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Fake Malaria Meds Meet Their Match in a Handheld SpectrometerUp to 35 percent of antimalarial drugs are useless. Engineers are combatting this counterfeit menacePhoto: David Longstreath/APPailin Pharmacy: Malaria drugs in Cambodia could be suspect.Counterfeit malaria medications can easily fool the eye: The fake drugs sold in markets throughout Africa and Asia often look exactly like the authentic products. The pills are the right shape and size, the packaging is identical to that of the real brand, and the boxes often feature the duplicated logos and holographic stickers of official regulators.But these knockoffs can’t fool chemistry. That’s why engineers from Global Good, a philanthropic invention lab in Bellevue, Wash., are trying to solve the counterfeit problem with a handheld device that uses optical spectrometry to check the chemical composition of medications. In the next few months, drug inspectors and pharmacists in Kenya, Namibia, and Laos will begin field trials of the technology.The researchers foresee “a top-down path to adoption,” says Ben Wilson, the project’s lead investigator. Global Good is funded by Bill Gates and the Bellevue-based innovation hub Intellectual Ventures, and it benefits from well-established partnerships with government ministries of health and international aid groups. “If our field trials go well, the technology could be used on a country level next year,” Wilson says.Counterfeit drugs are a huge problem in the developing world, and antimalarials are a particular source of concern. “The active ingredient in antimalarials is the biggest cost, so by leaving it out, the counterfeiter can make a better margin on the pills,” Wilson explains. A 2012 survey published in The Lancet Infectious Diseases found that 35 percent of 3,700 drug samples tested in Southeast Asia and sub-Saharan Africa were either fake or of poor quality.The new system uses near-infrared (NIR) spectrometry, directing a beam of NIR light at a pill and recording how the light is absorbed. That pattern of absorption is a unique spectral signature that reveals the chemical composition of the pill without damaging it. Until recently, NIR spectrometry required bulky and expensive tools that limited it to fields like astronomy and medical imaging. But rapid advances in the technology have led to cheap and miniaturized devices that enable new applications.The researchers from Global Good first built a smartphone app that worked with SCiO, a handheld infrared spectrom­eter that recently came on the market for consumers and businesses. In one proof-of-­concept experiment, which they reported in The American Journal of Tropical Medicine and Hygiene, the researchers tested 77 brands of antimalarial drugs purchased in Equatorial Guinea and 31 bought in Ghana. The app contained a library of the appropriate spectral signatures for each of those brands, and the researchers found that the software was able to reliably distinguish between authentic and fake pills. But the SCiO required that the smartphone be connected to the cloud for analysis of the medicine, which Wilson says isn’t always possible in remote towns and health clinics. So, his team switched out the hardware and is now working with a handheld NIR spectrometer made by the ­Taiwanese company Young Green Energy Co.Photo: Intellectual Ventures Counterfeit Fighter: A portable spectrometer scans pills and sends their spectra to a smartphone for chemical analysis.The new system hosts all the analysis locally on a smartphone. With the Global Good app, developed for both iOS and Android phones, the user inputs the brand of medication that’s being checked and hits the scan button. Two seconds later, the system gives an answer: The app shows the spectral signature of the pill and states whether or not it’s authentic.In the 2012 Lancet study on antimalarials, the authors wrote that “production and distribution of counterfeit antimalarial drugs should be prosecuted as crimes against humanity.” The lead author of that report, Gaurvika Nayyar, says fake malaria meds cause thousands of deaths in countries where malaria is epidemic, and they particularly affect young children.Nayyar, a consultant who serves as an advisor at the Global Health Policy Institute in San Diego, recently reviewed new technologies used to combat fake drugs. She says there is a need for low-power portable devices that don’t require much user training, as such devices could be used by pharmacists or patients themselves to check their medications. But she also sees value in more systemic approaches, such as using RFID tags or blockchain technology to track authentic medications from factory to pharmacy. “I think we need a clear comparative assessment of the various emerging technologies to find out which ones work for which parts of the supply chain,” she says. “There’s no one solution that will solve the problem.”When Global Good set out to develop a tool for the fight against fake drugs, Wilson says his team considered all the ways counterfeiters could game the system, including setting up fake websites that “verify” fake meds. They decided to develop a technology using NIR spectrometry because it’s so hard to spoof; trying to match the spectral signature of a pill would be an expensive proposition, he says. “For the counterfeiter, it would probably be cheaper to just put the active ingredient in.”This article appears in the August 2017 print issue as “Fake Malaria Meds Meet Their Match.”This article is from IEEE spectrum(By ELIZA STRICKLAND). If there is any infringement ,please call us and we will deal with it in the first time.

