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Human Research Violations By UCSD Eye Doctor Showcase A National Problem

 April 18, 2019 at 10:42 AM PDT

Speaker 1: 00:00 Every year. Millions of human research subjects help create breakthroughs in medicine. In exchange, the researchers are expected to follow ethical guidelines meant to protect those patients. I knew source investigative reporter Brad Racino found that wasn't the case with a renowned UC San Diego. I doctor who for years put patients in harm's way. Today I'm going to tell you Speaker 2: 00:25 a story of a repair and regeneration of our body. Doctor Kang Zang is the chief of Ige genetics at Uc San Diego where he also has a lab named after him. He receives millions of dollars in federal grants and presents his research at symposiums around the world. I'm an eye doctor. I want to cure blindness, but the U s food and Drug Administration inspected zangs research in 2016 and found several violations in a drug trial that had been going on for years. Zang enrolled people he shouldn't have in his medical trial, failed to document what happened to 25 units of an experimental drug and kept poor records on his patients. He also didn't provide a plan to the FDA to protect his human research subjects going forward like he was supposed to. Speaker 3: 01:12 The problem's identified during the inspection were significant and certainly undermined the protection of human subjects in the trial. Speaker 2: 01:22 Michael [inaudible] is a former associate director at the U S Office for Human Research Protections, one of many federal agencies that protects human research subjects. He's now at public citizen, a consumer advocacy nonprofit. Caroma zeroed in on one FDA finding that half of the patients in Zang study shouldn't have been enrolled in the first place. That's a big problem. He said because the drug's Ang was testing could potentially lead to serious side effects for the volunteers like cataracts or blindness. Speaker 3: 01:51 I'm a scientific standpoint and from an ethical human subject protection standpoint, not complying with the enrollment criteria is a big deal. Speaker 2: 02:00 Zangs I study was eventually shut down. Then you see as came out with an audit of its own, which looked into more of sangs research. It found violations everywhere. It looked Zang and his staff failed to get proper consent from all patients. Didn't report problems to ucs research oversight board lost documents, kept inaccurate records wrongly built patients and didn't complete the training required to work with human embryonic stem cells. In one study, Zang staff tested patients blood for HIV and aids without telling them against federal policy. Speaker 4: 02:36 Okay. She's lucky that all the time I think should we do Speaker 2: 02:43 Amy Caruso Brown is an assistant professor of bioethics at New York's upstate medical university. She's also a member of an institutional review board, a safety committee that approves and overseas projects like Zangs Brown, red, the ucs D and said, Speaker 4: 03:00 I have not seen this number of issues in the five years that I've been on an IRB. Basically, Speaker 2: 03:06 we reached out to Zang and other officials that you CSD for interviews in response [inaudible] send a statement that said the university had quote implemented a Comprehensive Management Plan to address these issues. And quote, UC SD also said it's suspended saying indefinitely from serving as a primary researcher overseeing human research studies at the school. But that means he can still apply for federal grants, publish in medical journals and train the next generation of scientists. Uc Sd later told, I knew source zangs research had undergone multiple audits since 2012 which prompted his suspension in 2017 when asked if that meant the university had known about zangs violations for five years before taking action or UC SD spokeswoman would not comment further. Doctor Zang story is the latest in our new services risky research investigation and was reported by Brad Racino and Jill Castillano, both of whom join me now. Welcome. Thank you. Speaker 2: 04:08 And Maureen. So Brad, just to be clear, all of these problems with Dr Zangs research programs did not lead to any harm to the research subjects involved. We can't actually say that. We don't know. Um, the problem with looking at a lot of these things is that there is there a strong federal rules that protect patient privacy. And when we look at audits or we look at certain things, a lot is left out also ucs d and its audit that we looked at only sampled a very small percentage of patient files when they looked through zangs research. So we don't know if uh, any harm actually happened, but that's part of the reason that we wanted to come on today and also, uh, solicit if anybody knows anything about these studies and wants to come forward. Was there an any evidence that they were at risk of harm? Well, there's always a risk for harm in any kind of clinical trials such as these. There was one Zang study that involved I injections once a month into patient's eyeballs and the drug had serious side effects such as cataract blindness. I hemorrhaging. Um, but there is inherent risk in any kind of clinical study that you do now, Jill, when the grant or the research project is approved, are the rules and protocols of that research spelled out right up front? Speaker 5: 05:21 Yes, they always are. Everything is