ISSN Print 2713-0894    ISSN Online 2713-0908
Medical Ethics
BIOMEDICAL JOURNAL OF ERMC EASTERN EUROPEAN

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Original research A reproduced combination of ivacaftor and lumacaftor, CFTR protein modulators. Ethical and pharmacokinetic aspects
Noskov SM, Radaeva KS, Arefeva AN
The lack of effective and affordable therapies for rare diseases is an important ethical issue. One example is cystic fibrosis (CF), a chronic, progressive disease characterized by an impaired function of all exocrine glands. The combination of ivacaftor and lumacaftor (CFTR potentiator and corrector) should lead to a sufficient level of protein on the cell surface and to an increase in its activity, thereby correcting the impaired function. Development of a generic drug containing ivacaftor and lumacaftor as active pharmaceutical substances will increase the availability of this medication and improve patient survival. To study comparative pharmacokinetics and bioequivalence of drugs containing ivacaftor and lumacaftor in healthy volunteers. It was conducted as an open-label, randomized, crossover bioequivalence study involving a single intake of the drug during each period under fed condition in healthy male and female volunteers. The conclusion about bioequivalence was made if 90% confidence interval for primary pharmacokinetic parameters (Cmax, AUC0-t) fell within the accepted bioequivalence limits of 80–125%. According to the results of the study, it was shown that the values of 90% CI of the geometric mean of the main pharmacokinetic parameters for ivacaftor and lumacaftor fall within the acceptance limits for bioequivalence. According to the applied criteria, the drugs are bioequivalent, which makes it possible to recommend the investigational drug to the Ministry of Health of the Russian Federation for obtaining the registration status.
Received: 2024-05-13
Published online: 2024-07-21
DOI: 10.24075/medet.2024.014
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Review Ethical aspects of creating clinical guidelines for practitioners
Dreytser ED, Mudrova AV, Pavlov ChS
Clinical guidelines represent documents that contain structured information based on scientific evidence on prevention, diagnosis, treatment and rehabilitation, and regulate professional activities of the medical community. Starting from January 1, 2025, it is planned to switch to the mandatory use of clinical recommendations approved by the Ministry of Health of the Russian Federation, while the year of 2024 is an interim period for their application. However, various methodological and ethical issues arise while developing and discussing clinical recommendations. They include a conflict of interests of the authors, as well as aspects of its disclosure and settlement, accessibility of clinical recommendations for patients, as well as the discrepancy between the provisions of the recommendations and their evidence base such as results of systematic reviews and meta-analyses. Resolution of these problems will significantly improve the quality of clinical recommendations, and increase patient awareness of diseases and treatment approaches. This review analyzes a wide range of methodological problems related to the development of clinical recommendations, examines regulatory acts and ethical principles issued by government agencies, professional communities and international organizations, and makes suggestions to reduce the level of bias and, as a result, to increase the degree of evidence of clinical recommendations.
Received: 2024-05-24
Published online: 2024-07-21
DOI: 10.24075/medet.2024.013
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Opinion Biomedical research involving elderly subjects: ethical aspects
Semenova NV
Due to the aging of the population and growing proportion of the elderly, medicine requires a more active and purposeful approach not only to study theoretical aspects of gerontology, but also to search for new drugs designed specifically for this category of the population. Clinical trials in older people are more in demand than ever. However, researchers must ensure that they conduct their studies ethically. Key ethical issues include prevention of discrimination and violations of the autonomy of older people, as well as special requirements for informing and obtaining voluntary informed consent. When preparing voluntary informed consent for older people, especially for those with cognitive decline, special attention should be paid not only to the information itself, but also to the form of its presentation. The documents should be concise, clear and contain all the key information. In addition, the use of modern multimedia technologies can help the subjects make an informed decision about their participation in the study. For patients with cognitive impairment, it is important to adhere to the principle that the higher the risk for the study participants, the more the patient’s cognitive functions and decision-making ability should be preserved. Excluding patients from studies with potential benefit due to age or cognitive impairment is considered unethical and discriminatory. This is taken as an unfair restriction of their access to the achievements of scientific and technological progress in the field of medicine.
