Medical experiments conducted in prison should give us pause. When those experiments use drugs not approved by the FDA, that should make us cringe. In 1976, Congress created protections against repeating atrocities in medical experimentation that shocked the world in preceding decades. In crafting the Belmont Report, lawmakers developed guidelines, later codified under federal law, that required entities conducting research to follow strict protections for human subjects. This is especially important for vulnerable populations, such as people in prisons. Louisiana’s recent revelations bring that entire oversight structure into question.
It is shocking that healthcare company BioCorRx has been given permission by the Louisiana Department of Corrections to pilot a non-FDA approved naltrexone implant on people in prison. Naltrexone, a medication that blocks opioid receptors to reduce cravings, is used for the treatment of opioid and alcohol use disorders. Currently, it is only FDA-approved as a daily pill or monthly injection. The surgically implanted formulation would last up to four months, but little is known of this formulation’s safety or efficacy. Equally startling is the fact that the National Institute for Health supports this pilot. BioCorRx and DOC claim this is not a study, and thus does not need an Institutional Review Board or the approval of a prisoner advocate. The stated goal of BioCorRx is to “demonstrate the effectiveness” of the implants, which will be done under the “oversight and monitoring” of the DOC. BioCorRx is providing the DOC with tracking tools and therapy modules, yet somehow officials have determined for themselves that this is not research. By law, “research” means a “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
A pilot program for treating Louisiana prisoners addicted to opioids relies on a surgical implant that hasn’t been approved by federal regulat…
No company and no prison should be able to evade the law simply be saying said law does not apply to it. The job of the IRB and the prisoner advocate is to review research under clear guidelines regarding coercion, risk-benefit analysis, power dynamics, and follow-up support. If a study is designed in an exploitative or dangerous manner, such an advocate will not sign off until researchers make the necessary changes.
Approximately 80 percent of people incarcerated under Louisiana DOC have substance use problems. There are FDA-approved drugs proven to help people overcome opioid addiction, and yet these drugs are not made available to them. If the goal is to provide treatment for substance use disorder, then these approved medications should be provided, rather than experimenting with unapproved treatments, especially without IRB oversight. Ultimately, our communities would save many years of suffering, along with an incredible amount of money, if we recast this pervasive struggle as a public health issue rather than a marketing opportunity.
Dr. Anjali Niyogi
assistant professor, Tulane University School of Medicine
deputy director, Voice of the Experienced