How Effective is The Bridge Medical Device for Treating Opioid Withdrawal?
The Bridge medical device is being marketed as a medical breakthrough in addiction treatment. It was FDA-approved for alleviating opioid withdrawal pain in November 2017. However, test results are not scientifically sound. While the Bridge has helped many people to successfully withdraw from opioids with minimal discomfort and begin a maintenance medication such as Vivitrol or buprenorphine, there are also a large number of patients who did not make it though withdrawal using The Bridge.
Without scientifically sound medical testing of this device, there’s no way to know what the real percentages are.
The Bridge evolved from the P-Stim (auricular electroacupuncture stimulation device), a medical device which was FDA-approved as a Class II Device (moderate risk; most medical devices fall under this classification) for use in treating post-operative pain in 2014. The Bridge was developed for use in treating opioid withdrawal pain in 2016. After using it successfully on some patients, it’s been aggressively marketed as an addiction treatment breakthrough.
What Does the Bridge Do to Ease Opioid Withdrawal?
The Bridge is an auricular percutaneous nerve field stimulator which looks like a large hearing aid. It works by sending electronic signals to the brain which interfere with pain signals and block anxiety and fear. In order to begin Medication Assisted Treatment (MAT) patients need to first go through early withdrawal from the opioid drug. Fear of the pain of withdrawal has kept many addicted people from seeking help. Patients wear the Bridge for four to five days, during the worst part of acute opioid withdrawal. This device was named the Bridge because when it works, it rapidly and drastically reduces the excruciating pain of withdrawal and provides a bridge from addiction to safety.
What is Off-Label Promotion?
Off-label promotion is promoting a medication or treatment for another use than the FDA-approved use. While this is illegal and unethical, it happens. The Bridge was marketed for opioid withdrawal long before it was FDA-approved.
The device was pioneered by Addiction Psychiatrist Arturo Taca, who runs a private clinic in Creve Coeur, Missouri. Taca had been trying out the P-Stim electroacupuncture device on patients with various pain issues, to see if it worked to ease their pain. When he used it in a late-night session on a patient going through opioid withdrawal, he found it relieved the patient’s pain temporarily, but needed to be adjusted to provide the long-term relief necessary to see patients through opioid detox. He then contacted Brian Carrico of Innovative Health Solutions, to tweak their existing P-Stim device to treat opioid withdrawal.
Upon reading the article in STAT which details how Taca pioneered the Bridge, one may think of a mad scientist experimenting on human subjects. However, Taca knew the P-Stim, which had received FDA approval and was already in use, did not pose serious health risks. Where the history of the Bridge becomes murky is in the marketing and promotion of this device.
The Bridge Test Results are Inconclusive
While use of this medical device to treat opioid withdrawal is not known to physically injure patients, it doesn’t work for everybody like Taca, Carrico, and scores of others who have eagerly jumped on the Bridge bandwagon claim. These false claims regarding the efficacy of the Bridge are targeting people who are gravely ill and desperate for help, fleecing them of their money and giving them false hope without providing accurate information about the likelihood of the device working.
According to a recent article in NPR, the original P-Stim wasn’t the only thing that was tweaked; the testing prior to FDA approval skirted the rules and also didn’t yield scientifically accurate results. According to one medical worker who assisted in a study to gain FDA approval, no record was kept of the percentage of patients who dropped out before completing the Bridge-assisted detox.
Another huge problem was lack of standard monitoring. Test subjects were given the bridge, which looks similar to a large hearing device, and then they were sent home. There was no reliable monitoring to ensure adherence to standard scientific procedural guidelines, and no record was provided of the number of patients who never completed withdrawal or never returned. Clearly, the test results were skewed to support the efficacy of the Bridge device, with little or no regard to scientific accuracy.
Does the Bridge Work or Not?
Apparently the Bridge does drastically reduce withdrawal symptoms for many patients. However, there are also a large number of patients who it doesn’t help. Without accurate scientific testing and reliable test results it’s impossible to know what the percentages are or why it doesn’t always work.
If you have the resources to buy the Bridge, which runs around $595 though some providers charge as much as three times that amount, or if you’re provided a free Bridge medical device by law enforcement as some jurisdictions are doing, it’s probably worth giving it a try. But it’s very important to know that The Bridge might not work for you. Remember that you’re taking a gamble—the Bridge doesn’t always live up to the claims being made about it. By understanding that the Bridge isn’t the miracle cure promoters are claiming it is you’ll save yourself a potentially crushing and painful disappointment.