Here's everything we know about the unapproved antibody drug Trump took to combat coronavirus
Christina Farr, Kevin Stankiewicz, CNBC, PUBLISHED FRI, OCT 2 20208:44 PM EDT
克裡斯蒂娜·法爾，凱文·斯坦凱維奇，CNBC，發布於2020年10月2日
KEY POINTS
要點
President Trump has received a dose of an experimental treatment from Regeneron.
川普總統接受了雷根龍的一劑實驗性治療。
Doctors have shared that they have mixed feelings about that, given that the antibody cocktail has not yet been approved.
鑑於該抗體雞尾製劑尚未獲得批准，醫生們對此感受複雜。
Dr. Scott Gottlieb notes that it's not necessarily any cause for alarm regarding the president's health.
斯科特·戈特利布博士指出，這並不必然意味著總統健康令人擔憂。
Using Regeneron cocktail to treat Trump was a wholly appropriate call: Dr. Gottlieb
圖：用雷根龍雞尾製劑來治療川普是一個完全合適的做法:戈特利布博士
Former Food and Drug Administration commissioner Dr. Scott Gottlieb told CNBC on Friday he believes the White House carefully considered all of its treatment options before it opted to give President Donald Trump the experimental coronavirus antibody cocktail from Regeneron Pharmaceuticals.
前食品和藥物管理局專員斯科特·戈特利布博士周五告訴CNBC，他認為白宮在選擇給川普總統服用雷根龍製藥公司的實驗性冠狀病毒抗體雞尾製劑之前，已仔細考慮過所有的治療方案。
"This was a wholly appropriate decision to give him active therapy, and then it just became a choice of which therapy," Gottlieb said on "Fast Money," prior to Trump being taken to Walter Reed Medical Center "out of an abundance of caution" following his coronavirus diagnosis.
在川普被診斷出新冠病毒、「出於高度謹慎」被帶到沃爾特·裡德醫療中心之前，戈特利布在「快錢」節目中說，「給他進行積極治療是一個完全合適的決定，然後這就變成了一個選擇哪種治療的問題」。
"I wouldn't infer anything from the fact they chose the Regeneron product over another product — other than they probably had confidence looking at the data on the Regeneron product that it seemed to be the most effective of the products, given what they knew," added Gottlieb, who led the regulatory agency under Trump from May 2017 to April 2019.
「我不會因他們選擇雷根龍產品而不是另一種產品的事實去推斷任何東西——除了我們可推斷他們可能有信心看了雷根龍產品的數據、考慮過他們已知情況之後決定這似乎是最有效的產品，」戈特利布補充說，他在2017年5月至2019年4月期間領導川普領導下的這一監管機構。
Not everyone in the medical community agrees with Gottlieb about the decision to give Trump an experimental treatment. Some shared concerns about the preferential treatment provided to the president, as the drug has not been approved by federal regulators, and others pointed to the limited available data.
然而醫學界並不是每個人都同意戈特利布所說的給川普進行實驗性治療決定是正確的。一些人對這種向總統提供的優先待遇表示擔憂，因為該藥物尚未得到聯邦監管機構的批准，其他人則指出可用數據有限。
On Twitter, as one doctor commented, "V.I.P. medicine doesn't mean better medicine when there is no data."
在推特上，正如一位醫生評論的那樣，「在沒有數據的情況下，靜脈注射藥物並不意味著更好的藥物。」
Regeneron confirmed it provided a single, 8-gram dose of its REGN-COV2 treatment for use by the president, whose coronavirus diagnosis was announced just before 1 a.m. ET Friday. Regeneron's antibody drug is still experimental and has not received emergency use approval from the FDA, but it was provided in response to a compassionate use request.
雷根龍證實本公司提供了一劑8克的REGN-COV2治療藥物供總統使用，總統的冠狀病毒診斷是在美國東部時間周五凌晨1點前宣布的。雷根龍的抗體藥物仍處於試驗階段，尚未獲得FDA的緊急使用批准，但它基於同情性使用請求而提供給總統。
CNBC's Meg Tirrell on Friday reported that a "limited number of patients" had also received the drug on that basis after speaking with Regeneron's chief scientific officer, Dr. George Yancopoulos.
CNBC的梅格·提爾雷爾周五報告稱，在與雷根龍的首席科學官喬治·揚科普洛斯博士交談後，「有限數量的患者」也在此基礎上接受了該藥物。
On Tuesday, Regeneron said its REGN-COV2 treatment improved symptoms and reduced viral loads in non-hospitalized patients who have mild to moderate Covid-19. That was based on results for the first 275 trial patients.At the time, the company indicated it plans to "rapidly" discuss the early results with regulatory agencies, including the FDA.
周二，雷根龍表示，其REGN-COV2治療改善了輕度至中度新冠肺炎病的非住院患者的症狀，降低了病毒載量。這是基於第一批275名試驗患者的結果。當時，該公司表示，它計劃「迅速」與監管機構，包括美國食品和藥物管理局討論早期結果。
Regeneron is not the only company developing antibody drugs; Eli Lilly and GlaxoSmithKline also are testing monoclonal antibodies, which experts have viewed as a promising potential Covid-19 treatment.
雷根龍並不是唯一一家研發抗體藥物的公司；禮來和葛蘭素史克也在測試單克隆抗體，專家認為這是一種有希望的潛在新冠肺炎療法。
Regeneron's REGN-COV2 is an experimental shot of lab-generated antibodies that mimics how the body would mount a reaction to a foreign invader. The goal is to boost the immune system's defenses, rather than to wait on human biology to do its job.
雷根龍的REGN-COV2是實驗室產生的抗體的實驗藥劑，模擬人體對外來入侵者的反應。其目標是增強免疫系統的防禦能力，而不是等待人類生物機制來完成它的工作。
In a memo provided Friday by the White House, Trump's physician, Dr. Sean Conley, said the president was given Regeneron's antibody cocktail "as a precautionary measure." Conley also wrote that Trump "remains fatigued but in good spirits."
在白宮周五提供的一份備忘錄中，川普的醫生肖恩·康利博士表示，總統被給予雷根龍抗體雞尾酒「作為預防措施」。康利還寫道，川普「仍然疲憊不堪，但情緒很好。」
Trump also has a low-grade fever, NBC News reported Friday afternoon, citing three people familiar with his condition.
美國全國廣播公司(NBC News)周五下午報導稱，川普還患有低燒，NBC引用了三名熟悉他病情的人的話。
The White House did not immediately respond to CNBC's request for comment on the decision to give Trump the antibody drug.
白宮沒有立即回應CNBC對給川普抗體藥物的決定發表評論的請求。
Gottlieb said he thought that if Trump were going to receive any early treatments for Covid-19, it was likely to be Gilead Sciences' remdesivir. The antiviral drug has received emergency approval from the FDA, but for hospitalized coronavirus patients who are severely ill.
戈特利布說，他認為如果川普要接受新冠肺炎的任何早期治療，很可能是賈裡德科學公司的倫德西維爾。這種抗病毒藥物已獲得美國食品和藥物管理局的緊急批准，但適用於病情嚴重的住院冠狀病毒患者。
"I would have thought they would use remdesivir because there's more data around that drug at this point and we are seeing that drug be used earlier and earlier in the course of the disease," Gottlieb said, adding that he is "optimistic" about Regeneron's drug, but it's still very early.
「我本以為他們會使用瑞得西韋，因為在這一點上有更多的關於該藥物的數據，我們看到該藥物在疾病過程中被越來越早地使用，」戈特利布說，並補充說他對雷根龍的藥物「樂觀」，但現在下結論還為時過早。
"You might get a lot of benefit but you just don't know," he said.
「你有可能從中得益頗多，但你確實還不能確定結果，」他說。
However, Gottlieb pushed back on any suggestion that Trump receiving Regeneron's treatment should be cause for alarm.He said virtually any other American, at this point of their coronavirus diagnosis, would just be monitored by medical professionals, hoping symptoms don't intensify.
然而，戈特利布拒絕了任何所謂川普接受雷傑龍治療可能引起恐慌的任何提議。他說，幾乎任何其他美國人，在冠狀病毒診斷的這一點上，都會受到醫療專業人員的監測，都會希望症狀不會加劇。
"For a president of the United States, if you have available therapy, I think you deliver it, especially if you understand the safety profile of these products and you believe they are otherwise going to be safe and aren't going to worsen his condition," Gottlieb said.
「對於一位美國總統來說，如果你有可用的治療方法，我認為你應該提供它，尤其是如果你了解這些產品的安全性，並且相信它們是安全的，不會使他的病情惡化，」戈特利布說。
Some doctors are skeptical, however, of the decision to treat Trump with the antibody drug. "It is bad science, bad medicine and bad ethics to give unproven things to powerful people," wrote Dr. Vinay Prasad in a Twitter post.Prasad is an associate professor of medicine and practicing hematologist-oncologist at University of California San Francisco.
然而，一些醫生對用抗體藥物治療川普的決定持懷疑態度。維奈·普拉薩德博士在推特上寫道:「把未經證實的東西交給有權有勢的人是糟糕的科學行為、糟糕的醫學行為和糟糕的道德倫理。」普拉薩德是加州大學舊金山分校的醫學副教授和執業血液學家兼腫瘤學家。
"I will say that in no case have I heard of a patient, especially of the importance of the president, getting an experimental infusion of an antibody cocktail," added Seattle-based pulmonologist Dr. Vin Gupta on MSNBC, who also pressed for more information from the White House.
「我要說的是，在任何情況下我都沒有聽說過基於一個病人、尤其是總統的重要性，需讓病人接受一種抗體雞尾製劑的實驗性輸注，」西雅圖的肺學家萬·古普塔博士在談到MSNBC時補充說，他也要求白宮提供更多的信息。
In addition to Regeneron's antibody cocktail, the president is also taking zinc, Vitamin D and the histamine-blocker famotidine.
除了雷根龍的抗體雞尾製劑，總統還服用鋅、維生素D和組胺阻滯劑法莫替丁。
The famotidine treatment was "speculative" at this point, even though there are studies looking at whether it could be beneficial on coronavirus patients, Gottlieb said.
戈特利布說，法莫替丁的治療在這一點上是「推測性的」，儘管有研究在關注它是否對冠狀病毒患者有益。
"There are studies that suggest if you're low on Vitamin D, Vitamin D supplementation can be beneficial, but you'd want to be on Vitamin D prior to getting sick," he added. "I don't think any of those drugs are problematic or could cause harm, I just don't know that they're going to provide a treatment effect in this setting."
「有研究表明，如果你缺乏維生素D，補充維生素D可能是有益的，但你恐怕只想在生病前補充維生素D而不是事後，」他補充說。「我不認為這些藥物有任何問題或可能造成傷害，我只是不知道它們會在這種情況下能提供治療效果。」