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奥环没有得到欧监会的认证!圆锥角膜治疗的抉择过程

已有 523 次阅读 2019-8-13 10:50 |系统分类:科研笔记

 

我之所以想参加还处于试验中的滴眼液治疗圆锥角膜的临床试验组,是基于我对美国FDA药物试验的了解。获得FDA药品生产许可,是药品研发人员的终身追求,被称为Holy Grail。一般来说要经过三个阶段的试验:第一阶段是安全性,第二阶段是有效性,第三阶段是高效性。每一个阶段都是经过严格控制的,应用到临床试验,至少对人体是无害的。

电影living proof里面详尽地描述了这一过程和这一过程的艰难程度,任何一步不过关,都将药品开发的进程打回原处,让你所有的努力都化为乌有。第一阶段安全性试验就是不管病人是否得了此药物用于治疗的病,即使是健康的,用此药物都是无害的;第二阶段是针对此病症的有效性,就是证明此药物能够有效地治愈这种疾病,第三阶段是高效性,就是多样本下检测多少比例的病人会从此药物中受益。

我相信如果一种医疗方案获得FDA的认证,那么这种医疗方案一定可靠的。有关《奥环对圆锥角膜治疗的历史、原理及常见问题》对奥环进行了详尽的解说,https://mp.weixin.qq.com/s/JrGnZPP6RPsOl37JRG7Jbw里面说在2007年奥环通过了欧洲药品监管认证,从2008年至2016年底共有来自欧洲二十多个国家的8000多名患者接受了CISIS的治疗。我当时就想,如果奥环得到欧监会的认可,那么这个手术肯定是可靠和可信的。因为欧洲比美国更为保守一些,能得到欧监会的认可,应该比得到美国FDA认可更为艰难一些,其结果也更为可靠一些。

我初时对去欧洲进行奥环手术,非常排斥,心里责怪孩子不懂事,一点也不考虑这种手术的后果。但看到这一点,我就放心了,准备带孩子去,为了保险起见,我查了这篇文章所提供的原文和链接,但在奥环的官方网站上,我都没有看到说这种手术已经被欧监会认证了。

在其官方网站https://www.cisis.com/en/quality/有关有关奥环历史中,是这样说的

2005: Financial support from AWS (Austria Wirtschaft Service), the support bank of the Republic of Austria for new and innovative technologies, for the development and approval as a medical device in the EU.

2007: Approval as a medical device in the EU.

但这句话并不是说起得到欧监会的认证,而是说,在欧洲地区奥环被获准可以作为医疗设备或者医疗器材来应用。如果是欧监会认证,这么重要的信息不可能不在官方网站中标识出来。恰好,中国医学信息研究所的杜建来上海访问我,我就和他说起这回事,他帮我在欧监会的网站上查了查,也没有发现说欧监会认证了这一技术。

事关儿子的眼睛,我不得不小心求证,我开始咨询我在国外认识的有可能了解相关信息的人。

我草拟了一封信,然后稍加修改发给不同的人。大致内容如下:

 

Dear Michael,

 

I deadly need your expertise to make a medical decision.

my son, Quan Liu, whom you had met, was diagnosed keratoconus. his vision is geting worse and worse. In China, I've see the top doctors in this field. But the method we can get is crosslinking, but  crosslinking in itself does not lead to an improvement of visual acuity. some patients in China went to Austria for CISIS (Corneal IntraStromal Improvement System). it is said that CISIS leads to improvements of visual acuity. My son is preparing for this surgery.

 

However, some patients in China are getting better and better, but some didn't get improved. But I don't know why this surgery was not conducted in the hospital, but in a company. I wonder if it is safe.  Moreover, from the webpage, https://www.cisis.com/en/quality/, it is said that in 2007, CISIS get Approval as a medical product in the EU. I don't know which institute approved the CISIS as a medical product, does it reliable?

 

I really need help, Michael, so that I can make a right decision to treat my son and save his eyes.

 

Best wishes,

Yuxian

因为在奥环的官方网站上,看到他们的合作方都是公司性质的,只有西班牙是在一个正规的医院里,我就问了西班牙的Ismael Rafols.我导师Ronald Rousseau也问了SPRUEly和SPRU的研究主任Michael,Ismael是个民族主义者,作为加泰罗尼亚人,和西班牙势不两立。所以给我回信说,他几乎不去马德里,因而没有办法给我提供任何信息。Ely说他不懂,所以不给我任何建议。我导师鲁索说这可能只是一个大学试验性的许可,要我千万要小心。Michael是SPRU研究医疗创新管理政策的权威,详尽地给我解释了这一治疗手段到底从多大程度具有政策保障性。

 

Dear Yuxian,

 

I am very sorry to hear about your son's eyes. This is a terrible concern for any parent. As a medical device the Myoring will not be regulated in the strict manner that drugs are regulated in the EU. The EU has a series of directives to national agencies to standardise the preparation of such devices for the market. Under these directives  commercial sellers will need to ensure they can address the queries of the regulator at any time if problems are reported, but there is generally no pre-market approval process. Each country has its own enforcement agency. For the UK it is the Medicines and Healthcare products Regulatory Agency (MHRA). Not sure what the Austrian one will be. The good thing about the European system is that medical device innovation is uninhibited and rapid, but the bad news is that some devices are later found to be problematic, often after many patients have been exposed to them.

 

For that reason my advice would be to look for independent research papers published on the use of this treatment and independent devices to see if there are any reports of problems occurring already.

 

I hope you can find a solution and that your son recovers.

 

Best wishes,

 

Michael

这就是说Myoring不是药品,而只是医疗装置,在欧洲,医疗装置,并不需要像药品一样进行严格论证和控制。欧盟发布了一系列指导性条例,指导和核准这些装置是否可以走向市场。这些指导性条例需要这些装置的销售者确保问题出现时,能够回应问责。但在销售之前,一般没有批准和核准过程。这样做的好处是欧洲系统,医疗装置设备的创新不收限制而且很快就能走向市场,但坏处是一些装置后来也发现有问题,经常是很多问题被暴露后这些装置被勒令停止销售。

所以,他建议我查阅了一下有关Myoring的研究论文看看用Myoring后是否出现过什么问题,然后再看看是否值得去做这个手术。



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