Group wants FDA investigation of implant program in La. prisons
A short-lived pilot program involved treating opioid addiction using a surgical implant never approved by regulators
WASHINGTON — A Washington, D.C.-based advocacy group is calling for a federal investigation into a short-lived pilot program that involved treating Louisiana prisoners addicted to opioids using a surgical implant never approved by regulators.
The group, Public Citizen, sent a letter to the U.S. Food and Drug Administration Wednesday demanding they “launch a formal compliance investigation” into a program developed through a partnership between the Louisiana Department of Public Safety and Corrections and a California health care company that distributes the implant.
The device, which is surgically implanted in those addicted to opioids, releases the well-known and widely used drug naltrexone. The drug is used to fight opioid and alcohol addictions by blocking the effects and cravings for such drugs in patients who have been clean for at least seven days.
While naltrexone has been approved by the FDA in the form of daily pills and monthly shots, the agency has not approved the time-release naltrexone implant product.
The company, BioCorRx, Inc., originally offered Louisiana’s corrections department 10 surgical implants at no cost to the state to be issued to any inmates who volunteered for the treatment as they prepared for their release back into society. The implant was intended for use alongside behavioral therapy and other support for inmates struggling with addiction.
One inmate at Louisiana State Penitentiary at Angola voluntarily requested and received the implant earlier this year, according to DOC spokesman Ken Pastorick.
The inmate, Alvin Dutruch, 39, of New Orleans, said in an interview that he's doing well in his recovery from substance abuse disorder since his release from prison and was positive about his experience.
After that inmate received the implant, the DOC discontinued its use for reasons that aren't clear.
Now, some advocates are asking whether the program violated the inmate's rights and are arguing the original plan to treat multiple inmates was an experiment where the inmates were the test subjects.
Public Citizen alleges the agencies conducted “what clearly amounts to a clinical investigation” to test an unapproved drug implant on inmates, all without receiving informed consent from the inmates and proper approvals from outside agencies.
Public Citizen's complaint to the FDA was signed by a coalition of doctors, ethicists, prisoner advocates and academics.
Their formal letter includes a copy of the agreement between DOC and the company, which states the purpose was to “demonstrate the effectiveness of the BioCorRx Recovery program.”
The goal, according to the document, was to “help those suffering and to illustrate the cost benefit of using the BioCorRx Recovery Program in lieu of incarceration of an individual for 6 months.”
The agreement was signed in April.
BioCorRx CEO Brady Granier insists the program was not a study. Dr. Michael Carome, director of Public Citizen’s Health Research Group, argues otherwise.
“That language couldn’t be clearer,” Carome said. “That’s going beyond clinical care. They’re doing this to collect an assessment of the benefits of this implant.”
Research involving human subjects legally requires the approval of an independent ethics committee, a result of disturbing reports in the 1970s chronicling research abuses. This outside panel, known as an Institutional Review Board, ensures test subjects — particularly vulnerable subjects, such as inmates — are protected, and that they are informed when they agree to participate in a study.
Although consent forms were available to inmates interested in the program, Public Citizen maintains the forms did not provide sufficient information for the inmates to legally consent to their involvement. Among other things, potential risks should have been acknowledged, along with a clear statement that those participating were part of what the organization considers a study.
“There were consent documents that the subjects were supposed to sign, but they were for clinical care,” Carome said. “They were the typical clinical consent forms you would sign if you were going to have a surgery for your hip, but that type of consent is very different than consent for research.”
And advocates say seeking consent from an incarcerated person — for a study or otherwise — is already a fraught question.
Kerry Myers, deputy director with The Parole Project, a Louisiana-based advocacy group for the formerly incarcerated, said consent is always going to be problematic for someone behind bars.
“The people in prison just do not have the freedom or the options in many cases to protect themselves from people who might want to exploit them,” Myers said. “They are vulnerable because they really have no control. They are living in an arbitrary world with people who have arbitrary power over them.”
According to the agreement, the program also included a “patient tracking” element, with the DOC expected to provide “general oversight and monitoring.”
Granier, the BioCorRx CEO, had said in May his company would be collecting data from the prisoners who volunteered for the pilot program in Louisiana by monitoring how successful they were.
But a BioCorRx spokesperson clarified on Wednesday no data was collected by the company from the inmate who participated in the program. Rather, the tracking referred to a mobile app that would provide peer support for the inmate.
“BioCorRx welcomes any investigation by the FDA and believes it has done everything regarding its comprehensive program to fight addictions in full compliance with the letter and spirit of the law,” Granier said.
Dutruch said he was presented with the option to accept the implant in February or March, about 90 days before his release.
Dutruch was eager to try an option that would mitigate his cravings and would require little attention from him, unlike a daily pill or an injection. The implant, he said, was easy and automatic. He has been incarcerated multiple times and hoped he could find a solution to his addiction struggle that would stick on the outside.
“Every other time I was released from an institution, I was always using within 24-48 hours,” he said. “So, this go around I was willing to do whatever it took in order to maintain sobriety.”
He was told the implant was not FDA approved and given time to consult with his family, doctors and outside resources before he made a decision.
The implant, he felt, was the best option. He underwent the surgery several days before his release so he could be monitored for post-operation issues.
“This is the longest amount of sobriety I’ve had in 16 years,” Dutruch said. “And I attribute it to the implant.”
- Prisoner Treatment