New York City’s child welfare department opens an investigation into whether they forced HIV positive children in foster care to submit to experimental AIDS drug trials. We speak with the commissioner for New York’s Administration for Children’s Services, New York City councilman Bill Perkins and Vera Sharav of the Alliance for Human Research Protection. [includes rush transcript]
Last December, Democracy Now reported that a BBC documentary exposed how the city of New York had been forcing HIV-positive children under its supervision to be used as human guinea pigs in tests for experimental AIDS drug trials.
All of the children in the program were under the legal guidance of the city’s child welfare department, the Administration for Children’s Services or ACS. Most lived in foster care or independent homes run on behalf of the local authorities and almost all the children were believed to be African-American or Latino.
ACS initially dismissed the allegations as unfounded and stated that the source “appears to be a group of individuals holding the views that HIV does not cause AIDS.” But just last week, ACS did an about-face and announced that they will be conducting a review of their policy that was in place the late eighties and nineties, which did force HIV positive children in foster care to submit to clinical drug trials.
The commissioner of ACS will be joining us to talk about this later in the show, but first we are joined in the studio by New York City councilman Bill Perkins, who will be holding hearings about this on Thursday and Vera Sharav, of the Alliance for Human Research Protection.
- Bill Perkins, New York City councilman. He represents Central Harlem, Morningside Heights, parts of East Harlem and the Upper West Side.
- Vera Sharav, Alliance for Human Research Protection.
- John Mattingly, appointed Commissioner of New York City’s Administration for Children’s Services on July 6, 2004.
AMY GOODMAN: The Commissioner of ACS will be joining us to talk about this later in the program, wanted to be separate from our current guests, who are joining us in the studio right now: New York City Council member Bill Perkins, who is holding hearings about this on Thursday; we’re also joined by Vera Sharav from the Alliance for Human Research Protection. And we welcome you both to Democracy Now!
BILL PERKINS: Good morning.
AMY GOODMAN: Well, why don’t we start with you, Council member Perkins? What are your concerns right now? What are you claiming?
BILL PERKINS: ACS grossly misled us in terms of the numbers of children that were participating in these experiments. They originally said only 76. Last week they informed me that there were over 465, and could not even indicate as to whether there were — that number was going to grow even larger. That gross misrepresentation leads one to believe that maybe there are similar gross misrepresentations with regard to the total clinical trials protocols and program, and therefore, an investigation has to take place, an independent investigation, not a review of what happened, but rather an investigation of what happened, in order to assure the public that what took place was in the best interest of the children. And, in fact, one cannot assume that that was the case.
AMY GOODMAN: What do you believe took place?
BILL PERKINS: I believe that there were instances of children being put into these trials, perhaps without the proper protocols, perhaps without the proper parental consent and information being provided. I believe that ACS has misled us in terms of what has been going on, and therefore, I’m led to be very concerned about the integrity of any investigation that they decide to do on their own.
AMY GOODMAN: Vera Sharav, you’ve been on this story for quite a long time. What is your understanding, if you can describe for us, what you believe took place in the 1980s and 1990s?
VERA SHARAV: It went on until 2002, so it’s not just 1980s. What took place is essentially a complete violation of current federal regulations, which were established for protecting children such as these in 1983. This was after Willowbrook. The intent of the regulations was to protect the most vulnerable children from exploitation in medical experiments.
AMY GOODMAN: Willowbrook being the mental institution in New York.
VERA SHARAV: That’s correct. And now we have the ACS essentially bypassing the federal regulations, creating its own guidelines, expedited review, disregarding very fundamental human rights issues, such as informed consent. These children, according to the ACS guidelines, did not so much as have the dignity of individual consent on their behalf. They were herded like animals.
AMY GOODMAN: Who were these kids?
VERA SHARAV: These children were in foster care under the ACS, as well as Catholic charities. Many of the homes were run by them.
AMY GOODMAN: HIV+?
