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.

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.

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.