The private Facebook group for the Bridge — a wearable medical device claiming to help opioid users overcome the pain of withdrawal — feels like a recovery meeting. Doctors sing the device’s praises. Patients describe it as a miracle and offer to help spread the gospel.
The Food and Drug Administration cleared the device, which sends small electrical pulses through four cranial nerves, for treatment of chronic and acute pain three years ago. Now, doctors from Alaska to Florida are charging $600 to $1,500 or even more to attach it to patients’ ears in a bid to curb the intense nausea, anxiety, and aches of opioid withdrawal. A municipal judge in Indiana allows defendants addicted to heroin to choose the Bridge over jail. State officials in Utah recently agreed to buy 100 devices for inmates. Ohio Gov. John Kasich even mentioned it during his State of the State address.
But the Bridge has never been tested in a controlled clinical trial to evaluate whether it’s effective for treating opioid withdrawal. The only published study looking at its use as a detox device is flimsy — and co-authored by a doctor with a financial incentive to promote the device. And much of the extensive hype about the Bridge has been ginned up by that same doctor, who runs the Facebook group, responds to positive posts with applause emojis — and routinely asks satisfied patients and providers to speak with reporters.
At a time when drug deaths are soaring, and only a tenth of people with opioid-use disorders make it to medical treatment, the excitement surrounding the Bridge underscores a conundrum of the opioid crisis. New products promising to improve recovery are flooding the market. But advocates worry that vulnerable patients desperate to kick their drug habits are being sold hope ahead of hard evidence.
“We don’t know how often [the Bridge] works, and what’s going to happen to patients for whom it doesn’t work,” said Jack Mitchell, former director of the FDA’s Office of Scientific Investigations. “That’s going to be tough to tell without any comparative trials. You just don’t know.”
At the center of the Bridge’s rise is Dr. Arturo Taca Jr., an addiction specialist based here in this well-off suburb of St. Louis. He pioneered the idea of using the device for detox patients almost by chance, trying it out on a frazzled patient late one evening as she battled through withdrawal. He’s since launched a savvy marketing campaign. The result: The device, which looks rather like a hearing aid, has been described in glowing terms everywhere from PBS to DrugRehab.com to Alaska Dispatch News, under headlines like: “Taking the pain out of addiction.”
Taca says he doesn’t have a financial stake in the Bridge itself. But he’s filed for a patent on a pricey detox method that uses the Bridge to help patients transition to extended-release naltrexone, a drug often sold under the popular brand Vivitrol that blocks the brain from wanting more opioids. He has been paid tens of thousands a year in recent years by Alkermes, the company that makes Vivitrol.
Taca doesn’t apologize for his financial positions, or for his rush to promote the device before it’s been fully vetted. We’re in the midst of a national crisis, he explains. And he’s seen first-hand that the Bridge can help.
“This could be the greatest medical contribution since the polio vaccine,” he said in an interview in his office. “There are a lot of people dying [from opioids]. Think about how many lives can be saved.” […]
Taca is keenly aware of addiction medicine’s fraught past.
“In addiction medicine, you have a lot things that aren’t based on science — horse-petting, kite-flying, saunas, and spas,” Taca said. “People are going, ‘OK, what is this little gadget?’ People, rightfully so, should be curious about the science behind it.”
Taca pointed to several studies authored by Dr. Adrian Miranda, a pediatric gastroenterologist, which he said provides evidence the Bridge works to reduce pain in general, though the trials don’t address opioid withdrawal specifically. Most recently, in a paper published this month in Lancet Gastroenterology and Hepatology, Miranda conducted a double-blind randomized clinical trial that found adolescents who were treated with the device for pain-related gastrointestinal disorders had a “significant reduction in pain and disability compared with the sham control group” without any “serious adverse events.” (Carrico said IHS has provided Bridge devices to scientists for some trials, but has never paid for or sponsored a study.)
This past spring, the American Journal of Drug and Alcohol Abuse published the only peer-reviewed study to date looking at the Bridge’s effectiveness in treating opioid withdrawal in adults. The study, co-authored by Miranda and Taca, looked at 73 patients in five states. They found 89 percent “successfully transitioned” to medication-assisted treatment. But the small study wasn’t randomized, controlled, or double blind. Miranda also said the study was conducted retrospectively — meaning the authors went back to examine data collected at clinics where select patients were already being outfitted with the Bridge.
Dr. Lance Dodes, a retired professor at Harvard Medical School who has written several books about addiction, said the study’s design makes it impossible to conclude whether patients responded to the device or if there was a placebo effect. To “draw conclusions” about its effectiveness from this study, he said, is “bad science.”
“I’m not against it, but if they’d been more patient, done the pilot, then a full study with a control group, we’d have results,” Dodes said. “This pilot study by itself doesn’t prove efficacy.”
Dr. Joshua Sharfstein, an associate dean at Johns Hopkins Bloomberg School of Public Health, said every kind of treatment for opioid use disorder should be studied “rigorously.”
And consumer advocate Diana Zuckerman points out that bold claims from manufacturers have failed patients in the past. “Claims were made about opioids being non-addictive and people became addicted,” said Zuckerman, president of the nonprofit National Center for Health Research. “The FDA is trying to do the right thing… [but] wouldn’t it be great if they solved the problems by having products tested to make sure they work?”
Carrico, the company president, said he recently started talking with Indiana University Health about launching a controlled study. For now, though, he insists the FDA has enough evidence to reclassify the device for opioid withdrawal. (A FDA spokesperson declined to comment on the pending application.)
“I’ve never seen it not work for an opioid patient,” Carrico said. “… For us to sit on this technology, from a humanity standpoint, is incredibly irresponsible.” […]
Taca hopes the Bridge becomes more than just a fad. He wants more evidence. To some degree, he’s banking on it.
The Missouri psychiatrist said he hasn’t received “a penny” from IHS, nor does he hold equity in the company. “We should’ve had something on paper, but nothing is on paper,” he said. “That’s frustrating on my end.”
But he does have a patent pending for a treatment program that uses the Bridge followed by a regimen of extended-release naltrexone, currently only available as Vivitrol. Since 2013 the maker of Vivitrol, Alkermes, has paid Taca at least $164,000 for consulting, meals, travel, and speaking engagements. Taca notes that he knows the product well; he’s used it in his clinic thousands of times. (An Alkermes spokesperson declined to comment on the record.)
“I’m a paid speaker for Vivitrol,” Taca said. “I’m not going to apologize. I don’t feel embarrassment. It’d be different if I didn’t know anything about this. But I’ve got lots of experience with it.”
Taca understands why some patients might see his relationship with Vivitrol as casting a shadow over his work with the Bridge. But it won’t stop him.
“Is that going to cause them to not get treatment? That’s up to them,” Taca said. “We have limited choices for treatment. If they say, ‘there’s a conflict of interest,’ well … where else are they going to go?”
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