VERA SHARAV: HIV+. Now there’s even an issue about some of the trials, some of the protocols say that the children are, and I quote, “presumed to be HIV+.” Now, what kind of — what kind of society are we that children who are only presumed, and by whom are they presumed — what criteria makes them presumed to be HIV, that those children then get exposed to as many as seven highly toxic experimental drugs? These children were not in treatment, and ACS can’t fudge that. Research and treatment are two very different things. Our first question when we filed our federal complaint to the FDA and the Office of Human Protection a year ago — and those investigations, by the way, are still ongoing — we asked, why were those children denied the best treatment that was available, that was known already to be as effective as whatever it was?
AMY GOODMAN: Which was what? What was the best treatment?
VERA SHARAV: We don’t know that. You see, part of the problem with AIDS and with HIV is there is a great deal of uncertainty as to what is effective, what is not. Would some children be better off without the drugs? All of those sort of things are not to be decided by bureaucrats who want to expedite simply the enrollment of children and couldn’t care less as to what kind of experiments. I think it’s very important to note that when ACS on their official documents refers to these as minimal risk, that’s nonsense. These were phase I and phase II trials, which are the most experimental.
AMY GOODMAN: Who gave permission for the kids to be tested?
BILL PERKINS: That’s the very important question. The assumption is that ACS gave the permission, but we don’t know for sure if parental involvement or guardian involvement was made available. So it becomes very questionable —
AMY GOODMAN: Who — I have a question. Who is the guardian of a foster child? Is it the foster parent or is it the city?
VERA SHARAV: The city.
BILL PERKINS: It’s a combination of the city and the foster parent, but the city has some legal prerogatives in that respect, and that becomes another question as to exactly what prerogatives does the city have with regard to putting these children in these types of tests. Do they have a unilateral authority to do this? If the parent objects, if the guardian objects, do they override that objection? And under what authority are they allowed to override that objection? These are very, very fundamental and important questions that determine the integrity of what was going on, and whether or not these children were simply used as guinea pigs, as opposed to being actually treated or as opposed to being researched on. And these are very fundamental questions that we think can only come out through some sort of independent investigation.
VERA SHARAV: We really think that at this point, since there are two federal investigations ongoing, that it really has risen to the level of crime, and that the Justice Department ought to be involved. And there is a place for the Justice Department to look into research. That was, in fact, done at Willowbrook.
AMY GOODMAN: Did the city work with drug companies in this testing?
VERA SHARAV: I don’t know whether the city, but the hospitals that were involved certainly did. The investigators, the doctors certainly did.
AMY GOODMAN: Explain the scenario that would take place. How was a child enrolled in this program? Where would the child go? And what were the drugs that were used?
VERA SHARAV: There isn’t a simple answer to what you’re asking, because it depends where and what kind of condition the children were in in the first place. From the ACS guidelines, it informs that the ACS was giving approval to enroll children before hospitals actually even approved the protocol. They had the children ready to go into trials before anyone even approved the specific — the specific protocol. There is a very unseemly way in which these children were dealt. Their dignity, their humanity was just stripped. They were treated as numbers.
AMY GOODMAN: How old were they?
VERA SHARAV: They were from three months old on.
AMY GOODMAN: Council member Perkins.
BILL PERKINS: These questions are the most important questions that we will be dealing with on Thursday at 11:15 at the City Council. We will have a hearing with the new Commissioner and others to get to the heart, to the bottom, of what actually took place, and hopefully this time we’ll get the truth.
AMY GOODMAN: Were the guardians, the foster parents, paid for the kids going into these programs?
VERA SHARAV: We don’t know.
BILL PERKINS: Again, that’s part of the problem here, that we don’t know truly what ACS was doing. They basically operated in what one might assume was a confidential way, but what appears to be a secretive way, especially when you discover that they have gone from 78 cases already to 465 cases, which were accidentally found in a closet at the agency. Now, it would seem to me that if this new Commissioner was so easily able to find these records, how come the former Commissioner , Bell, did not find them when they were asked about earlier?
AMY GOODMAN: The numbers again? You originally were told?
BILL PERKINS: 78 to now over —
AMY GOODMAN: And when were you told 78?
BILL PERKINS: It’s about a year ago. And now over 465, and potentially growing, because there’s not clarity as to whether or not these are the only ones that are to be found, because these were found, in a sense, by accident.
