據《華爾街日報》報導,美國國立衛生研究院(National Institutes of Health)3月16日稱,生物科技公司Moderna Inc. (MRNA)針對新型冠狀病毒的試驗性疫苗已開始首次人體測試。對於全球首次針對新型冠狀病毒的疫苗人體試驗在美國啟動一事,專家表示,美國這一針實在太快了,除非很早就開始進行試驗,更早的拿到了病毒株。美國疫苗人體試驗為何進行得如此之快?美國是什麼時候通過什麼方式獲得的毒株?
據美國《紐約時報》報導,在由副總統邁克·彭斯領導美國防疫工作之後,白宮於當地時間2月27日開始,加強了對新冠病毒資訊“發聲”的控制。包括美國國立衛生研究院(NIH)過敏和傳染病研究所(NIAID)主任、美國疾控中心(CDC)頂級傳染病專家安東尼·福西(Anthony S. Fauci)在內的眾多科學家和政府衛生官員被要求:只有與美國副總統辦公室協調商議後,才能發聲明或公開露面談論新冠病毒的相關話題。為什麼號稱言論自由的美國不允許專家學者自由公開討論新冠病毒?是想隱瞞什麼還是在害怕什麼?
7.全球首個啟動新冠疫苗人體試驗,這麼快是怎麼拿到毒株的?
據《華爾街日報》報導,美國國立衛生研究院(National Institutes of Health)3月16日稱,生物科技公司Moderna Inc. (MRNA)針對新型冠狀病毒的試驗性疫苗已開始首次人體測試。對於全球首次針對新型冠狀病毒的疫苗人體試驗在美國啟動一事,專家表示,美國這一針實在太快了,除非很早就開始進行試驗,更早的拿到了病毒株。美國疫苗人體試驗為何進行得如此之快?美國是什麼時候通過什麼方式獲得的毒株?
9.不許美國專家學者隨意公開談論新冠病毒,是想幹什麼?
據美國《紐約時報》報導,在由副總統邁克·彭斯領導美國防疫工作之後,白宮於當地時間2月27日開始,加強了對新冠病毒資訊“發聲”的控制。包括美國國立衛生研究院(NIH)過敏和傳染病研究所(NIAID)主任、美國疾控中心(CDC)頂級傳染病專家安東尼·福西(Anthony S. Fauci)在內的眾多科學家和政府衛生官員被要求:只有與美國副總統辦公室協調商議後,才能發聲明或公開露面談論新冠病毒的相關話題。為什麼號稱言論自由的美國不允許專家學者自由公開討論新冠病毒?是想隱瞞什麼還是在害怕什麼?
「英國南安普敦大學(University of Southampton)的這份研究顯示,如果在中國起初隱瞞病毒具傳染性的1月初就祭出防疫策略,疫情擴散將會減少95%...但在歷經數週訊息打壓後,中國政府1月20日才正式宣布此發現。如果中國境內能提早一週、兩週、三週採取防疫措施,確診病例將可分別減少66%、86%、95%。」
而且,該論文旨在分析中國防疫措施的具體成效,對之高度評價,就如該論文第一作者 Shengjie Lai 所說,「我們的這項研究顯示,任何一個國家,當它面對突然其來的疫情爆發時,採取迅速果斷的系統性防疫措施,在每一道防線上阻斷疾病的擴散,至關重要。我們的研究亦同時表明:中國政府在疫情初發之際,在極短的時間內做出全面性的決策反應,大大降低了疫情對於公眾健康的巨大潛在衝擊。」(Our study demonstrates how important it is for countries which are facing an imminent outbreak to proactively plan a coordinated response which swiftly tackles the spread of the disease on a number of fronts," the study's lead author, Shengjie Lai, added at the time. "We also show that China's comprehensive response, in a relatively short period, greatly reduced the potential health impact of the outbreak.") 台灣的無恥記者卻居然能睜眼說瞎話,完全說成相反的意思。
該研究並說:「中國具有魄力的多面向防疫措施,有效預防了疫情的全球蔓延,避免了更慘烈的後果。我們從中國所學到的各項強而有力的證據,一再為全球防疫戰鬥提供了寶貴經驗。」("China's vigorous, multifaceted response is likely to have prevented a far worse situation, which would have accelerated spread globally. The lessons drawn from China provide robust evidence and provide a preparation window and fighting chance for containing the spread of COVID-19 in other regions around the World.")
