Fetal Death

NIH findings may lead to insights on pregnancy complications, adult health BETHESDA, Md., May 2, 2025 /PRNewswire-HISPANIC PR WIRE/ -- What: The genes of male and female placentas have marked differences in how they are expressed, according to a study by researchers at the National Institutes of Health (NIH) and other institutions. These differences involve the presence or absence of tags on DNA known as methyl groups, which switch genes on or off without changing their structure. Understanding these DNA methylation patterns may inform future research on the higher risk for pregnancy complications involving male fetuses, such as stillbirth and prematurity, as well as later life health conditions that occur in adults who were born after a complicated pregnancy. Researchers analyzed male and female placental samples from a larger study for differences in their methylation patterns, and found differences in gene activity between male and female placentas that may play a role in birthweight and adult diseases. The study identified 2,497 previously unreported DNA sites that had different methylation patterns for males and females. Of these and more than 2,500 sites that had also been identified by previous studies, 66.9% of large increases in methylation occurred in DNA from male placentas and 33.1% from female placentas. Increases in methylation in male placentas was linked with greater neonatal size whereas those in females was linked with greater placental size. Some increases in methylation found in male placentas were located near the CCDC6 gene. Lower activation of CCDC6 has been linked with preterm birth in previous studies. Higher methylation near the FNDC5 gene was associated with lower expression of the gene in male placentas but not in female placentas. FNDC5 is involved with the manufacture of irisin, which protects the placenta from damage by reactive oxygen molecules and insulin resistance (cells' difficulty in using insulin to lower blood sugar.) Lower irisin levels have been associated with the pregnancy-related high blood pressure disorder, known as preeclampsia. Variations in the genes ATP5MG and FAM83A, expressed in female placentas, have been associated with asthma, hay fever, eczema (dry, itchy, inflamed skin) and higher risk for breast cancer later in life. Genetic factors influence the health differences between males and females, from before birth to later in life. Male fetuses grow faster than female fetuses and their pregnancies are more likely to be complicated by such conditions as preeclampsia (a hypertensive disorder of pregnancy), failure to grow at an adequate rate, and preterm birth. They also are more likely to die in the year after birth. Dysfunction of the placenta underlies many pregnancy complications and is thought to set the stage for male and female health differences that occur later in life. Variations in methylation patterns are thought to underlie many of these differences. The study was conducted by Fasil Tekola-Ayele, Ph.D., of the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and colleagues at other institutions. It appears in Nature Communications. Who: Fasil Tekola-Ayele, Ph.D., is available for comment on this study. Reference Tekola-Ayele F, et al. Sex-differentiated placental methylation and gene expression regulation has implications for neonatal traits and adult diseases. Nature Communications. DOI: 10.1038/s41467-025-58128-3 (2025) SOURCE Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Institutes of Health (NIH) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