Received: 2024-05-19
Published online: 2024-06-30
DOI: 10.24075/medet.2024.012
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VIEWS 84
Original research Medical rehabilitation: ethical and legal issue research
Pleshchev IE, Shkrebko AN, Kostrov SA, Ivashkovskaya AV, Savgachev VV, Efremov KN, Shishkin AA
Medical rehabilitation is currently in an active phase of its development. This relevant area of domestic medicine is essential for human health. It helps patients recover from long-term illnesses, effects of injuries and diseases of the musculoskeletal system, peripheral nervous system and has a huge impact on the prognosis and outcome of treatment in general. This publication provides a comprehensive analysis of the ethical aspects of medical rehabilitation with an emphasis on legal definitions in medicine, which will improve understanding and regulation of relationship between rehabilitation, prevention and treatment. The research includes the study of domestic and international regulatory legal acts concerning medical rehabilitation, history of the specialty, the formulations that laid the foundation for the concept further development, consolidating an integrated approach to the issue of medical rehabilitation, as well as review of the problem-associated scientific papers. Explaining the principles of medical rehabilitation will help doctors avoid legal risks associated with their professional activity and serve as a guideline for taking ethically sound decisions in difficult clinical situations, whereas patients will get a full picture of their rights within the framework of medical rehabilitation.
Received: 2024-06-04
Published online: 2024-06-30
DOI: 10.24075/medet.2024.011
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VIEWS 110
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Original research School of research ethics. Axiology of bioethics and challenges of technological development
Firsov DE
Intensive development of modern science expands the scope of bioethical issues. Debates on ethical aspects of bioinformatics, neurotechnology, genetics, bioeconomics, ethics of preclinical and clinical trials are actively developing. Axiology of bioethics is of particular relevance. It is the structure of valuable categories that determines the priorities of ‘human science’ development taking into account the historical experience of interaction between a person and community, and criteria of civilized changes in the actual and perspective (prognostic) sense. Development of bioethical axiology is influenced by the challenges of technological development of the current decade, the issues that objectively demand a reaction on the part of the state and society. One of the main tasks of modern bioethics is to develop bioethical thinking, and grounds for using bioethical axiology in the scientific process. Health axiology, which represents a fixed conscious attitude to the issues of health developed during the academic process to be subsequently used during a labor process, is practical expression of bioethical thinking. Bioethical dialogue is essential as it urges young perspective specialists to examine novel bioethical scientific issues and achieve technological country-specific goals. Focus on young scientist’s potential totally corresponds to the cross-cutting goal of axiological, prognostic and educational tasks of bioethics. Bioethical thinking is developed based on the experience of the school of ethics of scientific research, which is an educational project intended for young Russian researchers.
Received: 2024-02-05
Published online: 2024-03-04
DOI: 10.24075/medet.2023.035
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VIEWS 369
Review Ethical and legal aspects of administration of antibacterial reserve preparations
Yarovoy SK
The article explains what an antibacterial reserve preparation means. It has been shown that the drug belonging to the group is determined by its pharmacological properties only such as a clinically significant (sufficient for empirical application) activity in relation to Pseudomonas aeruginosa or nosocomial (methicillin-resistant) strains of Staphylococcus aureus. It allows to differentiate between two categories of reserve antibiotics, which exert an anti-Gram-negative and anti-Gram-positive activity. There is an exhaustive list of preparations included into each group and available in the Russian market. Meanwhile, no drugs that correspond to inclusion requirements for both groups are available. Possible conflicts that occur during clinical application of antibacterial reserve drugs are comprehensively analyzed. It is based on divergence of interests of a patient and the patient’s representatives, treating physician, management of the clinic, hospital epidemiologists and manufacturers of reserve generics. Economic and general biological (selection of drug-resistant strains in extensively wide application) arguments commonly contradict the legal (compliance with clinical recommendations), moral and ethical (independence of aid quality from the patient’s prognosis) standards. The Legislator’s position in relation to the issue has been reviewed. Imperfect regularity framework and insufficient legal safety of a doctor make it possible to resolve conflicts through concessions and agreements including reserve antibiotics prescribed as per conditionally social indications.
Received: 2024-02-19
Published online: 2024-03-15
DOI: 10.24075/medet.2024.003
Comments 0
VIEWS 317