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中国干细胞法规仍不够完善 Stem-cell laws in China fall short 3 W$ f! ]5 h0 Z5 O% R" x& {- B2 o
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笙箫奈何 2010-10-17 译言网 . R+ |' b) @# t, Y
" p3 _3 \2 W- W6 Y6 ?# _The Chinese government's regulations of stem-cell treatments are admirable in principle, but tougher enforcement measures are needed to protect patients.7 d9 \% M$ a7 b5 v. c
中国政府对于干细胞治疗所采取的法规在原则上是极好的，但仍需要更严厉的执行措施来维护患者的权益。
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& e, `; r- z; D! ~9 F& l* TChina does not want to be known as the Wild West of unproven medical technologies. Last year, the government took an important step when it announced regulations requiring, among other things, that anyone who offers stem-cell procedures should present clinical data supporting their efficacy, and secure approval from the health ministry (see Nature 459, 146; 2009).! }: T- Y- }9 A; ?( ]) y4 d, K
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* ]( I# h" u9 j) f5 W E- _( wThe Chinese government's regulations of stem-cell treatments are admirable in principle, but tougher enforcement measures are needed to protect patients., B/ u1 J9 z2 c8 M
中国政府对于干细胞治疗所采取的法规在原则上是极好的，但仍需要更严厉的执行措施来维护患者的权益。
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) s W) E' |. {9 j3 |* wChina does not want to be known as the Wild West of unproven medical technologies. Last year, the government took an important step when it announced regulations requiring, among other things, that anyone who offers stem-cell procedures should present clinical data supporting their efficacy, and secure approval from the health ministry (see Nature 459, 146; 2009).* H2 l- d0 h2 C0 S5 D/ d
中国并不希望被看做是拓荒时代的美国西部，只拥有未经检验的医疗技术。去年，中国迈出了重要的一步，政府出台了一系列法规，要求所有提供干细胞疗法个人和机构必须出具临床数据证明其有效性，并要得到卫生部的安全许可证明。' D R2 i: ?% N4 \
8 f' i2 d7 o) c' f$ P5 l* QSuch regulations are sorely needed. A leading bioethicist in China last year estimated that more than 100 laboratories there offer stem-cell procedures, many of them unproven, although some clinics reportedly stopped offering the treatments after the regulations took effect. But the government needs to do more than simply announce rules; it needs to give companies clear instructions for complying with them.
3 I6 J S) C1 x' ^( ~- J: Q6 d目前这类法规是非常必要的。一位在中国著名的生物伦理学家在去年估计，中国有超过100家实验室都在提供干细胞疗法，其中很多都是未经检验的，尽管有部分医疗机构宣称他们在相关法规生效后就已经停止提供干细胞治疗。但是政府所做的不应该只是颁布法规，而是要提出明确的指示，让相关企业遵守法规。
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The regulations have made little difference so far to Beike Biotechnology in Shenzhen, China's — and perhaps the world's — most prolific purveyor of stem-cell treatments. Beike develops therapies for disorders ranging from multiple sclerosis to lupus, based on adult and umbilical-cord stem cells. Its treatments, offered by more than 30 hospitals throughout China, have been injected into about 9,300 patients, who pay as much as US$26,000 for the procedure. Roughly half have muscular dystrophy or spinal-cord injuries, but many experts say that stem-cell treatments for those conditions are not ready for clinical use.
