The BMJ最新文献

{"title":"Regulatory change could improve biosimilar access in the US","authors":"Tiffany E Jiang, Reshma Ramachandran, Joshua J Skydel","doi":"10.1136/bmj-2025-084860","DOIUrl":"https://doi.org/10.1136/bmj-2025-084860","url":null,"abstract":"Tiffany E Jiang , Reshma Ramachandran , and Joshua J Skydel argue that US requirements for interchangeability are not supported by evidence and hamper use of biosimilars Biological medicines (biologics) such as monoclonal antibodies have improved the treatment of numerous cancers, autoimmune diseases, and other conditions. They provide targeted treatment that enables patients to control their disease and lead healthier lives. Biologics are also among the most expensive available medications, accounting for almost one half of US drug spending in 2023 despite representing just 2% of prescriptions.1 Biosimilar products can lower prices and expand access to treatment, much like generic versions of small molecule drugs (box 1). However, whereas generic drugs are readily accepted as alternatives to branded products, biosimilars face challenges that have so far prevented them becoming widely used, especially in the US. Proposed changes to the Food and Drug Administration guidance could relax requirements and improve access to lower cost versions of these transformative therapies, but further changes are needed to maximise the benefits. Box 1 ### Key definitionsRETURN TO TEXT","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"144 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144719605","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":"Nawal Bagaria: GP who set up care homes and helped found a Hindu temple in Edinburgh","authors":"Tim Bullamore","doi":"10.1136/bmj.r1541","DOIUrl":"https://doi.org/10.1136/bmj.r1541","url":null,"abstract":"The opening of Edinburgh Hindu Mandir and Cultural Centre in a former church in 2015 was a joyous occasion, attended by more than 1300 people. This was thanks in no small part to Nawal Bagaria, who was president until February this year, overseeing a thriving congregation that meets twice weekly for prayer, meditation, and community worship. Bagaria and his wife, Sheela, a gynaecologist-turned-psychiatrist, had made their home in Scotland since 1975, when he became a GP in the new town of Livingston. He recalled being asked at his interview what guarantee there was that he would stay in the area; he responded by committing to provide for the local community for the rest of his life. He was true to his word. Increasingly, the couple found that their interests lay in caring for the elderly and in 1988 they approached Livingston Development Corporation for a site where they could provide accommodation for older people unable to live at home. Overcoming objections from residents worried about additional traffic close to a primary school, they opened the 40 bed Peacock Nursing Home in 1989. Two years later it expanded to 80 beds, this second phase being opened …","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144719614","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":"Half of resident doctors finishing training are set for unemployment next month, BMA warns.","authors":"Kate Bowie","doi":"10.1136/bmj.r1592","DOIUrl":"https://doi.org/10.1136/bmj.r1592","url":null,"abstract":"","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"215 1","pages":"r1592"},"PeriodicalIF":0.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144737191","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":"Core GRADE 4: rating certainty of evidence—risk of bias, publication bias, and reasons for rating up certainty","authors":"British Medical Journal Publishing Group","doi":"10.1136/bmj.r1468","DOIUrl":"https://doi.org/10.1136/bmj.r1468","url":null,"abstract":"An error occurred in figure 2 of this paper by Guyatt and colleagues ( BMJ 2025;389:e083864, doi:10.1136/bmj-2024-083864, published 13 May 2025). …","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"59 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144719608","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":"Doctors' strike: Tories vow to ban strikes as Streeting says NHS staff are \"picking up slack\" of ongoing action.","authors":"Adrian O'Dowd","doi":"10.1136/bmj.r1588","DOIUrl":"https://doi.org/10.1136/bmj.r1588","url":null,"abstract":"","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"722 1","pages":"r1588"},"PeriodicalIF":0.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144737194","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":"Sex related differences in efficacy and safety of antithrombotic therapy in patients with coronary artery disease: systematic review and meta-analysis","authors":"Raffaele Piccolo, Angelo Laino, Antonio Pio Vitale, Anna Franzone, Giovanni Esposito","doi":"10.1136/bmj-2024-082974","DOIUrl":"https://doi.org/10.1136/bmj-2024-082974","url":null,"abstract":"Objective To evaluate sex related differences in the treatment effect of antithrombotic therapy in patients with established coronary artery disease. Design Systematic review and meta-analysis. Data sources Ovid Medline and Embase databases from inception to April 2025. Inclusion criteria Included studies were randomised controlled trials reporting sex stratified outcomes, including ischaemic and major bleeding events, and comparing any experimental versus control antithrombotic strategy in coronary artery disease. Data extraction and synthesis Two reviewers extracted data and