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 Nocebo Effect: A Bias in Clinical Practice-An Ethical Approach.

BACKGROUND: The nocebo effect is often disregarded in medical practice and is certainly much less known than the placebo effect, although, in reality, both can influence therapeutic decision making and the quality of life of patients. However, the nocebo effect raises a number of issues not only of a practical nature related to clinical activity but also ethical dilemmas related to the observance of the patient's autonomy, nonmaleficence, or informed consent and the information on which it is based. AREAS OF UNCERTAINTY: The ethical dilemmas raised by the nocebo effect revolve around how informed consent can be achieved, the accuracy and volume of information that is transmitted to the patient, and how to report negative side effects of therapeutic treatment. DATA SOURCES: In September 2023, a narrative analysis of the literature was conducted using a combination of keywords such as nocebo, placebo, ethics, therapeutic relationship from PubMed, Scopus, Google Scholar, and so on, as well as from official documents developed at an international level (World Health Organization), for a period of 10 years (2012-2021). RESULTS: Analyzing the articles that remarked upon the significant impact of ethics in nocebo research or in the therapeutic relationship, we can state that the existence of several relevant issues of interest have been detected regarding the ethical use of nocebo and its impact in research or in clinics and thus the need for proper knowledge and management of the impact of nocebo effects. The ethical paradox of obtaining informed consent with the 2 goals, first, the need for complete information and second, the preservation of the autonomy of the patient, respectively, that of "primum non-nocere" and of avoiding unnecessary harm by revealing probable adverse effects is a point of interest for numerous studies. The potential for a nocebo effect is present when we inform patients about the risks and benefits of treatment, there being a clear link between the moral and ethical duty to inform patients and the need to avoid situations that increase the nocebo impact on how the disease or the adverse effects of the treatment are perceived. Adapting information about the side effects of medicines should focus on ensuring a balance between transparency and caution, especially in patients with a high potential for nocebo effect. CONCLUSIONS: The nocebo effect had for a long time been unknown or denied, although it can interfere with the results of the treatment used. As the nocebo phenomenon becomes increasingly known in medical practice, the clinical and ethical implications are identified by medical staff, and nocebo's adverse responses are no longer ignored.

Can Medication be a Factor that Can Negatively Affect the Effect of Transcranial Magnetic Stimulation in Depression?

BACKGROUND: This study aims to evaluate the efficacy of transcranial magnetic stimulation (TMS) in patients with depression and whether concurrent psychotropic medication use negatively affects the treatment outcome of TMS. Patients' characteristics, predictors of treatment response, the relationship between demographics, and the selection of TMS as a treatment modality were also analyzed. STUDY QUESTION: Can psychotropic medication be a factor that can negatively affect the efficacy of TMS in patients with depression? STUDY DESIGN: This pilot-controlled study included 40 subjects from Romanian clinical practice who were treated with pharmacological treatment and TMS for major depressive disorder. The severity of depression and anxiety symptoms was measured using validated scales at baseline (day 1) and follow-up (day 30). DATA SOURCES: All patients' characteristics and information were collected manually from the clinic's medical records, deidentified, and then introduced into an electronic database for analysis. LIMITATIONS: Conducting the study in a clinical routine practice, it was not possible to include an active and/or sham control group. In addition, because TMS is not used as a monotherapy in this type of practice, we could not evaluate its safety and efficacy without concomitant pharmacological treatment. The study sample is small; therefore, the results cannot be generalized. RESULTS: Sixty percentage of patients (n = 24) included in this study obtained a clinical response, and 30% of patients (n = 12) obtained remission of depression. The group with pharmacological treatment obtained clinical responses in 80% of patients (n = 16) and remission of depression in 45% of patients (n = 9). The group with pharmacological treatment and TMS obtained clinical responses in 40% of patients (n = 8) and remission of depression in 15% (n = 3) of cases. CONCLUSIONS: The study results show a lack of efficacy for TMS as an adjunctive therapy to pharmacological treatment for patients with depression. In addition, a negative impact of psychotropic medication on TMS efficacy is observed in our study sample.

Pharmacological Management of Cholera: A Century of Expert Opinions in Cecil Textbook of Medicine.

