所采取的实验性抗体治疗总统唐纳德·特朗普治疗新冠肺炎(新型冠状病毒肺炎)他称之为“治愈法”,是利用来自人类胎儿组织的细胞开发的,这是一项研究技术,但他的政府一直试图限制这项技术。
在特朗普将自己塑造成一名激烈的反堕胎候选人的总统选举之前,这一披露对开创性研究中胎儿组织和干细胞的伦理使用提出了新的问题。
“特朗普总统一直直言不讳地反对胎儿组织研究——他利用了这一点。美国国立卫生研究院人类胎儿组织研究伦理咨询委员会成员、加州大学圣地亚哥分校高级教师劳伦斯·戈尔茨坦说:“我认为这是极其虚伪的。
Regeneron鸡尾酒是用小鼠和仓鼠细胞开发的。但是抗体中和病毒的能力的有效性是用20世纪70年代流产胎儿的细胞系测试的。
Regeneron说,它不认为这种治疗依赖于胎儿组织,因为这些细胞是很久以前获得的。据专家称,293T细胞系在几十年的培养中不断分裂和生长,并用于科学发现,尽管它们来自胎儿组织。
雷根龙的一名发言人在一份声明中告诉美国广播公司,“它们被认为是‘永生化’细胞(而不是干细胞),是研究实验室中常见和广泛使用的工具”。细胞系“没有以任何其他方式使用,胎儿组织也没有在这项研究中使用。”
其他公司竞相寻找有效的治疗方法,最后疫苗反对小说冠状病毒,也利用了这些通常用于医学研究的细胞系。
2020年10月5日,美国总统唐纳德·特朗普在新冠肺炎接受治疗后,走出马里兰州贝塞斯达的沃尔特·里德医疗中心。
阿斯利康是目前开发疫苗的公司之一,该公司的一名发言人向美国广播公司新闻证实,他们在疫苗开发中使用了293T细胞系,并进一步强调,它“来源于生物研究中最常见的细胞系之一”。
《纽约时报》据报告的莫德纳也依赖于同样的细胞系。当被要求置评时,莫德纳的一名发言人告诉美国广播公司新闻,该公司“过去曾将此用于疫苗的实验室研究,但我们没有将此用于制造疫苗。”
2019年,政府暂停了对依赖选择性流产胎儿组织细胞的科学研究的联邦资助。流产的胎儿组织是允许的,尽管许多科学家说这很难使用,因为经常会有异常和其他问题。
但该政策允许使用从流产胎儿组织中提取的旧的现有细胞系,如Regeneron使用的细胞系。
“促进人类生命从受孕到自然死亡的尊严是特朗普总统政府的重中之重,”卫生和公众服务部在一份声明中说声明当时。"要求从选择性流产中获得新的胎儿组织的校内研究将不会进行."
当被要求发表评论时,白宫和一名高级卫生和公众服务部官员只会指出雷根龙的研究符合其2019年的政策,该政策允许以前建立的细胞系。
这位HHS官员在一份声明中说,政府关于在研究中使用选择性堕胎中的人类胎儿组织的政策明确排除了“已经建立的(截至2019年6月5日)人类胎儿细胞系”因此,使用2019年6月5日之前存在的现存细胞系制造的产品不会影响政府关于使用选择性流产的人类胎儿组织的政策。"
2020年10月10日,纽约塔里敦,雷根龙制药公司研发总部位于旧锯木河路。
夏洛特·洛奇尔研究所反对堕胎权和胎儿组织研究,称关于特朗普治疗的辩论“不知情”,并表示支持开发抗体鸡尾酒。
副总裁兼研究主任大卫·普伦蒂斯在周五的新闻发布会上说:“这些细胞本身并不是用来制造抗生素鸡尾酒的。”。普伦蒂斯也是美国国立卫生研究院胎儿组织伦理咨询委员会的成员,他告诉记者,这些研究是“独立于生产”治疗总统的鸡尾酒的。
“是的,这种药物仍然受到干细胞或流产胎儿组织细胞系的污染,”他说。“但它并没有像人们声称的那样受到污染,当然也不会让共和党人前后矛盾。”
到目前为止,这种新型冠状病毒还没有“治愈”的方法。一些治疗已经获得紧急授权。这抗体鸡尾酒由生物技术公司Regeneron制造的这款产品被认为很有前景,尽管仍处于试验阶段。
特朗普周三在椭圆形办公室前表示:“对我来说,这不是治疗,只是让我变得更好。”“我称之为治愈。”
科学家表示,无数重要的医学发现都依赖于类似的实验室培养细胞,这些细胞最初来自干细胞,这是一种特殊的“空白”细胞,通常取自人类胚胎或胎儿组织。
国际干细胞研究协会在7月份的一份报告中写道:“利用人类胎儿组织的研究对于挽救了数百万人生命的科学和医学进步至关重要,并且仍然是生物医学研究的重要资源。”信特朗普政府建立的新的胎儿组织伦理委员会。
“胎儿组织具有独特而有价值的特性,这些特性通常是其他细胞类型无法替代的,”该小组写道。
在2020年10月2日星期五雷根龙制药公司提供的视频中的这张未注明日期的图像中,在该公司位于纽约州的设施中,对小瓶进行了检查,以研究一种实验性冠状病毒抗体药物。
今年8月,HHS伦理委员会建议拒绝资助几乎所有涉及胎儿组织的提案:14项中有13项。根据委员会的报告,一个被批准的提议依赖于已经获得的组织,“不需要获得额外的组织”;还注意到“流产组织是HFT的可行替代物”
格拉德斯通研究所(Gladstone Institute)所长、国际干细胞研究学会(International Society for Stem Cell Research)前主席迪帕克·斯里瓦斯塔瓦(Deepak Srivastava)表示,重要的是要注意,如果特朗普政府的禁令在Regeneron使用的细胞系被制造出来时就已经到位——由此产生的创新是不可能的——包括测试特朗普接受的治疗。
斯利瓦斯塔瓦说:“这将无法制造我们已经拥有的药物——特朗普也不会收到这些抗体。”“我担心任何会减缓进一步发现的举措——因为我们仍处于这场流行病的中间。”