assessed the risk of bias. To avoid ecological bias, a within trial framework was developed to evaluate sex related heterogeneity in the treatment effect of antithrombotic therapies. Sex specific risk estimates were reported as hazard ratios with 95% confidence intervals, whereas trial level ratios of hazard ratios were pooled with an inverse variance model. Results A total of 33 trials enrolling 274 433 participants, of which 72 601 (median proportion 25%) were women, were included. Patients were enrolled between 1999 and 2025. A total of 6018 deaths occurred in 187 580 patients across 22 trials (3064 deaths in patients using more intensive antithrombotic therapies and 2954 in those using less intensive therapies). The relative risk of all cause death was comparable for more intensive versus less intensive antithrombotic therapies in both women and men, without sex based interaction (interaction hazard ratio 1.06, 95% confidence interval 0.94 to 1.19; P for interaction=0.33; I2=0.00%; P for heterogeneity=0.76). 7558 myocardial infarctions occurred among 172 504 patients. More intensive antithrombotic therapies were associated with a reduced risk of myocardial infarction by ~15% in both men and women (interaction hazard ratio 1.05, 0.95 to 1.17; P for interaction=0.36; I2=14.05%; P for heterogeneity=0.28). Conversely, major bleeding was significantly increased by ~40% for more intensive versus less intensive antithrombotic therapies irrespective of sex (interaction hazard ratio 0.99, 0.86 to 1.15; P for interaction=0.93; I2=33.56%; P for heterogeneity=0.05). Overall, 4003 major bleeding events occurred (2384 in patients using more intensive therapies and 1619 in those using less intensive therapies). Conclusions Antithrombotic therapies in patients with established coronary artery disease provided consistent efficacy and safety outcomes in women and men. Systematic review registration PROSPERO CRD42024560908. Requests for data sharing should be sent to the corresponding author at Raffaele.Piccolo@unina.it.","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"93 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144719607","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":"South Korean government restarts talks with trainee doctors after mass resignation in medical school places row.","authors":"Flynn Murphy","doi":"10.1136/bmj.r1590","DOIUrl":"https://doi.org/10.1136/bmj.r1590","url":null,"abstract":"","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"6 1","pages":"r1590"},"PeriodicalIF":0.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144737195","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":"Sex differences in antithrombotic therapy for coronary artery disease","authors":"Upasana Tayal","doi":"10.1136/bmj.r1560","DOIUrl":"https://doi.org/10.1136/bmj.r1560","url":null,"abstract":"Balanced trial recruitment is needed to build the evidence base for sex stratified care Antithrombotic therapies, comprising antiplatelet agents and anticoagulants, are a cornerstone of secondary prevention in patients with established coronary artery disease. Many randomised controlled trials have evaluated various intensities and combinations of antithrombotic therapy, showing reduced risks of recurrent ischaemic events. However, longstanding concern has existed about the generalisability of these findings to female patients, given the underrepresentation of female patients in cardiovascular trials and the sex based biological differences in response to antithrombotic agents.1 Sex differences in platelet reactivity, vascular biology, and pharmacokinetics have raised the hypothesis that female and male patients may experience different benefit-risk profiles with antithrombotic therapies. Clinically, concern has existed that female patients are more prone to bleeding complications and are therefore less suitable for more intensive treatment strategies. Observational data have also suggested potential sex based disparities in treatment allocation and outcomes, with female patients less likely to be referred for intervention.2 In a linked systematic review and meta-analysis (doi:10.1136/bmj-2024-082974), Piccolo and colleagues examine whether the efficacy and …","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144719618","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":"Can AI teach medicine? Not whether but how","authors":"Molly Jankowski","doi":"10.1136/bmj.r1571","DOIUrl":"https://doi.org/10.1136/bmj.r1571","url":null,"abstract":"In my work as an educational fellow engaging with students from multiple universities, it has become increasingly evident that it is not a matter of whether artificial intelligence (AI) can be used in the undergraduate setting,1 but how curriculums are going to adapt to its benefits and risks. AI is a broad and poorly defined term,2 and many training clinicians are probably already using AI in the form …","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"93 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144719615","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":"US fertility rate sank to new low in 2024 amid rise of \"pronatalism\" politics.","authors":"Jacqui Wise","doi":"10.1136/bmj.r1589","DOIUrl":"https://doi.org/10.1136/bmj.r1589","url":null,"abstract":"","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"285 1","pages":"r1589"},"PeriodicalIF":0.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144737197","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}