第二任总统任期才将近百日，唐纳德·特朗普已把美国科学领域搅动地覆天翻。例如，根据新政府的提议，美国宇航局76亿美元的科研预算可能会被削减近一半。而在医药行业，冲击更加强烈且密集。就职典礼当天，特朗普发布行政命令，禁止任何与多样性、公平和包容性（DEI）相关的美国联邦拨款。作为一名医生和研究员，丽贝卡·西蒙斯感到十分震惊。这种在她五十多年职业生涯中闻所未闻的动荡，意味着对生命健康的巨大威胁。西蒙斯一直想弄清楚，为什么黑人女性更容易在怀孕期间出现并发症，包括死产、高血压和早产。但特朗普的禁令下，申请美国国立卫生研究院（NIH）的资金变得困难。“无法研究的影响深远，”西蒙斯表示，“忽视弱势群体在健康方面受到的影响差异，以及忽视试图理解这些影响原因的研究，将使这些群体面临极高的健康状况恶化风险。”自“二战”以来，美国政府资助的科学研究长期是发现和全球经济增长引擎之一，而科研领域的动荡对制药等行业不啻为釜底抽薪，因为创新药往往建立在公共资助的研究基础之上——NIH前院长弗朗西斯·柯林斯引用的一项研究显示，2010年至2019年期间，超过99%的获批药物由NIH资助。即使特朗普的政策被软化或逆转，其影响也可能是持久的。新政府的行动，动摇了数十年来人们的普遍观念：美国是一个坚实、资金充足、思想开放的研究环境。更何况，政策被软化或逆转的趋势并不明显。恰恰相反，3月，特朗普再次公开挑战美国宪政底线，声称自己“寻求第三个总统任期不是开玩笑”。如果2028年之后，特朗普还能第三次进入主白宫，那么美国医药行业上空的阴霾恐怕还会继续盘旋下去。此外，这种破坏性一定程度会加速创新资源等外流，重塑中国等其他国家在全球市场格局中的地位。1科学机构危矣已经有许多生命科学机构陷入混乱，例如拥有约2万名员工的NIH。从19世纪一间实验室起步，NIH如今发展成为一个举足轻重的生物医学巨头。2022年，NIH为医药行业提供的研究经费总额高达330亿美元——是排名第二的惠康基金会（Wellcome Trust）25倍之多。NIH的资助下，从基因编辑到mRNA技术的突破进入临床，推向市场。根据3月发表的一项研究，NIH每花费1美元，就能在美国国内创造2.56美元的新经济活动。而媒体初步报道，特朗普政府计划将NIH每年470亿美元的拨款削减约40%。NIH已宣布将削减其每年向研究人员提供的数十亿美元的拨款。当前，管理NIH的美国卫生与公众服务部（HHS），由长期对疫苗持怀疑态度的罗伯特·F·肯尼迪领导。自那以来，HHS解雇了NIH约1200人，其他员工则被调任或休假，少部分人重返工作岗位。NIH还因与安东尼·福奇的联系，而具有额外的政治象征意义。作为美国白宫COVID-19工作组的公众形象代言人，福奇有时会反驳特朗普关于病毒的说法。他成了“让美国再次伟大”（MAGA）运动中某些人憎恨的对象，埃隆·马斯克呼吁对他进行起诉。2022年12月，福奇从美国国家过敏与传染病研究所（NIAID）所长和总统首席医疗顾问的职位上卸任。而此次特朗普上台后，数日内就撤掉了福奇的安保人员。知情人士透露，目前，包括福奇盟友和同事在内的NIH高级官员正面临被调职的命运。福奇的妻子、NIH临床中心生物伦理学部门负责人克里斯汀·格雷迪，受到降职威胁并被行政休假。福奇的继任者、NIAID所长珍妮·马拉佐也面临同样的境况。意识形态驱动的冲突，正在吞噬其他卫生机构。3月，辞去FDA疫苗主管职务的彼得·马克斯，指责肯尼迪散布有关疫苗的“错误信息和谎言”。与此同时，这位HHS新掌门已取消旨在消除疫苗犹豫的项目。“反科学”观念正在酝酿。媒体称，肯尼迪已聘请长期批评疫苗的戴维·盖尔，后者曾因无证行医而受到处罚。盖尔一直宣扬疫苗接种与自闭症有关的观点，而事实上，支持这种说法的研究本身就被质疑。肯尼迪承诺将在9月之前找到“自闭症流行的原因”，这引起公众的警惕。一些批评政府人士将这些“清洗”行动，与20世纪50年代麦卡锡主义对被指控同情共产主义的公众人物的迫害进行比较。然而，密歇根大学名誉校长玛丽·苏·科尔曼认为，即使是这种比较，也无法完全体现当前情况的本质。“对我来说，这感觉就像一个几乎史无前例的时代。”科尔曼表示。2创新格局重塑正如瑞典皇家科学院候任院长斯文·利丁所指出的，“科学或许比其他任何事情都更依赖于可预见的、稳定的条件”。美国资助研究经费削减留下的巨大缺口，不太可能被公司、慈善机构来填补——它们既无意愿，更没有实力。美国生物技术创新组织（BIO）董事会成员，同时也是一家Biotech的首席执行官的杰里米·莱文，将NIH的拨款比作美国的高速公路系统。尽管高速公路是由美国联邦政府修建的，但没有高速公路，各行各业都无法运转。“历史告诉我们，基础科学是所有药物的基础。”莱文指出，从高血压治疗，到利用免疫系统开发的抗癌药物，这一系列治疗手段都离不开政府支持的数十年研究。长期来看，缺乏稳定研究环境的影响可能“非常严重”。许多人认为，随着时间推移，患者及其家属将深受其害。肯塔基州范德比尔特大学校长丹尼尔·迪尔迈尔表示，阿尔茨海默病患者依赖于大学实验室的研究工作。“如果减少资金，药物研发就会减少，”他说道，“这无法靠私人资金弥补。这不可能。那里的资金不够。”此外，尽管特朗普的第二任期才刚开始三个月，但打压科学的余波，已远远超出美国本土。莱文分析，削减开支可能会导致优秀从业者流向海外更具吸引力的地方，并最终导致科学领导地位被中国等其他国家占据。中国在材料科学和量子通信等领域跻身前列，这在很大程度上得益于国家资金的投入。批评人士认为，从地缘政治角度来看，限制美国的研究显得轻率，尤其是在特朗普正在其他领域（尤其是贸易领域）挑战中国的情况下。其他国家的机构，已开始主动为心存疑虑的美国研究人员提供避风港。而外国科学家也因一些事件而不敢前往美国，例如，一位法国研究人员因批评特朗普政府的科学政策而被拒绝入境。同写意特约评论员孟八一曾多年研究美国及全球制药工业也表示，特朗普政府这一系列事件，极有可能催生如此结果：在美从事生物研究的部分华人科学家或将失去工作、选择回国，同时带回在海外习得的经验、知识、项目，为中国创新药发展提供助力，于国内创新药项目的立项带来利好。但是，挑战也会随之而来。特朗普政府主导的脱钩运动波及科学领域。在此背景下，包括BD、并购，甚至去年以来风头颇盛的NewCo，均将迎来不确定性——届时，中国公司出海交易的数量或将有所减少，市场对交易标的的选取标准将更为严格。3沉默的大多数某种程度看，抗议运动愈演愈烈。3月，近2000名研究人员——包括数十名诺贝尔奖获得者——发表了一封公开信。信中写道：“我们此刻看到了真正的危险。我们发出这封求救信号，是为了发出明确的警告：国家的科学事业正在遭受重创。”科尔曼表示，大学是商业科学研究的“源泉”，但她没有听到很多首席执行官为之辩护：“我希望更多的公司能够站出来发声。”由于担心遭到强烈抵制，制药业高管基本上保持沉默。他们希望低调，同时努力应对该行业面临的其他威胁，包括关税和降低药价的政策。高管们声称，他们正与政府进行私下交谈，指出削减科研公共资助最终将对美国的全球科学地位造成的灾难性影响。除了商业公司，一些科研机构同样深陷困境。科学家们正在纠结，究竟是应该公开对抗政府，还是谨慎游说，满足政府的部分或全部要求。