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19岁美少女/31岁亿万富姐/斯坦福肄业/乔布斯第二/改变世界… 精选

已有 33977 次阅读 2015-10-20 00:19 |系统分类:海外观察



2003年 Elizabeth Holmes 从斯坦福化学工程专业退学创业时年仅 19 岁。花季少女,隐身十年,2014年,绚丽亮相,其公司 Theranos 估价 90 亿美元,Holmes个人财富 46 亿美元。

Holmes 成功了,她被带上了又一个“乔布斯”的帽子,她自己也声称因为年幼时害怕扎针抽血作化验,而立志改变世界。现在已拥有改变世界的技术 – 指头几滴血,健康全得知。在乔布斯之后,高科技产业呼唤英雄的当头,Holmes 的传奇太令人血脉喷张了!美女,富姐,生命健康朝阳产业,改变世界的革命性、颠覆性体外诊断技术平台,而且公司还未上市就被估值 90 亿美元…Wow!

Holmes 究竟拥有什么技术呢?这是个保守十年的秘密。不告诉你们,就是不告诉你们 -- 怕你们偷,怕其它投资者和创业者模仿。

几个月前,我带着迷惑和崇敬登陆 Theranos 网站(ww.theranos.com),试图搞明白其革命性、颠覆性体外诊断技术平台如何用几滴指头血完成几百个项目的检验。然而不像美国的其它高技术 start-ups, 其网站没有技术平台介绍,更没有技术细节介绍。我于是看它的招聘栏,想从职位描述上推测其研发工作和技术内容。以下这些研发岗位(太多,只列部分)是刚从其网站下载的,大致与我几月前看到的差不多。

·  Chemist(Quality Control)

·  Chemist(Reagent Stability)

·  LaboratoryAssociate (Immunoassay)

·  LaboratoryAssociate, Clinical Studies

·  ResearchAssociate (Formulations Chemistry)

·  ResearchAssociate (Immunoassay)

·  ResearchAssociate II (Assay Development)

·  ResearchAssociate II (Immunoassay)

·  ResearchAssociate, Enzymology

·  ResearchAssociate, Molecular Diagnostic Assay Development

·  Scientist(Chemistry, Assay Development)

·  Scientist(Immunoassay)

·  Scientist,Molecular Diagnostic Assay Development

·  Sr.Chemist (Formulation/Production)

·  Sr.Process Engineer, Reagent Manufacturing

·  Sr.Scientist (Chemistry)

·  Sr.Scientist (Chemistry, Assay Development)

·  Sr.Scientist (Immunoassay)

由于低成本的生化及其多重检测(multiplexing,multi-analyte detection)没有什么了不起,而分子诊断在当今火爆得快成吸金黑洞的时刻并没有被 Holmes 及其团队伙伴念叨,我于是猜测,Theranos 的真正突破(或是拿到钱后的未来颠覆)应该主要是在免疫分析这一临床检验的最大细分领域。这一领域目前有大约一百多亿美元的全球市场(中国市场一百多亿人民币)。

2015年2月17日,美国医学会(American Medical Association)的 peer-reviewed 杂志The Journal of the American Medical Association发表了一篇文章,题目是“Stealth Research Is Biomedical Innovation Happening Outside the Peer-Reviewed Literature?。该文针对 Theranos 的技术, 讨论了没有文献报道过的生物医学创新成果的科学透明性问题。文章指出,Theranos(的技术)只出现在大众媒体中,而不在 peer-reviewed 杂志中。(“Information about Theranos, a privately held biotechnology company that has developed novel approaches for laboratory diagnostic testing, has appeared in The Wall Street Journal, Business Insider, San Francisco Business Times, Fortune, Forbes, Medscape, and Silicon Valley Business Journal — but not in the peer reviewed biomedical literature. As of January 5, 2015, a search in PubMed using Theranos as a search term identified affiliations for only 2 unrelated articles coauthored by Theranos Inc employees, although these 2 reports do not offer insights about their company.)文章作者进一步指出,至 2015年1月5日,只检索到 75 篇 Theranos 的专利文献。但从这些专利中,几乎不可能评价其底层的科学的有效性。作者对同行评议有时伤害创新技术的客观现实表示一定程度的认同,但提出问题 --“隐身模式”产生的技术有效性如何评价呢?

