Questions Raised About Study Of Device To Ease Opioid Withdrawal

Jake Harper, NPR, May 2, 2018

To the untrained, the evidence looks promising for a new medical device to ease opioid withdrawal. A small study shows that people feel better when the device, an electronic nerve stimulator called the Bridge, is placed behind their ear.

The company that markets the Bridge is using the study results to promote its use to anyone who will listen: policymakers, criminal justice officials and health care providers.

The message is working.

In the face of a nationwide crisis of opioid addiction, people are eager for new solutions. Criminal justice officials in multiple states have started Bridge pilot programs. At least one such program in Indiana received state funds. Providers with a major hospital chain in Indiana began prescribing the Bridge. And politicians in Indiana, Utah and Ohio publicly touted the device.

Innovative Health Solutions, the device maker, has marketed the Bridge for opioid withdrawal for more than a year, even before it had clearance for that use from the Food and Drug Administration. Then, last November, the Versailles, Ind.-based company got that, too. Citing the study, the FDA allowed the Bridge to be promoted for opioid withdrawal.

Indiana State Sen. Jim Merritt, a Republican who is known for sponsoring legislation addressing the opioid crisis, held an effusive press conference after the FDA gave its OK to the Bridge. “People will detox,” he told reporters. “They will withdraw from drugs if it’s a simpler process, and this is it.”

But some addiction specialists aren’t persuaded by the evidence behind the device. The study informing the agency’s decision didn’t randomly compare the experience of patients treated with the device with others who got a sham treatment. Andy Chambers, an addiction psychiatrist in Indianapolis, said there’s no way to know if the $595 device works, or if patients and providers simply believe that it does.

“For the sake of patients, I do hope the Bridge works,” Chambers wrote in a letter published in the Indianapolis Star in November. “But for me to use it in regular practice, don’t show me a sales job, or the enthusiasm of lobbyists, politicians or prosecutors; just give me the solid science.”

An investigation by Side Effects Public Media and NPR reveals that researchers working with Innovative Health Solutions, maker of the Bridge, submitted to a medical journal a study that wasn’t what it appeared to be. The study authors said it was a “retrospective study,” which means they would have simply reviewed existing medical data. But it seems that they instead conducted a clinical trial that skirted FDA rules and ethical norms, using vulnerable people suffering from addiction as test subjects. The FDA then relied on the results of the study in making its decision to clear the Bridge for marketing as a treatment for opioid withdrawal.

In a response to questions from Side Effects and NPR, the FDA said it cleared the Bridge for use in opioid withdrawal because the study demonstrated “a clinical benefit that outweighs the risk of the device.” The agency also said it is reviewing the issues raised by the investigation but didn’t say what, if any, action it might take.

Innovative Health Solutions said that company representatives and researchers followed FDA rules when the study was conducted.

To Chambers, the FDA decision in favor of the Bridge was another sign of unsupported enthusiasm for the device. Chambers said policymakers and clinicians should support the use of proven therapies, instead of the Bridge. “You’re potentially draining money away from other treatments that we know are efficacious,” Chambers said. […]

Experts we consulted found the ethical and regulatory issues in the study troubling. “In an ideal world, the journal would retract the article and the FDA would take the product off the market until an appropriate study was done,” said Diana Zuckerman, president of the National Center for Health Research. […]

Read the original article here.