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2017.10.09

Global Good:不作恶,NIR让假药无所遁形

假药在现实中将遭遇真正的技术硬汉——NIR,目前高达35%的抗疟药物是无效的。工程师正在想方设法打击这种威胁人类健康的造假行为。Photo: David Longstreath/APPailin Pharmacy: 柬埔寨的疟疾药物可能是令人怀疑的。 假冒疟疾药物可以很容易欺骗人类的眼睛:在非洲和亚洲市场上销售的假冒药品通常看起来和真正的药品相似。药丸的形状和大小,包装与真实品牌相同,药品包装盒子通常具有官方监管机构的重复标志和全息标签。 但是这些仿冒品却无法愚弄化学这门学科,如何透过现象看本质,来自华盛顿州贝尔维尤的慈善组织实验室Global Good 的工程师们正试图通过使用近红外光谱法(NIR)的手持设备检查药物化学成分来解决假冒问题。在接下来的几个月里,肯尼亚,纳米比亚和老挝的药品检查员和药剂师将开始对该技术(NIR)进行现场试验。另外一项与世界卫生组织合作的试验将于2018年开始。 该项目的首席研究员本·威尔逊(Ben Wilson)表示,研究人员预计将采用自上而下的途径。 Global Good由比尔·盖茨(Bill Gates)和位于贝尔维尤(Bellevue)的Intellectual Ventures创业投资公司资助,其与政府卫生部和国际援助团体都有良好的合作。威尔逊说,如果我们的现场试验顺利进行,那么明年这项技术(NIR)可以在国家层面进行推广使用。仿冒药品在发展中国家是一个巨大的问题,其中抗疟药物更是一个特别令人担忧的问题。威尔逊解释说:抗疟药物的最大成本是活性成分,若是不考虑这个成分,造假者可以在药片上获得更好的利润。 《柳叶刀》期刊在2012年发表的传染病的调查发现,东南亚和撒哈拉以南非洲地区测试的3,700种药物样本中有35%是假冒的或者质量比较差的。全新系统使用近红外(NIR)光谱法,将一束NIR光照射到药片并记录药品的光谱特征,从而在不损害药品的情况下获取了药品的化学成分。直到最近为止,近红外光谱原理需要庞大而昂贵的设备,因此这也是将其限制在像天文学和医学成像等领域的重要因素。但是,技术的快速发展使得价格便宜以及小型化便携式成为可能,因此NIR也会拥有更多新的应用领域。 来自Global Good的研究人员首先研发了一款智能手机应用程序,该应用程序原本与最近在消费级和商业级手持式近红外光谱仪厂家SCiO合作的。SCiO在美国热带医学和卫生杂志上报道的一个概念验证实验中,测试了在赤道几内亚购买的77种品牌的抗疟药物,31种在加纳购买。该应用程序包含每个品牌的药物光谱特征库,研究人员发现该软件能够可靠地区分正品和假药。但是,SCiO要求将智能手机连接到云端以分析药物,Wilson说,然而药品检测并不总是在城镇和诊所里面进行。所以他的团队把这个硬件选项砍掉了,现在正在和台湾公司Young Green Energy Co.合作,YGE也是手持式NIR光谱仪的生产厂家。 Photo: Intellectual Ventures Counterfeit Fighter: A portable spectrometer scans pills and sends their spectra to a smartphone for chemical analysis.合作开发的新系统可以在智能手机上进行所有分析而无需通过云端分析。手机开发的APP目前有iOS和Android两个版本,用户输入正在检查的药物品牌,并点击扫描按钮。两秒钟后,系统给出答案:APP显示药片的光谱特征,并说明其是否可信。 《柳叶刀》在2012年关于抗疟疾药物的研究中,作者写道:“生产和分销假冒抗疟药物应被视为危害人类罪”。该报告的主要作者Gaurvika Nayyar说,假疟疾药物在一个国家将造成造成数千人死亡,疟疾作为流行病对儿童的影响最大。 Nayyar在圣地亚哥担任全球卫生政策研究所顾问,她最近正在审查用于打击假药的新技术。。她说,目前最大的需求是低功耗便携式设备而且不需要复杂的用户培训,因为药剂师或患者自己可以使用这些设备来检查其药物真伪。但她也看到更加系统的解决方案的价值,例如使用RFID标签或区块链技术跟踪从工厂到药店的正宗药物。她说,我认为我们需要对各种新兴技术进行明确的比较评估,以了解哪些新技术在哪些供应链中起作用。问题的解决方案不止一个。当Global Good刚开始研发打击假药的产品时,威尔逊说,他的团队考虑到所有的假冒者都可以对这个系统进行欺骗,包括设立假冒网站“验证”假药。所以他们决定开发使用NIR原理的光谱技术,因为它很难被欺骗;他说,尝试匹配所有药物的光谱特征将是一个昂贵的主题。 因此对于药品造假者来说,与其造假不如把活性成分加入药品中。对现代近红外人来说,药品造假是一个我们能够也应该解决的技术问题。一切新的事物,一开始都是不被大众接受的。就像一个走在时代前沿的人,往往不被这个时代所理解。大家有没有发现,这几年新的现象,新的科学技术,新的商业模式,新的连接方式,完全改变甚至颠覆我们传统的认知。从十几年前大家觉得网上购物有风险,到现在动辄千亿消费的电商狂欢节都习以为常。我们总是用属于大众的肤浅舆论来判断一个新生事物,或者用静止的眼光来评判,这些都是肤浅的,所以对于NIR,我们需要用动态的未来的眼光去看待,或许会有不一样的感悟。 此次Global Good选用NIR技术进行假药检测,无独有偶,之前6月份联合国原子能机构立项离子迁移谱检测食品掺假(如何看待联合国原子能机构立项核技术检测食品掺假?),从国际层面上来看,我们似乎正在享受着科技发展带来的红利,那么在未来,中国近红外将扮演什么角色呢? 参考消息来源:Fake Malaria Meds Meet Their Match in a Handheld Spectrometer 此文章转自指点网,如涉及侵权,请来电协商,我们将在第一时间处理。 

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2017.10.09

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