Louisiana Prisoners to Receive Unapproved Naltrexone Implant

By Victoria Kim 05/09/19

Participation in the program is strictly voluntary but advocates of prisoners’ rights say it sets a "dangerous precedent."

Louisiana Prisoners

A pilot program is drawing controversy over the use of Louisiana prisoners to test a surgical implant for the treatment of alcohol or opioid use disorder.

While some laud the idea of expanding access to medication-assisted treatment (MAT) for substance use disorder, others are critical of the pilot program since the implant, a "pellet" which delivers naltrexone in the body, is not approved by the Food and Drug Administration (FDA).

“There’s extra precaution to be taken when there’s a vulnerable population,” said Bruce Reilly, deputy director of the Voice of the Experienced, a New Orleans-based organization which advocates for prisoners’ rights. “It’s commendable that we’re pursuing treatments. We’re moving in a positive direction. [But] to sidestep or overstep the FDA approval process, that’s a little troublesome when it comes to an incarcerated environment.”

Naltrexone, which blocks the effects and cravings of opioids and alcohol, is only approved in pill or injection form—the implant is not.

Treating prisoners with the FDA-approved naltrexone has yielded success before in the Louisiana prison system. As The Advocate notes, of the 100 prisoners who were given naltrexone over a two-year period in conjunction with education and therapy prior to their release, only 4 have since landed back in prison.

Encouraged by this success, corrections officials seem to want to take it a step further by approving the surgical implant pilot program.

This time, the Louisiana Department of Public Safety and Corrections partnered up with BioCorRx, which provided the implants. The California-based health care company has donated 10 of the naltrexone pellets to the state of Louisiana to implant in 10 inmates. Corrections officials stress that it is completely voluntary to participate in the pilot program.

As part of the program, participants will receive both cognitive behavioral therapy (CBT) through the BioCorRx Recovery Program, and medication-assisted treatment (the naloxone pellets) administered by Department of Corrections physicians.

At $700 each, the naltrexone implant is cheaper than the monthly injection (about $1,000 each). The implant is said to metabolize in the body over 3-4 months, while the injection must be administered monthly and the pill is taken daily.

It’s not hard to see why the implant may be more cost-effective than the pill or injection, but without FDA approval none of that matters, say advocates of prisoners’ rights.

“If you’re really concerned about the population, why don’t you start with what’s approved? Consent is always problematic (in prison),” said Dr. Josiah “Jody” Rich, co-director of The Center for Prisoner Health and Human Rights.

BioCorRx CEO Brady Granier said the implants have yielded positive results in more than 1,000 people. But Rich is not convinced.

“We have a pretty bad history with experimentation in American prisons, I think the least we can do is use drugs that have been declared safe by our regulatory board,” said Rich.

“Just because it’s free… I think it’s a really dangerous precedent,” he added. “We can’t afford to be stupid about this.”

BioCorRx reached out to The Fix to respond to critics of its pilot program. "The medical staff at [the Department of Corrections] have the best practices and protocols for treating the patient who volunteered for this and from what we understand, was given plenty of documentation on all aspects of this for consent," the company stated. "No one is being coerced into this and we make zero dollars on this. We are trying to establish our cognitive behavioral therapy (CBT) and peer support platforms as this is the most important part of long-term recovery." 

Asked if any complications should arise with the implant following the inmates' release, the company said that the DOC handles medical follow-ups, not BioCorRx. 

"Seemingly, the most common reported complication which can occur is local tissue reaction to the implant," the company added. "Most of the time these are self contained or treatable with certain meds. With a more moderate to severe reaction, the implants can be removed. With any procedure, there is always a risk of infection if an improper technique was used." 

There is normally no need to remove the implant, as it was designed to fully dissolve in the body in a span of 3-4 months.
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Victoria is interested in anything that has to do with how mind-altering substances impact society. Find Victoria on LinkedIn or Tumblr