The U.S. Department of Food and Drug Administration is being called to investigate a short-lived pilot program that sought to treat inmates with anti-addiction implants never approved by federal regulators.
According to The Advocate, the group, Public Citizen, sent a letter to the U.S. Food and Drug Administration this week 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 pilot program involved a surgical implant that released the opioid and addiction fighting 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.
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.
For reasons that are unclear, the pilot stopped after the first implant. Recipient 39-year-old Alvin Dutruch says he has been doing well in recovery since his release.