Critics are debating whether the use of an implant to control opioid addiction is a breach of ethics. This is after opioid patient Alvin Dutruch became the first recipient of a new opioid addiction treatment that came in the form of an implant. Dutruch received the implant after volunteering for the medical procedure while still an inmate at the Louisiana State Penitentiary.
Doctors implanted a pellet of Naltrexone into Dutruch’s abdomen, to serve as an opiate antagonist that can treat substance abuse. Dutruch reported that within hours “it was like magic, and it was like these cravings that I’ve had since 2005 were gone”.
Alvin Dutruch’s descent into opioid addiction began with a car crash back 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. Breaking his back, Dutruch had to be given Roxicodone to relieve his pain.
To help soothe his back after the accident, he took 30 milligrams of Roxicodone four times a day as prescribed for more than two months. This got him hooked on the drug, which led to him spending the next 15 years cycling through jail, addiction, and depression.
“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.”
His prescription ran out just as his dependency peaked, so he started stealing prescription pads in doctors’ offices. When he was caught, it landed him in a drug rehab program for three years. He started using opioids again in 2008, and was soon arrested for writing himself a prescription and then paying for it with bad checks. By the time he was released in 2012, he had already graduated to heroin. He landed back in prison in 2016 It was then that he learned of BioCorRx’s implant. He decided to take a chance.
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. Although BioCorRx wanted to enlist five patients addicted to alcohol and five addicted to opioids, Dutruch ended up as the only participant in the test.
Although Dutruch had been informed the implant wasn’t FDA-approved, he said he volunteered because all other methods he’d tried had failed. The implant, inserted into a skin fold in his lower abdomen, was designed to slowly release Naltrexone for 90 days.
Consumer advocates are now accusing the company behind the treatment, BioCorRx—an Anaheim, California-based company—of using Dutruch as a human “guinea pig”. His case raises difficult but important questions about medical ethics, as well as ways to deal with substance abuse among prisoners.
“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. “The only thing I have to worry about is me and working on my recovery and working on getting myself together.” Dutruch said that the treatment helped him turn his life around. Critics say he has been used.
Consumer advocacy group Public Citizen urged the Food and Drug Administration to investigate BioCorRx and Louisiana's Department of Public Safety and Corrections. Naltrexone has existed for decades in both pill and injectable form, and is FDA-approved. However, the implant version has not been cleared for use on humans.
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,” said Dr. Michael Carome, Public Citizen’s health research director. “A drug company should not be allowed to go into a prison and start treating the inmates like unwitting guinea pigs. BioCorRx responded that it followed standard medical practice.
“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.”
If someone in the family is struggling with drug or alcohol addiction, it is important to seek help. A combination of medical detox and behavioral therapy can go a long way in the fight against drug abuse. But because every individual is affected by addiction differently, a comprehensive program tailored to their specific needs is necessary. Look for a nearby addiction treatment facility today and find out how drug treatment programs work.
SOURCE: Press Advantage [Link]
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