A California company seeking to expand its role in battling opioid addiction has come under fire for an aborted plan to recruit prisoners with drug and alcohol problems to be human guinea pigs for its novel addiction recovery program.
This week, the watchdog group Public Citizen asked the Food and Drug Administration to investigate the initiative launched by Anaheim-based BioCorRx, Inc. and Louisiana’s Department of Public Safety and Corrections on the grounds that it lacked the ethical, safety and legal protections that are commonplace in medical research studies involving human subjects.
The prisoners who had been asked to participate “were likely to be vulnerable to coercion or undue influence,” according to a letter signed by Public Citizen and 31 independent experts in bioethics and public health. If allowed to proceed, the initiative’s lack of safeguards “would represent egregious violations” of FDA regulations designed to protect human subjects and ensure drug and device safety, they added.
Both BioCorRx and the Louisiana Department of Corrections dispute many of the allegations laid out in the letter. They say prisoners were offered the addiction treatment as a voluntary option, and that the treatment, while novel, is not experimental.
A single inmate received the treatment — a long-acting implant of the anti-addiction drug naltrexone — on May 2, about two weeks before he was released. The program appears to have been discontinued after the New Orleans Advocate published a story about it on May 6.
The man who turned out to be the program’s sole participant — Alvin Dutruch, 39 — said that in 2004, he was prescribed narcotic pain pills for a year after he suffered a broken back and wound up addicted. He worried he would fall prey to drug cravings once his 2-year prison sentence ended in May.
“I was so geared to doing anything that could possibly help me prepare myself for my release,” Dutruch said in an interview. After hearing about the naltrexone implant, “I said, ‘You know what? That’s what I really want.’”
And he doesn’t regret it, the said. The treatment has given him “the longest period of clean time I’ve had in 16 years, and opened doors for me I thought weren’t possible,” said Dutruch, who was sent to prison for bank and prescription drug fraud.
The nation’s opioid epidemic has reached every corner of the country, especially its jails and prisons. A 2010 study found that roughly 65% of the nation’s then-2.3 million prison inmates suffered substance abuse or addiction disorders. But correctional officials in many states have been reluctant to treat prisoners like Dutruch with low-dose opioid treatments such as buprenorphine and methadone out of fear that they’ll be diverted or abused by other inmates.
The consequences of doing nothing can be fatal: In the first two years after their release, former inmates are 3.5 times more likely to die compared with their peers in the general population. In their first two weeks of freedom, their risk of death — mainly due to drug overdose — is 13 times higher.
As a result, correctional officials have been casting about for addiction treatments that aren’t opioid-based and can be efficiently provided to inmates.
It’s a potentially lucrative business opportunity for companies like BioCorRx, said New York University bioethicist Arthur Caplan. And it underscores the need for protecting unusually vulnerable populations from coercion or exploitation when novel treatments are being tried.
“There may be pressure from company investors or founders to move things along and take advantage” of the urgent need, he said. “That’s why it’s important to treat it as research” and put in place the kinds of protections that are standard for biomedical studies, he added.
“I don’t think that’s too onerous,” said Caplan, who signed the Public Citizen letter.
The controversy involves a partnership between BioCorRx and the Louisiana Department of Corrections to offer treatment for inmates about to be released from the state’s maximum-security penitentiary in Angola. In a news release issued in May, BioCorRx said the aim was to “demonstrate the effectiveness” of its treatment regimen and “help those suffering while illustrating the cost and societal benefit” of using the treatment “in lieu of incarceration.”
The Recovery Program Pilot envisioned that 10 soon-to-be-discharged prisoners would receive a surgically placed implant that releases the naltrexone gradually over several months. After they leave prison, the former inmates would also participate in a counseling and peer support program devised by BioCorRx.
The 10 participants were to have been chosen by Louisiana officials. Physicians working for the corrections department would implant the naltrexone in a very slow-release form, called a “depot,” under prisoners’ skin in the lower abdomen.
