We begin with questions about ethics concerning medical research on humans. We have investigated numerous studies, some conducted by federal researchers, and prominent hospitals and universities, that were found to have violated strict rules governing studies on people. Today, we look at a medical implant offered to prison inmates as an opportunity to help them. But critics claim it qualifies as an unapproved study that could have put them at risk.
Sharyl: Alvin Dutruch was 24-years old back in 2004, when he broke his back in a car accident. His doctor prescribed an opioid medicine. Opioids, made from poppies, can relieve pain, create euphoric highs and be dangerously addictive.
Alvin Dutruch: What had happened is that I became completely dependent on that pain medication. I ended up stealing a prescription pad from one of the physicians that I was seeing at the time. And I started writing my own prescriptions, and that's what landed me in jail.
Sharyl: He says the compulsion to satisfy his addiction touched off a decade and a half long descent into depression and crime. Last May, while doing time at Louisiana State Penitentiary, a prison education program offered him the chance to try a free medical implant to cure his addiction. He took it.
Dutruch: When you're an addict, there's either death or you're going to end up with a life sentence. And that was when I actually decided, that I made the conscious decision that, you know what, I'm done with this, I'm tired of this.
Sharyl: The implant, surgically inserted into skin on his abdomen, slowly released a medicine called naltrexone to reduce opioid cravings.
Dutruch: I got the implant one week before my release and within just hours upon having the implant, I could automatically tell that there was a difference in the way I viewed things. That metaphorical monkey that was on my back, that was gone.
Sharyl: That might be the end of a positive story if it weren’t for one detail. The implant is not approved by the Food and Drug Administration. Dr. Michael Carome of the watchdog Public Citizen says the maker of naltrexone, BioCorRx, sidestepped strict federal rules, using Dutruch as a human guinea pig in an unapproved study.
Dr. Michael Carome: The plan was to test it in prisoners to see if it is effective for treating opioid and alcohol addiction, and that was done without complying with the federal rules, the FDA regulations for oversight of human research and for protecting human subjects.
Sharyl: Carome was once an official at the government’s Office for Human Research Protections, which oversees federal studies on people. He and more than two dozen doctors and ethicists say the FDA has approved naltrexone pills and injections but not implants. They’re asking the FDA to investigate.
Sharyl: Can you explain why that's so important?
Dr. Carome: There's a long history of abuses of human subjects both in the U.S. and outside the U.S. during the last century. We need to make sure that when we enroll subjects in research, when we ask them to consent, that we select subjects fairly, that we don't just prey on some vulnerable population to participate in all our human research. And so those core ethical principles were formulated in the 1970s and they form the basis of the federal regulations today.
Sharyl: Carome says while most human research is conducted ethically, there are growing numbers of disturbing violations. A federally funded experiment on premature infants at major hospitals drew criticism from the Office for Human Research Protections. Some parents said they were never told their babies were put in a study, and some infants died. No action was ever taken against the researchers, who defended their work and lashed out at the ethics officials who flagged problems.
Dr. Carome: Almost every several months we see another example and I think the reason that's occurring is two fold. One is I think the regulators, like the FDA in this case and the Office for Human Research Protections for NIH funded research, they're just no longer being aggressive in enforcement actions in their oversight of human research. And I think that's contributed to a weakening of protections nationally.
Sharyl: What do you think is making them no longer actively pursue such allegations?
Dr. Carome: I think they've gotten a lot of pushback from, in the instance of Office for Human Research from NIH, sort of the 800-pound gorilla that funds human research in this country, which criticized the office in some cases for how it handles some compliance cases, made findings of serious violations of the human subject protection regulations that the NIH didn't like and they pushed back hard both on the agency, the Office for Human Research Protections, and on their superiors in the office of the secretary of the Department of Human Services and that led to the agency being more timid about how it approaches compliance oversight.
Sharyl: BioCorRx, which spearheaded the prison project, would not agree to an interview but are the ones who put us in touch with Dutruch. They say their program with the Louisiana Department of Corrections did not qualify as a “study” and countless doctors have used naltrexone implants on patients for over twenty years from licensed compounding pharmacies, long before the existence of BioCorRx. “We hope that this attention leads to more people getting the help that they need.”
The FDA has not said whether it will investigate but Carome says the hard truth is, even if it found issues, not much would likely happen in today’s climate.
Dr. Carome: Unfortunately, the violations of the federal regulations don't carry with them any penalties. You can't be fined, you can't be put in jail.
Sharyl: What do you think should happen that would actually be something that made companies and other government research not violate these important regulations?
Dr. Carome: I think in this case, the company has repeatedly denied that it did anything wrong and they've in multiple statements to the media, statements to us, they've denied that they in any way violated the human subject protection regulations. So at a minimum, I think the federal regulators, in this case, the FDA, it's critical that they tell this company, again, if the facts are confirmed as we understand them, that they did indeed violate the human subject protection regulations, and that will send, I think, an important message both to this company and to other companies that you have to follow the rules.
Sharyl: Carome also questions naltrexone implants used in Philadelphia on addicted homeless people and being tried for weight loss on people in Silver Spring, Maryland.
After the whole controversy became public, the Louisiana prison program was halted with Dutruch the only one who had taken part. Now he says he’s a success story, graduating from the implant and off opioids.
Dutruch: I'm doing better today than I've ever done in my whole entire life and a majority of that I contribute to, because I had the ability to get the implant that lasted for four months and I had the ability, those urges and those cravings that were always there, were gone.
Sharyl: Some might say this is a treatment that could prove super helpful for a lot of people if it helps opioid addiction and that the prisoners did consent to it in some form. What's really the harm if they're trying to help people?
Dr. Carome: So that's correct. Naltrexone implants someday may be an FDA approved product because it's been shown to be safe and effective for treating opioid addiction. But to date, the FDA has not approved such a drug and the FDA has not reviewed evidence from appropriately conducted clinical trials that provide the evidence to support such approval, and so if you're going to do clinical trials to evaluate the effectiveness of a drug that's not approved by the FDA, you have to do it in a way that protects the human subjects. That has to be a primary principle.
Dr. Carome says any companies or researchers found to have violated human ethics rules should be called out and prohibited from getting federal money for future studies.
Additional feedback from BioCorRx received on May 12: For several years, BioCorRx has announced it is developing and manufacturing naltrexone implants, but they are not yet FDA approved or sold. The company’s contract with Louisiana’s prison system committed to providing naltrexone implants directly from a compounding pharmacy at no cost to the Department of Corrections and free to any inmates taking part. BioCorRx did not make or administer the implant Dutruch received. The company says that it “helped pay for and offered the Louisiana Department of Corrections access to the BioCorRx Recovery Program which includes behavioral support services. An independent physician worked with Dutruch and a compounding pharmacy that produced the naltrexone implant.”