BACKGROUND: Cholera is a potentially lethal diarrheal disease produced by Vibrio cholerae serotypes O1 El Tor and O139. Known since antiquity, the condition causes epidemics in many areas, particularly in Asia, Africa, and South America. Left untreated, the mortality may reach 50%. The crucial therapeutic intervention is intravenous or oral rehydration and correction of acidosis, dyselectrolytemia, and renal impairment. Antibiotic use represents the main pharmacological intervention. STUDY QUESTION: What are the milestones of the antibiotics use recommended by experts for the pharmacological management of cholera in the past century? STUDY DESIGN: To determine the changes in the experts' approach to the management of cholera and particularly the use of antibiotics as presented in a widely used textbook in the United States. DATA SOURCES: The chapters describing the management of cholera in the 26 editions of Cecil Textbook of Medicine published from 1927 through 2020. RESULTS: Sulfonamides were recommended in 1947, followed by the introduction of tetracyclines, chloramphenicol, and furazolidone in 1955. The options were restricted in 2000 to doxycycline. In the past decade, patients infected with strains known to have a degree a resistance to tetracyclines were treated with azithromycin or ciprofloxacin. Antibiotic use decreases the volume of stool and the duration of diarrhea but has not been considered lifesaving. Drugs with antimotility, antiemetic, or antisecretory properties are not useful. CONCLUSIONS: The utility of antibiotic use in cholera has been endorsed by experts, but only as an adjunct to rapid and complete fluid and electrolyte replacement.

Prehospital Care of Coronary Artery Disease and Its Major Risk Factors in Geropsychiatric Inpatients.

BACKGROUND: Older adults with serious mental illness have a high prevalence of coronary artery disease and of its major risk factors, that is, arterial hypertension, dyslipidemia, and diabetes mellitus. The prevalence and clinical control of these conditions have not been compared in geropsychiatric inpatients with dementia versus those with mood or psychotic disorders. STUDY QUESTION: What is the prevalence and acuity of coronary artery disease, arterial hypertension, dyslipidemia, and diabetes mellitus among patients with dementia, mood, and psychotic disorders admitted for geropsychiatric care? STUDY DESIGN: Patients 65 years of age or older were identified in a cohort of 1000 patients consecutively admitted over a 3-year period to the geropsychiatric unit of a 200-bed mental health hospital in suburban New York. All patients had a structured clinical and laboratory evaluation within 72 hours of admission. DATA SOURCES: Primary psychiatric diagnoses, medical history, the frequency of poorly controlled cardiometabolic comorbidity requiring an immediate change in the management plan, and the Charlson Comorbidity Index (CCI). RESULTS: The 65 years and older patient sample (N = 689) had a mean age of 74.8 years, and 58.8% of the subjects were women. The 205 patients with dementia were older ( P < 0.001) than the 337 patients with mood disorders and the 147 patients with psychotic syndromes. The numbers of medical conditions and the CCI after exclusion of dementia were similar in patients with dementia versus patients without dementia. A substantial number of patients had poorly controlled arterial hypertension (51.2%), dyslipidemia (25.4%), diabetes (24.2%), and coronary artery disease (15.4%). Patients with dementia had a lower prevalence of poorly controlled dyslipidemia ( P = 0.0006), diabetes ( P = 0.0089), and coronary artery disease ( P = 0.045). CONCLUSIONS: Compared with mood or psychotic disorder, a diagnosis of dementia with behavioral disturbance seemed to be associated with better control of coronary artery disease, dyslipidemia, and diabetes mellitus in geropsychiatric inpatients.

Self-Medicating for Pain: A Public Health Perspective.

BACKGROUND: Pain is one of the symptoms for which any man is willing not only to go to the doctor but also to resort to any means, including self-medication, to "get rid" of it. Self-medication is not only a current practice but also a public health problem, under the circumstances that it can influence the way in which a disease is diagnosed and/or treated in a timely manner, and, consequently, repercussions may occur on the cost of treatment, in the case of severe forms. Pain is a vital symptom, and the diminution until the disappearance of pain is a fundamental right of each individual; the analysis of ethical issues in the case of self-administration of analgesic medication has not been a major concern. AREAS OF UNCERTAINTY: Understanding the problem is important to realize whether self-medicating for pain is a necessity or an abuse, and in this respect, we review scientific articles from international databases: PubMed and ProQuest. DATA SOURCES: The study is based on the consultation of scientific articles from international databases-PubMed and ProQuest, the main keywords in the search being pain and self-medication, to which a stigma or public health is sequentially added. RESULTS: Pain is becoming more and more a global problem and the extent of its spread can substantiate our assertion about pathology with pandemic impact. Under the pressure of patient associations, of the media, and of nonmedical authorities, the opinion about the need for a stoic approach to pain has long become an outdated theory, and chronic pain, beyond a multidimensional approach, is increasingly considered not only a useless element but also even a destructive one. CONCLUSIONS: Pain and self-medication must be addressed, including in medical practice, starting from their multidimensionality from the following perspectives: medicobiological, sociocultural, instructive-educational, legal-political, and especially ethical. They are not only individual health problems but also become, when connected with a stigma, a public health problem.