最後,它建議中國政府至少應部份維持現有的防疫措施至少數個月,避免疫情捲土重來。研究者相信,他們從中國成功防疫的這項全面性研究中,具體分析了不同階段的不同防疫作法,這將能夠提供給其它國家做為一種防疫指南。("The results here provide some guidance for countries as to the likely effectiveness of different NPIs at different stages of an outbreak." )
此外,一如Peter Law 教授的想法,我相信,新冠病毒就是一場來自美國的生物戰。戰爭不是兒戲,從來沒有一場戰爭只打一回合兩回合就罷手,就如同一顆墜落的石頭必有最後的轟然巨響而不會停留在半空中;往後一定花樣百出,打到分出勝負為止。這場鬥爭或戰爭,善惡如此明顯。我不知道在一個如此卑鄙險惡的時代中,一個平民百姓能夠做些什麼,但我毫無疑問會站在善的這一邊;美國橫行霸道無惡不作的日子,應該讓它儘快成為過去。
閱讀 Peter K. LAW 這篇文章,即便是對於一個臨床醫生來講,都仍具有相當的難度,何況一般人。但是,如果暫且不論專業核心細節,它其實並不難理解,只是需要一點閱讀上的專注與耐心。也就是說,諸如像這樣一篇文字,不外包含三個部份,一是專業核心細節,二是綜合性論點,三是各種相關背景事實。做為一個外行人,至少可以看懂二和三,並且從文章所附之文獻能找到更多理解問題的管道。
從1998年的病毒穿梭載體P-shuttle SN Vector到現在的常規散佈短回文重複序列簇(CRISPR)基因編輯技術,2019新型冠狀病毒的原型SHC014CoV是病毒基因工程的雛形,也是致命的。這是最好的生化武器...這項發明對人類和蝙蝠都沒有好處;如果不加以控制,將會導致數以百萬計的人和蝙蝠的死亡。
波義耳教授的職責正是監督美國的生物戰。據波義耳說,"功能獲得性突變"(GOF)是一種能夠將危險生物戰物質或病原體進行“渦輪增壓”的DNA基因工程技術。在亞歷克斯•鐘斯節目(Alex Jones Show)上,他談到了12個在美國擁有許多生物安全3級生物安全4級(BSL3BSL4)實驗室的戰爭基地,這些實驗室專門從事生物戰武器方面的系統工程,北卡羅萊納州教堂山德特裏克堡的生物安全3級生物安全4級(BSL3BSL4)戰爭實驗室就是其中之一。
[譯注1]
羅蓋(Peter K. LAW):《2019冠狀病毒大瘟疫(COVID-19):起源、影響與治療》(COVID-19 Pandemic: Its Origin, Implications and Treatments),《再生醫學開放雜誌》(Open Journal of Regenerative Medicine),第9卷(2020年),第43~64頁。2020年04月08日收稿;2020年04月18日接受;2020年04月21日發表。漢譯版由錢學森學派生命系統工程平臺、社會系統工程平臺及北京實現者社會系統工程研究院官網之“抗疫系統工程頻道”授權首發。
他因為在遺傳研究方面的貢獻,於2007年、2009年先後被授予美國白宮頒發的總統自由勳章(Presidential Medal of Freedom)和國家科學獎章(National Medal of Science)。他長久以來對科學和信仰兩者之間的邊緣區域感興趣,他曾在《上帝的語言:一個科學家呈現信仰的證據》(自由出版社2006年版)中寫過相關內容,這本書曾持續數周登上紐約時報暢銷榜。他還著有《生命的語言:DNA和個性化醫療革命》(哈珀柯林斯2010年版)。
從1998年的病毒穿梭載體P-shuttle SN Vector到現在的常規散佈短回文重複序列簇(CRISPR)基因編輯技術,2019新型冠狀病毒的原型SHC014CoV是病毒基因工程的雛形,也是致命的。這是最好的生化武器。它以科學的眼光和熱情實施,發明人為其發明在資金和發表方面獲得了應有的支援。然而,這項發明對人類和蝙蝠都沒有好處;如果不加以控制,將會導致數以百萬計的人和蝙蝠的死亡。
波義耳教授的職責正是監督美國的生物戰。據波義耳說,"功能獲得性突變"(GOF)是一種能夠將危險生物戰物質或病原體進行“渦輪增壓”的DNA基因工程技術。在亞歷克斯•鐘斯節目(Alex Jones Show)[47]上,他談到了12個在美國擁有許多生物安全3級生物安全4級(BSL3BSL4)實驗室的戰爭基地,這些實驗室專門從事生物戰武器方面的系統工程,北卡羅萊納州教堂山德特裏克堡的生物安全3級生物安全4級(BSL3BSL4)戰爭實驗室就是其中之一。