preapproved, including the commitment that the doctors and researchers make to protecting patient's rights. That always happens up front, but it also includes the exact details of what's going to be done in that study. They need to know in advance exactly what they're going to do and that includes how long it's expected to take and the kinds of patients that can be enrolled. So for example, in the study that Brad was talking about that doctor Zang did, if they had a pretty serious advanced case of macular degeneration, if their eyes were progressing and getting really bad, then we can take that risk and give them this drug that has potential side effects. Unfortunately, Zang did not do exactly what it said in the protocol up front. He enrolled people who shouldn't have been enrolled in this study. Yeah. About half the subjects that were enrolled should not have been enrolled in that one study. Speaker 5: 06:09 Jill, who's in charge of seeing that these rules are followed. You know, it actually comes down to the researcher himself or herself. A lot of it is built on trust. They're supposed to come forward and say if something's not going as planned, not part of that preapproved plan. They're supposed to go back and talk to the people who approved it and say and ask for more approval or ask them to change the protocol as they go on. The people that are reporting that to our, the university's Institutional Review Board or IRB and they're responsible for making sure the study is going well, but a lot of it comes back to the doctor themselves and realize on, on the trust that they are going to do the right thing. Now, Brad, in terms of dollars, how much grant Speaker 2: 06:50 research money did doctor Zang yet for these projects? So we have limited information on that as well because some of these studies were privately funded so we don't, they're not, um, like federally funded projects where we can easily see how much went towards him. We know that for just two of the studies that ucs Dee looked at, the Zang had gotten close to $3 million and that involves, those two studies alone involve more than 16,000 patients. So the UC SD audit looked at five studies total. And then we also wrote in the story about an FDA warning letter that involved another study. So these are just six studies. Zang has been at UC SD for a very long time and has a lot of projects and not just at UC SD. He also is a researcher for other institutions including the San Diego VA or he has other studies that have also happened. Millions and millions of dollars. Yeah, a lot of money. Jill. This is a highly renowned researcher. Okay. Doctor Zang, and yet he's been suspended from doing further research at Uc San Diego. Has either the school Speaker 5: 07:47 or the doctor commented on why or how these ethical lapses happened? No, we would really like to get to the bottom of that and talk to somebody to clarify how this all went down, but unfortunately we have not been able to get an interview and have a real conversation with anyone. We reached out to a number of people at UC San Diego, including the doctor, the doctor's boss, who's the director of the eye institute where he works the head of the office that protects human research subjects at UC SD. None of them granted us interviews. We did talk to a spokesperson who provided us some statements and some clarification, but it's now no longer providing us any additional clarification, so we're kind of stuck with what we know at this point and we'd like to get to the bottom of what really happened here Speaker 2: 08:32 in your lengthier, I knew source piece on this subject. You talk about how Dr [inaudible] case is emblematic of the lack of oversight in human research projects. Tell us a little bit about that. Yes, so half, I would say half of this story is about Zang and Isabelle, these audits and these research violations in the risks. But the other half is really putting it into the context of what Jill and I are, I've spent months looking at and what we hope to keep reporting on, which is there is a larger system in place that has been there for years and years to protect these patients. And there are millions of patients every year than enroll in these kinds of trials. And the system is designed, it's well intentioned, but there are serious gaps. It's a patchwork of, of systems at the federal, local, state agencies, academic institutions. Um, and so there are lots of ways where the system can break. Speaker 2: 09:19 There's a lack of communication between different institutions and agencies. There's also institutions like UC SD that have a lot of money involved in this and a lot of prestige and reasons why they don't want this to come forward. So, and in, and the system also realize, as Jill had said on self reporting. So we don't even know how much of these noncompliance, um, things have happened over the years because unless we find them, we don't know. I've been speaking with our new source of reporters, Brad Racino Anjell cast. Alana, you can read more about their investigation at, I knew. So. [inaudible] dot org thanks a lot. Thanks. Thank you. Speaker 6: 09:55 [inaudible].

Tens of millions of people have volunteered their time and bodies to help create breakthroughs in medicine. You see the results with the pain relievers in your medicine cabinet, the vaccines that protect you from disease, the pacemakers that keep your heart beating and the innovations happening now with stem cells.