NIH Tested AIDS Drugs on Foster Children

Earlier this May, the Associated Press reported that National Institutes of Health researchers tested AIDS drugs on hundreds of foster children in the late 1980s and '90s. In many instances, the drugs were given without independent advocates who monitor the safety of these children. Ed Gordon explores the controversy with two AIDS experts: Dr. Jonathan Fishbein of the National Institutes of Health and Baylor College of Medicine's Dr. Mark Kline.

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ED GORDON, host:

From NPR News, this is NEWS & NOTES. I'm Ed Gordon.

Earlier this month, the Associated Press reported that researchers at the National Institutes of Health had tested AIDS drugs on hundreds of foster children in the late 1980s and '90s. In many instances, allegedly, the drugs were given without having independent monitors assigned to the children, which is the law in most of the states where these tests were conducted. Dr. Jonathan Fishbein, an AIDS research expert at the NIH, has criticized his agency for what he says is irresponsible drug testing. Dr. Fishbein joins us from Bethesda, Maryland.

Doctor, thanks for joining us.

Dr. JONATHAN FISHBEIN (Division of AIDS, National Institute for Allergy and Infectious Disease): My pleasure being here, Ed.

GORDON: I think a lot of people would be shocked and will be shocked as this story gets further play in the media to find out just how many young people were, in fact, part of this, quote, "experiment," if you will. When you found out and when you looked at the numbers, did it surprise you?

Dr. FISHBEIN: I was surprised. I did not realize that foster children were a readily available source of clinical trial participants. I don't feel that foster children should not be given this opportunity to be involved in research, but I do feel strongly that federal rules regarding the use of foster children ought to be followed closely.

GORDON: We'll get into that in just a moment, but I'm curious whether or not you see this as an opportunity, or whether or not those who were conducting the research saw it as an opportunity, to utilize these kids as, for lack of a better term, guinea pigs, particularly based on the livelihood of most kids in foster care, and by that I mean many of them minority, many of them going into the system poor and, really, a voice with little political muscle.

Dr. FISHBEIN: One of the things that you need to consider is, back in the late '80s and early '90s, when there were no established treatments for children with AIDS, that clinical research was the only opportunity for some of these children to get some of the drugs believed to be beneficial to their condition. I think these children are easily available to researchers, and I think that the issue of protection is one that needs to be more closely scrutinized by the institutional review boards where the research is conducted. Many of the states where the research was conducted require that advocates be appointed to oversee each child who is enrolled in a clinical trial.

GORDON: These advocates, if you will, these overseers, were not, for the most part, in most cases, given to each one of these young people. With that, and we should note that you've been very up front and, quite frankly, one could see you really going after the hand that feeds you in being, to some degree, a whistle-blower, if you will--you see this as waste, fraud and abuse, the use of foster kids in this sense, do you not?

Dr. FISHBEIN: Well, what I see it is a situation where there has been neglect for federal rules that are supposed to protect these children. And in my role at the NIH, I was very interested in making sure that researchers, whether they were doing clinical trials in vulnerable populations or not-so-vulnerable populations, make sure that federal rules were followed, because federal rules were designed to protect people who are in clinical trials and to make sure that the data that is generated from clinical trials is credible. And I'm concerned about a lack of compliance on the part of many investigators, and I'm concerned about the lack of oversight from the federal government, particularly the NIH, in making sure that rules are followed.

GORDON: What was it personally, Doctor, that moved you to contact the inspector general at the Health and Human Services Department to put on record your concern about this?

Dr. FISHBEIN: The issue of foster children was not something that I brought to the attention of the inspector general. I brought issues of non-compliance...

GORDON: Right.

Dr. FISHBEIN: ...in other clinical trials, and the lack of enforcement by the institute that I belong to and by the fact that the institute seemed unwilling to enforce many of the federal research rules, and punished me for trying to do so.

GORDON: I would suspect it is at best, perhaps, an uneasy relationship with NIH now?

Dr. FISHBEIN: It is. I was hired to create and implement clinical research policy at the Division of AIDS and the National Institute for Allergy and Infectious Disease, and I did that and tried to be effective in making certain that researchers were compliant with federal regulations involving research.

GORDON: Doctor, let me ask you this as relates to all of what has gone on. When you look at this--initially, people in our office started to think back to the days of the Tuskegee experiment. While this is completely different in the sense of these kids are not being given a disease, is there any way, in your mind, to couple or concern ourselves with the idea of that kind of abusive treatment for these young people?

Dr. FISHBEIN: Well, the similarity is that the rights of a vulnerable population were denied, and this population, foster children, were denied the right of an independent advocate who looked out for their best interests. That's where the similarity is with this...

