Drug Promotions Between Ethics, Regulations, and Financial Interests.

BACKGROUND: The promotion of the latest medicines produced by the pharmaceutical industry is an important issue both from an ethical point of view (the level of accessibility, the way research is carried out) and from the point of view of marketing and especially from the lobbying issues raised. AREAS OF UNCERTAINTY: The ethical dilemmas raised by the promotion of new drugs revolve between the need to discover new molecules important for treating a wide range of diseases and the need to establish a battery of ethical rules, absolutely necessary for regulations in the field to be compliant with all ethical principles. DATA SOURCES: A literature search was conducted through PubMed, MEDLINE, Plus, Scopus, and Web of Science (2015-2023) using combinations of keywords, including drugs, medical publicity, and pharma marketing plus ethical dilemma. ETHICS AND THERAPEUTIC ADVANCES: The promotion of medicines is governed by advertising laws and regulations in many countries, including at EU level, based on the need for countries to ensure that the promotion and advertising of medicines is truthful, based on information understood by consumers. The ethical analysis of the issues raised is more necessary and complex as the channels used for promotion are more accessible to the population, and the information, easier to obtain, can be the cause of increased self-medication and overeating. Large amounts of money invested in the development of new molecules, but also the risk of scientific fraud through manipulation of data during clinical trials, selective or biased publication of information can have repercussions on the health of the population. CONCLUSIONS: The development of new pharmaceutical molecules is necessary to intervene and treat as many conditions as possible, but marketing must not neglect the observance of ethical principles. The promotion of medicines should be the attribute especially of the medical staff, which should also be a mandatory part of the mechanism for approving the marketing methods and means used by the pharmaceutical companies.

Ethical Dilemmas of Using Artificial Intelligence in Medicine.

BACKGROUND: Artificial intelligence (AI) is considered the fourth industrial revolution that will change the evolution of humanity technically and relationally. Although the term has been around since 1956, it has only recently become apparent that AI can revolutionize technologies and has many applications in the medical field. AREAS OF UNCERTAINTY: The ethical dilemmas posed by the use of AI in medicine revolve around issues related to informed consent, respect for confidentiality, protection of personal data, and last but not least the accuracy of the information it uses. DATA SOURCES: A literature search was conducted through PubMed, MEDLINE, Plus, Scopus, and Web of Science (2015-2022) using combinations of keywords, including: AI, future in medicine, and machine learning plus ethical dilemma. ETHICS AND THERAPEUTIC ADVANCES: The ethical analysis of the issues raised by AI used in medicine must mainly address nonmaleficence and beneficence, both in correlation with patient safety risks, ability versus inability to detect correct information from inadequate or even incorrect information. The development of AI tools that can support medical practice can increase people's access to medical information, to obtain a second opinion, for example, but it is also a source of concern among health care professionals and especially bioethicists about how confidentiality is maintained and how to maintain cybersecurity. Another major risk may be related to the dehumanization of the medical act, given that, at least for now, empathy and compassion are accessible only to human beings. CONCLUSIONS: AI has not yet managed to overcome certain limits, lacking moral subjectivity, empathy, the level of critical thinking is still insufficient, but no matter who will practice preventive or curative medicine in the next period, they will not be able to ignore AI, which under human control can be an important tool in medical practice.

The New Mythology of the Body and the Transformation of the Therapeutic Space.

