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标题: 欧洲麻醉界曝大型丑闻：伪造的科研成果成英国麻醉医师指南？ [打印本页]
作者: 华西小卒 时间: 2011-3-5 20:30
标题: 欧洲麻醉界曝大型丑闻：伪造的科研成果成英国麻醉医师指南？
本帖最后由 华西小卒 于 2011-3-6 09:05 编辑
伪造的科研成果成英国麻醉医师指南？
欧洲曝大型医疗丑闻，数百万病人被使用或致肾衰竭的药物
2011年3月5日 成都商报电子版
据《每日电讯报》3月3日消息，德国一名顶级麻醉医师伪造研究数据，他的研究成果被应用于英国麻醉医师医学指南，导致数百万接受外科手术的病人被使用有争议的药物。目前，警方已经对该麻醉医师展开犯罪调查。
57岁的约阿希姆·博尔特供职于德国路德维希港医院，被认为是静脉注射药物研究方面的专家，他的研究成果广泛地刊登在欧洲各大医学刊物上。现在他由于伪造研究数据嫌疑，已经被医院解雇。
据了解，约阿希姆是羟乙基淀粉注射液的极力推崇者，但他涉嫌从10年前开始收取羟乙基淀粉生产商的赞助。在英国麻醉医师医学指南上，该药物被用于外科手术中促进病人血容量。但最近研究表明，羟乙基淀粉氯化钠注射液用于外科手术中可能导致肾衰竭，失血过多，心脏衰竭等问题而增加死亡风险。该药物目前已经被取消使用。
这次事件是继去年安德鲁·维克菲尔德医生伪造“麻疹疫苗导致孤独症”研究数据丑闻后的又一大医学丑闻。(国际台)
作者: jiang535 时间: 2011-3-5 20:49
麻醉中是否还适用？
作者: feiliu2005 时间: 2011-3-5 20:58
羟乙基淀粉？D-130?很常用的胶体啊，到底还能不能继续用呢
作者: wpy7696 时间: 2011-3-5 22:25
羟乙基淀粉是现在术中特别好的液体！此消息究竟可靠与否
作者: 谢燕斌 时间: 2011-3-5 22:27
真的假的啊！！
我们羟乙基用的很多啊
作者: 华西小卒 时间: 2011-3-6 08:56
本帖最后由 华西小卒 于 2011-3-6 08:58 编辑
羟乙基淀粉是现在术中特别好的液体！此消息究竟可靠与否
wpy7696 发表于 2011-3-5 22:25
信息来源于英国的每日电讯报，提供详细的原始新闻链接，有空闲的战友请翻译下，对麻醉界战友息息相关的一个爆炸性新闻：
http://www.telegraph.co.uk/health/8360667/Millions-of-surgery-patients-at-risk-in-drug-research-fraud-scandal.html
Millions of surgery patients at risk in drug research fraud scandalMillions of NHS patients have been treated with controversial drugs on the basis of "fraudulent research" by one of the world's leading anaesthetists, The Daily Telegraph can disclose.
Guidelines for British anaesthetists regarding colloids are being revised after it emerged that four of the key studies on which they were based are to be formally retracted Photo: ALAMY
By Heidi Blake, Holly Watt and Robert Winnett 10:31PM GMT 03 Mar 2011 Comments
Joachim Boldt is at the centre of a criminal investigation amid allegations that he may have forged up to 90 crucial studies on the treatment. He has been stripped of his professorship and sacked from a German hospital following allegations about his research into drugs known as colloids.
Experts described Mr Boldt's alleged forgeries as possibly the biggest medical research scandal since Andrew Wakefield was struck off last year for falsely claiming to have proved a link between the MMR vaccine and autism.
Guidelines for British anaesthetists regarding colloids – used to boost blood volume in patients undergoing surgery – are being revised after it emerged that four of the key studies on which they were based are to be formally retracted.
Mr Boldt, 57, was regarded as a leading specialist in intravenous fluid management, and his work was published widely in British medical journals.
He claimed to have proved that colloids were as safe as other, similar treatments despite earlier studies showing them to be more dangerous. Mr Boldt's alleged forgeries date back up to a decade.
