In May, a drug company called BioCorRx began offering free Naltrexone implants, a slow-release drug that reduces opioid cravings, to incarcerated people. The first prisoner underwent the surgical procedure at the Louisiana State Penitentiary, a former cotton plantation. Although Naltrexone in the form of daily oral pills or monthly injections is FDA-approved, the longer-lasting implants are not. And according to the consent forms, BioCorRx and the Louisiana Department of Corrections failed to disclose to prisoners that they would be receiving an unapproved implant.
Advocates and medical professionals sounded an alarm. “Are we somehow finding a way to experiment with pharmaceuticals in a prison setting?” said Anjali Niyogi, director of the Formerly Incarcerated Transitions Clinic in New Orleans.
BioCorRx insists this was not a clinical trial but a program to help incarcerated people stay clean after their release. The dissolvable Naltrexone pellet, which is surgically implanted in the lower abdomen, can block opioid effects for three months. But the language in the company’s agreement with the Louisiana Department of Corrections resembles that of a clinical trial. According to the agreement, which was retrieved through a public records request, BioCorRx intended to “demonstrate the effectiveness” of the implants.
The company’s spokesperson also confirmed to me in an email that BioCorRx “is working with a government agency to demonstrate its cost-effectiveness and success rate over other methods of medication-assisted treatment ...” This, by definition, is a research study. And it is illegal to conduct a study with human subjects without oversight.
“Especially with a vulnerable population like prisoners, there are special rules governing when you can try novel interventions with them,” said Arthur Caplan, the director of NYU Langone Health’s Division of Medical Ethics. “It’s a part of the law governing human experimentation.”
It doesn’t matter that the oral and injection versions of Naltrexone are FDA-approved. “The mode of administration changing counts as a very novel shift. It isn’t the same thing,” Caplan said. “You’ve got to get it reviewed.”
Since the 1970s, any research involving human subjects is legally required to have the rigorous oversight of an independent ethics committee called an Institutional Review Board (IRB). The U.S. government established IRBs after the Tuskegee syphilis study, a cruel 40-year medical experiment that examined the effects of untreated syphilis on 600 black men.
Prisoner advocates are worried BioCorRx set a dangerous precedent for pharmaceuticals to get away with experimenting on vulnerable populations without oversight. By calling something a “program” instead of a trial, drug companies can get the data they need for FDA approval in a much shorter time. “I have no doubt that if this flies—what is the incentive for other companies and other pharmaceuticals to not bypass IRBs?” said Niyogi.
BioCorRx says it didn’t need to go through a review board because it was not technically conducting a trial. Brady Granier, BioCorRx’s CEO, dismissed the suspicious wording of the contract as an issue of “semantics.” “We want to demonstrate effectiveness. But we already know it is effective,” he told me. “We’re not collecting medical data on anyone ... this is not a study at all.”
According to NYU Langone’s Caplan and other medical ethicists, BioCorRx does not have the authority to determine whether a procedure conducted in a prison setting is a trial or a program. This should still have been determined by an independent review board.
“If you are using an unapproved drug, you can’t just call it a therapeutic program,” Caplan said. “You should be in front of an institutional review board in the U.S. if you’re going to do something of which the outcome is unknown.”
And even if this wasn’t a trial, the drug company and the Department of Corrections still cannot offer a program featuring an unapproved drug without an IRB. “It’s likely illegal,” Caplan said. “You can get penalties, fines, be prohibited from doing research in the future. It’s not just unethical.”
BioCorRx disputes the notion that prisoners need special oversight
to receive non-FDA approved drugs. “Tens of thousands of U.S. citizens have received
Naltrexone implants over [the last] two decades. It’s nothing new,” Granier
said. “Why is the general population different from the prisoner
population when it comes to receiving medical care?”
The answer is pretty straightforward: There are special rules in place for prisoners because, unlike the general population, it’s not clear they can give true informed consent. That is why any clinical programs need to be reviewed by a prisoner advocate, which BioCorRX has told me it also had not done. “I wouldn’t expect a hospital administrator or an academic researcher to know the dynamics of prison staff,” said Bruce Reilly, deputy director of Voice of the Experienced (VOTE), a New Orleans nonprofit that advocates for prisoners.
To be fair, there is a dire need for more opioid treatment programs. Opioid overdose is the leading cause of death for formerly incarcerated people in the U.S. “Prisoners with opiate addictions who are released from prison without any medications have a particularly high overdose death in the weeks after they leave prison,” said George Woody, a University of Pennsylvania emeritus professor of psychiatry who has studied the efficiency of Naltrexone implants. “It’s an under-treated group.”
The drug Naltrexone can thoroughly block opioid effects—including overdose. And the implant version could be a lot more effective than the FDA-approved Naltrexone pills and shots. Studies have shown people with opioid addiction often give in to craving and stop taking the daily oral pills. An implant is a good way to provide a sustained release of Naltrexone over the course of three months.
Alvin Dutruch, the 39-year-old male who received a Naltrexone implant at Louisiana State Penitentiary, described his implant as a “game-changer.” Dutruch’s addiction to opioids had landed him in prison three times. “I was always using within 48 to 72 hours after my release,” he said. “My cravings were so overwhelming they never allowed me to get help.”
But after receiving the Naltrexone implant, he had a very different experience re-entering society. “It was the first time that I’d gotten out of prison, the first thing I was thinking about wasn’t going to get high,” he said. “That allowed me to actually go into a recovery process.”
But this doesn’t absolve BioCorRx from failing to go through the proper channels to implement its program. After the prison was criticized for giving an unapproved drug to a prisoner, the Louisiana Department of Corrections discontinued its use of Naltrexone implants in the spring. “Now people in prison won’t get the help that the general population gets. This is the opposite of prisoner advocacy,” lamented Granier, the CEO of BioCorRx.
Yet the company did not respond to questions about whether it would be willing to get an IRB or work with prisoner advocates to restart the Naltrexone implant program. As with any endeavor where profits are involved, there’s more to this than helping incarcerated people with addiction re-enter society.