Natalie Rahhal | The Daily Mail | Source URL
A Louisiana prisoner has been implanted with an unapproved 'pellet' to treat addiction.
The inmate is soon to be released from a Louisiana Department of Corrections (DOC) facility and is the first of 10 patients that California-based BioCorRx intends to place the implant in.
Over half of the prisoners incarcerated in the US have a substance misuse disorder, according to the Center for Prisoner Health and Human Rights.
The standard addiction treatment in jails and prisons in the US is cognitive behavioral therapy (CBT), which can be helpful in addiction treatment - but is far and away most effective when given in conjunction with medication.
But, even if they had been in recovery programs that included medically-assisted therapy (MAT) prior to their arrests, prisoners are not usually given access to drugs like buprenorphine or naltrexone.
BioCorRx wants to change that - but their prisoner program is skipping some safety and efficacy steps.
The company is developing two 'sustained release' versions of naltrexone.
Naltrexone itself is already FDA approved to treat both alcohol and drug addiction.
But BioCorRx's implant is a biodegradable pellet full of the addiction treatment, to be released over the course of three or four months, according to Houma Today, which has to be surgically implanted into a person's abdomen.
The implant is not only unapproved, it's still in its preclinical phase, according to the company's website.
In 2018, one of its delivery systems was green-lighted to go through an accelerated approval process.
But preclinical testing is the stage before something is tested in humans - let alone prisoners, who live in high-risk environments in communities notorious for ignoring health complaints.
'I'm not against trying to improve drug treatment for prisoners - it's a high-risk group and it's important to come up with better methods to keep them clean,' says New York University bioethicist Dr Arthur Caplan.
'But why the company doesn't set this up as a research project, I don't understand.'
BioCorRx's justification for the prisoner program is two-fold: it's completely voluntary and comes at no cost to the federal prison system.
In a press release about the program, it argues that it costs an average of $100 a day to keep a person in prison.
BioCorRx president and director Brady Granier said in a statement that 'this type of therapy has been used successfully for decades in many modern countries and I am tremendously grateful for the opportunity to finally implement the program in Louisiana.'
But it has not been tested, much less approved, in the US.
Since the majority of inmates are jailed for drug crimes - and many are drug addicted - BioCorRx imagines its automatic delivery system and paired CBT program as an alternative program to incarceration in the future.
But despite reinforced walls, 24 hour watches and barbed wires, prisoners still obtain drugs smuggled in from the outside.
And, coupled with drugs or alcohol, naltrexone can lead to overdoses.
While access to naltrexone could certainly be live-saving to some inmates, the program only offers the drug if it comes in an experimental, surgical form, raising serious ethical questions.
'Overall, it would be great to have more options in the battle against addiction, particularly in this often-neglected prison population, but this is not the way to proceed,' Dr Caplan says.
BioCorRx had not responded to DailyMail.com's request for comment at the time of publication.
The surgery on the first patient to implant the pellet was reportedly a success, but how well they tolerate the drug dispensing mechanism remains to be seen.
Another nine implantations are planned.