loading ...
loading...

2007-02-28 | 关于“拯救sepsis运动”那些风花雪月的故事(一)....

分享

关于“拯救sepsis运动”那些风花雪月的故事(一)....

     Surviving Sepsis Compaign就是“拯救sepsis”运动,别告诉我你不知道!2002年10月间,巴塞罗那的欧洲危重病协会(ESICM)年会上的“动人的一幕”:SCCM、ESICM和国际sepsis论坛(ISF)共同发起了拯救sepsis的全球性创议——拯救sepsis运动(surviving sepsis campaign,SSC),并签署了著名的“巴塞罗那宣言”。该宣言作为SSC第一阶段的标志,以进一步认识sepsis为主题,“呼吁全球医务工作者和他们的医学专业组织、政府、慈善机构甚至公众对该行动的支持,力图在5年内将sepsis的病死率减少25%”。第二阶段为以循证医学为基础的治疗指南的制定。第三阶段将致力于治疗指南的临床应用和疗效评估,以期最终降低sepsis的病死率;在评估临床疗效的同时,将根据临床研究的进展和新的依据,每年对治疗指南进行修订。为了实现“巴塞罗那宣言”所提出的目标,代表11个国际性学术组织的44位各国危重症、呼吸疾病和感染性疾病专家组成委员会,就感染性疾病的诊断和治疗达成共识,在循证医学的基础上制定了《SSC之severe sepsis和septic shock治疗指南)》,并于2004年3月在《Critical car medicine》和《Intensive care medicine》上同时发表。治疗指南的提出是SSC第二阶段的工作,旨在进一步提高全球对sepsis的认识并努力改善预后,以上就是背景知识。

      后来的问题大概就出在那“11个国际性学术组织上”,通过Peter Q. EichackerCharles Natanson,两位NIH的资深研究员在《New England Journal of Medicine 》的揭露(Eichacker PQ, Natanson C, Danner RL (2006) Surviving Sepsis: practice guidelines, marketing campaigns, and Eli-Lilly. N Engl J Med 355:1640–1642),我才知道这个“拯救sepsis”运动和之后的指南实际上都是礼来公司为推广活性蛋白C而雇用商务公司进行的一次成功的商业推广活动,不过是披上了学术的美丽外衣,多么险恶和丑恶的行动!但是我不明白,其实当事人,包括国际学术组织的负责人绝对不可能不知道内情,为什么任由其发展,直到越来越多的证据表明这个药物造成出血的副作用太大,也就是付出了巨大的生命代价才被有良知的研究者披露。更不可思议的是,上述两位作者一直就是危重病界重大疗法的怀疑者,先是2000年左右对誉满全球的ARDS小潮气量疗法提出质疑,引发全球震动,这次矛头直指活性蛋白C,勇气颇为感人。

好了,现在既然黑幕暴露了,当事人和学术组织应该有人出面道歉了。礼来那边好像没有听到什么消息,可能发展和推广新药比承认错误更重要吧。这次第三期的《Intensive care medicine 》刊登了特稿——The European Society of Intensive Care Medicine (ESICM) and the Surviving Sepsis Campaign (SSC) —— ESICM与拯救SEPSIS运动不得不说的故事.... 作者是V. Marco Ranieri(意),Rui P. Moreno(葡)和Andy Rhodes(英),为什么是这三个人?第一位ESICM主席,第二位ESCIM选委会主席,第三位ESICM的科学委员会主席,作者在文后郑重声明:This work was done on behalf of the Council and Executive Committee of ESICM —— 本文代表ESICM执行委员会!,如果我们仔细看看这些人在本文之前提供的接受“科学赞助”或相关业务的列表,我们就明白科学永远不可能纯洁地存在的原因了,他们分别:

Declaration of potential conflicts of interest:
V. M. Ranieri is a paid member of the advisory board of Maquet and received research grants from Tyco, Draeger and Hamilton. From February 2005 to June 2006 he consulted for Eli-Lilly in the creation of the “AboutSepsis.com” website. He is a member of the SSC guidelines group. He is the president of ESICM.
R. P. Moreno received a traveling sponsorship and honoraria from Eli-Lilly to chair an industry-organized session in 2003. He is the president-elect of ESICM.
A. Rhodes consults and performs research for Edwards Lifesciences and consults for Abbott Laboratories. He is a member of a DSMB for Orion Pharma and is a member of the SSC guidelines writing committee. He is the chair of the Division of Scientific Affairs for ESICM.
 
