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A pilot program for treating Louisiana prisoners addicted to opioids relies on a surgical implant that hasn’t been approved by federal regulators — a source of concern for prisoner advocates and some medical professionals.

The program, which was announced last week by Louisiana prison leaders, is the product of a partnership between the Louisiana Department of Public Safety and Corrections and a California health care company that makes the implant.

The device, which is surgically implanted in prisoners addicted to opioids, releases the well-known and widely used drug naltrexone. The drug is used to fight opioid and alcohol addictions by blocking the effects and cravings for such drugs in patients who have been clean for at least seven days.

Naltrexone has been approved by the U.S. Food and Drug Administration only in the form of daily pills and monthly shots; the implant would work for about three to four months, officials said.

The company, BioCorRx, offered Louisiana’s corrections department 10 surgical implants at no cost to the state. Corrections officials said they will be used on inmates who volunteer for the treatment as they prepare for their release back into society.

Addiction treatment for qualified inmates in Louisiana have already included naltrexone shots, known as Vivitrol, which officials said they have found to be successful in reducing recidivism and overdoses.

Corrections leaders, the California company and some doctors say the move is a step forward for providing medication-assisted treatment to prisoners dealing with opioid addiction — especially as the epidemic continues to plague Louisiana.

But advocates for prisoners and others say they are troubled about the program’s implications.

“If you’re really concerned about the population, why don’t you start with what’s approved?” said Dr. Jody Rich, the co-director of The Center for Prisoner Health and Human Rights, a Rhode Island nonprofit that works to improve health in the criminal justice system. “Consent is always problematic (in prison). The least we can do is the gold standard of medical approval ... to make sure they’re safe.”

Corrections department administrators stressed that the program is voluntary and that only the manner for getting the FDA-approved drug into an inmate’s system has yet to be approved.

The first inmate had the implant surgically inserted into his abdomen at the Louisiana State Penitentiary at Angola on Wednesday, said corrections department spokeswoman Natalie Laborde.

“It’s not FDA approved, which is why this is a completely voluntary program,” Laborde said. “I can’t stress how voluntary.”

She added that although it’s not FDA approved, the implant device is still available for purchase and used by doctors in the U.S., although it’s not covered by insurance.

Brady Granier, the CEO and president of BioCorRx, said the implants have been used successfully by more than 1,000 people.

Although medication-assisted treatment for addiction has been the direction advocates have been pushing prison systems to adopt, they worry the implant pilot is the wrong step for Louisiana to take.

“There’s extra precaution to be taken when there’s a vulnerable population,” said Bruce Reilly, the deputy director of the Voice of the Experienced, a New Orleans nonprofit that advocates for prisoners. “Its 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."

‘Something’s working’

Through a federal grant shared by Louisiana Department of Health in mid-2017, the corrections department used $1.2 million over two years to provide inmates with the naltrexone shot, known as Vivitrol. That program provided 100 prisoners with the shot prior to their release, and only four have since returned to prison, said Ken Pastorick, a corrections department spokesman.

The program spanned four facilities and provided comprehensive treatment, including education and therapy while in prison, then worked to connect inmates with medical care upon their release.

“Something’s working,” said Dr. Susan Tucker, a clinical psychologist who works at the Steve Hoyle Intensive Substance Abuse Program in Bossier Parish, the state’s largest prison-run addiction center. “It is making a difference. It is effective.”

Tucker said because naltrexone works only with those who have been clean, it makes the most sense for this specific population.

“For the correctional population who are leaving us and are clean, it really is the perfect drug to use,” Tucker said. “This one cannot be abused.”

Two other drugs used in addiction treatment, buprenorphine (commonly known as Suboxone) and methadone, have the potential to be abused for a high, but studies have shown they are still important, and effective, treatment options. Corrections Secretary Jimmy LeBlanc has said he does not want to bring those medications into the state’s prisons.

Rebecca Devillier, 39, is one of the 100 people who were given the Vivitrol shot while in prison to help her manage her addiction. She said it has changed her life in her first year out of prison. She said she became hooked on opioids after she was prescribed pain killers following a golf cart crash.

“The shot is my lifeline, because when it gets close to when the shot is due, I can tell,” said Devillier, who was released from prison in July 2018 and drives every month from her Ville Platte home to Lafayette to continue the shot. “Every addict, regardless of whatever drug they use, they always want to get high.”

Devillier said that if given the chance for a safe, longer-lasting implant of the medication, she would take it.

Pastorick said the implant costs around $700 each and lasts about 3 or 4 months, eventually metabolizing in the body, while the shot costs about $1,000 and requires monthly visits back for another shot.

“It’s cost effective and its less hassle,” Pastorick said of the new implant.

And while it is not FDA approved, Granier said, there are about a dozen or so doctors who use the implant across the nation. He said his company will be collecting data from the prisoners who volunteer for the pilot program in Louisiana by monitoring how successful they are, but he said it is not a study.

He said his company is working to become FDA approved for a naltrexone implant. He said it is similar to but not the exact product the company is giving for free to the Louisiana Department of Corrections.

“We want to be good corporate citizens,” Granier said of the partnership with the Louisiana corrections department. “We want to help people whenever we can, but it also adds credibility to us as a company, and it gives us exposure.”

Granier said his company has also partnered with the City of Anaheim for those seeking help with addiction, though have not worked with any other prison systems.

“No one wants to be first, but (Louisiana DOC) realized something needs to be done,” Granier, a Louisiana native, said of the opioid epidemic. “I’m proud that my home state is doing this.”

'Dangerous precedent'

Rich, the inmate advocate and physician, said he might be willing to support an unapproved implant if there were not other medication choices and alternatives available that are federally approved and backed by the medical and research community.

A March report from the National Academies of Sciences, Engineering and Medicine on medications to treat opioid addiction found that withholding or failing to provide all available and approved forms of medication for addiction — no matter the setting — is denying appropriate medical care.

The report notes the FDA approved medications — methadone, buprenorphine and naltrexone — are "effective and save lives," and the most appropriate treatment varies by patient.

To deny treatment or withhold medications, the report says, is unethical.

However, Louisiana prisoners are not offered methadone or buprenorphine for addiction treatment.

Rich said naltrexone doesn’t work for everyone and is not a “fully medication assisted treatment.”

He also questioned how inmates can fully give consent for a voluntary implant program, when they are in an environment that inherently takes away their free will.

“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,” Rich said.

Dr. Marcia Glass, an associate professor of internal medicine at Tulane University, said she is concerned about using anything that is not completely safe on prisoners. She agreed with Rich that there are other approved medications that Louisiana should be looking at first.

“Using a form of the drug that is not FDA approved for a very vulnerable population is very problematic,” Glass said.

There have been studies and tests on naltrexone implants in other countries, but none in the U.S. Rich said he’s worried about what this decision will mean for future medications to be used in Louisiana’s prisons and to deal with the opioid epidemic.

“Just because it’s free (from BioCorRx)... I think it’s a really dangerous precedent,” Rich said. “We can’t afford to be stupid about this.”


Follow Grace Toohey on Twitter, @grace_2e.