Former opioid addict says implant changed his life, but critics call him a "guinea pig"
Alvin Dutruch's descent into opioid addiction began with a car crash. In 2004, two years after he'd earned his degree from Tulane University, the then 24-year-old swerved to avoid rear-ending another driver and crashed into a ditch. Dutruch broke his back, and doctors prescribed Roxicodone, a powerful and potentially dangerous pain reliever. Hooked on the drug, he would spend the next 15 years cycling through jail, addiction and depression.
Dutruch said he finally broke free earlier this year after volunteering for a medical procedure while still an inmate at the Louisiana State Penitentiary: Doctors implanted a pellet of Naltrexone, a so-called opiate antagonist used to treat substance abuse, into his abdomen. Within hours, "It was like magic, and it was like these cravings that I've had since 2005 were gone," he told CBS MoneyWatch.
Now, consumer advocates are accusing the company behind the treatment, Anaheim, California-based BioCorRx, of using Dutruch as a human "guinea pig." Against the backdrop of a devastating national opioid epidemic, his case also raises difficult questions about medical ethics, ways to deal with substance abuse and even personal agency within a population — prisoners — largely deprived of their freedoms.
The "really good" life
Dutruch grew up upper middle class in Covington, Louisiana, a town of 10,000 people roughly 40 miles north of New Orleans. Encouraged by his parents to excel in school, he took honors classes, while also participating in theater and playing in the school band. He described his childhood as "idyllic."
"I was more spoiled than anything. I really didn't go without," said Dutruch, 39. "My life was really good until I got in that car accident."
To help soothe his back pain after the accident, he took 30 milligrams of Roxicodone four times a day as prescribed for more than two months.
"It kept me out of pain, but at the same time, we didn't realize the effects it was having on me," Dutruch said. "I had become utterly dependent on this pain medication to where I couldn't function without it."
Dutruch's prescription ran out just as his dependency peaked, so he devised a way to satisfy his craving. He started visiting doctors' offices to steal prescription pads; when he was caught, it landed him in a drug rehab program for three years. After starting to use opioids again in 2008, he was arrested and jailed for four years for writing himself a prescription and then paying for it with bad checks. Authorities released Dutruch in 2012, but by then he had graduated to heroin. He landed back in prison in 2016.
Dutruch said he committed those crimes because of "these overwhelming urges that were taking over my rationality, and the only thing you think about is getting high."
Seeking inmates with substance abuse problems
Dutruch's battle with addiction took a decisive turn during his most recent stint behind bars. He learned about BioCorRx's implant in a class about opioid addiction he took shortly before his release from prison, and decided to take a chance.
As part of the trial, BioCorRx provided 10 implants to the Louisiana corrections department so the agency could find volunteers for treatment, according to an April 2019 contract between the parties. The department in return was asked to provide monthly evaluations of any participants. BioCorRx was hoping to enlist five patients addicted to alcohol and five addicted to opioids, according to the document.
Dutruch, the only inmate to ultimately participate in the test, received the implant on May 1. Other prisoners declined and weren't pressured to take the implant, Dutruch said. Although he had been informed the implant wasn't FDA-approved, he said he volunteered because all the other methods he'd tried to kick his habit had failed.
The implant, inserted into a skin fold in his lower abdomen, was designed to slowly release Naltrexone for 90 days.
"For three months, I don't have to worry about going to the doctor to get a shot or going to the pharmacy to get a prescription," Dutruch said of the treatment. "The only thing I have to worry about is me and working on my recovery and working on getting myself together."
A breach of ethics?
Although Dutruch said the treatment has helped him turn his life around, some critics say he has been used. Consumer advocacy group Public Citizen last week urged the Food and Drug Administration to investigate BioCorRx and Louisiana's Department of Public Safety and Corrections.
Although Naltrexone is FDA-approved and has existed for decades in both pill and injectable form, the implant version has not been cleared for use on humans, Public Citizen said in a Nov. 20 letter. The group also said BioCorRx should have conducted the clinical trial in coordination with a FDA review board.
"The failure to comply with the requirements for the protection of human subjects represents a serious violation of the basic ethical principles of respect for persons, beneficence and justice," Dr. Michael Carome, Public Citizen's health research director, said in a statement. "A drug company should not be allowed to go into a prison and start treating the inmates like unwitting guinea pigs."
Public Citizen said it obtained emails between BioCorRx and Louisiana corrections officials that show the company didn't seek FDA approval to test the implant.
BioCorRx defends its actions, saying that it followed standard medical practice. It also notes that the implant is only one element in a three-part program BioCorRx uses to help patients fight addiction, including behavioral therapy and access to a "recovery coach" for six months through a mobile app.
"Naltrexone implants have been utilized by countless medical doctors under their discretion with their patients for over 20 years," the company said in a statement. "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."
Ken Pastorick, a spokesman for the Louisiana corrections department, confirmed that Dutruch volunteered to participate in the trial. Dutruch "is doing very well in his recovery from his substance use disorder," said Pastorick, who added that the department has not offered the implant to anyone else.
"The implant which delivers the medication is not currently approved by the FDA, but has been used in other countries and here in the U.S. to deliver Naltrexone," Pastorick said.
The FDA has not said whether it will pursue an investigation. The agency "will review the letter and will respond directly to the petitioner," spokesman Nathan Arnold said.
Today, Dutruch is back in Covington and working full time as a peer support specialist for Volunteers of America, a nonprofit helps people deal with substance abuse. Dutruch said anyone with an opioid addiction should consider the implant, despite not having a FDA approval. The implant helped him get his life back, Dutruch said.
"This is the first time in 16 years I can walk around with a smile on my face," he said. "I have the trust of my family, and I have my career back."
