RFK Jr. stacks FDA panel with peptide peddlers as FDA scientists oppose access
RFK Jr. stacks FDA panel with peptide peddlers as FDA scientists oppose access
小罗伯特·肯尼迪向FDA专家组安插多肽药物推销员，FDA科学家表示反对
Anti-vaccine Health Secretary Robert F. Kennedy Jr. has stacked another federal advisory panel with allies, advancing his efforts to force the Food and Drug Administration to reverse its stance on a dozen popular but unproven injectable peptide drugs. 反疫苗立场的卫生部长小罗伯特·肯尼迪（Robert F. Kennedy Jr.）再次向一个联邦咨询委员会安插了自己的盟友，此举旨在推动FDA改变其对十几种流行但未经证实的可注射多肽药物的立场。
While FDA scientists determined in 2023 that the drugs lack evidence of benefits and may pose safety risks, Kennedy is a self-professed “big fan” of the dubious drugs and has vowed to “end” FDA’s “aggressive suppression” of them. 尽管FDA科学家在2023年认定这些药物缺乏疗效证据且可能存在安全风险，但肯尼迪自称是这些可疑药物的“忠实粉丝”，并誓言要“终结”FDA对它们的“激进打压”。
On Monday, the Food and Drug Administration updated its list of advisors who will review the peptides, adding nine new members—almost all of whom personally promote peptide use and/or have financial ties to wellness clinics that offer peptide treatments. The additions bring the total number of advisors to 13, making it easy for the new members to determine the outcome of upcoming meetings. 周一，FDA更新了负责审查这些多肽药物的顾问名单，新增了9名成员。这些新成员几乎都亲自推广多肽药物，或与提供多肽治疗的健康诊所有经济往来。此次增补使顾问总数达到13人，这使得新成员能够轻松左右即将召开的会议结果。
At the same time, the FDA released briefing documents for the upcoming meetings with the advisors, in which FDA scientists reaffirm that there is not enough evidence of safety and efficacy to justify making the peptides more accessible. 与此同时，FDA发布了即将与顾问团举行会议的简报文件，其中FDA科学家重申，目前没有足够的安全性和有效性证据来支持放宽对这些多肽药物的获取限制。
Upcoming meetings
即将召开的会议
The advisory panel will meet July 23 and 24 and discuss seven peptides. On the first day, advisors will discuss the use of peptides BPC-157 for ulcerative colitis, KPV for wound healing and inflammation, TB-500 for wound healing, and MOs-C for obesity and osteoporosis. 咨询委员会将于7月23日和24日开会讨论七种多肽药物。第一天，顾问们将讨论用于治疗溃疡性结肠炎的BPC-157、用于伤口愈合和炎症的KPV、用于伤口愈合的TB-500，以及用于肥胖症和骨质疏松症的MOs-C。
On the second day, advisors will discuss the use of peptides emideltide for opioid withdrawal, chronic insomnia, and narcolepsy; semax for cerebral ischemia, migraine, and trigeminal neuralgia (a condition causing severe facial pain); and epitalon for insomnia. There will also be a meeting scheduled before the end of February 2027, in which advisors will discuss five additional peptides. 第二天，顾问们将讨论用于阿片类药物戒断、慢性失眠和发作性睡病的emideltide；用于脑缺血、偏头痛和三叉神经痛（一种引起剧烈面部疼痛的疾病）的semax；以及用于失眠的epitalon。此外，会议还计划在2027年2月底前举行，届时顾问们将讨论另外五种多肽药物。
Specifically, the meetings will discuss whether these unproven peptides can be produced by compounding pharmacies, which make specialty drugs. Currently, the FDA does not allow compounding pharmacies to make the peptides in question for human use, though the drugs can be sold for research use. 具体而言，会议将讨论这些未经证实的肽类药物是否可以由配制药房（compounding pharmacies）生产，这些药房专门制造特殊药物。目前，FDA不允许配制药房生产用于人类使用的相关肽类药物，尽管这些药物可以作为研究用途销售。
The panel that Kennedy has now stocked with peptide advocates is the Pharmacy Compounding Advisory Committee. While the FDA is not obligated to accept the recommendations from its advisory committees, it often does. 肯尼迪目前安插了多肽药物倡导者的委员会是“药房配制咨询委员会”（Pharmacy Compounding Advisory Committee）。虽然FDA没有义务接受其咨询委员会的建议，但它通常会这样做。
In an introductory briefing document for the meeting next month, the agency said it “does not intend to issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized. The final determination may be affected by issues not discussed at the advisory committee meeting.” 在下个月会议的介绍性简报文件中，该机构表示：“在考虑了咨询委员会的意见并完成所有审查之前，不打算对当前问题做出最终决定。最终决定可能会受到咨询委员会会议上未讨论的问题的影响。”
New and old members
新老成员
The nine new members are: Gabriel Alizaidy, who promotes peptides on social media and in a newsletter he runs. He is a scientific director at Maximus, a “personal performance medicine” clinic offering peptide injections. The FDA recently sent Maximus a warning letter over “false or misleading” claims on peptides used for weight loss, The Washington Post reported. 九名新成员包括：在社交媒体和他运营的通讯中推广多肽药物的Gabriel Alizaidy。他是Maximus的科学总监，这是一家提供多肽注射的“个人表现医学”诊所。据《华盛顿邮报》报道，FDA最近向Maximus发出警告信，指控其对用于减肥的多肽药物存在“虚假或误导性”宣传。
Asare B. Christian, a sports medicine doctor who founded Aether Medicine in Pennsylvania, which uses peptides in its treatments for pain, anti-aging, injuries, and neurological disease. Asare B. Christian，一位运动医学医生，在宾夕法尼亚州创立了Aether Medicine，该诊所在治疗疼痛、抗衰老、损伤和神经系统疾病时使用多肽药物。
Robert Harshbarger, a Republican state senator in Tennessee who is a pharmacist and son of US Rep. Diana Harshbarger (R). In November, Diana Harshbarger specifically asked Kennedy to have the FDA reevaluate six peptides. Robert Harshbarger，田纳西州共和党州参议员，同时也是一名药剂师，是美国众议员戴安娜·哈什巴格（Diana Harshbarger，共和党籍）的儿子。去年11月，戴安娜·哈什巴格曾专门要求肯尼迪让FDA重新评估六种多肽药物。
Melissa Loseke, the founder and medical director of the Re-New Institute in Nebraska, which offers peptide treatments in its focus on “whole-person healing” and its mission to “extend lifespan.” Melissa Loseke，内布拉斯加州Re-New研究所的创始人和医学主任，该机构专注于“全人疗愈”和“延长寿命”的使命，并提供多肽治疗。
Haleem Mohammed is the chief medical officer at Gameday Men’s Health, which offers peptide therapy as part of its focus on “hormone optimization, vitality and longevity care.” Haleem Mohammed，Gameday Men’s Health的首席医疗官，该机构提供多肽疗法，作为其“激素优化、活力和长寿护理”重点的一部分。
Gerald Morris, medical director at the wellness clinic AMG Medical in Tucson, Arizona. His website says he has “a passion for regenerative medicine, peptide therapy, and human longevity.” Gerald Morris，亚利桑那州图森市AMG Medical健康诊所的医学主任。他的网站称他“对再生医学、多肽疗法和人类长寿充满热情”。
Josh Starbuck, a concierge doctor in Hawaii who focuses on functional medicine and peptide therapy for anti-aging and longevity. Josh Starbuck，夏威夷的一名礼宾医生，专注于抗衰老和长寿的功能医学及多肽疗法。
Kris Wusterhausen, founder of The Resurge Clinic, a wellness and longevity clinic in Texas, which promotes peptides. Kris Wusterhausen，德克萨斯州Resurge诊所的创始人，这是一家推广多肽药物的健康与长寿诊所。
Last is David Pope, a chief pharmacy officer at XiFin Pharmacy Solution, a company that makes healthcare workflow and billing software. It’s unclear if he has a public stance on peptide use. 最后是David Pope，XiFin Pharmacy Solution的首席药剂官，该公司生产医疗工作流程和计费软件。目前尚不清楚他对多肽药物的使用是否有公开立场。
The four previous members are: Timothy Fensky, a pharmacy industry consultant and representative from the National Association of Boards of Pharmacy. Elizabeth Rebello, an anesthesiologist and executive director at the University of Texas MD Anderson Cancer Center. Brian Serumaga, director of personalized medicines at US Pharmacopeia. Donnette Staas, vice president of regulatory strategy at Jazz Pharmaceuticals, who is a non-voting industry representative. 之前的四名成员是：药房行业顾问兼美国药房委员会协会代表Timothy Fensky；德克萨斯大学MD安德森癌症中心的麻醉师兼执行主任Elizabeth Rebello；美国药典委员会个性化药物主任Brian Serumaga；以及Jazz制药公司监管战略副总裁、无投票权的行业代表Donnette Staas。