这篇文章显然是客气的。2015年5月9日,国际知名的加拿大临床化学(免疫分析)专家,多伦多大学教授 Eleftherios P. Diamandis (曾编过一本 Immunoassay 书, Academic Press, 1996), 在专业杂志上撰文直斥 Theranos 的所谓技术 ("Theranos phenomenon: promises and fallacies", Clin Chem Lab Med 2015; 53(7): 989–993)

在文章的引言部分,Prof. Diamandis 指出,对 Theranos 的欢呼雀跃足以保证它将为医疗系统提供所声称的好处吗?答案是“No”。历史告诉我们,无数的由高大上科学家(包括诺奖得主)发展的貌似颠覆性的医疗技术(尤其在诊断领域)最终都从云端跌落,尸首无存。

“Are all these accolades enough to guarantee that the company will deliver the promised goods in health care? The answer is no. History teaches us that there are numerous examples of seemingly disruptive technologies in healthcare (and especially in diagnostics), developed by high-profile scientists, including Nobel Laureates, which later collapsed, due to their inability to deliver the promised goods”.

Prof. Diamandis的文章全文在此不翻译了,他的结论是“The spectacular successes of Theranos with fund-raising, for attracting high-profile individuals on their Board (although most with non-medical background, such as ex-politicians and military,拉官员入伙,有点像中国) and with wide spread exposure to the public media are well-recognized. However, as mentioned earlier, their claims of superiority over current systems and practices are speculative, at best. There is an apparent lack of appreciation of the dangers of self-screening and self-interpretation of results by asymptomatic individuals who are trying todetect occult disease. An open discussion of the merits and shortcomings of the Theranos and similar approaches should take place in the scientific literature and other public forums, so that the benefits and harms are better understood by the public.”

Prof. Diamandis 和其它专业人士的评论已经受到公众关注。2015年10月16日,《华尔街日报》依据Theranos 的四名前雇员爆料,发表了一份调查报告(Hot Startup Theranos Has Struggled With Its Blood-Test Technology),称 Theranos严重夸大其技术能力。据四名前雇员举报,该公司接受的大量血液检验样品中,只有一小部分是采用其专利技术和仪器检验的,而且结果不准。大量的样品测试是用其它公司产品完成的。Google 一下“Theranos”,首页就是以下这些标题。

Theranos' Scandal Exposes the Problem With ... - Wired

The most-hyped company in biotech is in big, big trouble - Vox

Internationally respected Experts in Clinical Pathology and Laboratory Medicine Ask: Why Don’t We Know More about Theranos’Technology?

Theranos Trouble: A First Person Account

Theranos Continues Damage Control Messaging

Hot Startup Theranos Dials Back Lab Tests at FDA’s Behest

Theranos Is Made-For-Hollywood Silicon Valley Scandal ...

Elizabeth Holmes is 'shocked' by WSJ story on Theranos ...

初创公司要吹牛,这是融资的基本要求。但是,Facebook 可以吹 "全世界人民连接起来", 没有用户会抱怨还有十三亿人连不上;十三亿人连不上,也不会骂 Zuckerberg。Uber 可以吹几年灭掉出租车,也不会有人要他兑现。然而,医学诊断,测试结果不准,医生病人要骂;用竞争对手的设备和试剂去蒙人,政府要管,这不,FDA 也来了。

Blood Test Startup Theranos Faces Scrutiny: FDA Says Nanotainer An 'Unapproved Medical Device'

《华尔街日报》(Hot Startup Theranos Dials Back Lab Tests at FDA's Behest)称,“The FDA concluded that data Theranos submitted before the inspection and additional data gathered during the examination were insufficient to prove the accuracy of many of its tests, this person said.”

Holmes 从小怕针扎,看来她吹起来的大泡泡要被针扎了,不是明天,就是后天。

(见下文Holmes深入虎穴, 说不发表 peer-reviewed 结果



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