好了,我们还是把他们的全文刊登出来,如果这该死的BLOG又因为字数限制,我就连载:

Sir: During the annual congress of the European Society of Intensive Care Medicine (ESICM) in Barcelona (September 2002), several hundred participants signed a declaration giving birth to the Surviving Sepsis Campaign (SSC) [1]. This declaration called on health care professionals and their organizations, governments, health agencies and public to support an initiative to reduce the mortality from sepsis by 25% within 5 years. This process involved a number of leading international societies coming together to develop an evidenced-based set of guidelines [2] for the management of severe sepsis that could then be implemented into clinical practice with beneficial effects for patient outcome. In recent months, however, this process has been strongly criticized by a number of authors [3, 4, 5]. These criticisms include the following issues:

1. The sponsors of the SSC were too closely aligned with the process.

2. This closeness allows the integrity of the guidelines to be questioned.

3. The implementation process of the guidelines has become part of a marketing strategy for one of the sponsors.

Although ESICM is not synonymous with the SSC, it is one of the founding societies of the campaign and by association is therefore criticized in these papers.

The integration of recent research findings into routine clinical practice is often slow, and this delay is part of the reason why patient outcomes do not always improve as quickly as the underlying data suggest they should [6, 7]. The production of evidence-based guidelines that aim to change current clinical practice to improve patient outcomes should therefore be actively encouraged as they can help accelerate this process. The SSC is therefore an example whereby research data are incorporated into a set of guidelines with the aim of producing recommendations that accelerate the change in clinical practice to a new and theoretically superior standard of care. All of the recommendations included in the SSC guidelines reflect an evidence-based appraisal of available data. Unfortunately the processes involved with the SSC have become entangled in a web of controversy despite the good will, best intentions and integrity of the leading experts involved in the development of the SSC guidelines.

The major issue that has been raised surrounds the need for industrial money to support the process. The fact that the SSC had a single sponsor that provided almost 80% of the financial support certainly amplified the consequences of such limitations and potentially led to the perception that biased behavior may have affected the process. It must be remembered that although there is the general perception that industry and one company in particular funded the guidelines, the relative contributions of the involved societies has never been either quantified or taken into account. When we consider the number of society officers and members that have worked on this process without reimbursement, we can begin to recognize that the relative contributions from industry are not perhaps as significant as we may be led to believe.

At the onset of this process ESICM recognized the limits that industrial support of this type of process change project may bring. The utilization of sponsors to support the process was not considered ideal; however, other streams of funding were not readily available and it was felt that careful handling of the situation would enable a clear and transparent method for supporting the process. The debate within ESICM bodies came to the conclusion that appropriate distancing between the sponsors and the guidelines writing committees would ensure that direct influence was kept to the minimum. These firewalls were instituted so that there were no industrial representatives present in either the original guideline development meeting in Windsor, U.K., or the revision meeting held in San Francisco in 2006. These firewalls should allow us to be confident that the SSC guidelines document is the considered recommendations from a number of esteemed scientific experts and remains scientifically valid. It should be stressed that the guidelines deserve to be judged only on their scientific merit, which will inevitably change following appropriate open debate and the appreciation and understanding of new data that becomes available. Whether or not inappropriate industrial influence occurred within the SSC process is difficult to discern; however, it is plain to see that, in general, the interests of the marketing departments are in direct conflict with independent clinician's views.

The relationships between scientific societies and industry are complex and fraught with problems. Although inextricably linked, each society has very different strategies, behaviors, interests and end points. In theory, each group exists to improve the care of patients; however, in practice this is not always the prime motivation for any decision-making process. The primary objective of industry is to sell their products and make money for their owners or shareholders. Societies such as our own should impartially represent their members and should therefore provide advice and support that is in the best interests of patient care irrespective of the implications of that advice for outside parties. There is, therefore, and always has been, a potential for a direct conflict of interest between these groups. These conflicts can take the form of many different guises and can often be difficult to detect. Although economic conflicts can be disclosed and managed, academic issues are less easy to handle. If we take the example of the “New England Journal of Medicine” article about the SSC [3], authors that did not directly contribute to the recent multi-centre randomized clinical trials on sepsis, despite their leading position at the National Institutes of Health, one of the most relevant institutions supporting and producing clinical research worldwide, may have had quite obvious academic interests in publishing their points of view. These conflicts have been neither declared nor discussed.

.....

看来还是要连载了!

分享 分享 |  评论 (0) |  阅读 (?)  |  固定链接 |  类别 (Sepsis/ARDS/MODS) |  发表于 06:02  | 最后修改于 2007-09-07 04:36
搜狐博客温馨提示:警惕博客留言诈骗, 搜狐博客管理员的正确地址为http://admin.blog.sohu.com, 其他都是冒牌。搜狐博客官方不会要求参加活动的各位博友缴纳任何的手续费用。请勿轻信留言、评论中的中奖信息,更不要拨打陌生电话及向陌生帐户汇款,谨防受骗!识别更多网络骗术,请 点击查看详情
您还未登录,只能匿名发表评论。或者您可以 登录 后发表。
 
  一个单亲妈妈的心愿:治好7岁儿子的白血病
表  情:
加载中...
回复通知: 同时用小纸条通知对方该回复