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, BYLINE 1: 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 withdrawal 2.

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, joint 3 pain, diarrhea and vomiting 4. And you basically just end up laying in bed for days. So it's pretty miserable 5.

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 marketing 6 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 assessment 7, 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 actively 8 performing an experiment on people with addiction 9 trying to see if this device works, and they didn't get the proper oversight 10 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 valid 11. One of the really common issues in addiction studies in general is dropout 12, 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 applied 13 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 bias 14.

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 questionable 15, 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 epidemic 16 when really there isn't scientifically validated 17 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 partnership 18 with Side Effects Public Media and Kaiser Health News. Jake, thanks so much for sharing your reporting on this.

HARPER: Yeah. Thank you.