Former prisoner says medical implant helped him overcome addiction to opioids
The implant has not been FDA approved, as Sharyl Attkisson reports on her program, Full Measure.
Shortly before getting out of prison, Alvin Dutruch opted to receive an implant that would gradually dispense a medication called naltrexone to help curb his desire for opioids. But as journalist Sharyl Attkisson reported during the latest episode of her "Full Measure" program, the implant has not been approved by the U.S. Food and Drug Administration (FDA).
Dutruch became addicted to opioids following a car wreck in which he broke his back. A doctor prescribed the pain medicine, but Dutruch says the implant helped him to overcome the addiction.
Dr. Michael Carome from the watchdog organization Public Citizen says that naltrexone maker BioCorRx failed to abide by federal regulations.
"The plan was to test it in prisoners to see if it is effective for treating opioid and alcohol addiction," said Carome, who previously worked for the Office of Human Research Protections within the U.S. Department of Health and Human Services. "And that was done without complying with the federal rules, the FDA regulations for oversight of human research and for protecting human subjects."
Carome is among a number of people who signed a letter calling for an FDA investigation. In a post about that letter, Public Citizen says that while injection and tablet versions of naltrexone have been cleared for use in treating patients with addictions, the implant has not been approved.
Attkisson said that BioCorpRx would not give an interview: "They say their program with the Louisiana department of corrections did not qualify as a study—and countless doctors have used Naltrexone implants on patients for over 20 years from licensed compounding pharmacies long before the existence of BioCorRx."
Carome indicated that even if the FDA uncovered problems, no action would be taken. "Unfortunately the violations of the federal regulations don't carry with them any penalties, you can't be fined, you can't be put in jail," he said.
Attkisson noted that Dutruch is the only Louisiana prisoner who received the implant before the program was stopped.