血清療法在19世紀末就已經出現了。事實上,1901年諾貝爾獎授予埃米爾•馮•貝林(Emil von Behring),以表彰他在這方面的開創性工作。馮•貝林博士負責用馬血清療法戰勝德國白喉疫情。當時沒什麼設備,他用冰為病人取凝結的血清,這對他來說是一個巨大的勝利。馮•貝林博士開闢了免疫學領域,使科學家和醫生都能瞭解許多疾病的發病機理和治療方法。
在2009年甲型H1N1流感(H1N1pdm09)病毒感染的患者,孔和他的同事進行的一項前瞻性佇列研究顯示,接受康復期血漿治療的患者的相對死亡率(比值比0.20[95% CI 0.06–0.69],p=0.01)顯著降低[74]。此外,在亞組分析中,從重症監護病房入院後的第3、5和7天,康復期血漿治療後的病毒量顯著減少。未觀察到不良反應。孔和他的同事進行了一項多中心、前瞻性、雙盲、隨機對照試驗結果顯示,使用從甲型 H1N1pdm09 流感病毒感染中痊癒患者的康復期血漿治療甲型H1N1流感的嚴重感染患者,在症狀出現後5天內病毒量減少,死亡率降低[75]。
讓我們重溫一下免疫學之父埃米爾•阿道夫•馮•貝林(Emil Adolph von Behring)的智慧。1917年脊髓灰質炎流行期間,阿莫斯(Amoss)和切斯尼(Chesney)證明,在脊柱內和靜脈注射康復期血清可顯著降低危重病人的癱瘓率、死亡率、症狀嚴重程度和住院時間[80]。病程中越早使用適量血清,就越有可能受益。應根據臨床檢查——腦脊液的顯微鏡和化學研究結果決定是否使用血清。12~24小時後再次注射可能更有利;可根據體溫變化決定再次注射時間。
盧克(Luke)和同事進行統合系統分析發現涉及1918年~1925年間輸注了流感康復期人類血液製品的1703名1918年流感肺炎患者的8項研究,顯示在低偏差風險下,總體粗略病死率絕對下降了21% (95% CI 15-27;p<0.001) [81]。
在埃米爾•馮•貝林(Emil von Behring)博士首次證明血清療法對白喉治療有效後,半個世紀以來,血清療法成功地用於治療許多傳染病(炭疽病、鼠疫、猩紅熱、麻疹、土拉熱病、白喉、痢疾、腦膜炎球菌性腦膜炎、狂犬病、肺炎球菌性肺炎)。隨著抗生素療法的出現,以及考慮到動物來源的血清和全血清的不良反應問題,血清療法遭受普遍的冷遇。然而,人類和動物來源的免疫球蛋白仍然是治療各種疾病(細小病毒、巨細胞病毒、乙型肝炎、狂犬病、甲肝、肉毒中毒、毒血症等)的重要方法。
這些便是2019冠狀病毒病的治療、起源與影響:好的,壞的、醜陋的。在我們創建這個非常重要的生物醫學領域30年後,吉娜•柯拉塔(GinaKolata)或其他人也許會利用這個平臺,讓我與威廉•弗蘭奇•安德森(William French Anderson)和法蘭西斯•柯林斯(Francis Collins)討論基因療法。
致謝羅蓋(Peter K. LAW)係中國的國家特聘專家,本項工作獲肌母細胞醫學研究院(武漢)支持。
利益衝突聲明作者聲明本論文的發表不存在利益衝突。
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華裔科學家羅蓋(Peter K. LAW)教授,是人類基因治療及體細胞治療(Human Gene Therapy and Somatic Cell Therapy)的世界首創者。他是一位站在世界細胞治療、基因治療前沿的,具有極高創造性、極強研發實力、理論緊密結合實踐、知行合一的世界著名科學家。他於1990年在世界著名醫學雜誌《柳葉刀》(Lancet)發表的世界第一篇人體肌母細胞移植治療杜興氏肌萎縮症(DMD)的論文,成為世界人體細胞移植治療創始人和人基因治療創始人,比世界上號稱“基因治療之父”的美國病毒基因治療學家W. French Anderson的工作早2個月,比其發表論文早2年;同年,他開創了用肌母細胞治療肌肉萎縮的美國食品藥品監督管理局(U.S. Food and Drug Administration, FDA)FDA I~ III期臨床試驗,並獲FDA快速通道及五年收費許可。
