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打游戏可以治病?FDA批准打电游为处方疗法

打游戏可以治病?FDA批准打电游为处方疗法

Sy Mukherjee 2020年06月22日
有公司研发出基于视频游戏的处方数字疗法,以帮助注意力有问题的ADHD儿童患者。

多家机构的调研数据显示,美国约有5%到11%的儿童患有注意力缺陷多动障碍(ADHD)。因此,阿德拉、利他林、Vyvanse等治疗ADHD的药物存在巨大的市场。

通过药物成分来缓解ADHD症状属于传统疗法。而现在,数字治疗竞争者也开始加入,有公司研发出基于视频游戏的处方数字疗法,以帮助注意力有问题的ADHD儿童患者。

该款设备叫作EndeavorRx,由总部位于波士顿的数字医疗公司Akili开发。EndeavorRx在同类产品中首个获得美国食品与药品管理局(FDA)批准。自2010年以来,Akili公司就一直在数字医疗领域发力,另辟蹊径获得了今天的成绩。

Akili公司的首席执行官埃迪•马图奇告诉《财富》杂志:“关键在于数据。获得临床验证之后,人们才会相信。这里指的是病人、医生,每个人。”

马图齐在耶鲁大学获得了生物化学和生物物理学的博士学位,随后进入健康创业领域。他从骨子里就密切关注证据和数据。他说:“我最大的愿望就是让研究人员完成科学研究,然后造福患者。”

也许这就是Akili能成功通过FDA审核的秘诀。数字健康领域里充斥着诸多激进的说法,却往往难以实现。而马图齐的理念是,技术以及相关炒作要通过现实世界中随机试验得到的证据加以佐证。

马图齐说:“我们与技术领域和医疗健康领域的投资者合作,董事会也由两个行业的专家组成。我们与加州大学旧金山分校、杜克大学等众多顶尖大学合作,进行严格的临床试验。”公司还与一些企业达成战略合作,开展市场推广,其中包括日本药业巨头盐野义制药(Shionogi)。

Akili已经进行了五项临床研究,涉及600多名多动症儿童。其中包括业界认为可作为黄金标准的随机对照试验。试验将不同的研究对象随机分组,观察不同的治疗方法效果如何。

马图奇强调,数字疗法并不会完全替代传统药物治疗。他认为这是能提升注意力的针对性数字化治疗。他说,公司的研究表明,不管患者服用还是不服用ADHD药物,该疗法在提升注意力方面都有良好效果。

马图奇指出:“我们关注的重点并不是将新疗法强加入现有的药物治疗模式中。我们更希望实现纯粹的数字疗法。”(财富中文网)

译者:Feb

多家机构的调研数据显示,美国约有5%到11%的儿童患有注意力缺陷多动障碍(ADHD)。因此,阿德拉、利他林、Vyvanse等治疗ADHD的药物存在巨大的市场。

通过药物成分来缓解ADHD症状属于传统疗法。而现在,数字治疗竞争者也开始加入,有公司研发出基于视频游戏的处方数字疗法,以帮助注意力有问题的ADHD儿童患者。

该款设备叫作EndeavorRx,由总部位于波士顿的数字医疗公司Akili开发。EndeavorRx在同类产品中首个获得美国食品与药品管理局(FDA)批准。自2010年以来,Akili公司就一直在数字医疗领域发力,另辟蹊径获得了今天的成绩。

Akili公司的首席执行官埃迪•马图奇告诉《财富》杂志:“关键在于数据。获得临床验证之后,人们才会相信。这里指的是病人、医生,每个人。”

马图齐在耶鲁大学获得了生物化学和生物物理学的博士学位,随后进入健康创业领域。他从骨子里就密切关注证据和数据。他说:“我最大的愿望就是让研究人员完成科学研究,然后造福患者。”

也许这就是Akili能成功通过FDA审核的秘诀。数字健康领域里充斥着诸多激进的说法,却往往难以实现。而马图齐的理念是,技术以及相关炒作要通过现实世界中随机试验得到的证据加以佐证。

马图齐说:“我们与技术领域和医疗健康领域的投资者合作,董事会也由两个行业的专家组成。我们与加州大学旧金山分校、杜克大学等众多顶尖大学合作,进行严格的临床试验。”公司还与一些企业达成战略合作,开展市场推广,其中包括日本药业巨头盐野义制药(Shionogi)。

Akili已经进行了五项临床研究,涉及600多名多动症儿童。其中包括业界认为可作为黄金标准的随机对照试验。试验将不同的研究对象随机分组,观察不同的治疗方法效果如何。

马图奇强调,数字疗法并不会完全替代传统药物治疗。他认为这是能提升注意力的针对性数字化治疗。他说,公司的研究表明,不管患者服用还是不服用ADHD药物,该疗法在提升注意力方面都有良好效果。

马图奇指出:“我们关注的重点并不是将新疗法强加入现有的药物治疗模式中。我们更希望实现纯粹的数字疗法。”(财富中文网)

译者:Feb

Depending on whose numbers you use, somewhere between 5% and 11% of American children have ADHD (attention deficit hyperactivity disorder). That has created a massive market for attention deficit disorder drugs such as Adderall, Ritalin, Vyvanse, and others.

But those treatments are all traditional therapeutics, imbibed via pills. Now, a digital competitor is heading into the space—a prescription video game that’s meant to help children with ADHD focus.

The product is Boston-based digital health firm Akili’s EndeavorRx, and it’s the first of its kind to gain Food and Drug Administration (FDA) clearance. Akili has been around since 2010 but walked a very specific path to get to this milestone.

“Everything is about data,” Akili CEO Eddie Martucci tells Fortune. “Getting the clinical evidence, so people can trust it. And by that I mean the patients, their doctors, everyone.”

The focus on evidence and data is built into Martucci’s academic pedigree. He has a Ph.D. in biochemistry and biophysics from Yale and then headed into the world of health entrepreneurship. “I’ve always been interested in letting the science be done by the researchers and then bring it to patients,” he says.

And therein lies the secret sauce to Akili’s success with the FDA. The digital health realm is littered with bold proclamations which often don’t pan out. Martucci’s philosophy is that the tech and the hype must always be supplemented by evidence in the real world via the means of randomized trials.

“We’ve worked with investors in both the technology field and the health care field. Our board is a hybrid of those two [forms of] expertise,” he says. “We partner with top-tier universities, such as UC–San Francisco, Duke University, and countless others to run rigorous clinical trials.” The company also has strategic partnerships with companies such as Japanese drug giant Shionogi to market its product.

Akili has conducted five clinical studies involving more than 600 children with ADHD. These included randomized controlled trials—considered the gold standard in the clinical study world—which place different study participants into various groups to see whether or not one therapeutic approach is as effective as another.

Martucci emphasizes that the video game approach isn’t meant to supplant traditional drugs. He considers it a targeted digital treatment to increase focus and says the company’s studies have shown the product is just as good on that front for patients who take ADHD medications as well as for those who don’t.

“We’re not focused on just shoving this into some existing pharmaceutical model,” he says. “We want this to be what the model for digital therapeutics actually should be.”

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