Trump's COVID-19 treatment developed using cells originally drawn from fetal tissue
The experimental antibody treatment taken byPresidentDonald Trumpto treatCOVID-19, which he called a "cure," was developed using cells derived from human fetal tissue -- a research technique that his administration has sought in general to limit.
The disclosure has raised anew questions about the ethical use of fetal tissue and stem cells in groundbreaking research, ahead of a presidential election in which Trump has cast himself as a fierce anti-abortion candidate.
"President Trump has been an outspoken opponent of fetal tissue research -- and he used it. I just think it's incredibly hypocritical across the board," said Lawrence Goldstein, member of the National Institutes of Health's Human Fetal Tissue Research Ethics Advisory Board and senior faculty member at the University of California at San Diego.
The Regeneron cocktail was developed using mouse and hamster cells. But the effectiveness of the antibody's ability to neutralize the virus was tested using a cell line derived from an aborted fetus in the 1970s.
Regeneron said it does not consider the treatment to have relied on fetal tissue, since the cells were acquired so long ago. The 293T line used continued to divide and grow within a culture for decades, and for use in scientific discovery, even though they originated from fetal tissue, according to experts.
They "are considered 'immortalized' cells (not stem cells) and are a common and widespread tool in research labs," a Regeneron spokesperson told ABC in a statement. The cell line "wasn't used in any other way, and fetal tissue was not used in this research."
Other companies racing to find effective treatments, and at last, avaccineagainst the novelcoronavirus, have also made use of these cell lines, which are commonly used in medical research.
President Donald Trump walks out of Walter Reed Medical Center in Bethesda, Md. after being treated for Covid-19, Oct. 5, 2020.
A spokesperson from AstraZeneca, one of the companies currently developing a vaccine, confirmed to ABC News their use of the 293T cell line in their vaccine development, further emphasizing, it is "derived from one of the most common cell lines used in biological research."
