FDA urged to investigate use of unapproved drug on prisoners
pharmafile | December 2, 2019 | News story | Sales and Marketing | FDA, Opiods, US Opiods, opiod crisis
The Louisiana Department of Public Safety and Corrections (LDPSC) and BioCorRx Inc are alleged to have collaborated in testing an unapproved drug on prison inmates to determine its effectiveness in managing opioid and alcohol use disorders.
On 20 November, non-profit consumer rights advocacy group Public Citizen and 31 doctors, ethicists, prisoner advocates and academics sent a letter to the FDA urging an immediate investigation into the tests.
The tests involved sustain release naltrexone implants, which are surgically inserted under the skin in the abdomen.
Humans testing of a drug that is new or has a new dosage form must be approved by the FDA and by an ethics review board. That board must also approve the informed-consent document, which tells patients that the drug is experimental, and explains both potential risks and benefits. According to the petition, BioCorRx did not meet any of these requirements.
The testing of these alleged unapproved implants came to the public’s attention on 2 May 2019, when BioCorX released a press release announcing its partnership with the LDPSC and how it had enrolled its first prisoner in its “Recovery Program Pilot.” The written agreement between them detailed the treatment using the naltrexone implant along with “proprietary cognitive behavioural therapy.”
Only one prisoner actually received the implant before the LDPSC stopped testing due to criticism.
Leo Beletsky, one of the signers of the petition and a Professor of Law and Health Sciences at Northwestern University, said: “The US has a long and troubling history of exploiting prisoners and other vulnerable groups for medicinal research. The apparent clinical trial launched by BioCorRx at the Louisiana State Penitentiary reminds us that even today, we must remain vigilant to prevent such abuses.”
Responding to the petition, BioCorRx CEO Brady Granier said in an email: “We’ve worked hard to battle the current epidemics plaguing our great nation. BioCorRx welcomes any investigation by the FDA and believes it has done everything regarding its comprehensive programme to fight addictions in full compliance with the letter and spirit of the law.”
The FDA has said it will review the letter and will respond directly to the petitioners.
Conor Kavanagh
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