FDA CBER主任Peter Marks博士的辞职信（附：中英文版本）推荐阅读（图片来源：FDA官网）【药时代编者按】美国当地时间2025年3月28日，星期五，美国食品药品监督管理局（FDA）生物制品评价与研究中心（CBER）主任Peter Marks博士宣布辞职，引发业界广泛关注。作为基因治疗和疫苗审评领域的权威专家，Marks博士在任期间主导批准了美国首个基因疗法，并在新冠疫情期间为”曲速行动”疫苗研发计划作出重要贡献。药时代特别整理刊发Marks博士的辞职信全文及专业翻译版本（主要由DeepSeek协助完成）。这封信不仅展现了一位科学家对公共卫生事业的执着追求，更折射出当前美国科学界面临的严峻挑战——信中直指”对科学真理的前所未有的攻击”，揭露了对政治干预科学决策的隐忧。通过中英对照形式呈现，我们既希望为读者朋友们提供第一手专业资料，也期待引发对以下问题的思考：如何保障科研机构的独立性？当科学遭遇政治压力时，学者应当何去何从？Marks博士的案例，或将成为审视科学与政治关系的一个重要样本。仅供感兴趣的专业人士朋友们个人谨慎参考。欢迎大家对中文译文进行批评指正！衷心感谢！彼得·马克斯 医学博士、哲学博士美国食品药品监督管理局生物制品评价与研究中心主任地址：马里兰州银泉市新罕布什尔大道10903号（邮编20903）2025年3月28日萨拉·布伦纳 医学博士、公共卫生硕士美国食品药品监督管理局代理局长地址：马里兰州银泉市新罕布什尔大道10903号（邮编20903）尊敬的布伦纳博士：我怀着沉重的心情决定辞去美国食品药品监督管理局生物制品评价与研究中心主任一职，并将于2025年4月5日正式退出联邦公职。与我共事的这支专业团队，无疑是我四十年来在公共和私营部门工作中所遇到过的最致力于守护与促进公众健康的队伍。一直以来，我都竭力维护他们的权益，在此艰难时期，恳请您也能同样支持他们——当前我们国家卫生安全体系中最关键的这群人，或许正面临着价值被低估的处境。过去数年间，我始终致力于提升国家血液供应安全、推动细胞与基因治疗领域发展，并参与应对突发公共卫生事件。尤其在新冠疫情期间，我有幸见证了自己于2020年3月与罗伯特·卡德莱克博士共同构想的”曲速行动”计划，在卫生与公众服务部部长阿扎尔和特朗普总统的领导下，通过FDA及联邦政府各部门公职人员的不懈努力成为现实。FDA全体同仁夜以继日的工作，在确保质量、安全性和有效性的前提下，以惊人速度推进了新冠病毒疫苗研发。这些疫苗显著降低了美国乃至全球范围内新冠疾病的发病率和死亡率。正是这群专业人士运用抗疫经验，在2022年猴痘疫情应对中展现出完美执行力，助力美国迅速控制疫情。如今，这些曾参与抗疫的精锐力量仍严阵以待，准备迎战未来数年必将面临的传染病威胁——包括已兵临城下的H5N1禽流感病毒。当前某些人士鼓吹疫苗危害健康的论调令人忧心。疫苗接种对个人与社会的裨益，可追溯至我们伟大国家的诞生之初——独立战争初期，乔治·华盛顿将军为驻守马萨诸塞州剑桥的部队接种天花疫苗，以防英军通过感染者渗透战线；1777年2月在新泽西莫里斯顿驻扎期间，他更以非凡魄力签署全军接种天花疫苗的命令。此后，随着天花疫苗的改良和大规模接种，人类最终根除了这种肆虐千年的疫病。索尔克与萨宾博士的疫苗科研成果，更直接促成美国消灭脊髓灰质炎的壮举。仅这两种疫苗，就已拯救了数以百万计的生命。当前美国多州爆发的麻疹疫情（德克萨斯州尤为严重）正警示我们：当公众对公共卫生基石的科学共识产生动摇时，将引发何等后果。这种去年在亚非未接种地区导致超10万儿童死于病毒性肺炎和脑炎的疾病，本已在我们的国土绝迹。过去数十年使用的麻疹-腮腺炎-风疹联合疫苗（MMR）两剂接种方案，始终保持着卓越的效益风险比——该疫苗完成两剂接种后预防麻疹有效性达97%以上，其安全性更经过充分验证。虽然极少数情况下可能引发发热性惊厥（百万分之一概率），或更罕见的过敏反应、凝血障碍，但疫苗与自闭症绝无关联，也不会导致脑炎或死亡。相反，它能有效预防麻疹感染后最凶险的并发症：亚急性硬化性全脑炎（SSPE）。这种无法治愈的进行性神经系统疾病，约每1万名麻疹感染者中就有1例会因此丧命。那些质疑经过FDA数十年严苛质量安全标准验证的成熟疫苗的行为，不仅是对公共卫生的背叛，更是对国家健康安全的公然威胁。疫情过后这些年，生物制品评价与研究中心始终秉持着守护公众健康的坚定信念，全力推动细胞与基因疗法研发，以攻克遗传性与获得性罕见疾病。在我担任中心主任期间，我们已批准了22种基因疗法——其中包括美国历史上首个获批的基因治疗产品。但我们深知，面对过去几十年分子医学进展可能治愈的数千种疾病，我们必须加快为患者提供治疗的步伐。中心团队正运用抗疫期间积累的宝贵经验，例如加强与产品开发者的沟通协作，进一步加速急需疗法的审批流程。同时，我们也在积极探索监管模式的重大变革，以加速直接给药的基因组编辑产品上市。若能审慎推进并不断完善，这些疗法有望在未来数年彻底改变人类健康格局。过去十三年来，我始终竭尽全力确保我们将最前沿的科研成果高效转化为公共卫生福祉。如您所知，为回应部长对疫苗安全性和透明度的关切，我曾积极推动举办公众听证会，并与美国国家科学院、工程院和医学院开展多种形式的公开研讨。但事实证明，部长所求并非真相与透明——他想要的，不过是对其虚假言论的卑躬屈膝。我衷心希望，近年来这场戕害科学真理、损害国民健康的前所未有的风暴能够终结，让美国民众得以充分享受医学进步的丰硕成果。尽管无法继续参与FDA的未来工作令我深感遗憾，但能与FDA如此杰出的同仁共事，我由衷感激。未来，我仍将不遗余力为推进公共卫生事业贡献力量。此致敬礼彼得·马克斯 医学博士、哲学博士Peter Marks, MD, PhDDirector, Center for Biologics Evaluation and ResearchU.S. Food and Drug Administration10903 New Hampshire AvenueSilver Spring, MD 20903March 28, 2025Sara Brenner, MD, MPHActing Commissioner of Food and DrugsU.S. Food and Drug Administration10903 New Hampshire AvenueSilver Spring, MD 20903Dear Dr. Brenner:It is with a heavy heart that I have decided to resign from FDA and retire from federal service as Director of the Center for Biologics Evaluation and Research effective April 5, 2025. I leave behind a staff ofprofessionals who are undoubtedly the most devoted to protecting and promoting the public health of any group of people that I have encountered during my four decades working in the public