美国国家公共电台 NPR Questions Raised About Study Of Device To Ease Opioid Withdrawal

 

RACHEL MARTIN, HOST:

There's a device on the market that is supposed to help people who are trying to quit opioids. The FDA has allowed the device based on a study, but that study may have serious flaws. Jake Harper from our member station WFYI in Indianapolis wrote an article for NPR's Shots blog, and he joins us now to talk about it. Hey, Jake.

JAKE HARPER, BYLINE¹: Hey.

MARTIN: Let's start off by just explaining what this device is, what it's supposed to do.

HARPER: Sure. So the device is called the BRIDGE, and it looks a little bit like a hearing aid. It attaches around your ear with these little electrodes, and those electrodes deliver a mild electrical pulse that in theory reduces the symptoms of opioid withdrawal².

MARTIN: Which, I imagine, can be overwhelming. Just describe what those symptoms are like.

HARPER: Most people I've talked to compare it to the flu but they say it's five times worse. The symptoms can include hot and cold sweats, joint³ pain, diarrhea and vomiting⁴. And you basically just end up laying in bed for days. So it's pretty miserable⁵.

MARTIN: OK. So what did you find out about this device and how it works or doesn't work?

HARPER: So in November of last year, the FDA gave the company permission to start marketing⁶ the BRIDGE, and that permission was based on a study. And when we looked into it, we found that the study had some pretty serious flaws. The researchers, they published it as a retrospective assessment⁷, which means they looked at medical records after providers had treated patients in withdrawal and pulled data out of those records. But actually talking to those providers, it looks like the company and the researchers had actually conducted a clinical trial. They were actively⁸ performing an experiment on people with addiction⁹ trying to see if this device works, and they didn't get the proper oversight¹⁰ that would be required by the FDA to do that.

MARTIN: So the bottom line is that this company didn't get the right oversight for this device. What are the consequences of that?

HARPER: Yeah. So those FDA guidelines are designed to do two basic things. One is to protect patients. Addiction is a dangerous disease so when someone is finally ready to go in and get treatment, you want to make sure that they're offered something that's proven to work. Or if they're part of an experiment, you want to make sure that they understand that and that they know what the risks are. The other thing that oversight would have done is ensure that the data that researchers were collecting was valid¹¹. One of the really common issues in addiction studies in general is dropout¹², and that was definitely an issue with the BRIDGE. I actually followed a patient through his experience, and he said he felt better right after the device was put around his ear, but a couple days later, he said it stopped working for him and he went back to using opioids. But the researchers left that kind of information out of the study. Another thing that we found that was missing was that one of the study authors had applied¹³ for a patent on a treatment regimen using the BRIDGE, which could be a pretty significant conflict of interest and something that you want to keep in mind, that the author might have some potential bias¹⁴.

MARTIN: But, I mean, we clearly live in a time where the opioid crisis is at such proportions, everyone's desperate to try to come up with ways to address this. So I imagine that's why something like this particular device, even if the results are questionable¹⁵, it would still be appealing to a lot of people.

HARPER: Yeah. So there are a lot of politicians in particular who are really interested in this technology. It's made here in Indiana. It's potentially a non-opioid treatment tool so it is very appealing. And around the time of that presentation to the legislature, I was told that lawmakers went to the state Medicaid agency and were basically pushing for the device to be covered. I think it's important to say that it's definitely possible that this device works, but addiction professionals that I've been talking to are worried that policymakers see this as part of the solution to the opioid epidemic¹⁶ when really there isn't scientifically validated¹⁷ evidence to support that yet.

MARTIN: Jake Harper. Jake's article appears on NPR's Shots blog today. He is part of NPR's reporting partnership¹⁸ with Side Effects Public Media and Kaiser Health News. Jake, thanks so much for sharing your reporting on this.

HARPER: Yeah. Thank you.