Therapeutic Interventions for Adjustment Disorder: A Systematic Review.

BACKGROUND: Adjustment disorder requires therapeutic intervention because of its complications, which include a significant risk of suicide, but evidence-based therapeutic guidelines are not available. AREAS OF UNCERTAINTY: The main problem is related to answer to the following question: What is the optimal therapeutic approach to adjustment disorder? In this respect we review all randomized controlled trials that aimed to investigate therapeutic interventions for adjustment disorder in adult populations. DATA SOURCES: Comprehensive search of the electronic database PubMed (January 1980-June 2019). The review included clinical trials that aimed to investigate a psychological or pharmacological treatment for adjustment disorder in adult population and reported outcome data for therapeutic interventions. RESULTS: The search identified 23 studies that fulfilled the inclusion criteria for this review. Pharmacotherapy interventions were the focus of 11 studies that used various medications and dosages including viloxazine, lormetazepam, S-adenosylmethionine, pivagabine, trazodone, clorazepate, etifoxine, lorazepam, diazepam, afobazole, and plant extracts (Kava-kava, Euphytose, and Ginkgo biloba) on a total number of 1020 patients. Psychotherapy interventions were identified in 12 studies that used mirror therapy, short-term dynamic psychotherapy, yoga meditation, body-mind-spirit technique, mindfulness, bibliotherapy (self-help manual), humor training, and cognitive behavioral therapy. CONCLUSIONS: Psychotherapy seems indicated for mildly symptomatic adjustment disorder. Given the fact that adjustment disorder with severe symptoms is associated with a high risk of suicidal ideation and suicide attempts, clinicians must consider the potential benefit of using psychotropic agents such as benzodiazepines, antidepressants, or etifoxine.

Correlations on the protection of personal data and intellectual property rights in medical research.

PURPOSE: International regulations regarding the protection of individuals concerning the processing of personal data and the free movement of such data highlight the need for their systematization and customization, depending on the purpose for which they are collected and used. BACKGROUND: Medical legislation is structured so that the constitutional right to healthcare is guaranteed and at the same time be protected by respecting the right to privacy with respect to identity, physiological state of the person and the way this, by health maneuvers, was restored. European Union (EU) legislation is more and more complex related to the patients' right and also to the General Data Protection Regulation (GDPR). After the Second World War, in all Europe the problem related to the human rights become a sensible one in all countries and become aware the importance of clear rules for protecting people, to develop and protect their rights. CONTENT: The article presents the correlation between personal data and intellectual property right in the field of medical research, one of the most dynamic fields of scientific research both in the field of fundamental and applied research. Dissemination of medical information collected through scientific works is subject to the fact that progress in any field should be encouraged, in order to increase the quality of life while, at the same time, creating a balance between the interests of the researcher and the public interest and the interest of the academic community represented by any person in the situation of recourse to a medical service. CONCLUSIONS: In the context of the EU guidelines and implementation of GDPR starting to 2018, the medical research and the education of scientific researchers in the field has gone into a new stage of the ethical approach.

Bioethical dilemmas in using animal in medical research. Challenges and opportunities.

PURPOSE: The study aims to present the main ethical dilemmas that research on animals raised for anyone involved in this process, starting from the idea that there are rights of animals to be known and respected. BACKGROUND: The evolution of medicine is inextricably linked to the production of new drugs, the occurrence of surgical techniques; none of these can be possible without the study of experimental animals, in vivo experimentation being part of the process of medical research. CONTENT: The article analyzes the main ethical dilemmas related to the use of animals in medical research, in the current legislative context and historical perspective of achieving such studies. DISCUSSION AND CONCLUSIONS: The use of animals in medical research must be conducted in accordance with clearly established moral rules, which facilitate reducing to the maximum the negative effects on the animals, avoiding unnecessary suffering to them and especially to facilitate progress achievement with the minimum possible animals sacrificed.

