{"title":"Pharmaceutical product recall and educated hesitancy towards new drugs and novel vaccines.","authors":"Peter Rhodes, Peter I Parry","doi":"10.1177/09246479241292008","DOIUrl":null,"url":null,"abstract":"<p><p><b>Background:</b> Of many pharmaceutical products launched for the benefit of humanity, a significant number have had to be recalled from the marketplace due to adverse events. A systematic review found market recalls for 462 pharmaceutical products between 1953 and 2013. In our current and remarkable period of medical history, excess mortality figures are high in many countries. Yet these statistics receive limited attention, often ignored or dismissed by mainstream news outlets. This excess mortality may include adverse effects caused by novel pharmaceutical agents that use gene-code technology.<b>Objective:</b> To examine key pharmaceutical product withdrawals and derive lessons that inform the current use of gene-based COVID-19 vaccines.<b>Methods:</b> Selective narrative review of historical pharmaceutical recalls and comparative issues with recent COVID-19 vaccines.<b>Results:</b> Parallels with past drug withdrawals and gene-based vaccines include distortion of clinical trial data, with critical adverse event data absent from high-impact journal publications. Delayed regulatory action on pharmacovigilance data to trigger market withdrawal occurred with Vioxx (rofecoxib) and is apparent with the gene-based COVID-19 vaccines.<b>Conclusion:</b> Public health requires access to raw clinical trial data, improved transparency from corporations and heightened, active pharmacovigilance worldwide.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"35 4","pages":"317-333"},"PeriodicalIF":0.9000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/09246479241292008","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/11/6 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Of many pharmaceutical products launched for the benefit of humanity, a significant number have had to be recalled from the marketplace due to adverse events. A systematic review found market recalls for 462 pharmaceutical products between 1953 and 2013. In our current and remarkable period of medical history, excess mortality figures are high in many countries. Yet these statistics receive limited attention, often ignored or dismissed by mainstream news outlets. This excess mortality may include adverse effects caused by novel pharmaceutical agents that use gene-code technology.Objective: To examine key pharmaceutical product withdrawals and derive lessons that inform the current use of gene-based COVID-19 vaccines.Methods: Selective narrative review of historical pharmaceutical recalls and comparative issues with recent COVID-19 vaccines.Results: Parallels with past drug withdrawals and gene-based vaccines include distortion of clinical trial data, with critical adverse event data absent from high-impact journal publications. Delayed regulatory action on pharmacovigilance data to trigger market withdrawal occurred with Vioxx (rofecoxib) and is apparent with the gene-based COVID-19 vaccines.Conclusion: Public health requires access to raw clinical trial data, improved transparency from corporations and heightened, active pharmacovigilance worldwide.
期刊介绍:
The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed. This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety.