Trump may be mystery patient in odd case of 79yo getting experimental obesity drug
Trump may be mystery patient in odd case of 79yo getting experimental obesity drug
特朗普可能是 79 岁老人获得实验性减肥药这一离奇案例中的神秘患者
In an extremely odd case, a single 79-year-old patient was granted early access to Eli Lilly’s powerful, still-experimental obesity drug retatrutide through the Food and Drug Administration’s “compassionate use” program—raising immediate questions if that sole patient is President Donald Trump, according to a report by Stat News. 据 Stat News 报道，在一桩极其离奇的案例中，一名 79 岁的患者通过美国食品药品监督管理局（FDA）的“同情用药”计划，获得了礼来公司（Eli Lilly）强效且尚处于实验阶段的减肥药 retatrutide 的早期使用权，这立即引发了人们对该患者是否为唐纳德·特朗普总统的质疑。
Lilly’s retatrutide is a highly anticipated next-generation obesity drug that targets GIP and glucagon hormones in addition to GLP-1. It is currently in late-stage trials to treat obesity, diabetes, sleep apnea, and other conditions. Data from a Phase 3 trial that Lilly released in May indicates that patients with obesity (but without diabetes) who took the drug for 80 weeks lost 28 percent of their weight, an amount comparable to bariatric surgery. 礼来公司的 retatrutide 是一款备受期待的下一代减肥药，除了针对 GLP-1 外，还同时靶向 GIP 和胰高血糖素激素。目前，该药物正处于治疗肥胖症、糖尿病、睡眠呼吸暂停及其他疾病的后期临床试验阶段。礼来公司 5 月公布的 3 期临床试验数据显示，肥胖（但未患糖尿病）患者在服用该药物 80 周后，体重减轻了 28%，减重效果堪比减肥手术。
Millions of Americans with obesity are eager to get the drug, with options being limited so far to enrolling in a clinical trial or trying to obtain it by dodgy methods. But according to a barebones public notice and Stat’s sources, a single person has been granted early access through the expanded access, aka “compassionate use” pathway, which is typically used to grant access to patients with a “serious or immediately life-threatening disease or condition” and who are not able to enroll in a clinical trial, often because they are too ill. 数百万美国肥胖患者渴望获得这种药物，但目前的获取途径仅限于参加临床试验或通过不正当手段获取。然而，根据一份极其简略的公开通知和 Stat 的消息来源，有一人通过“扩大使用”（即“同情用药”）途径获得了早期使用权。该途径通常仅用于为那些患有“严重或直接危及生命的疾病或状况”，且因病情过重而无法参加临床试验的患者提供药物。
The access request was first made in April, when the person was 79 years old (Trump turned 80 on June 14). It was made by a senior clinician at the National Institutes of Health named Ranganath Muniyappa, who requested it on behalf of a patient with refractory obesity, obstructive sleep apnea, and pulmonary hypertension, which is high blood pressure in the lungs. 该用药申请于 4 月首次提出，当时患者为 79 岁（特朗普于 6 月 14 日年满 80 岁）。申请人是美国国立卫生研究院（NIH）的高级临床医生 Ranganath Muniyappa，他代表一名患有难治性肥胖、阻塞性睡眠呼吸暂停和肺动脉高压（即肺部高血压）的患者提出了申请。
Sources told Stat this patient had spent a year on tirzepatide, a drug that targets the GLP-1 and GIP hormones. But the patient had achieved only moderate weight loss on the drug. The patient was not recommended for bariatric surgery, given their age and other conditions. It was unclear whether the person would have been eligible for a trial. It’s also unclear if retatrutide would work in patients who have failed to see success with tirzepatide. 消息人士告诉 Stat，该患者曾服用过一年针对 GLP-1 和 GIP 激素的药物替尔泊肽（tirzepatide），但减重效果仅为中等。考虑到患者的年龄和其他身体状况，医生不建议其进行减肥手术。目前尚不清楚该患者是否符合临床试验的资格，也不清楚 retatrutide 对那些使用替尔泊肽无效的患者是否有效。
“Something very wrong” “非常不对劲”
The public notice of the expanded access is suspicious, omitting much of the information that such a notice would normally include, such as the conditions that might qualify a patient for such access. “Only people in the know would be able to find this [notice], using the drug name,” Richard Klein, who helped launch the FDA’s expanded access program in the 1980s, told Stat. “There is something very wrong with the way this is listed because no one would know what it is from the listing, or what it’s for.” 这份关于扩大使用的公开通知十分可疑，它省略了此类通知通常应包含的大部分信息，例如患者获得此类准入资格的条件。曾于 20 世纪 80 年代协助启动 FDA 扩大使用计划的 Richard Klein 对 Stat 表示：“只有知情人士才能通过药物名称找到这份通知。这种列出方式非常不对劲，因为没人能从清单中看出这是什么，或者它的用途是什么。”
Stat asked both the White House and the Department of Health and Human Services if Trump is the patient, and if he has obstructive sleep apnea and pulmonary hypertension, which were not included in a memo of his most recent medical evaluation. White House spokesperson Kush Desai did not answer the question and deferred to the health department. HHS spokesperson Emily Hilliard also did not directly deny that Trump is the patient. She provided a statement saying: The FDA supports expanded access programs that can provide patients with serious or life-threatening conditions access to investigational treatments when no comparable or satisfying approved therapies are available. Each request is reviewed on a case-by-case basis based on the clinical circumstances and applicable statutory and regulatory requirements. Stat 分别询问了白宫和卫生与公众服务部（HHS），确认特朗普是否为该患者，以及他是否患有阻塞性睡眠呼吸暂停和肺动脉高压（这些病症未包含在他最近的医疗评估备忘录中）。白宫发言人 Kush Desai 没有回答该问题，并将问题推给了卫生部门。HHS 发言人 Emily Hilliard 也没有直接否认特朗普是该患者。她发表声明称：“FDA 支持扩大使用计划，在没有可比或令人满意的获批疗法时，为患有严重或危及生命疾病的患者提供获得研究性治疗的机会。每项请求均根据临床情况及适用的法律法规要求进行个案审查。”
After this story was published, Desai posted on social media that the expanded access application, which had drawn interest from top health officials, “was not for the President.” Stat reporter Lizzy Lawrence replied, saying, “I asked you, the FDA, and HHS multiple times yesterday whether this application was for the President. No one answered my question directly.” Desai then seemed to confirm that no one had answered the question, calling it an “idiotic question.” 报道发布后，Desai 在社交媒体上发文称，这份引起高级卫生官员关注的扩大使用申请“并非针对总统”。Stat 记者 Lizzy Lawrence 回应称：“我昨天多次问过你、FDA 和 HHS，这份申请是否是为总统提出的。没有人直接回答我的问题。”Desai 随后似乎证实了确实无人回答该问题，并称这是一个“愚蠢的问题”。
Over a dozen experts who spoke to Stat said it was highly unusual for a drug company to grant expanded use of a drug for common conditions to a single patient rather than a cohort of patients with a specified profile. Lilly spokesperson Misty Fuller did not answer Stat’s questions, saying, “We make these decisions following all applicable regulations.” The NIH clinician who made the request, Muniyappa, also did not respond to questions. 十几位接受 Stat 采访的专家表示，制药公司为单一患者而非特定人群提供常见疾病药物的扩大使用权是非常罕见的。礼来公司发言人 Misty Fuller 没有回答 Stat 的提问，仅表示：“我们是在遵循所有适用法规的前提下做出这些决定的。”提出申请的 NIH 临床医生 Muniyappa 也未回应置评请求。