FDA urged to investigate use of unapproved anti-opioid implant on prisoners and the homeless
BioCorRx bills itself as a developer of "advanced solutions" for alcohol and opioid addictions. But the California-based company has come under fire for plans to test an unapproved naltrexone implant on Louisiana prison inmates and homeless22 Nov 2019
Philadelphians who are struggling with addiction, in violation of federal laws protecting human research subjects.
Only one prisoner actually received the implant before the Louisiana Department of Corrections discontinued the testing this spring amid criticism, according to the New Republic. And no homeless Philadelphians have received the implant because BioCorRx has failed to get state approvals, said Mel Wells, president of One Day at a Time, the recovery support organization that BioCorRx enlisted to find subjects.
Still, 33 experts in consumer protection, bioethics, human rights, and the law on Wednesday petitioned the U.S. Food and Drug Administration to investigate whether BioCorRx conducted an illegal clinical trial. The petition, filed by the consumer advocacy group Public Citizen, also questioned the legality of BioCorRx's use of the naltrexone implant for an unapproved use—weight management.
"The U.S. has a long and troubling history of exploiting prisoners and other vulnerable groups for medical research," said petition signer Leo Beletsky, Northwestern University professor of law and health sciences. "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."Share this on: