Anti-opioid implant tests draw fire
PHILADELPHIA — 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 homeless Philadelphians who are struggling with addiction, in violation of federal laws protecting human research subjects.
Only one prisoner received the implant before the Louisiana Department of Corrections discontinued the testing last 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 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.”
One example of such exploitation occurred in Philadelphia’s Holmesburg Prison from 1951 to 1974. The medical experiments were led by Albert Kligman, a University of Pennsylvania dermatologist who co-invented the acne medication Retin-A.
Asked for comment about 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 program to fight addictions in full compliance with the letter and spirit of the law.”
For its part, the FDA said: “We take all complaints and concerns reported to us seriously. The FDA will review the letter and will respond directly to the petitioner.”
Naltrexone, which blocks the effects of opioids and alcohol while curbing cravings, is a mainstay of addiction treatment. It has been approved as a daily pill and a monthly injection.