CREVE COUER, Mo. — 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.
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.
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.
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.
Taca is keenly aware of addiction medicine's fraught past.
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.
In lieu of stronger evidence, Taca has turned to tireless advocacy for the Bridge.
"How can I get this for my son?" one mother wrote from Colorado.
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.
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.
Taca hopes the Bridge becomes more than just a fad. He wants more evidence. To some degree, he's banking on 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.
Are the devices available in mississippi? If not, how close do you travel to Mississippi?
Hi I am very interested in knowing how this is obtained or if it is possible for me and anyone else I know that may be interested? I live in Milwaukee Wisconsin. I currently don't have the money to pay for it but could very soon. I have insurance through the state at the moment. Please if you can provide any and all information on how and where to go about getting this I would be so appreciative!!! I am a addict, currently on suboxone and have been for a long while now . I've wanted to get off it for some time and just don't know how to manage withdrawals. This is the next step in my recovery which I am wanting so bad as I have burned the bridge to relapse and going to be finishing my degree in hopes to counsel for addiction. Please any info I would be greatful for ! Thank you so much !!!