Vulnerable patients — easy targets for companies willing to sacrifice ethics for profits

Vulnerable patients — easy targets for companies willing to sacrifice ethics for profits
© Artisteer/iStock/Thinkstock

A small medical device has just become embroiled in a large controversy, suggesting violations of fundamental ethical norms and settled principles of scientific research.

At first glance, the Bridge — a neuro-modulation device that attaches behind the ear — resembles a hearing aid with wires. The Bridge received Food and Drug Administration (FDA) clearance in November 2017 for easing opioid withdrawal symptoms during detoxification; before, it was approved only for acupuncture.

This device is supposed to help patients get through the difficult opioid withdrawal process. It’s used in pilot programs in several states, available in at least one major Indiana hospital chain, and is starting to be covered by insurance.  

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But the Bridge was in troubled waters as early as 2016, when its manufacturer, Innovative Health Solutions (IHS), appears to have participated in “off label” promotion with misleading claims, potentially violating the Federal Trade Commission Act and FDA regulations.

For example, according to publicly available archives, IHS President Brian Carrico told an Indiana legislative study committee on Aug. 18, 2016 the Bridge was “FDA-approved . . . in December [of 2015]” and that a “prospective randomized double blind sham-controlled” study had proven its efficacy, and was being presented at a “World Congress” by Adrian Miranda. But the device was only cleared for acupuncture and the study didn’t involve opioid withdrawal, or even humans, but rats with colitis.

This trouble intensified on May 2, 2018, when an NPR and Side Effects Public Media reported that the only published study of the Bridge’s use in human opioid detoxification that had supported the 2017 FDA clearance included serious ethical and legal violations.

The article by Drs Arturo Taca and Adrian Miranda, published in the American Journal of Drug and Alcohol Abuse, claimed to prove that the Bridge reduced opioid withdrawal in patients by 84.6 percent within one hour. IHS recently issued a response to this article on their website.

This data supposedly came from a retrospective review of 73 patients’ medical records from eight outpatient clinics, all of which use the Bridge in the “initial treatment of opioid withdrawal.” NPR alleged, however, that Taca conducted a prospective clinical trial without IRB oversight or patients’ informed consent, giving each clinic the same protocol and asking them to submit data on treatment results.

In response to the NPR article, IHS asserted that, after each clinic contacted Taca independently, he “shared his ideas” about the Bridge “to help them find solutions,” including “close monitoring of patients.” Thus, when Miranda approached Taca to write the article, the researchers “were able to identify physicians who might have pertinent data to share.”

IHS’s claims ring false. Even assuming that these clinics knew of the Bridge and coincidentally thought to use a device cleared only for acupuncture for managing opioid withdrawal, why would they all measure withdrawal symptoms at the same time interval - ones that physicians do not typically used with the Clinical Opiate Withdrawal Scale (COWS) scale used to measure symptoms? Indeed, IHS's response features a provider who reports that, when a device didn’t work, “I called Dr. Taca and asked what I should do. . . . I appreciated Dr. Taca and his and [sic] availability.”

Doctors are usually hesitant to answer treatment questions over the phone for non-patients, lest this create a physician patient-relationship, along with potential legal liability. Moreover, one of the study sites also appeared to be Taca’s private clinic, where he generated the very records that he later obtained retrospectively.

There is a big difference between a retrospective medical records review and a prospective clinical trial. Medical device clinical trials on humans must have an Institutional Review Board (IRB) approve and oversee the study to safeguard ethics and patients. But if this was a clinical trial as NPR claims, then Taca and Miranda didn’t obtain proper IRB permission.

Patients do not appear to have been told that they were participating in a research study, that the Bridge was experimental and not cleared for opioid withdrawal management, that it could fall off or stop working (initiating full withdrawal), or what they should do if that occurred.

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Patients in full withdrawal are in pain, vulnerable, and at high risk of relapse—but if this was a prospective study without IRB oversight, then they were on their own—a scary prospect, given that NPR quoted Alaskan physician’s assistant Paul Finch as stating, “a little more than half of his Bridge patients successfully complete the detox.”

One provider IHS quoted in its response even seemed to blame patients — not the Bridge — when the device failed: “it’s not the BRIDGE that causes things to go wrong, its [sic] patients not using the technology correctly.”

Even aside from purported legal and ethical violations, the article’s scientific evidence is shaky at best for playing such a central piece in FDA clearance. There was no control group, no blinding, and few participants. Furthermore, because there was supposedly no clinical trial, participant dropout rates were unreported.

Finally, Taca didn’t disclose that he had applied for a patent on a detoxification process involving neurostimulation devices, including the Bridge, leading to the journal later issuing a correction. IHS claims that Taca’s “oversight was the result of the fact that he had (and still has) no patent, nor had or has a financial relationship with IHS.” Taca’s patent, however, would allow him to directly profit from any use of devices like the Bridge, as would IHS, marrying their financial futures.     

These purported violations are serious. According to NPR — IHS, Taca, and Miranda exploited vulnerable individuals and made a mockery of the peer review process and government regulations. Such conduct undermines public trust in addiction medicine, which is already made fragile by fears that pharmaceutical industries and medical corporations are trying to reap profits at patients’ expense. The first response to these developments is for the American Journal of Drug and Alcohol Abuse and FDA to properly investigate this conduct.

Vulnerable patients make easy targets for companies willing to sacrifice ethics for a shortcut to profits. Greater scrutiny of devices for use in potential deadly diseases, like opioid use disorder, is warranted, from peer reviewer processes at academic journals to FDA oversight. For now, it’s high time to put the Bridge device in suspension until solid evidence backs up its efficacy and safety.

Such data can’t be obtained without adequate IRB oversight, patient informed consent and full disclosure of researchers’ conflicts of interest. Until then, we must strongly repudiate unethical conduct, burning the bridges linking respected academic research and institutions to practices that coerce, mislead, and harm.

Jody Lyneé Madeira J.D. Ph.D. is a professor at Indiana University Maurer School of Law.