental illness. We provided information for each drug such as Dr. Hale's lactation risk category, RID, half-life, and time to peak plasma level as references for the risk analysis. There was no contraindicated psychotropic medication during breastfeeding, but for lithium, close monitoring of infant serum levels is warranted. In conclusion, most of medications used to treat mental illness in lactating women were usually safe. Nevertheless, medication use in lactating women should always be considered on an individualized risk-benefit analysis, and untoward adverse effects on the infant should be monitored.

Animal welfare: concepts, study methods and indicators / Bienestar animal: conceptos, métodos de estudio e indicadores / Bem-estar animal: conceitos, métodos de estudos e indicadores

There is now increasing public concern about the welfare of animals in most countries of the world. Applied ethological studies of motivation, cognition and the complexity of social behaviour in animals has resulted in the rapid development of animal welfare science. A definition of animal welfare is: the state of the individual as regards its attempts to cope with its environment. Welfare concerns all of the mechanisms for coping: involving physiology, behaviour, feelings and pathological responses. Welfare is a wider term than health but health is an important part of welfare. In order to enforce laws and standards, animal welfare outcome indicators are useful. Many measures of welfare are now used and indicate how good or how poor the welfare is. The concept of animal welfare and the methods of assessment are now taught in hundreds of universities around the world. In recent years, animal welfare has become established as one of the criteria used to decide on whether a system is sustainable and whether product quality is good. Legislation on how animals should be kept is now referring to welfare outcome indicators and analysis of the scientific literature about animal welfare includes risk assessment and benefit assessment.

Actualmente existe una creciente preocupación pública por el bienestar de los animales en la mayoría de los países del mundo. Los estudios etológicos aplicados de motivación, cognición y de complejidad del comportamiento social en los animales, han generado un veloz desarrollo de la ciencia del bienestar animal. Una definición de bienestar animal es: el estado del individuo respecto a sus intentos de enfrentar el ambiente en que se encuentra. El bienestar está relacionado con todos los mecanismos para enfrentarlo: involucrando la fisiología, el comportamiento, las sentimientos y las respuestas patológicas. Bienestar es un término más amplio que salud, pero la salud es una parte importante del bienestar. Con el objetivo de respetar las leyes y normas, el bienestar animal cuenta con algunos indicadores que son de gran utilidad. Gran cantidad de las mediciones del bienestar se utilizan para indicar que tan bueno o que tan pobre es el bienestar. El concepto de bienestar animal y sus métodos de evaluación se enseñan ahora en cientos de universidades de todo el mundo. En los últimos años, el bienestar animal se ha establecido como uno de los criterios utilizados para decidir si un sistema es sostenible y si la calidad del producto es buena. La legislación sobre cómo los animales deben mantenerse ahora se refiere a los indicadores de resultados de bienestar y al análisis de la literatura científica sobre el bienestar animal incluyendo la evaluación de beneficio-riesgo.

Atualmente há uma crescente preocupação pública sobre bem-estar animal na maioria dos países. Aplicados estudos etológicos de cognição, motivação e complexidade do comportamento social nos animais, levaram a um rápido desenvolvimento da ciência do bem-estar animal. A definição de bem-estar animal é o estado do indivíduo em suas tentativas de lidar com o ambiente em que ele está localizado. O bem-estar está relacionada com todos os mecanismos para lidar: envolver a fisiologia, comportamento, sentimentos e resposta patológica. Bem-estar é um termo mais amplo de saúde, mas a saúde é uma parte importante do ser. A fim de respeitar as leis e regulamentos, bem-estar animal tem alguns indicadores que são úteis. Um grande número de medidas a ser utilizado para indicar o quão bom ou quão pobre é o bem- estar. O conceito de bem-estar animal e os seus métodos de avaliação são agora ensinadas em centenas de universidades ao redor do mundo. Nos últimos anos, bem-estar animal foi estabelecida como um dos critérios utilizados para decidir se um sistema é sustentável e se a qualidade do produto é bom. A legislação sobre como os animais devem ser mantidos agora se refere a indicadores de resultados bem-estar e análise da literatura científica sobre bem-estar animal, incluindo a avaliação benefício-risco.

Pharmacovigilance as a New Discipline / 薬剤疫学

In last ten years or more, the term pharmacovigilance has been often used instead of post-marketing surveillance (PMS) or drug monitoring. However, this term, pharmacovigilance, is not just another term for PMS but should be understood as a new discipline, namely, science for the benefit-risk evaluation of medicinal products on humans with the final aim of individualization of medical therapy. It will be more clearly understood why nowadays this term pharmacovigilance has been used, when one considers the historical development of the safety issue of medicinal products. Pharmacovigilance as a new discipline should evaluate constantly safety and efficacy of medicinal products in daily practice considering all available data from non-clinical data, clinical data, pharmacoepidemiological data, post-marketing clinical data, risk-benefit evaluation and applied pharmacologies such as gender-specific pharmacology, pharmacogenetics, graviduspharmacology etc. in order to collect, evaluate and disseminate systematically necessary information and data on the safety and efficacy of medicinal products.<BR>In addition, one should realize the presence of two different aspects of pharmacovigilance, namely obligatory duty of care and voluntary duty of care. The former aspect is defined by regulatory authorities and each pharmaceutical industry should carry out all necessary countermeasures and studies defined by regulatory authorities in order to keep the optimal standard on the efficacy, safety and effectiveness of the company's medicinal products. The latter aspect can also be considered as ethical duty of care for pharmaceutical industries, and refers to more detailed studies in particular patients such as children, pregnant women, aged patients, ethnically different patients, etc.

The Ethical Problems in Neurotherapeutics Research / 中国医学伦理学

Three key ethical issues in neurotherapeutics research are discussed: the ethical challenges arising from changes in the financial incentive of researchers and their institutions,risk-benefit analysis on testing innovative interventions,and the research for informed consent.