BACKGROUND: The history of medicine has flowed in the wake of knowledge and social perceptions about the body and corporeality. There is no idea of health without reference to the notion of body (although "health" can have other meanings, figuratively). Considering the same history, the body was the subject of numerous segregations and categorizations due to which it was and is a "social object" and a "political object." In turn, the spatial and cultural framework was the environment and determinant of the medicine development which is not only a science but also an inter-human interactive practice. AREAS OF UNCERTAINTY: In this article, we will analyze the current social (re)construction of the notions of body and space by referring to the technological and structural changes that are manifested in medicine and society and their ethical implications. DATA SOURCES: A review of the specialized literature was performed in June-July 2023, using keywords like human enhancement, therapeutic enhancement, transhumanist medicine, ethics from PubMed, Scopus, Web of Science, and Google Scholar, and official documents issued at the international level (World Health Organization, European Commission). ETHICS AND THERAPEUTIC ADVANCES: This literature review suggests that few practical solutions to human enhancement, both curative and preventive, whether cognitive or physical, have been approached entirely from an ethical point of view. The historical evolution of the concept of human enhancement has led to debates between "transhumanists" and "bioconservatives" depending on how they relate to the improvement of the human condition without or with reticence interventions to improve human capabilities being related to various interventions, from pharmacological, surgical ones to those in the field of genetics, nanomedicine, or cybernetics. In addition to the technical aspects, which are often the major concern of researchers and those applying new technologies, there are also ethical and legislative aspects, to better understand the impact that the dynamics and diffusion of these processes have on the evolution of the human species. CONCLUSIONS: In interference with these technologies, the body is exposed to possibilities of change and evolution with colossal (expected) social impact that can change norms and values that have been stable for centuries. Social space and place are also proving to be "processes in the making'" for which we need to detect what developments are possible or have already imposed themselves as a trend in the social and medical world.

Reimplantation of Implantable Cardiac Devices-An Ethical Controversy?

BACKGROUND: Cardiovascular diseases are an important public health problem, the main cause of death in both men and women, with a continuous increasing prevalence and consequences upon morbidity in economic, physical, and psychological terms.The new technology have made possible the development of innovative devices, which have increased the possibility of therapeutic interventions today, extending the life of the population with cardiovascular pathology, transforming the patient care, and providing a complex, personalized therapeutic approach. FIELDS OF UNCERTAINTY: The aim of the study was to evaluate from an ethical perspective the need, feasibility, and safety of reusing cardiac pacemakers to revise the legal terms and requirements.In recent years, the problem of accessibility to cardiovascular drugs has been increasingly accompanied by the accessibility to technology, interventional cardiology advancing recently, and becoming an increasingly important standard of care. DATA SOURCES: A review of the specialized literature was performed in March 2023, using keywords such as implantable cardiac devices, reuse, ethics from PubMed, Scopus, Web of Science, and Google Scholar, as well as official documents issued at the international level (World Health Organization). ETHICS AND THERAPEUTIC ADVANCES: An ethical analysis assesses the extent to which a medical act (PM reimplantation) is covered by the 4 universally accepted principles: nonmaleficence, beneficence, autonomy (respect for the person), and social justice, the analysis addressing to the risk-benefit ratio based on studies that analyzed the phenomenon over the past 50 years. The ethical analyzed issues start from the fact that although 80% of pacemakers, most of them working perfectly, with a battery life of more than 7 years are buried with their owners, while approximately 3 million patients die annually due to the lack of access to these devices in undeveloped and developing countries.But beyond the ethical issues, legal practice has meant that in many countries, reusing of these devices is prohibited, mostly being single-use devices. Low-income countries continue to accept this practice as the only one economically accessible to them, considering the prohibition of reusing them to be an economic rather than a medical issue. CONCLUSIONS: Reusing implantable cardiac devices is of great interest because of the costs, being in certain situations, the only possibility that certain people can have access to a therapeutic method that ensures their health recovery and increases their quality of life. But this is not possible without clear procedures, without clear criteria on how sterilization should be performed, how the technique should be performed, without obtaining a truly informed consent, and especially without a proper patient's follow-up.

Against Authority: The Bioethics of Ivermectin Use for COVID-19 Infection.

