The Bridge

 

 

 

 

 

 

 

 

 

A little over a year ago (October 2, 2016), I blogged about a new device being marketed to reduce opioid withdrawal symptoms. I didn’t give the name of the device, because of a lack of data showing it works. Earlier this month, the FDA authorized the company that makes the device to start marketing it, for use in easing opioid withdrawal symptoms.

This device, called the NSS-2 Bridge, is a little bigger than a hearing aid, and is attached behind the ear. The device delivers electrical impulses to three electrodes placed around the ear. The cost for a five-day course of treatment with the device is around $500, and the manufacturer says it eliminates opioid withdrawal symptoms.

Mistakenly, I thought the FDA only approved medications and medical devices after multiple studies showed the treatments were effective. That doesn’t appear to be correct. Instead, according to an article in Forbes magazine online, the FDA is relatively quick to authorize medical devices that appear to have low or moderate risk to the consumer, even if there’s limited data to support their efficacy. This may be particularly true for devices purported to help in any aspect of treatment for opioid use disorder, since so many people are desperate for relief. [1]

I hope this device works as well as it is advertised. A safe device that controls opioid withdrawal symptoms…that sounds great.

But after suffering through several courses in medical statistics, I learned not to assume a given treatment will work unless it’s backed by solid research. There have been far too many products promoted with great fanfare to desperate people that later were found to be no more effective than placebo.

So what evidence did the FDA consider when deciding to approve advertising for the NSS-2 Bridge for the purpose of reducing opioid withdrawal? There’s only one small study, published earlier this year in the American Journal of Drug and Alcohol Abuse.

This retrospective pilot study of 73 people showed the Bridge device significantly improved withdrawal symptoms. Patients had an average COWS (clinical opioid withdrawal scale) score of 20 before the device was placed, and the average score dropped to 7.5 twenty minutes after the device was turned on. After an hour of use, withdrawal scores went down to an average of 4.

These patients were ultimately transitioned to maintenance medications.

After reading this pilot study, I have questions. For example, the Bridge was being used to help patients get through the opioid withdrawal of early medication-assisted treatment. But if the device gets rid of withdrawal symptoms, how do physicians and patients find the dose of medication that suppresses withdrawal? And at what point did the researchers start the medication?

So far as I can tell, there’s no randomized placebo-controlled trials of this device. This type of trial is more reliable to find out if a treatment works or not.

In the Forbes article, Dr. Nora Volkow, the Director of the National Institute on Drug Abuse (NIDA) agreed, saying, “The only way that you can determine the extent by which this device has potential clinical effects is by doing a randomized controlled trial.”

She also went on to say that we shouldn’t perpetuate treatments that aren’t proven by evidence that they work, because patients with opioid withdrawal are desperate, and have a serious disease.

Thank you, Dr. Volkow. You’ve summed it up nicely.

The company that makes NSS-2 Bridge, Innovative Health Solutions (IHS), gave a sales presentation to a group of doctors several years ago. At that meeting, I asked some challenging questions, like why is the company marketing the device before they’ve done the necessary research. I didn’t get a satisfactory answer. The salesman claimed they didn’t have to do more research because it worked 100% of the time. At that time, the company’s credibility took a big hit with me. I don’t know of any legitimate treatment that works for 100% of patients.

Then another doctor said our company has enough patients to power a large study, if IHS wanted to do a good study. The salesman said great, but then indicated the patients would still have to pay for the device.

No, no, no. That’s not the way research works. The manufacturer of the product funds the research, or should be willing to do so, if they believe in their product.

Just think – if that company had started a randomized controlled trial two years ago at that meeting, they might have good data by now, showing if the product works or not. But maybe that’s what they want to avoid.

I will not be prescribing the Bridge until/unless I see randomized controlled studies of this product, proving it works. Because I don’t trust products with better marketing than research.

  1. https://www.forbes.com/sites/ritarubin/2017/11/18/this-device-is-the-first-marketed-to-treat-opioid-withdrawal-but-evidence-it-works-is-lacking/#7383ed1826df

4 responses to this post.

  1. Posted by Steves on November 28, 2017 at 3:02 am

    Couldn’t agree more! Multiple anecdotes do not equal data.

    Reply

  2. Posted by David Faber MD on November 28, 2017 at 2:32 pm

    Love reading your blog. I had a similar experience when Zyprexa first came out. The claim was that it would reduce recidivism but they had no data. I was medical director for a 250,000 member HMO and offered our population. Uh, no. Thanks. Just buy it.

    Reply

  3. Posted by dbcincsa on November 28, 2017 at 5:54 pm

    Sure it lowers the COWS score, they are distracted by being shocked in the ear. The FDA is a lapdog to the corporations (not even just pharmaceuticals anymore, as we see). Even pharmaceuticals can selectively show the FDA the clinical trials they prefer to show, and as long as it is generally safe… the FDA doesn’t care. It kind of sums up the state of all US government. Sickening.

    Reply

  4. Posted by Maximilian Alexander on December 4, 2017 at 3:50 am

    This reminds me of Meg Patterson’s Black Box – a device apparently used since the 1970’s to cure opioid withdrawal and was taken up by Eric Clapton and Pete Townsend. Meg Patterson is still trying to have her device taken seriously 3 decades later.

    Click to access article-omni-black-box.pdf

    Reply

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