Indian journal of medical ethics最新文献

Following the pharmacovigilance crises of 2004 involving the use of Vioxx and antidepressants in minors, medicine regulators turned to big data, also called real-world evidence, to support their efforts to establish the safety of treatment protocols. In many areas of drug development, big data can clearly play a part; but to date, it has not helped resolve safety issues. Developments in artificial intelligence may help clarify the respective roles of big data and clinical expertise in pharmacovigilance in surprising ways.

Global climate change due to anthropogenic carbon emissions has created and deepened problems in medicine and public health, such as ecological upheavals and ambient heat-associated health detriments. The fields of biomedicine and biomedical ethics must pay heed to problems arising from global climate change, but such reflection on research into climate change-responses appear inadequate [1]. A number of authors have proposed changes or climate change-related extensions to existing biomedical ethics frameworks. These range from Hantel and colleagues' scope-expanding and climate-conscious updates [2] to Jonsen and Siegler's four-topics principles of clinical medical ethics (CME) ("medical indications", "preferences of patients", "quality of life", and contextual features) [3], which are lucid and informative. However, prescriptive theoretical frameworks have limits in their epistemic construction and practical constraints in implementation. Below, I shall cite three examples that illustrate how advances in science and research are needed to facilitate climate-conscious extensions to more classical CME.

Background: Domestic violence is a pervasive public health issue in India, significantly impacting women's health and well-being. Disclosures of domestic violence frequently occur during healthcare encounters, making hospitals and related settings critical spaces for inquiry. In this context, the aim of the study is to explore the social and medicolegal dimensions of domestic violence within a hospital setting through the lens of healthcare documentation and understand the role of healthcare providers in managing and recording these cases.

Methods: This study examined the medicolegal classification and documentation of domestic violence cases in a tertiary care hospital in West Delhi by manually reviewing medicolegal case registers, the quality of case documentation, and assessing standard operational procedures of hospitals. Interviews were also conducted with healthcare professionals to gain insights on the same.

Results: The findings reveal that poor documentation practices in medical records compromise the reliability of evidence, hinder the assessment of prevalence and patterns, and obstruct effective interventions. Despite the existence of a comprehensive legal framework, cultural challenges significantly impede the effective identification and documentation of domestic violence incidents. Healthcare providers reported multiple barriers in identifying and documenting domestic violence, including high patient loads, resource limitations, lack of training, and the overarching challenge of integrating healthcare with medicolegal requirements.

Conclusion: Insights from the study underscore the urgent need for improved recognition, training, and standardised documentation practices to enhance the response to domestic violence within healthcare settings.

This case presents the challenges faced in managing a premature infant with multiple unexplained neuromuscular symptoms. The discussion focuses on the ethical dilemmas surrounding the initiation of palliative care in the absence of a clear diagnosis. Key ethical questions include the appropriateness of continuing intensive care when the prognosis is uncertain, and the role of parental autonomy in making informed decisions. This case underscores the importance of ongoing ethical deliberation and sensitive communication in neonatal end-of-life care.

The 2024 Declaration of Helsinki (DoH) marks a significant milestone in medical research ethics, addressing contemporary challenges and emphasising global ethical issues. In India, the 2017 Indian Council of Medical Research (ICMR) National Ethical Guidelines, align well with the 2024 DoH principles, particularly in safeguarding vulnerable populations and promoting ethical review processes. However, there is scope to work on further harmonisation and better implementation, such as registering all medical research, empowering ethics committees, and ensuring equitable access and inclusion. This perspective highlights the strengths and limitations of the ICMR guidelines in light of the 2024 DoH, aiming to foster a research environment that upholds ethical integrity, inclusivity, and the well-being of all participants.

A recent publication in an Indian journal stated that "Charak is known as the dad of Ayurveda (or) the dad of Ayurvedic medication." Such inappropriate terms used in science communication are called "tortured phrases". The use of such phrases could suggest deeper issues in science communication, such as concealment of plagiarism and fraudulent research facilitated by paper mills. Non-expert writers and AI tools are being used in the mass production of research articles in paper mills that report fabricated data, graphs and tables mimicking legitimate research papers. Although efforts are being made to detect tortured phrases, poor editorial review allows the publication of articles with tortured phrases in reputed journals. This compromises scientific integrity and leads to wastage of resources. Proper screening, rejection of inappropriate language and transparency in the editorial process can help to curb this unethical practice.

Off-label use of drugs, when not supported by sound scientific evidence, hinders the development of evidence-based medicine and therapeutic innovation, is costly to the healthcare system, and exposes patients to unnecessary risks, including mortality, for an uncertain benefit. Off-label use of baclofen is the preferred pharmacotherapy for alcohol use disorders in India, despite its negative benefit/harm ratio, and the fact that acamprosate or naltrexone have long been established as robustly evidence-based medicines. This unacceptable state of affairs only illustrates the fact that the marketing strategies of industry cannot be the sole basis for prescribing a drug.

This is a response to Dr Panchal's opinion piece that accused us, teachers, directors and staff of the programme he participated in, of not discussing or protesting against the situation in Gaza during the academic year of 2023-24. We find this accusation to be utterly wrong and incorrect. Beyond taking care of the safety of our students, the School facilitated discussion in class regarding the situation. Furthermore, some of the authors participated in protests and publicly advocated for the wellbeing and health of the Gazan population starting already in the early days of this war. Finally, we find it unethical that Dr Panchal did not approach us on this issue, either during his stay in Israel or before or after he chose to publish his opinion.

The "discussion" on our commentary about baclofen use in India perpetuates misconceptions. We want to: a) highlight the flood of overlapping and conflicting meta-analyses that obscure rather than clarify baclofen's effects; b) stress the importance of pivotal trials which support hypothetico-deductive reasoning and provide the basis for regulatory decisions. Such trials use only high-dose baclofen without proven benefit but serious safety concerns, including mortality. Practitioner enthusiasm, lived experience, or off-label consensus - whether in the global North or recycled in the global South - cannot replace rigorous trial evidence. We call for careful evaluation of pivotal evidence and robust research.

The cost of healthcare became an intense political issue with the systematic analysis of multinational pharmaceutical corporations and their track record. Medicines and their cost, and affordable access to healthcare, were too important to be left to doctors in big hospitals and executives of drug companies, and to indifferent governments. Such issues were discussed through the 1970s to the turn of the 21st century. Dr Zafrullah Chowdhury was part of this generation of pioneers. On his second death anniversary, the author remembers his qualities as a person and as a freedom fighter, and his contributions to public health, especially the landmark 1982 Drug Policy of Bangladesh.