BACKGROUND: The COVID-19 pandemic has brought new ethical challenges to both health care professionals and the general public. Among the ethical problems amplified during this period were the making of medical decisions to quickly introduce some drugs into therapeutic practice with unproven or insufficiently proven effects (such as ivermectin), the validity of drug testing, and the allocation of limited resources. FIELDS OF UNCERTAINTY: The COVID-19 pandemic brought to the attention of the entire scientific world a new problem, which exceeded the guidelines and rules known until then. Out of the desire to quickly solve this medical problem, a series of measures were taken, however not sufficiently validated in scientific terms; the recommendations regarding the use of drugs known for their properties to treat a greater number of conditions, such as ivermectin, was tried. DATA SOURCES: A narrative review of the specialized literature was carried out using keywords such as COVID-19, ivermectin, ethics, and off-label medication from Scopus and Google Scholar but also of official documents developed at the international level (World Health Organization). ETHICS AND THERAPEUTIC ADVANCES: The off-label use of ivermectin alone or in combination with other medications during COVID pandemic raised problems related to the demonstration of its effectiveness, but also to ethics, starting from the expectations that both the medical staff and the population had of it. Ivermectin therapy was also evaluated by analyzing the behavior of ivermectin based on ethical principles (nonmaleficence, beneficence, and respect for one's autonomy) or on justice. Even in times of pandemic, exceptionalism must not triumph, and finding an effective treatment must be done through studies that respect ethical standard. CONCLUSIONS: The failures or rather lack of success in decision making during the pandemic showed that alongside scientific knowledge and the development of health policies, it is necessary to constantly evaluate the measures and decisions from an ethical point of view, and the prevention of slippages and abuses is not only necessary but even mandatory.

Advances in Genetic Editing of the Human Embryo.

BACKGROUND: Genetic engineering has allowed a major development of research in this field, with specialists attempting to edit the human genome, after the successful editing of the genomes of plants and animals. However, human gene editing technologies are at the center of ethical debates around the world. AREAS OF UNCERTAINTY: Ethical concerns about genetic editing of the human embryo raise several issues that can be viewed through the prism of optimism and reluctance leading to a number of recommendations regarding the acceptance of what may soon become a reality. DATA SOURCES: A literature search was conducted through PubMed, MEDLINE, Plus, Scopus, and Web of Science (2015-2022) using combinations of keywords, including: human genome or gene editing plus ethics. ETHICS AND THERAPEUTIC ADVANCES: Gene therapy is seen by researchers as a way to solve congenital diseases, multifactorial diseases in general or specific diseases such as cystic fibrosis, muscular dystrophy, or can increase resistance to HIV infection. Genome editing technologies, germline gene editing, clustered regularly interspaced short palindromic repeats gene editing technology, technologies such as zinc finger nucleases are not only advanced gene therapies that require solving technical problems, but also techniques that require complex and complete analysis of ethical problems. Genetic engineering raises many ethical concerns such as: safety concerns especially the risk of off-target effects; autonomy of the individual-with the limitation of the future generations to consent for an intervention over their genome; social justice-keeping in mind the costs of the procedures and their availability to the general population. Discussions can go further from questions such as "How can we do this?" to questions such as "Should we do this?" or "Is society ready to accept this technology and is it able to manage it rationally?" CONCLUSIONS: The ethics of biomedical research should be based on global dialogue, on the involvement of experts and the public, to achieve a broad social consensus. The fundamental review of the ethics of genetics is a desire and an opportunity of the current period.

Ethical and legal aspects in medically assisted human reproduction in Romania.

Up to the present, there have not been any specific norms regarding medically assisted human reproduction in Romanian legislation. Due to this situation the general legislation regarding medical assistance (law no. 95/2006, regarding the Reform in Health Care System), the Penal and Civil law and the provisions of the Code of Deontology of the Romanian College of Physicians are applied to the field of medically assisted human reproduction. By analysing the ethical and legal conflicts regarding medically assisted human reproduction in Romania, some characteristics cannot be set apart because they derive from religious, cultural and socio-economic aspects. In this article the authors identify the development stages of medically assisted human reproduction in Romania, beginning from these characteristics and insisting upon the failure of the legal system in this specific field. The authors consider that the law regarding medically assisted human reproduction cannot be effective because it did not take into account the ethical and cultural aspects that might appear. Furthermore, in this framework of the legal process, no public debate involving the representatives of civil society was undertaken although the Council of Europe Oviedo Convention approved by our country according to law no. 17/2001 stipulated exactly this working method.