Health Letter, December 2019
By Michael Carome, M.D.
If you’re not outraged,
you’re not paying attention!
Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.
Image: LightField Studios/Shutterstock.com
On November 20, Public Citizen and 31 doctors, ethicists, prisoner advocates and academics sent a letter to the Food and Drug Administration (FDA) urging the agency to immediately investigate California-based BioCorRx, Inc., and the Louisiana Department of Public Safety and Corrections’ (LDPSC’s) testing of an unapproved drug on prison inmates to determine its effectiveness in managing opioid and alcohol use disorders.
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.
The testing of the unapproved naltrexone implants first came to public attention on May 2, 2019, when California-based BioCorRx issued a press release announcing that the company — in partnership with the LDPSC — had enrolled the first prisoner in its “Recovery Program Pilot” when LDPSC doctors had placed a sustained-release naltrexone implant into a soon-to-be-released inmate at the Louisiana State Penitentiary. Importantly, BioCorRx’s press release stated the following:
The purpose of the program is to demonstrate the effectiveness of the BioCorRx Recovery Program for those suffering from alcohol and/or opioid use disorders. Through this pilot program, BioCorRx intends to help those suffering while illustrating the cost and societal benefit of using the BioCorRx Recovery Program in lieu of incarceration.
Likewise, a written agreement executed by the LDPSC and BioCorRx before the launch of the pilot program stated the following:
Purpose: To demonstrate the effectiveness of the BioCorRx Recovery program for those suffering from alcohol and/or opioid use disorders. The program includes a long-term naltrexone implant, coupled with proprietary cognitive behavioral therapy (CBT) and ongoing peer recovery support and patient tracking.
Goal: Help those suffering and to illustrate the cost benefit of using the BioCorRx Recovery Program in lieu of incarceration of an individual for 6 months (including difficult to calculate costs of lost wages, cost to families, children without parent home, etc.)…
- Patient outcomes will be provided monthly and the success will be evaluated at 3 months and six (6) months post implant procedure.
Additionally, individuals enrolled in the BioCorRx pilot program apparently were asked to sign a “CONSENT FOR RELEASE/EXCHANGE OF INFORMATION” form that included the following statement:
I hereby authorize Treatment Center/Provider above to exchange information regarding my care with BioCorRx Inc. and 2nd Chance Counseling Service, LLC (if tele-counseling option selected).
Furthermore, if tele-counseling option is selected, I hereby authorize BioCorRx and 2nd Chance Counseling to exchange information regarding my care.
According to a May 6, 2019, report in The Advocate, a Louisiana newspaper, BioCorRx CEO and president Brady Granier said “his company will be collecting data from the prisoners who volunteer for the pilot program in Louisiana by monitoring how successful they are.” He also asserted that “[the pilot program] is not a study,” but that assertion is belied by the many other representations of the program noted in the company’s press release, written agreement executed by the LDPSC and BioCorRx and information in the release form.
The above statements taken together could not be clearer: BioCorRx and the LDPSC appear to have initiated a clinical trial under the rubric of a “pilot program,” the primary purpose of which was to evaluate the clinical effectiveness and cost-effectiveness of a non-FDA-approved, investigational, multimonth sustained-release naltrexone implant, in combination with cognitive behavioral therapy modules and peer support, for management of opioid use and alcohol use disorders in prison inmates.
Clinical trials must always be reviewed and approved by an institutional review board (IRB) to ensure that the enrolled human subjects 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. Such experiments testing unapproved drugs also may not begin unless an investigational new drug (IND) application has been submitted to the FDA.
Alarmingly, BioCorRx and the LDPSC initiated this apparent experiment without the approval of an IRB or the submission of an IND application to the FDA. Moreover, a review of email correspondence between BioCorRx and LDPSC officials revealed that the consent forms used for the clinical trial lacked the elements of legally effective informed consent required under FDA human subjects protection regulations, leaving the participating prisoner subjects unaware that they were part of an experiment.
Such circumstances, if confirmed, would represent egregious violations of the FDA human subjects protection regulations, as well as the basic ethical principles of respect for persons, beneficence and justice upon which these regulations are founded. A drug company should not be allowed to go into a prison and start treating the inmates like unwitting guinea pigs.
Other signers of Public Citizen’s 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.”
Public Citizen and the 31 cosigners of the November 20 letter to the FDA also expressed concern that BioCorRx has conducted or may still be conducting similar clinical investigations in other settings in the U.S. without complying with the FDA regulatory requirements. Notably, BioCorRx’s 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 single-active-ingredient naltrexone product is FDA-approved for such use.
The FDA must promptly investigate this matter, hold BioCorRx accountable for any regulatory and ethical lapses, and permanently stop any similar ongoing illegal clinical investigations being conducted by the company.