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The Consensus Guidelines on Intravenous Fluid Therapy, published by six British medical groups including the Association of Surgeons and the Intensive Care Society, were being withdrawn last night. Prof John MacFie, president of the Association of Surgeons, suggested that some British patients could have been put in danger. He said he would urge other medics to abandon colloids.
"We have withdrawn the guidelines from our website and we will need to rewrite the article," he added. "The profession I represent does not want to be to be associated with potentially fraudulent research.
"Some people are comparing this to the Andrew Wakefield scandal. What Wakefield did had terrible implications on children's lives, and the principle of this is the same." As chief anaesthetist at Ludwigshafen Hospital in the Rhineland, Mr Boldt was the leading advocate of colloids, which are now commonly used across Europe.
He published dozens of papers "proving" their benefits and contradicting studies which suggested they could increase the risk of death in surgery and cause kidney failure, severe blood loss and heart failure.
German medical authorities are scrutinising 92 of his key publications and a criminal investigation is under way into allegations that he forged documents, tested drugs on patients without their consent and fraudulently claimed payments for operations he had never performed.
Mr Boldt received funding from manufacturers of hydroxyethyl starch (HES) – the colloid he most strongly advocated – including B. Braun, Baxter and Fresenius Kabi.
He was frequently paid to speak at international medical conferences where he hailed HES as "the holy grail" of fluid drugs.
HES and other colloids are up to 10 times more expensive than the alternative fluid management drugs, crystalloids, which some experts believe are safer as they contain smaller molecules and are more easily absorbed. Mr Boldt was sacked from Ludwigshafen Hospital last November. It has established an investigating commission to review 29 of the 92 papers which have been identified as "highly suspected" of containing forged or distorted data. The others will be examined if serious evidence of forgery is found.
Prof Eike Martin, head of the investigating commission, told The Telegraph: "At first we thought that all the studies were 100 per cent invented, but now we have found a huge amount of clinical data from trials that were conducted.
"Our suspicion is that the trials are not reported accurately in the papers. Prof Boldt was an advocate for colloids and that was the conclusion of his studies, but the data he published is different from the original data we have seen.”
Prof Martin said investigators examining one study, which purported to show that HES caused less inflammation than another fluid management drug, had found that the original data contradicted the conclusion.
The editors in chief of a consortium of medical journals which published Mr Boldt’s work are also reviewing the 92 publications.
Sources close to the investigation said that the editors would announce the formal retraction of 89 papers next month.
Rhineland state prosecutors are investigating Mr Boldt over allegations that he forged the signatures of his alleged “co-authors” on his studies, conducted drugs trials without official approval and claimed money for operations that he never performed. Police raided his home and his offices at the hospital in December and seized paperwork and computers.
Lothar Liebig, the state’s director of public prosecutions, said: “Boldt
published certain studies about medical drugs in order to get them accepted.
“There there is a strong suspicion that he deliberately failed to obtain the approval of the institutional review board in Ludwigshafen, which is a criminal offence.”
Other medical research has contradicted Mr Boldt’s findings.
Research by Dr Gill Schierhout and Dr Ian Roberts of University College London found in 1998 that the use of colloids during surgery increased the risk of death by four percentage points – equivalent to four extra deaths in every 100 patients.
A review published 10 years later by Konrad Reinhart and Christiane Hartog of Friedrich Schiller University in Jena, Germany cited two large-scale clinical trials which found that HES could prevent the blood from clotting, which can cause heavy bleeding. Other studies have shown that some colloids can result in complications including heart and kidney failure, fluid entering the lungs and anaphylactic shock.
Suspicion first fell on Mr Boldt in October when readers of an article that he had published in the US journal Anesthesia and Analgesia, about the benefits of HES in bypass surgery, noticed that the pattern shown by his data was “too perfect to be believed”.
Dr Rupert Pearse, a senior lecturer in intensive care medicine at Barts and the London School of Medicine, and co-author of the British guidelines on fluid drugs, said last night: “I specifically remember looking at a paper of his last year and being surprised at how lucky he had been with his results.
“For me, it shakes the world I work in and makes me feel less confident in it, and if I were a member of the public I would feel the same.”
Mr Boldt was unavailable for comment.