and privatesectors. I have always done my best to advocate for their well-being and I would ask that you do the same during this very difficult time during which their critical importance to the safety and security ofour nation may be underappreciated.Over the past years I have been involved in enhancing the safety of our nation’s blood supply, in advancing the field of cell and gene therapy, and in responding to public health emergencies. In the lastof these, during the COVID-19 pandemic I had the privilege of watching the vision that I conceived for Operation Warp Speed in March 2020 in collaboration with Dr. Robert Kadlec become a reality underthe leadership of HHS Secretary Azar and President Trump due to the unwavering commitment of public servants at FDA and elsewhere across the government. At FDA, the tireless efforts of staff across theagency resulted in remarkably expediting the development of vaccines against the virus, meeting the standards for quality, safety, and effectiveness expected by the American public. The vaccines undoubtedly markedly reduced morbidity and mortality from COVID-19 in the United States and elsewhere. Many of these same individuals applied learnings from the pandemic during a flawless response helping to facilitate the rapid control of the mpox epidemic in the United States during 2022. Individuals who participated in these responses remain at the ready to address the infectious threats that undoubtedly will confront us in the coming years, including H5N1, which is now on our threshold.Efforts currently being advanced by some on the adverse health effects of vaccination are concerning. The history of the potential individual and societal benefits of vaccination is as old as our great nation. George Washington considered protecting his troops in Cambridge, Massachusetts against smallpox early in the revolutionary war so that they would not be susceptible to infection by British troops infiltrating the ranks, and later in the war in February 1777 while encamped in Morristown, NJ, he went on to have the courage and foresight to sign an order requiring inoculation of his troops against smallpox. Subsequently, refinement of the smallpox vaccine combined with a widespread vaccination campaign resulted in the eradication of smallpox from the globe. The application of the remarkable scientific advances of Drs. Salk and Sabin’s vaccines led to the elimination of polio in the United States. And these are just effects of two of the vaccines that have been associated with saving millions of lives.The ongoing multistate measles outbreak that is particularly severe in Texas reminds us of what happens when confidence in well-established science underlying public health and well-being is undermined. Measles, which killed more than 100,000 unvaccinated children last year in Africa and Asia owing to pneumonitis and encephalitis caused by the virus, had been eliminated from our shores. The two-dose measles, mumps, rubella vaccine regimen (MMR) using over the past decades has a remarkably favorable benefit-risk profile. The MMR