) ~' m: B% Z1 T2 d3 _2 d到目前为止，这些法规并没有对北科生物公司造成很大影响。深圳北科生物有限公司是中国——或许是全球——生产量最大的干细胞疗法供应商。北科生物以成体干细胞和脐带血干细胞为基础，为从多发性硬化症到狼疮的各种疾病研发了一系列疗程。在全中国各地有超过30家医院都在提供北科生物的干细胞疗法，全国约有9300名患者接受了北科的干细胞注射，他们每人大约要为其支付26000美元。这些患者中大约有一半都患有肌肉萎缩症或脊髓损伤，但是很多专家称这类疾病的干细胞疗法并没有做好临床使用的准备。
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Beike has not tested the efficacy of its treatments in formal clinical trials, says Alex Moffett, chief executive of Bangkok-based Beike Holdings and a spokesman for Beike Biotechnology, although he does say that some phase I safety trials are taking place. The company offers numerous testimonials on its website as evidence that its treatments work. But some media accounts report scepticism, and the mother of one Beike patient complained directly to Nature that her son's condition did not improve at all.2 }; `* g5 e# b& P% u9 a x
北科曼谷公司执行长官，同时也是北科公司发言人亚历莫菲特承认，北科生物还没有对这类干细胞疗法的有效性做过正式的临床试验，尽管他说过一些初级阶段的实验正在进行。北科生物在其网站上提供了大量鉴定书作为其干细胞疗法有效性的证明，但是一些媒体发表报道对此表示怀疑，而北科生物一位患者的母亲也直接向《自然》杂志抱怨说，在接受干细胞治疗后，他儿子的病情并没有什么改善。
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Moffett says that he believes in the need for evidence based on clinical trials. As the company plans an expansion into Malaysia, the Philippines and Thailand, he says, it will complete clinical trials of every treatment's safety and efficacy, at no cost to patients, before offering the procedures commercially. He says that Beike “probably should have” taken the same approach in China.7 `3 a' r. n& k
莫菲特说他相信基于临床试验的证明是很需要的。他说，北科生物正在计划向马来西亚，菲律宾及泰国扩展，在进行商业程序之前，公司将会完成各项疗效安全性及有效性的临床试验，并且不需要患者支付任何费用。莫菲特说，北科生物早就应该在中国采取同样的方式。) K4 n! _0 L& f8 n( v8 J1 n
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Yet the company has passed muster with the government, says Moffett. Officials have visited Beike's facilities without closing them down, which he interprets as tacit approval for the treatments. He says he knows of no application steps for formal approval from the health ministry — and requested that Nature forward him any information about such procedures.! x4 h) k8 z8 ^7 R
莫菲特称北科公司已经通过了政府的检验，应为政府官员已经来参观了北科的工厂设施，但并没有宣布将工厂关闭，他将此理解为政府对这种疗法的默认许可。莫菲特还说他并没有听说卫生部对正式许可有任何的申请程序，而且卫生部也没有要求《自然》杂志给他关于申请程序的任何信息。
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' \) h% r9 g0 Q+ x! `! z7 ]The problem, it seems, is that the regulations do not include enough details for implementation and enforcement. The health ministry is now considering proposed guidelines, created by a group of scientists and ethicists, that set out clear criteria for preclinical and clinical studies, and clinical applications. One of the committee members said that the guidelines call for an approval process that is easily accessible, includes an ethical review and is based on solid scientific data.
5 O' i1 ^' a: M5 I但问题似乎是这些法规中并没有为其贯彻和实施提供足够的细节。卫生部现在正在考虑提出由一批科学家和伦理学家制定的指导方针，这些指导方针清楚地阐明了干细胞的临床前及临床过程中的研究标准，还有临床申请准则。这个委员的一名成员说这些指导方针是以有力的科学数据为基础，并包括一项伦理审查，而且申请过程简单易行。
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The committee member says that the government will decide “soon” whether and how to implement the guidelines. (A Chinese academic who has been following the issue says that implementation has been held up by disagreements between different government agencies.)1 v4 i' E6 e4 p. W v" l8 E
该名成员还说政府将会“尽快”决定是否还有应如何实施这些指导方针。（一位关注这个问题的中国学者透露，目前指导方针的实施因为政府不同机关之间的分歧而遭到阻碍）& t" H/ J1 e# F* B7 q4 q
7 {# Z+ Z- O( D+ BSoon cannot be soon enough. The guidelines need to be approved and put in place as fast as possible, and enforced swiftly and effectively. The longer that unproven therapies stay on the market, the greater is the risk that a history of use can be framed as evidence of safety and efficacy.5 K+ i8 U$ x* o0 r. H+ R+ X
仅仅抓紧时间是不够的，这些方针应该尽快被批准并推出，然后迅速有效地实施。未经检验的干细胞疗法在市场上停留的时间越长，那些使用历史被做为其安全性和有效性的证明的风险就越大。! o# @. }1 k0 ^4 N
+ Q( l0 g& Y" C% Q2 gSince an investigation of China's food and drug agency a few years ago found it to be rife with corruption (see Nature 446, 598–599; 2007 and Nature Med. 13, 889; 2007), the government has worked hard to put together a system that balances drug-company profit, the requirements of drug innovation, and patients' health and welfare. Those efforts offer a model for regulation of stem-cell therapies. Anything less than a clear, detailed set of rules is a disservice to scientists who are working hard to understand stem cells and their clinical promise, to companies that are taking big financial risks and doing proper clinical trials, and most of all to patients.
5 ~" {, q% d! c6 k4 F中国政府在几年前花了很大的功夫整合了一套体系来平衡药品公司盈利，药品创新需求，患者的健康及福利，因为中国食品和药品监督管理局在在当时的的一项调查发现这三者之间充满了腐败。这些努力为今天干细胞疗法的准则提供了范本。所有不够明确，缺少细节的准则对那些努力了解干细胞及其临床保证的科学家，冒着极大经济风险做着正规临床试验的公司，最重要的是广大患者们，都是极为不利的。 |
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发表于 2011-1-4 09:39