GORDON: And we should reiterate that you are not saying that you are against, obviously, research, in particular with the people that you are attempting to help in the long run, and that is, in this case, young people, just that it be carried out in the correct way.

Dr. FISHBEIN: There are very good regulations that are on the books that the federal government requires investigators to follow which protect vulnerable populations, protect foster children. And I'm saying that those regulations need to be followed. We don't necessarily need more regulations or changes in the regulation; we need the regulation to be followed. We need the government to enforce the regulations, and when there are individuals, such as myself, who move to enforce the regulations, that we not be punished for doing it.

GORDON: All right. Dr. Jonathan Fishbein, thank you very much for spending some time with us and enlightening us...

Dr. FISHBEIN: Thank you.

GORDON: ...on what's going on.

Dr. Jonathan Fishbein heads research operations in the Division of AIDS at the NIH.

Now we hear from Dr. Mark Kline, professor of pediatrics and director of the international AIDS Program at the Baylor College of Medicine in Houston, Texas.

Dr. Kline, thanks for joining us. Appreciate it.

Dr. MARK KLINE (Director, AIDS Program, Baylor College of Medicine): Thanks for having me.

GORDON: Few would argue the importance of testing, but there are those who are concerned that these foster children were taken advantage of and concern themselves with the idea that this could happen again. I know that you had, indeed, enrolled some foster kids in this testing. Talk to me about your feelings.

Dr. KLINE: Well, I think there are a couple of things that are important to emphasize. The first is that foster children were not targeted for this research. Rather, they were given the same access that was given to children who had more resources and parents. And those of us who were caring for these children at the time felt strongly that, because available therapies were not particularly powerful and children were continuing to die at a high rate, we had to make sure that foster children had access to this treatment.

The second point that I would like to make is that I believe, and our legal experts believe, even in hindsight, that all of the federal regulations were followed. The necessity for an independent advocate really applies to a specific class of studies that was not pertinent in this particular case. It applies to children who were in studies where there was more than minimal risk and where there was no potential for direct benefit. But all of the studies we're talking about here had the potential and, actually, the expectation for direct benefit for the children. And...

GORDON: That being said, Doctor, I would imagine you would understand the concern, particularly from the minority community, where we see a history of, quote, "experiments," research, done on a class of people who, at the time, weren't seen, quite frankly, as valuable.

Dr. KLINE: Well, that may be true for some. It certainly wasn't true for me or for my colleagues, I believe. In fact, from the beginning, this epidemic has disproportionately affected children of color and people without resources, and we fought hard to see that everyone gained access to these trials because, at the time, it was the best option for prolonging life. And, in fact, many of these children who participated in these trials in the late 1980s and early 1990s are alive today because they had access to the trials. Had we not provided that access, they no doubt would have died.

GORDON: Doctor, how many, if you could put a percentage on the people that you dealt with--the young people--were not, in fact, in foster care that participated in this research?

Dr. KLINE: Well, in my own studies here in Texas, I would say 95 percent of the children who were enrolled in trials actually had parents, so really a small percentage came from foster care. That number may have differed in other locations. I just simply don't know. But, again, we were not targeting foster children. We simply were giving them the same access that children with more resources and with parents happened to have.

GORDON: As we move forward here, Doctor--and, obviously and unfortunately, though we've made great gains, we have not eradicated AIDS or HIV in our time. And as we continue to research this, would you have an issue with the idea--do you believe it will slow the process down to a grinding halt if, in fact--further studies, each child participating would have to have an advocate, an overseer, involved?

Dr. KLINE: No, I don't think it would slow things down substantially. And--but I think today is a very different time. In the late '80s, early '90s, the time period we're talking about, there were very few options available for treatment by prescription. But today we have a large menu of options for treatment. And so when I see a child with HIV, I know that I have 15 or 17 medications to choose from. And so I think it would be an extraordinary circumstance today where I would propose enrolling a foster child in a clinical trial. I actually don't have any foster children in clinical trials any longer for that reason.

GORDON: And, Doctor, much has been made, and I would suspect as this continues to broaden by virtue of more people reading about this research and also the investigation by the AP--and other government agencies are now looking into it. In your mind, do you believe this to be much ado about nothing?

Dr. KLINE: I do. I think the AP article has done a lot to educate all of us about independent advocates and when they are needed, but again, our legal experts are saying, even in hindsight, independent advocates were not required for the particular studies that we're talking about. There may be state laws that apply in some places, not in Texas, where there are additional protections that are provided. I don't know. But in most of the states, Texas included, the federal law just simply didn't apply in these cases.

GORDON: All right. Dr. Mark Kline of the Baylor College of Medicine down in Houston, Texas, thanks for joining us. Appreciate it.

Dr. KLINE: Thank you.

GORDON: This is NPR News.

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