今日行醫或者理想的行醫，是循證醫學（Evidence Based Medicine EBM）, 根據證據行醫。什麽是行醫的證據？ 1：醫學雜誌特別是一流雜誌如JAMA, NEJM, Annals of Internal medicine, Lancet, British Medical Journal (BMJ) 上發表的隨機臨床試驗和大型綜述（meta analysis）文章。 2： 各個醫學協會的指南（Guideline）。 3： 網絡醫學指導UpToDaTe。假設UpToDaTe推薦的依據都來自1和2。
作者John Abramson 當了20年的家庭醫生；作過兩年fellowship, 學習統計，流行病學和科研設計。他是哈佛醫學院講師，先後教授家庭醫學和醫療政策。2001年，他發現製藥公司發表在一流醫學雜誌上的證據與報給FDA的資料不符合。2004年，Dr. John Abramson 出版《Overdosed America： The Broken Promise of American Medicine》，從家庭醫生的角度描述了日益增長的商業侵擾對醫療保健的破壞程度。在幾個起訴製藥公司的全國性訴訟中，Dr. John Abramson被邀請作為原告的專家證人。作為專家證人，他查閱了上百萬內部文件，包括原始研究資料、電郵、商業和推銷計劃。他據此分析鑒定，醫生們接觸的證據，是否真正反映了這些藥物的療效和危險。
2000年11月23日，新英格蘭醫學雜誌（New England Journal of Medicine NEJM）發表了一篇Vioxx 的臨床研究文章： Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis. 文章的結論是：Vioxx 比老的消炎鎮痛藥萘普生比較，胃腸道副作用明顯減少。
Merck作的上述臨床試驗叫VIGOR（Vioxx Gastrointestinal Outcomes Research 的縮寫) 。Dr. John Abramson 研究了未發表的VIGOR 資料。2000年3月9日，VIGOR研究資料首次送給Merck 的科學家。Merck當時的研究主管Dr. Edward Scolnick在一個內部的email說：Vioxx 的心血管危險顯而易見。但是他又說：這類藥物會作的很好，我們也會。
2005年2月，柳葉刀發表了一篇關於Vioxx的文章，作者是FDA的David Graham，Kaiser 的6個MD、PhD, Vanderbilt University School of Medicine 的1個教授。他們估計，Vioxx 在5年上市期間，在美國導致了8.8-14萬心肌梗塞 ，4-6萬死亡。死於Vioxx 和死於越南戰爭的美國人，幾乎一樣多。
For sure, some newly approved drugs — one out of eight — provide heretofore unavailable medical benefits. These can be genuinely lifesaving or quality-of-life-improving, like the drugs that transformed HIV/AIDS from a death sentence into a chronic disease compatible with a normal life, drugs to treat hepatitis C, and drugs to treat (but not cure) cystic fibrosis. But unlike other wealthy countries, the United States lets drug companies charge as much as they want, so the drugs that offer unique benefits are generally priced at ransom like levels. Moreover, because the industry controls much of the scientific evidence that reaches health-care professionals and the public, the seven out of eight newly approved drugs that do not provide previously unavailable benefits can be promoted as if they do. The business environment for prescription drugs in the United States is so different from that of other wealthy countries that an estimated two-thirds to three-quarters of global pharmaceutical profits come from the United States.
回複 'passerby2016' 的評論 : 也許你是假設clinicaltrials.gov的資料可信而且完整。Sickening 書中有段話：Readers interested in the transparency of clinical trial data may be aware of the AllTrials campaign, the goal of which is to ensure that all clinical trials are registered prior to enrollment of the first patient and that a summary of study results is posted on an online registry (like clinicaltrials.gov) within one year of a study’s completion. This campaign, however, risks being counterproductive by creating the illusion that compliance with its requirements would adequately remedy the current lack of transparency in clinical trial reporting. This assumption fails in two ways. First, a 2020 article published in The Lancet found that compliance with the requirement to post study results within one year of completion “is poor, and not improving.”* Second, even if studies were registered and results posted as required by law, drug companies’ posting of unaudited summary results on internet registries is hardly a substitute for genuine transparency and independent analysis of clinical trial data. ? Currently, efforts by the International Committee of Medical Journal Editors (discussed in chapter 8) and the AllTrials campaign risk standing in the way of data transparency by creating the false impression that progress is being made when it is not.
Get the info from clinicaltrials.gov, Check for phase 4 reports.
野彪 發表評論於
在臨床研究的設計方麵，對於安全性的驗證是非常困難的。ICH在1994年10月27日頒布了E1：THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL SAFETY FOR DRUGS INTENDED FOR LONG-TERM TREATMENT OF NON-LIFE-THREATENING CONDITIONS，但這個指導原則僅僅是針對長期用藥的患者，並非針對罕見的不良反應。例如該指導原則中也提到： The safety evaluation during clinical drug development is not expected to characterise rare adverse events,for example, those occurring in less than 1 in 1000 patients.也就是很難捕捉到千分之一一下的不良反應。但一旦藥品上市，千分之一的不良反應其實就是很龐大的數量了。
對於那些非致命性的疾病，應該在安全性方麵有更高的保障才對。
反觀新冠疫苗的研發，不到一年時間就都上市了。這也是非常不負責任的。因為疫苗是應用於健康人的，對安全性方麵的要求就更高。沒有通過大規模的、嚴格的臨床研究，是不能上市的。
作者John Abramson 當了20年的家庭醫生；作過兩年fellowship, 學習統計，流行病學和科研設計。他是哈佛醫學院講師，先後教授家庭醫學和醫療政策。2001年，他發現製藥公司發表在一流醫學雜誌上的證據與報給FDA的資料不符合。2004年，Dr. John Abramson 出版《Overdosed America： The Broken Promise of American Medicine》，從家庭醫生的角度描述了日益增長的商業侵擾對醫療保健的破壞程度。在幾個起訴製藥公司的全國性訴訟中，Dr. John Abramson被邀請作為原告的專家證人。作為專家證人，他查閱了上百萬內部文件，包括原始研究資料、電郵、商業和推銷計劃。他據此分析鑒定，醫生們接觸的證據，是否真正反映了這些藥物的療效和危險。