对新药研发审批程序与长期服药的质疑  

Inquiries of drug approval process and long-term medication

作　　者：吴伟洁[1] 黄阎妹 耿利军[1] 肖剑龙 赵海潞[1] WU Weijie;HUANG Yanmei;GENG Lijun;XIAO Jianlong;ZHAO Hailu(Center for Systems Medicine, Guangxi Key Laboratory of Excellence, Department of Immunology, Guangxi Area of Excellence, Guilin Medical University, Guilin 541004, China)

机构地区：[1]桂林医学院广西系统医学重点实验室广西免疫学重点学科

出　　处：《医学争鸣》2019年第3期41-45,49,共6页Negative

基　　金：国家自然科学基金面上项目(81270934,81471054);广西研究生教育创新计划项目(JGY2015128)

摘　　要：公众以及医患人员一直以为经过食品药品监督管理局(FDA)批准的药品是安全而且有效的,新药审批程序是科学、客观,有医药专家层层把关的。百年来“药害”流行的事实以及近年来系列高质量的研究显示:美国FDA新药研发程序存在漏洞与局限性,慢性病患者长期服药深受毒害。临床前体外细胞实验的单体化合物靶点单一,动物实验结果难以转化为临床疗效;选择健康志愿者作为药代学试验受试者,不能反映出患者服药后的安全性;选择患者进行药物临床试验,结果不一致,结论往往以偏概全;新药一旦上市,常常失去随访与监管;对慢性病患者进行终身对抗与替代治疗,化药为毒。其实,疾病本身就是大众的一味良药,善服者无不康复。All the public, physicians and patients rarely question the safety and effectiveness of the drugs approved by the US Food and Drug Administration (FDA). FDA's drug approval process is regulated with scientific evidence and objective results and modified by medical experts. However, the epidemic of “drug crisis” in hundreds of years and recently a series of high-quality studies have disclosed serious pitfalls and limitations after opening the FDA black box. People with chronic disorders suffer from harmful effects due to long-term medication. Pre-clinical in vitro studies test single compound for specific target using cultured cells, followed by animal experimentation to generate results that rarely can be translated into clinical use. Phase I clinical trials involve healthy volunteers to explore the pharmacokinetics, which may not disclose the safety issues in patients. Phase Ⅱ and Ⅲ trials are controlled studies that often show inconsistent results and limited conclusions. Post-market surveillance for adverse drug events is often compromised by loss of follow-up records. Longterm use of antagonists (blockers) or agonists (activators) by patients with chronic diseases generally turns drugs into toxic agents. Indeed, disease per se works as an effective remedy for the right persons.

关 键 词：食品药品监督管理局 药物研发 动物实验 科学 长期服药 

分 类 号：R91[医药卫生—药学]