vaccine is 97% or more effective in preventing measles following the two-dose series, and its safety has been remarkably well studied. Though rarely followed by a single fever-related seizure, or very rarely by allergic reactions or blood clotting disorders, the vaccine very simply does not cause autism, nor is it associated with encephalitis or death. It does, however, protect against a potential devasting consequence of prior measles infection, subacute sclerosing panencephalitis (SSPE), which is an untreatable, relentlessly progressive neurologic disorder leading to death in about 1 in 10,000 individuals infected with measles. Undermining confidence in well established vaccines that have met the high standards for quality, safety, and effectiveness that have been in place for decades at FDA is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety. and security.In the years following the pandemic, at the Center for Biologics Evaluation and Research we have applied the same unwavering commitment to public health priorities to the development of cell and gene therapies to address both hereditary and acquired rare diseases. During my tenure as Center Director we have approved 22 gene therapies, including the first gene therapy ever to be approved in the United States. However, we know that we must do better to expedite the development of treatments for those individual suffering from any one of the thousands of diseases potentially addressable by the advances in molecular medicine over the past decades. Drawing from learnings of the pandemic, the staff at the Center for Biologics Evaluation and Research are implementing best practices learned during the pandemic such as increased communication with product developers to further expedite bringing needed treatments to those in need. They have also been exploring the dramatic transformation of our regulatory approach to expedite the delivery of directly administered genome editing products. If thoughtfully approached and further developed and refined, these treatments have the potential to transform human health over the coming years.Over the past 13 years I have done my best to ensure that we efficiently and effectively applied the best available science to benefit public health. As you are aware, I was willing to work to address the Secretary’s concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine. However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.My hope is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science. Though I will regret not being able to be part of future work at the FDA, I am truly grateful to have had the opportunity to work with such a remarkable group of individuals as the staff at FDA and will do my best to continue to advance public health in the future.Sincerely,Peter Marks, MD, PhD图片来源：FDA、Endpoints NewsFDA CBER主任Peter Marks博士的辞职信（附：中英文版本）2025-03-29 突遭逼宫离职！小肯尼迪赶走FDA核心高管？2025-03-29 罗氏AD大药“复燃”2025-03-28 国产初创Biotech与拜耳达成出海协议，合成致死领域起风云！2025-03-27 Biotech没钱开展III期临床试验怎么办？关门大吉！2025-03-26 版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn点击这里，查看更多精彩!
