CREVE COUER, Mo. — The private Facebook (FB) 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.”
A late-night moment of inspiration
Taca, 47, a sharp dresser who grows animated when discussing addiction medicine, discovered the technology behind the Bridge three years ago. A friend of his gave him an electroacupuncture device called a P-Stim used for pain relief. He tinkered with it, trying it on a fibromyalgia patient and even letting his mother use it after her knee replacement.
It was nearly midnight the first time he tried the device on a patient enduring detox. She needed relief from the agony of Suboxone withdrawal. He got her consent and attached the device to the side of her head, connecting to it four small prongs that he fixed on and around her left ear near four cranial nerves. By sending pulses through those nerves, the device is supposed to interfere with pain signals and block them from entering the brain.
“How fast is this supposed to work?” Taca recalled the patient asking.
“I have no idea,” he said. “You’re the first.”
“This could be the greatest medical contribution since the polio vaccine. … Think about how many lives can be saved.”
Dr. Arturo Taca, Jr.
Taca, a native of the Philippines who came here as a child when his father fled the Ferdinand Marcos regime, runs a private clinic called INSynergy, located in an office park near a golf course here in Creve Coeur. Board certified in addiction medicine and psychiatry, his eyes light up talking about both his practice and patients.
He says his many of his patients struggle to get onto medication-assisted treatment like Vivitrol — designed to block the brain from wanting more opioids — because all opioids must first be flushed from their systems before they start the new medicine, to avoid adverse side effects. Many of his patients relapse before that happens; others never show up to start the process, fearing withdrawal pain.
The P-Stim worked almost instantaneously on the first patient, he said. But it was only meant for use in short therapy sessions. He needed someone to tweak the device so it could provide continuous stimulation for as long as detox might take. In early 2015, he reached out through mutual acquaintances to Brian Carrico, now the president of Innovative Health Solutions, a medical device maker in Versailles, Ind.
Together they created the Bridge — named for its ability to create a path from opioid use to recovery — based off a similar device that IHS had already cleared with the FDA for acute and chronic pain.
By the end of 2015, a pitch emerged: a first-of-its-kind, non-narcotic detox therapy. Taca turned toward getting the Bridge into the hands of patients.
A limited study suggests big benefits
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.”
A marketing campaign takes off on social media
In lieu of stronger evidence, Taca has turned to tireless advocacy for the Bridge.
A pamphlet produced by Taca’s treatment center claims “our studies show that 85% of the symptoms are reduced within 30 minutes” — without explaining the study’s limitations. He and his staff have filmed clinical interviews with his patients, in which patients describe the effects of the Bridge — and they’ve posted positive ones on YouTube. Then there’s the closed Facebook group with about 1,000 members that he helps administer. The group’s page was originally titled: “There’s Hope with The Bridge Detox Program.” (It was later changed to “The Bridge Device.”)
One of the rules: “No Negativity!”
“We don’t know how often it works. … That’s going to be tough to tell without any comparative trials. You just don’t know.”
Jack Mitchell, former director of the FDA’s Office of Scientific Investigation
Last year, Taca’s clinic, INSynergy, recruited opioid users here into a study of the Bridge. Participants posted video diaries of their progress. A cascade of positive reviews soon followed in the Facebook group, with patients thanking Taca for saving their lives. As word spread through social media and beyond, those interested in the Bridge joined the group and posted questions:
“How can I get this for my son?” one mother wrote from Colorado.
“Is it available in Massachusetts?”
“Available in Virginia?”
Taca engaged with patients and their parents, telling them the real value in using the Bridge was to help them get clean long enough so they could get on to naltrexone, the opioid antagonist promoted under the brand Vivitrol. He’d asked one mother, “How is your son doing?” and told another patient he’d like “to hear about your story when you feel better.”
All the while, Taca pushed for positive press. This past February, he asked patients to message him if they’d be willing to speak with “a few media people.” And in March, he urged providers in the Facebook group to reach out Gary Enos, editor of Addiction Professional, for a story about the device.
“Ok, will do!” replied Paul Finch, a physician assistant in Fairbanks, Alaska.
Finch told STAT he first learned of the device through Facebook. He now charges patients $600 to install it — a little more than what he pays for the device, he said. Other providers charge as much as $1,500. It’s typically not covered by insurance.
Clinics often bundle the device in with a more comprehensive detox program. Taca’s, for instance, lists the price for a 10-day medical detox program, including the Bridge, at $3,500.
Finch has outfitted nearly 80 patients with Bridge devices. Roughly two-thirds have made it through detox, he said. One of those is Erica Anderson, a 47-year-old mother from Wasilla, Alaska, the small town where Sarah Palin once served as mayor. A doctor’s oxycodone prescription for fibromyalgia led to Anderson into addiction. When her doctors tried to cut her off, she drained her retirement account as she bought prescription pills from dealers. She lost her restaurant job, and felt like she “was going to die” if things didn’t change, she said.
After hearing about the Bridge on Facebook, Anderson scheduled an appointment with Finch and drove more than five hours to Fairbanks. Within 10 minutes of the device being turned on, she said, nearly all of her withdrawal pain subsided. She managed to make it onto Vivitrol — and has remained off the prescription pills since March.
“It saved my life,” she said. “I don’t know what would’ve happened without it.”
Providers in six states told STAT they’d like to see more clinical data behind the Bridge. For now, though, they say the lack of options to help patients like Anderson means they’re willing to settle for anecdotal evidence.
“The Bridge is a treatment fad,” Finch said. “But right now I’ve got moms tapping out one [dollar bills] trying to buy Bridges for their kids. It’s the best we have on the market.”
‘Where else are they going to go?’
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?”