Naltrexone, which blunts cravings for drugs and alcohol, is marketed with the FDA’s blessing as the addiction treatment medication Vivitrol. It is available in daily pill form and as an injection delivered in a doctor’s office which lasts for roughly a month.
The depot form of naltrexone, however, must be created in a compounding pharmacy, where it is reformulated to release slowly into a patient’s bloodstream. BioCorRx said the depot used in its treatment regimen remains effective for about three months.
The reformulation of existing drugs by compounding pharmacies is common and generally legal. But implantable depot drugs occupy an ambiguous space in the world of pharmacology. They involve an active agent (the drug) and a means of delivery (a medication packet that acts like a miniature pump, releasing that drug slowly and steadily into a patient’s bloodstream).
Because the rate of drug release is a key safety matter, the depot packet is sometimes viewed as a device that is subject to FDA review.
Depot drugs are often given to patients who might forget to take their medicine every day. Contraceptives and drugs that treat chronic, severe mental illnesses such as schizophrenia are widely prescribed in depot forms.
Anti-addiction medications such as naltrexone, suboxone and buprenorphine are considered highly effective in helping those with substance use disorders stop abusing drugs or alcohol. But addiction’s ability to hijack the brain is powerful, and people with addiction often discontinue the use of medications that could help them stay straight.
In February, the FDA issued a detailed Guidance for Industry document aimed at companies seeking to design depot versions of buprenorphine. But the agency has not released similar guidance for naltrexone.
The National Institute on Drug Abuse recently awarded BioCorRx a $2.84-million contract to develop a “three-month implantable depot pellet of naltrexone for the treatment of opioid use disorder.” Results of that work are expected in two to three years.
Public Citizen’s letter says the use of naltrexone in depot form is not common in the United States and its safety and effectiveness have not been demonstrated to the FDA. Its use is therefore experimental and should be subject to oversight by the FDA and/or a body of academic experts called an Institutional Review Board, or IRB, the watchdog group argued.
Dr. Anjali Niyogi, who directs Tulane University’s Formerly Incarcerated Transitions Clinic in New Orleans, said the BioCorRx program at the Angola prison amounted to a clinical trial. As such, it should have been monitored to ensure subjects signed up without coercion and had a full understanding of the risks and rules of their participation, as well as measures in place to minimize those risks and ensure their privacy, she said.
“But this company has decided this is not a study, and then went forward with it,” said Niyogi, who signed the Public Citizen letter. “Other companies could obviously do the same thing. The IRB process is in place for a reason.”
BioCorRx maintains that naltrexone has a lengthy history of safe use and therefore is not an experimental drug.
Brady Granier, the president and chief executive of BioCorRx, said in a statement that naltrexone implants “have been utilized by countless medical doctors under their discretion with their patients for over 20 years in the U.S.”
But when an FDA-approved drug is commercially available, the agency urges physicians to choose the approved formulation over a compounded version unless there’s a clear benefit in using the latter, according to an FDA spokesman.
“Why on Earth would you use an implant that’s not FDA-approved if you have access to Vivitrol?” said Dr. Marcia Glass, associate professor of medicine at Tulane University and a co-signer of the letter. “I think the intent was to try to do something helpful. I think the Department of Corrections were trying to treat more appropriately. But I think BioCorRx was in the right place at the right time and took advantage.”
The Louisiana prisons department confirmed in a statement that a single inmate received a long-acting naltrexone implant as part of its program to treat addictive disorders. No further implants were provided to inmates, who are now offered injections and oral medications to treat substance use disorders, it said.
“The implant which delivers the medication is not currently approved by the FDA, but has been used in other countries and here in the U.S. to deliver Naltrexone,” the statement said.
A 2016 study in the American Journal of Drug and Alcohol Abuse suggests naltrexone has been used in depot form in Russia.
FDA spokesman Nathan Arnold said the FDA “will review the letter and will respond directly to the petitioner.”