BioCorRx’s ‘Recovery Program Pilot’ Violated Federal Regulations for Protecting Human Research Subjects, Public Citizen and 31 Other Experts Say
WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) must immediately investigate California-based BioCorRx, Inc. and the Louisiana Department of Public Safety and Corrections’ testing of an unapproved drug on prison inmates to determine its effectiveness in managing addiction disorders, Public Citizen and 31 doctors, ethicists, prisoner advocates and academics said today in a letter to the agency.
The tests involved sustained-release naltrexone implants, which are surgically inserted under the skin in the abdomen. Although the FDA has approved naltrexone in oral tablet and injectable forms to treat alcohol and opioid dependence, the agency has never approved any surgically implanted form of the drug.
Not only did the experiment in Louisiana – which ended in the spring of 2019 amid criticism soon after it began – not follow regulations governing clinical trials, but BioCorRx apparently has conducted or may still be conducting similar clinical trials elsewhere in the U.S. in violation of regulations, the signers of the letter told the FDA.
BioCorRx CEO and President Brady Grainer told a reporter in May that the company has used the unapproved implant in more than 1,000 people. The company also has announced other pilot programs. One in Philadelphia involved vulnerable homeless people struggling with addiction. Another in Silver Spring, Md., evaluated use of the naltrexone implant for weight loss, even though no naltrexone product is FDA-approved for such use.
Clinical trials must always be reviewed and approved by an Institutional Review Board (IRB) to ensure that people enrolled are provided certain protections, including being given adequate information before consenting to participate in the experiment and having safeguards to ensure that vulnerable people – such as prisoners – aren’t coerced into participating in the trial.
But BioCorRx, Inc. and the Louisiana prison system had planned to conduct their experiment on 10 inmates without the approval of an IRB. A review of email correspondence between BioCorRx and Louisiana prison officials revealed that their participant consent forms lacked the elements of legally effective informed consent required under FDA human subjects protection regulations, leaving the participating prisoners unaware that they were part of an experiment or that the form of naltrexone they were to receive was not FDA-approved.
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. A drug company should not be allowed to go into a prison and start treating the inmates like unwitting guinea pigs.Dr. Michael Carome, director of Public Citizen’s Health Research Group
The experiment in Louisiana came to light on May 2, when BioCorRx issued a press release announcing that the company – in partnership with the Louisiana Department of Public Safety and Corrections – had enrolled the first prisoner in its “Recovery Program Pilot,” in which volunteers received surgically inserted, multimonth sustained release naltrexone implants with the goal of proving the drug’s effectiveness in managing opioid use and alcohol use disorders in prison inmates.
Other signers of the letter to the FDA include Joshua M. Sharfstein, M.D., former principal deputy commissioner of the FDA; Ruth Macklin, an internationally renowned bioethicist and distinguished university professor emerita at Albert Einstein College of Medicine; Josiah D. Rich, M.D., M.P.H., a professor of medicine and epidemiology and director of the Center for Prisoner Health and Human Rights at Brown University; and Leo Beletsky, J.D., M.P.H., professor of law and health sciences at Northeastern University.
“The U.S. has a long and troubling history of exploiting prisoners and other vulnerable groups for medical research,” said Beletsky, whose research interests include substance use, public health law and human rights. “The apparent clinical trial launched by BioCorRx at the Louisiana State Penitentiary reminds us that even today, we must remain ever vigilant to prevent such abuses.”
The FDA must hold BioCorRx accountable for any regulatory and ethical failures, the signers said. In addition to investigating the Louisiana trial and any other testing initiated by BioCorRx involving sustained-release naltrexone implants, the FDA must inspect the Louisiana prison system and any other entities that collaborated with BioCorRx on such pilot programs. The FDA also should investigate the compounding pharmacies that prepared the sustained-release naltrexone implants and explore whether the implants were being produced legally in the first place, the signers said.
Read the letter here.