{"title":"Cause, Effect, and Adverse Events: Evident-Based Medicine or Evidence-Based Medicine?","authors":"David Healy","doi":"10.20529/IJME.2025.011","DOIUrl":"10.20529/IJME.2025.011","url":null,"abstract":"<p><p>From the late 1940s to 1991, the adverse effects of prescription drugs were primarily established through the publication of detailed case studies by doctors in medical journals. Subsequently, pharmaceutical companies would change the labels of medicines accordingly. This will be called \"evident-based medicine\" in this paper. After 1991, what is now called \"evidence-based medicine\" offers a markedly different view on establishing the adverse effects of a treatment, with randomised controlled trials (RCTs) held up as the gold standard. The differences between evidence- and evidence-based medicine are often framed in terms of the differences between specific and general causation. This article outlines the origins of these distinctions and the confusions they generate among both clinicians and the general public.</p>","PeriodicalId":517372,"journal":{"name":"Indian journal of medical ethics","volume":" ","pages":"210-215"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143560571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Response to critique by Indira Chakravarthi.","authors":"Indraneel Mittra, Gauravi Mishra, Rajendra Badwe, Rajesh Dikshit","doi":"10.20529/IJME.2025.047","DOIUrl":"10.20529/IJME.2025.047","url":null,"abstract":"<p><p>Indira Chakravarthi's critique relates to our paper published in the British Medical Journal in 2021 titled \"Effect of screening by clinical breast examination on breast cancer incidence and mortality after 20 years: prospective, cluster randomised controlled trial in Mumbai\". The study addressed the unanswered questions as to whether clinical breast examination (CBE) conducted by female health workers would lead to a reduction in mortality from breast cancer. Chakravarthi raises multiple issues relating to our study and we provide in this paper point-by-point responses to these issues. The results of our study show that two-yearly CBE screening can reduce death rate from breast cancer by 30% in women above the age of 50 and to a lesser extent to those below this age. CBE screening if implemented in low- and middle-income countries can save thousands of lives globally each year.</p>","PeriodicalId":517372,"journal":{"name":"Indian journal of medical ethics","volume":"X 3","pages":"251-255"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145454406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Applying the non-maleficence principle to basic research in Alzheimer's disease.","authors":"Bor Luen Tang","doi":"10.20529/IJME.2025.024","DOIUrl":"10.20529/IJME.2025.024","url":null,"abstract":"<p><p>Despite the urgency for new leads towards Alzheimer's disease (AD) interventions, the impact of such basic research on patient welfare and potential socioeconomic repercussions are considered remote. Nonetheless, basic science research in AD must adhere to the highest level of ethical stringency. Even preliminary advances in AD basic research offer hope that percolates along the line from researchers to patients. A promising basic research result that is subsequently proven unreliable due to irreproducibility or research misconduct would not only dash hopes but might also misdirect downstream efforts. Furthermore, such misadventures could quash promising research directions that, if otherwise carefully and meticulously interrogated, could yield useful leads. Stringency and reproducibility in biomedical research should thus be framed in accordance with the principle of non-maleficence, which I posit should take priority over loose attempts at beneficence that offer more hype than hope.</p>","PeriodicalId":517372,"journal":{"name":"Indian journal of medical ethics","volume":"X 3","pages":"233-239"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145454347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Ethics in processing research participants' payments: navigating institutes' finance and administrative mandate.","authors":"Salik Ansari, Harikeerthan Raghuram, Gauri Mahajan, Anant Bhan","doi":"10.20529/IJME.2025.035","DOIUrl":"10.20529/IJME.2025.035","url":null,"abstract":"<p><p>Processing payments (reimbursements or honoraria) to study participants by researchers working in institutional setups can raise ethical concerns, as the institute's administration and finance departments control the procedural mandate of this issue. This commentary discusses this critical and often ignored aspect and provides suggestions that could help minimise the risk of violating research participants' anonymity.</p>","PeriodicalId":517372,"journal":{"name":"Indian journal of medical ethics","volume":"X 3","pages":"228-230"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145454353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kamran Abbasi, Parveen Ali, Virginia Barbour, Marion Birch, Inga Blum, Peter Doherty, Andy Haines, Ira Helfand, Richard Horton, Kati Juva, Jose F Lapena, Robert Mash, Olga Mironova, Arun Mitra, Carlos Monteiro, Elena N Naumova, David Onazi, Tilman Ruff, Peush Sahni, James Tumwine, Carlos Umaña, Paul Yonga, Chris Zielinski
{"title":"Ending nuclear weapons, before they end us.","authors":"Kamran Abbasi, Parveen Ali, Virginia Barbour, Marion Birch, Inga Blum, Peter Doherty, Andy Haines, Ira Helfand, Richard Horton, Kati Juva, Jose F Lapena, Robert Mash, Olga Mironova, Arun Mitra, Carlos Monteiro, Elena N Naumova, David Onazi, Tilman Ruff, Peush Sahni, James Tumwine, Carlos Umaña, Paul Yonga, Chris Zielinski","doi":"10.20529/IJME.2025.040","DOIUrl":"10.20529/IJME.2025.040","url":null,"abstract":"<p><p>This May, the World Health Assembly (WHA) will vote on re-establishing a mandate for the World Health Organization (WHO) to address the health consequences of nuclear weapons and war [1]. Health professionals and their associations should urge their governments to support such a mandate and support the new United Nations (UN) comprehensive study on the effects of nuclear war.