美國食品藥品監督管理局(U.S. Food and Drug Administration, FDA)於1993年制定的FDA細胞標準,與羅蓋1990年~1993年期間發表的研究報告一致,沿用至今。
圖為美國食品藥品監督管理局(FDA)根據美國聯邦法規,多次審查通過羅蓋教授(Peter K. LAW)發明的新藥臨床試驗申請(IND),准許進行臨床試驗及收費的官方文件。(圖見原文)
羅蓋教授通過40多年對變性衰退肌肉的基礎機制、病理學及概念證明的研究,在世界上首創肌肉和血管同時再生的醫療平臺技術。該技術主要應用於醫治藥物療效不好的肌肉萎縮、實體癌、心臟病、II型糖尿病、衰老及美容等領域。臨床試驗證明了人肌母細胞移植治療是再生藥物的高科技平臺技術。
83歲的英國劍橋科學家Sir John B. Gurdon 因證明青蛙體細胞核移植後能重複表達所有基因,而榮獲2012年諾貝爾生理學或醫學獎。羅蓋教授于20世紀70年代在世界上發表的動物實驗論文以及1990年他在《柳葉刀》(Lancet)雜誌發表的用健康人肌母細胞移植治療基因缺陷的杜興氏肌萎縮症(DMD)病人的結果,均充分證明了正常肌母細胞移植到基因缺陷的肌肉內,不僅可以有正常的基因重複表達,而且能修復因基因缺陷而退化的肌細胞,達到治療遺傳病的目的。
(1) Open Journal of Regenerative Medicine (《再生醫學開放雜誌》)主編。
(2) Recent Patents On Regenerative Medicine (《再生醫學最新專利》)副主編。
(3) Gene Therapy and Molecular Biology (《細胞治療與分子生物學》雜誌)編輯。
(4) Cell Transplantation (《細胞移植》雜誌) (影響因數6.2)副主編。
3. 主要專業研究與技術研發、治療實踐
1965年,羅蓋以優異的成績考上了加拿大麥吉爾大學,3年後以優異的成績獲得麥吉爾大學(McGILL University)的榮譽學士學位,並考入加拿大多倫多大學(University of Toronto)的研究所,師從世界知名無脊椎動物神經肌肉電生理專家Harold Atwood教授,開始了對哺乳動物肌肉萎縮的研究。
1979年,羅蓋升任美國田納西大學(University of Tennessee Memphis)醫學院的神經內科和生理學系副教授;2年後,在劇烈競爭下取得終身教授職位。
1988年,羅蓋升任美國田納西大學(University of Tennessee Memphis)醫學院神經內科和生理學系正教授。
1990年7月14日,羅蓋在《柳葉刀》(Lancet)雜誌上發表了世界上第1篇人體肌母細胞移植治療杜興氏肌萎縮症(DMD)的論文,成為世界人體細胞移植治療創始人和人基因治療創始人。此文的發表比世界上號稱“基因治療之父”的美國病毒基因治療學家W. French Anderson的工作早2個月,比其發表論文早2年。同年,羅蓋開創了用肌母細胞治療肌肉萎縮的美國食品藥品監督管理局(U.S. Food and Drug Administration, FDA) FDA I~ III期臨床試驗,並獲FDA快速通道,及5年收費許可。
1991年,羅蓋在美國創辦了世界第1個細胞治療研究基金會(Cell Therapy Research Foundation)。
1992年,羅蓋與另幾位科學家在世界上共同創辦細胞移植協會。
1993年,美國食品藥品監督管理局(U.S. Food and Drug Administration, FDA)制定的細胞標準,與羅蓋1990年~1993年期間發表的研究報告一致,沿用至今。
5 主要論文及著作
1. Law, P.K. and H.L. Atwood. Cross-reinnervation of dystrophic mouse muscles. Nature (《自然》雜誌), 238:287–288, 1972. (IF 42.3)
2. Law, P.K. et al. Dystrophin production induced by myoblast transfer therapy in Duchenne muscular dystrophy. Lancet (《柳葉刀》雜誌), 336:114–115, 1990. (IF 39.2)