“捍卫科学”运动的创始人都是相对年轻的研究人员，这或许很能说明问题。例如，来自纽约非营利性冷泉港实验室的博士生艾玛·考特尼说，年轻的科学家正在“实时观察着我们的职业道路变化”。“学术界的长期成功很大程度上取决于早期的成果——拨款、奖学金、关键机会——而这些正是被削减的，”考特尼说，“虽然许多资深科学家给予了极大的支持，但他们往往面临着更少的激励，有时甚至更大的风险，因为他们不敢直接表达自己的观点。”一些研究人员觉得，人们的情绪正在转变。但要将最初对科学界剧变的愤怒，真正转化为动员起来的意愿和领导力，还尚需时日。至于大药企，也在尝试做出调整。并且从当前的公开行动看，它们更像是顺应而非反抗。根据孟八一分析，FDA、NIH员工及经费的缩减，关税战的升级，将会把压力传导至各家MNC，继而引发其新一轮管线布局调整。诺华本月宣布了一项230亿美元的投资计划，强生在3月份承诺了550亿美元的投资，礼来在2月份承诺了一项270亿美元的投资计划。 2月以来，礼来、强生药企已承诺在美新建生产基地，投资额分别为270亿美元和550亿美元。4月，诺华也宣布了一项230亿美元的投资计划。而最新表态的罗氏，将在未来五年内投资500亿美元用于制造和研发。参考资料：1.The cost of Trump’s attack on American science；THE FINANCIAL TIMES2.特朗普声言要寻求“第三任期”，真的可能吗？；端传媒3.FDA、NIH相继裁员，如何搅动中国创新药风云？；同写意4.Roche to spend $50bn on US manufacturing and R&D；THE FINANCIAL TIMES

MONDAY, March 17, 2025 -- Pregnant women can get the COVID-19 vaccine without any fear of causing birth defects in their unborn child, a new study says. Researchers found no link between COVID vaccination in early pregnancy and birth defects, results show. There were also no differences in birth defect risk between either the Moderna and the Pfizer/BioNTech vaccines, researchers reported in the journal Pediatrics . “These results support the safety of COVID-19 vaccination in early pregnancy,” concluded the research team led by Stacey Rowe , a postdoctoral fellow in infectious diseases at the University of California-San Francisco. The vaccine is recommended for pregnant women, because COVID infection during pregnancy has been linked to an increased risk of preterm birth, stillbirth and newborns requiring care in a neonatal intensive care unit, researchers said in background notes. However, some resistance to the vaccine has been reported due to concerns that it might cause birth defects, researchers noted. For the new study, researchers examined more than 78,000 pregnancies detailed in claims data from public and private health insurance providers. In all, 1,248 birth defects were noted among unvaccinated people and 199 among vaccinated folks, results show. Overall, there were no significant differences between birth defects in vaccinated and unvaccinated women. There were a little more than 160 birth defects per 10,000 live births among the unvaccinated, compared with 156 per 10,000 for women who were vaccinated, results show. The rate of birth defects didn’t change even if pregnant women received other recommended vaccines, such as the influenza or whooping cough shots, researchers said. The same was true if a pregnant woman caught COVID during pregnancy, researchers said. “The study’s findings are consistent with a growing body of literature supporting the safety of COVID-19 vaccines and their use in pregnancy, including in early periods of gestation,” researchers concluded. “Vaccine safety is a common concern for patients considering vaccination,” they wrote. “Provider recommendations are the most important predictors of person’s decision to vaccinate during pregnancy, even for those who have previously declined.” “Our findings can strengthen provider-to-patient discussions relating to the safety of COVID-19 vaccines during pregnancy,” the report continued. “Providers across all clinical and public health settings should recommend COVID-19 vaccination for their pregnant patients at any period of gestation.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.