1 byline   

n.署名；v.署名

参考例句：

• His byline was absent as well.他的署名也不见了。
• We wish to thank the author of this article which carries no byline.我们要感谢这篇文章的那位没有署名的作者。

2 withdrawal   

n.取回，提款；撤退，撤军；收回，撤销

参考例句：

• The police were forced to make a tactical withdrawal.警方被迫进行战术撤退。
• They insisted upon a withdrawal of the statement and a public apology.他们坚持要收回那些话并公开道歉。

3 joint   

adj.联合的，共同的；n.关节，接合处；v.连接，贴合

参考例句：

• I had a bad fall,which put my shoulder out of joint.我重重地摔了一跤，肩膀脫臼了。
• We wrote a letter in joint names.我们联名写了封信。

4 vomiting   

吐

参考例句：

• Symptoms include diarrhoea and vomiting. 症状有腹泻和呕吐。
• Especially when I feel seasick, I can't stand watching someone else vomiting." 尤其晕船的时候，看不得人家呕。”

5 miserable   

adj.悲惨的，痛苦的；可怜的，糟糕的

参考例句：

• It was miserable of you to make fun of him.你取笑他，这是可耻的。
• Her past life was miserable.她过去的生活很苦。

6 marketing   

n.行销，在市场的买卖，买东西

参考例句：

• They are developing marketing network.他们正在发展销售网络。
• He often goes marketing.他经常去市场做生意。

7 assessment   

n.评价；评估；对财产的估价，被估定的金额

参考例句：

• This is a very perceptive assessment of the situation.这是一个对该情况的极富洞察力的评价。
• What is your assessment of the situation?你对时局的看法如何？

8 actively   

adv.积极地，勤奋地

参考例句：

• During this period all the students were actively participating.在这节课中所有的学生都积极参加。
• We are actively intervening to settle a quarrel.我们正在积极调解争执。

9 addiction   

n.上瘾入迷，嗜好

参考例句：

• He stole money from his parents to feed his addiction.他从父母那儿偷钱以满足自己的嗜好。
• Areas of drug dealing are hellholes of addiction,poverty and murder.贩卖毒品的地区往往是吸毒上瘾、贫困和发生谋杀的地方。

10 oversight   

n.勘漏，失察，疏忽

参考例句：

• I consider this a gross oversight on your part.我把这件事看作是你的一大疏忽。
• Your essay was not marked through an oversight on my part.由于我的疏忽你的文章没有打分。

11 valid   

adj.有确实根据的；有效的；正当的，合法的

参考例句：

• His claim to own the house is valid.他主张对此屋的所有权有效。
• Do you have valid reasons for your absence?你的缺席有正当理由吗？

12 dropout   

n.退学的学生；退学；退出者

参考例句：

• There is a high dropout rate from some college courses.有些大学课程的退出率很高。
• In the long haul,she'll regret having been a school dropout.她终归会后悔不该中途辍学。

13 applied   

adj.应用的；v.应用，适用

参考例句：

• She plans to take a course in applied linguistics.她打算学习应用语言学课程。
• This cream is best applied to the face at night.这种乳霜最好晚上擦脸用。

14 bias   

n.偏见，偏心，偏袒；vt.使有偏见

参考例句：

• They are accusing the teacher of political bias in his marking.他们在指控那名教师打分数有政治偏见。
• He had a bias toward the plan.他对这项计划有偏见。

15 questionable   

adj.可疑的，有问题的

参考例句：

• There are still a few questionable points in the case.这个案件还有几个疑点。
• Your argument is based on a set of questionable assumptions.你的论证建立在一套有问题的假设上。

16 epidemic   

n.流行病；盛行；adj.流行性的，流传极广的

参考例句：

• That kind of epidemic disease has long been stamped out.那种传染病早已绝迹。
• The authorities tried to localise the epidemic.当局试图把流行病限制在局部范围。

17 validated   

v.证实( validate的过去式和过去分词 )；确证；使生效；使有法律效力

参考例句：

• Time validated our suspicion. 时间证实了我们的怀疑。 来自《现代英汉综合大词典》
• The decade of history since 1927 had richly validated their thesis. 1927年以来的十年的历史，充分证明了他们的论点。 来自辞典例句

18 partnership   

n.合作关系，伙伴关系

参考例句：

• The company has gone into partnership with Swiss Bank Corporation.这家公司已经和瑞士银行公司建立合作关系。
• Martin has taken him into general partnership in his company.马丁已让他成为公司的普通合伙人。