Medical Ethics

ISSN Print 2713-0894 ISSN Online 2713-0908

BIOMEDICAL JOURNAL OF ERMC EASTERN EUROPEAN

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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 310

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: 2024-06-30

DOI: 10.24075/medet.2024.014

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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: 2024-06-30

DOI: 10.24075/medet.2024.013

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VIEWS 307

Currently, the prevalence of hearing loss in the population is extremely high both among elderly and younger patients due to the prolonged and intense load on the auditory analyzer. Auditory disorders are currently one of the most important geriatric and ethical problems, since it has a significant negative impact on a human’s emotional and physical condition, and is the cause of conflicts with other people. According to the research done in recent decades, there is a relationship between hearing loss and cognitive decline, which can be assessed using the MCAS (Montreal Cognitive Assessment Scale) test. This article presents a clinical case of a patient with progressive sensorineural hearing loss and, as a result, a decrease in cognitive functions, as well as the ethical aspect of the work of an ENT specialist with audiology patients.

Received: 2024-05-04

Published online: 2024-06-26

DOI: 10.24075/medet.2024.010

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VIEWS 312

At the turn of the XX–XXI centuries, Russia had to conduct active military operations twice to suppress the hotbed of separatism, crime and terrorism in the North Caucasus. Serious military medicine forces had to be involved. Meanwhile, the participation of medical professionals in two Chechen operations is still on the periphery of attention of domestic researchers. In the 1990s and early 2000s, the Russian mass media wrote that military doctors were helping wounded and sick servicemen of the federal troops directly on the front line and in rear hospitals, often informed the general public about maintaining the mental health of recent front-line soldiers, and also never ignored the assistance to the civilian population (women, the elderly, children) of the Chechen Republic. Some press publications described the most successful and complex operations performed by Russian military surgeons. In many publications of those years, you can also find reports about the doctors who distinguished themselves the most during the active hostilities and were awarded high state awards, including the Gold Star of the Hero of the Russian Federation. The practical activities of Russian doctors in the North Caucasus in the 1990s and early 2000s resulted not only in the saving of the lives of the vast majority of wounded soldiers, but also in restoration of the Chechen health system, prevention of epidemics and successful fight against numerous infectious diseases.

Received: 2024-05-24

Published online: 2024-06-20

DOI: 10.24075/medet.2024.009

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VIEWS 392

Khokholov AL, Eleskina AA, Belchik LM

The pandemic caused by the SARS-CoV-2 virus has put a huge strain on health systems around the world. Clinical trials of new drugs were also influenced by the pandemic, during which Sponsors came across a number of problems, including ensuring patient safety and maintaining the ability to obtain reliable data in the course of ongoing research. The purpose of this study was to compare the protocols of clinical trials of two Sponsors, approved by the Russian health authorities for three years, from 2017 to 2019, by their adaptability to the SARS-CoV-2 virus pandemic. 23 protocols and 51 amendments were studied in total. The amendments published in 2020 by both Sponsors underwent a comparative analysis to determine the degree of their influence by the pandemic. Statistical processing of the results was carried out using the correlation analysis. Conclusions were drawn about the Sponsors’ approach to clinical trial planning and establishing the safety margin of clinical trial protocols.

Received: 2024-04-24

Published online: 2024-06-18

DOI: 10.24075/medet.2024.008

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VIEWS 326

Kurmangaleeva AYu, Sibirskaya EV

Teen pregnancy remains one of the key social issues that deeply affects not only the life of a young mother and her child but their inner circle and society as well. In spite of multiple efforts to reduce its prevalence rate, teen pregnancy is still a pressing issue in many countries. Currently, there are several key problems that can result in an increased risk of teen pregnancy. They include an early beginning of sexual activity, history of sexual abuse, low social and economic status, lack of parental care and support, cultural and family behavioral models, use of psychoactive substances, poor academic performance and expulsion from school. In addition, the probability of a repeated teenage pregnancy is significantly increased, passing the problem on from one generation to another. This article is aimed at a comprehensive analysis of these factors and statistical data in order to better understand the problem of teenage pregnancy, assess its consequences for the health and well-being of those underaged and their children. Special attention is paid to the ethical and social aspects of teenage pregnancy.

Received: 2024-03-15

Published online: 2024-06-13

DOI: 10.24075/medet.2024.007

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VIEWS 344

Khokholov AL, Kotlovsky MYu, Pavlov AV, Potapov MP, Gabidullina LF, Tsybikova EB

At present, neurotechnologies are emerging rapidly. The scope of state and private investment in the trend, which is the investment priority, is growing steadily. Interstate, national initiatives and public-private alliances for their development are created. Meanwhile, a significant potential of neurotechnologies consists not only in treatment of a wide specter of diseases and disorders of the nervous system, but also in improvement of human nature. At the same time, uncontrolled use of these technologies can violate fundamental rights. This raises the questions associated with accessibility and potential use of neurotechnologies to improve the human nature. It can produce a deep effect both on certain people, and the entire society. Development of neurotechnologies requires a highly organized approach on the part of ethics and morality with subsequent fixation of these provisions in the legislative and regulatory acts. International, state and non-governmental organizations play a great role in this case.

Received: 2024-03-20

Published online: 2024-03-31

DOI: 10.24075/medet.2024.005

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VIEWS 476