The New York Timesreportedthat Moderna is also relying on the same cell line. When reached for comment, a Moderna spokeswoman told ABC News that it has "used this in the past for laboratory research for the vaccine, but we do not use this for making the vaccine."
In 2019, the administration suspended federal funding for scientific research reliant on fetal tissue cells derived from an elective abortion. Fetal tissue from miscarriages are permitted under this statute, although many scientists say it's difficult to use because there are often abnormalities and other issues.
But the policy allowed older existing cell lines derived from aborted fetal tissue -- such as the one used by Regeneron -- to be used.
"Promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump's administration," the Department of Health and Human Services said in astatementat the time. "Intramural research that requires new acquisition of fetal tissue from elective abortions will not be conducted."
When asked to comment, the White House and a senior Health and Human Services official would only note that Regeneron's research complied with its 2019 policy, which allowed previously established cell lines.
"The Administration's policy on the use of human fetal tissue from elective abortions in research specifically excluded "already-established (as of June 5, 2019) human fetal cell lines," the HHS official said in a statement. "Thus, a product made using extant cell lines that existed before June 5, 2019 would not implicate the Administration's policy on the use of human fetal tissue from elective abortions."
The Corporate and Research and Development Headquarters of Regeneron Pharmaceuticals stands on Old Saw Mill River Road in Tarrytown, N.Y., Oct.10, 2020.
The Charlotte Lozier Institute, which opposes abortion rights and fetal tissue research, called the debate on Trump's treatment "uninformed" and expressed support for the development of the antibody cocktail.
"The cells were not used to create the antibiotic cocktail itself," David Prentice, vice president and research director, said on a Friday press call. Prentice also sits on the NIH fetal tissue ethics advisory board, and told reporters those studies were "separate from production" of the cocktail treating the president.
"Yes, the drug is still tainted by the stem cell or aborted fetal tissue line, cell line," he said. "But it's just not tainted in any of the ways that people claim that it is, and certainly not in a way that makes Republicans inconsistent."
As of yet, there is no known "cure" for the novel coronavirus. Some treatments have been given emergency authorization. Theantibody cocktailgiven to the president -- made by biotech company Regeneron -- is thought to be promising, though still in its experimental phase.
"To me it wasn't therapeutic, it just made me better," Trump said from in front of the Oval Office Wednesday. "I call that a cure."
Scientists say countless important medical discoveries have relied on similar lab-grown cells that were originally derived from stem cells, special "blank-slate" cells usually taken from human embryos or fetal tissue.
"Research using human fetal tissue has been essential for scientific and medical advances that have saved millions of lives, and it remains a crucial resource for biomedical research," the International Society for Stem Cell Research wrote in a Julyletterto the new fetal tissue ethics board established by the Trump administration.
"Fetal tissue has unique and valuable properties that often cannot be replaced by other cell types," the group wrote.
In this undated image from video provided by Regeneron Pharmaceuticals on Friday, Oct. 2, 2020, vials are inspected at the company's facilities in New York state, for efforts on an experimental coronavirus antibody drug.
In August, the HHS ethics board advised rejecting funding for nearly every proposal involving fetal tissue: 13 out of 14. The one approved proposal relied on tissue already acquired, "with no need to acquire additional tissue," according to the board's report; it is also noted that "tissue from miscarriage was a viable alternative to HFT."
Deepak Srivastava, president of the Gladstone Institute and immediate past president of the International Society for Stem Cell Research, said it's important to note that if the Trump administration's ban was in place when the cell line Regeneron uses was made -- the innovations that have come from it would not have been possible -- including testing the treatment Trump received.
"That would not be available to make the drugs that we've had -- and Trump would not have received those antibodies," Srivastava said. "And I am worried about any moves that would slow further discovery -- because we're still in the middle of this pandemic."
来源:https://abcnews.go.com/Politics/trumps-covid-19-treatment-developed-cells-originally-drawn/story?id=73508455&cid=clicksource_4380645_9_film_strip_icymi_hed