Friday, December 06, 2019 11:11:55 AM
https://www.cbsnews.com/news/opioid-addiction-treatment-former-addict-says-implant-changed-his-life-critics-call-him-a-guinea-pig/?intcid=CNI-00-10aaa3a
"Although Dutruch said the treatment has helped him turn his life around, some critics say he has been used. Consumer advocacy group Public Citizen last week urged the Food and Drug Administration to investigate BioCorRx and Louisiana's Department of Public Safety and Corrections.
Although Naltrexone is FDA-approved and has existed for decades in both pill and injectable form, the implant version has not been cleared for use on humans, Public Citizen said in a Nov. 20 letter. The group also said BioCorRx should have conducted the clinical trial in coordination with a FDA review board.
"The failure to comply with the requirements for the protection of human subjects represents a serious violation of the basic ethical principles of respect for persons, beneficence and justice," Dr. Michael Carome, Public Citizen's health research director, said in a statement. "A drug company should not be allowed to go into a prison and start treating the inmates like unwitting guinea pigs."
Public Citizen said it obtained emails between BioCorRx and Louisiana corrections officials that show the company didn't seek FDA approval to test the implant."
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