5. Ye L, Haider H Kh, Tan R, Toh W, Law P K, Tan WB; Su L, Zhang W, Ge R, Zhang Y, Lim YT, Sim EKW. Transplantation of nanoparticle transfected skeletal myoblasts overexpressing vascular endothelial growth factor-165 for cardiac repair. Circulation (《迴圈》雜誌), 2007;116:I113-20. (IF 15.3)
6. Saito, A., Law, P.K., S. Fleischer. Ultrastructural study of nervemuscle interaction at the neuromuscular junctions of normal and dystrophic mice in parabiosis. Journal of Cell Biology (《細胞生物學雜誌》),. 75:112a, 1977. (IF 9.9)
7. Ye Lei, Lee KO, Haider Kh H, Law PK, Su L, Deng W, Zhang W, Sim EK. The effect of skeletal myoblast transplantation on hyperglycemia and glucose tolerance in a diabetic mouse model. Diabetes (《糖尿病》雜誌), 2006; 55(S1): A616. (IF 8.9)
8. Ye L, Haider H K, Tan R, Su LP, Law P K, Zhang W, Sim E K W. Angiomyogenesis using liposome based vascular endothelial growth factor165 transfection with skeletal myoblast for cardiac repair. Biomaterials (《生物材料》雜誌), 2008;29:2125-37. (IF 7.9)
9. YeL;LeeKO;SuLP; Toh W C; Haider H K; Law P K;Zhang W; Chan S P;Sim E K W. Skeletal myoblast transplantation for attenuation of hyperglycaemia,hyperinsulinaemia and glucose intolerance in a mouse model of type 2 diabetes mellitus. Diabetologia (《糖尿病學》雜誌), 2009;52:1925-34. (IF 6.97)
10. Law, P.K., T.G. Goodwin, Q. Fang, V. Duggirala, C. Larkin, J. A. Florendo, D.S. Kirby, M.B. Deering, H.J. Li, M. Chen, T.J. Yoo, J. Cornett, L.M. Li, A. Shirzad, T. Quinley, and R.L. Holcomb. Feasibility, safety, and efficacy of myoblast transfer therapy on Duchenne muscular dystrophy boys. Cell Transplantation (《細胞移植》雜誌), 1: 235–244, 1992. (IF 6.2)
11. Peter K. LAW: System Engineering of EmergentSerum Therapy to Combat COVID-19 and Other Pathogenic Pandemics, OpenJournal of Regenerative Medicine (《再生醫學開放雜誌》), Vol.9 (2020), page 8~14.