作者: 华西小卒 时间: 2011-3-6 09:02
胶体在麻醉中的应用有越来越泛滥之势，一些所谓的麻醉学家们狂热地鼓吹胶体的好处，这背后是否有同样的利益交换(Mr Boldt received funding from manufacturers of hydroxyethyl starch (HES) – the colloid he most strongly advocated – including B. Braun, Baxter and Fresenius Kabi.)？作为临床一线医生，我们应该正视胶体的负面作用了。
作者: donggua2214 时间: 2011-3-6 11:22
那美国的贺斯呢？
作者: 心超 时间: 2011-3-6 13:20
标题: 中国青年麻醉医生都来反思-真正的科研是什么
听到这样一个令人震惊的新闻反倒很平静：我们中国青年麻醉医生应该思考什么？
首先我们不必大惊小怪，让我们一起深刻反思一下，在当今的社会历史条件下，每一个
都会有两种本能的精神状态，自信和他信，这两种精神状态让人拥有自由和信仰的统一，
是人类社会发展的精神动力所在，绝对自信和绝对相信别人都不能让人获得自由；在科学产生之前
人类的信仰只能是宗教，这是一种主观的自由状态，然而仅仅是少数人驾驭他人思想的自由，
整个人类是没有真正意义上的自由的。在科学产生之后，人类区分了哲学和宗教，
相信自然科学是独立于我们之外的客观规律，人类懂得了自然辩证法，而且相信科学通往全人类自由的必由之路，
然而这条路充满荆棘与坎坷，会遇到各种保守思想的阻挠，现有的社会生产关系不会因为青年人看到了自由之路而畅通！
这条路上有一个一个拦路虎：被动的学历、被动的学位、被动的编制、职称论文、职称SCI、职称课题......，
我们为什么要逼着临床医生放这宝贵的临床病案不去总结，而去搞一个所谓的research paper, 我们为什么要逼着青年人
不去关心我们的病人而去做一些掺了水的数据。请问引导学术的专家大人们，这样做有意义么？
科学是自由王国的珍珠，但绝对不是随便就能获得的，而是需要兴趣和热情支撑的青年去创造、去发现的！
我们要引导青年人信仰科学，信仰自由探索，信仰独立思考，信仰关怀患者，服务患者。不要再让资本伤害我们的热情了！
哪些拿着大把钞票的商人们，我知道在你们眼里没有你们不能亵渎的信仰，你们可以干扰我们的生计，
但是你们不能干扰我们思考 、创造、发现。
心超 与全体青年麻醉医生共勉！
作者: 我让你不痛 时间: 2011-3-6 15:35
虽然我才工作5年但是我热爱我的职业
作者: mongo 时间: 2011-3-15 15:56
科研真谛？献身科学的热情？
作者: cuidawei 时间: 2011-3-15 20:18
在国外是爆炸性新闻，在国内这太正常了，药商拿着钱让你做你不做？看钱给多少吧。有一句话说得好，不要说你能不能学坏，关键看你受到多大的诱惑。麻醉科的主任用什么买车买房啊，药品，器械用谁家的都是用，看你的回扣多少了。大家都心知肚明的事，就不要再装了吧
作者: 97301301 时间: 2011-3-15 20:42
时刻关注中，我们这边现在用胶体比较多，好像是什么麻醉学泰斗开年会时说的，我会关注一些我的病人术后的一些情况，但有个问题，如果羟乙基，不能用了，我们只能用聚明胶提血压了！哪位大师能给把全文翻译一下，谢谢内容
作者: doc5 时间: 2011-3-20 17:28
HS 万汶都很常用呀，那现在到底还能不能用了 ？
作者: agandaidai 时间: 2011-3-23 15:54
本帖最后由 agandaidai 于 2011-3-23 20:27 编辑
羟乙基淀粉为系列产品，新闻报道没有明确规格，将会误导读者，给最新推广的羟乙基淀粉改进产品市场带来严重负面影响。也会被代血浆竞争对手大事宣扬，穷追猛打。按照临床应用评价来看，新一代的羟乙基淀粉130/0.4、200/0.5没有报道中那么严重的不良反应。 国家食品药品监督管理局在2004年11月22日公告的《药品不良反应信息通报》中也只针对羟乙基淀粉40、20氯化钠注射液对肾功能的损害作了报告。
http://www.sfda.gov.cn/WS01/CL0078/11280.html
药品不良反应信息通报（第8期） 羟乙基淀粉40、20氯化钠注射液与肾功能损害-2005.04.12发布.mht
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