A novel method to combat the cholera epidemic among the Romanian Army during the Balkan War - 1913.

The history of cholera, a specific infection caused by Vibrio Cholerae, starts in ancient times. The sixth pandemic that began in 1899 and lasted until 1923, started in India and came to Eastern Europe through Russia. The expansion of the epidemic in the Balkans was facilitated both by the 2 Balkan Wars and the First World War. Romania, as a participant in these wars was affected by cholera, which was especially common among the army during the Balkan War. If the original source of the cholera issue is still controversial, both Romanians and Bulgarians accusing each other of being the basis of the outbreaks south of the Danube, it is widely recognized that the extent of the disease was facilitated by the sanitary conditions of food preparation and drinking water sources among both Romanian soldiers and in the civilian population. Under these conditions, in addition to numerous measures against cholera taken by the Ministry of War, Prof. I. Cantacuzino successfully experiments outbreak vaccination for the first time in the world with a vaccine prepared by himself and his collaborators. The vaccine containing 25 breeds of vibriones was a success in terms of rapid development of a preparation, the application of which was achieved through a quick campaign and proved extremely efficient, imposing the Romanian method as an effective way to combat a disease in full outbreak.

Biomedical research - opportunities and ethical challenges.

PURPOSE: The principal purpose of this paper is to analyze the main opportunities and challenges in biomedical research, thus contributing to improving compliance with ethical norms within the context of continuously expanding research, such as to ensure better quality of patient care and reduce the risk of research not observing the totality of patient rights. BACKGROUND: Since antiquity finding ways to give care to people has represented not only an opportunity, but also a challenge materialized in experimenting and self-experimenting - a constant part of caregivers' activity. Medical research, whether fundamental or applied, is not only essential to evolution in medicine, but also the way towards increasing the quality of individual lives. CONTENT: The article undertakes to analyze the main ethical norms governing medical research, starting from historical experience and literature search. DISCUSSION: The growing number of people engaged in medical research over the last years has turned bioethics into an increasingly applicative science, capable of developing practical standards to ensure the moral advancement of the medical profession. CONCLUSIONS: The bioethics of the last years has been more and more tied to the reality of medical practice, as well as to that of scientific research, contributing increasingly to the integration of moral elements into medical activity and to the development of research in interdisciplinary bioethics. Bioethics and more so bioethical education need to be correlated with the transition from research itself for the purpose of publishing and career advancement to research based on altruism and the desire to contribute to the wellbeing of patients.

A doctoral thesis about Carol Davila written in Paris in 1936.

Carol Davila, the father of the Romanian modern medicine, made decisive contributions to the development of health sciences in the Romanian Principalities in the last decades of the nineteenth century. The merit of his scientific work was recognized beyond the borders of his country. His life (not devoid of anecdotic instances and unknown episodes) and especially his work have aroused considerable interest among numerous medical historians. This paper presents a historical study elaborated in France, but until recently ignored, dedicated to the biography of Carol Davila. It concerns the medical doctoral thesis (State Diploma) elaborated by Joseph Adler (born 1910 in Botosani, Romania) under the supervision of professor Maxime Laignel-Lavastine, whose interest in Romania is well-known. Professor Laignel-Lavastine held the office of Secretary General of the International Society of History of Medicine (ISHM), founded in 1921, (replaced in this position by another French professor with links to Romania: Jules Guiart). The thesis comprises 48 pages and an exhaustive bibliography. It represents a token of the appreciation given to Davila's achievements by Europe's medical community.

Alcoholism in Romania in the Late Nineteenth Century and at the Beginning of the Twentieth Century.

Although alcohol consumption has been described from the earliest times, alcohol abuse has grown significantly since the mid-nineteenth century as a consequence of the industrialization progress. Due to the socio-economic profile of Romania, which was considered to be agrarian, the idea of developing mainly the industry branches belonging to agriculture was considered. Amongst these branches, the production of alcohol appeared to be the most appropriate. The political state leaders from Romania enjoyed the taxes collected from alcohol commercialization, disregarding the costs involved in alcoholism which went far beyond them.