</p>","PeriodicalId":517372,"journal":{"name":"Indian journal of medical ethics","volume":"X 3","pages":"180-182"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145454338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Indian Stem Cell Research Governance after dissolution of the National Apex Committee.","authors":"Ketan Thorat","doi":"10.20529/IJME.2025.025","DOIUrl":"10.20529/IJME.2025.025","url":null,"abstract":"<p><p>The Government of India recently disbanded the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT). This decision followed expert and public consultations held last year and will significantly alter the review processes for human stem cell research in India. The NAC-SCRT played a crucial role in crafting and updating regulatory guidelines, fostering research and national discourse in human stem cell research, and defining safety and quality standards. The Institutional Ethics Committees are now being tasked to review stem cell research at the organisation level after due inclusion of two stem cell experts. The decision to merge regulatory frameworks is a welcome step, reflecting a dynamic regulatory landscape that is responsive to scientific advancements and aims to reduce the compliance burden. The effective implementation of the revised mechanism, however, necessitates further clarity on which agency will now be responsible for tasks earlier mandated to NAC-SCRT.</p>","PeriodicalId":517372,"journal":{"name":"Indian journal of medical ethics","volume":"X 3","pages":"240-243"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145454395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The intrinsic tension between articulating one's medical condition and explaining it: A commentary on An Unquiet Mind.","authors":"Sushma Shetty","doi":"10.20529/IJME.2025.021","DOIUrl":"10.20529/IJME.2025.021","url":null,"abstract":"<p><p>Kay Redfield Jamison, an author, clinical psychologist, and professor at Johns Hopkins University School of Medicine, grapples with bipolar disorder - shaping her professional focus. She dealt with manic-depressive disorder as a professor of psychiatry and a successful medical professional. What was that experience like? In her memoir, An Unquiet Mind: A Memoir of Moods and Madness, she navigates the inherent conflict of explaining her own condition while delving into the discomfort of taking, as well as being on different, \"sides\". Through a close reading of select chapters, this paper explores the nuanced approach needed to understand the complexity of human experiences and perspectives amidst the challenges of mental illness.</p>","PeriodicalId":517372,"journal":{"name":"Indian journal of medical ethics","volume":"X 3","pages":"231-233"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145454408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Revisiting the tridosha paradigm of Ayurveda.","authors":"G L Krishna","doi":"10.20529/IJME.2025.014","DOIUrl":"10.20529/IJME.2025.014","url":null,"abstract":"<p><p>The tridosha paradigm is foundational to Ayurveda. Ayurveda uses it to explain life processes, classify illness states, and facilitate therapeutic choices. The paradigm has an aspect that is heuristic and practical; it has another aspect that is purely speculative and conjectural. The paper sheds light on the distinctness of these two aspects by tracing the plausible steps in the conceptual evolution of the tridosha scheme. It also proposes a reimagining of the paradigm by jettisoning the conjectures and retaining the heuristics. Sans this reimagining, the paradigm would be pseudoscientific and its use in medical decision making, unsafe and unethical.</p>","PeriodicalId":517372,"journal":{"name":"Indian journal of medical ethics","volume":" ","pages":"203-210"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143560587","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Recording sex and gender data in clinical settings.","authors":"Sayantan Datta","doi":"10.20529/IJME.2025.054","DOIUrl":"10.20529/IJME.2025.054","url":null,"abstract":"<p><p>On April 16, 2025, the United Kingdom (UK) Supreme Court ruled that the legal definition of \"woman\" refers to biological females; the judgment also stated that biological sex is \"binary\" [1]. Less than ten days later, on April 25, 2025, the BMJ published an editorial titled \"Sex and gender should not be conflated in medical data\" [2]. In the editorial, authors Margaret McCartney and Susan Bewley critique the interchangeable use of sex and gender in medical data collection - a practice prevalent in the recordkeeping of the National Health Service, UK - and argue that such a conflation runs the risk of medical practitioners making erroneous decisions and diagnoses [2]. While recognising that \"A few people are found to have one of a small number of clinically recognized variations in sex development\", the authors too suggest that biological sex is a binary (\"male or female\") [2].</p>","PeriodicalId":517372,"journal":{"name":"Indian journal of medical ethics","volume":"X 3","pages":"175-179"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145454417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Ethical issues in a cluster randomised controlled trial for evaluating effectiveness of screening for breast cancer by clinical breast examination in India.","authors":"Indira Chakravarthi","doi":"10.20529/IJME.2025.046","DOIUrl":"10.20529/IJME.2025.046","url":null,"abstract":"<p><p>This article discusses issues of ethical concern in the conduct of a prospective, cluster randomised controlled trial for evaluating effectiveness of screening by clinical breast examination for downstaging of breast cancer, and in reducing mortality from the disease, in comparison to no screening. This trial was conducted in Mumbai, India, over 20 years, from May 1998 to March 2019. Trained primary health workers provided health education, visual inspection of cervix and clinical breast examination in the screening arm. Women in the control arm were provided only health education and not provided any intervention, though screening mammography is an established, standard procedure, which is also available in Mumbai; the risks of not having the examination, and the benefits of having the examination (mammography or clinical examination by health worker), in terms of early detection and hence the possibility of starting early treatment, were not explained; furthermore, there were several differences in the English and Marathi informed consent forms.</p>","PeriodicalId":517372,"journal":{"name":"Indian journal of medical ethics","volume":"X 3","pages":"215-222"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145454356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}