AMY GOODMAN: How?
BILL PERKINS: Apparently the Commissioner asked that there be some search of the records, and this is what the Commissioner shared, that they were found through the —
AMY GOODMAN: And we’ll be speaking to the Commissioner in just a moment. Vera Sharav?
VERA SHARAV: I tend to not believe that it was just by accident, that they were just laying there. I tend to think that the federal investigations must have actually kicked them up, and so the announcement now may be a pre-emptive admission prior to the findings of either the FDA or the OHRP, or both.
AMY GOODMAN: These are the two agencies that are doing an investigation right now.
VERA SHARAV: The two federal agencies, which — yeah, which have been investigating, and I was assured that, in fact, it was a very serious investigation, and they would, in fact, be privy. They would have to provide them with the numbers.
AMY GOODMAN: And again, these agencies are?
VERA SHARAV: The FDA, the Food and Drug Administration, and the Federal Office of Human Research Protection, which is under the Health & Human Services Secretary.
AMY GOODMAN: You say that this took place until 2002?
VERA SHARAV: Mm-hmm.
AMY GOODMAN: What stopped it?
VERA SHARAV: That is a major question that we have. What happened in 2002 that suddenly a very profitable, very profitable enterprise stopped? What happened that Incarnation House at that point changed its license? What happened that its executive director left? What happened in 2002 or the end of 2001 that this was stopped?
AMY GOODMAN: Council member Perkins.
BILL PERKINS: Well, even — has it stopped? Is the question — has it stopped? Then how do we know that it has stopped?
AMY GOODMAN: What is the Vera Institute of Justice?
VERA SHARAV: As far as I know, they generally look into police brutality and that sort of thing. I don’t think that they are — have the expertise to do an investigation of medical research malpractice.
AMY GOODMAN: Explain what is their role right now? Why are we even talking about them?
BILL PERKINS: Apparently they have been contracted with the Department of — ACS to look into what took place with regard to these experimental trials. Now, that is a sort of investigation that’s taking place by them for them. I don’t think that it provides the type of objectivity that a federal or the Department of Investigation in the City of New York would provide that would give us some sense of credibility as to exactly what is being investigated. We don’t know for sure what they’ll be looking at. They have been invited to come to the hearings and to explain what their role will be and exactly how they will go about fulfilling it.
AMY GOODMAN: The ACS has put out a press release saying that they are contracting with the Vera Institute of Justice to conduct an independent review of ACS policy and practice regarding the enrollment of HIV+ kids in foster care in clinical trials. Children’s Services also announced the formation of a panel of national healthcare experts to examine clinical trial issues and review Vera’s findings. Your response to that.
VERA SHARAV: One of the questions that we haven’t raised, and it’s a very serious one, is in fact, what happened during the trials to some of the children? What kind of adverse events did they suffer? How many died as a result of the trials? None of this is known at this point. And given the sleight of hand, the way in which ACS was not forthcoming about the numbers who participated, they clearly aren’t forthcoming with the numbers who have been harmed.
BILL PERKINS: You know, I think again that the Department of Investigation and some other entity needs to be involved in a truly independent investigation of what took place. I don’t know who this panel of doctors and other scientists and experts are. I don’t know what their role will exactly be. I’m not sure what Vera’s role will exactly be. Hopefully during the hearing we’ll get some insight about that. But nevertheless, it seems to me that considering the gross misrepresentation of the numbers of children that were involved, there seems to be some, (quote), “cover-up” type activity that’s taking place that needs to be looked into.
AMY GOODMAN: And the idea that — again, in the press release — the purpose of the drug trials, to develop effective treatment for pediatric AIDS at a time when there were no known FDA-approved medications available to treat children with the disease, and many children were dying.
BILL PERKINS: Again, who were the pharmaceutical companies that were involved? Did the treatments that were given to the children relate to what might have been diagnosed their real problem? Were they all infected? Were they all supposed to be receiving — participating in these trials? Who were these children that were determined to be a part of these trials?
VERA SHARAV: Part of the problem, as you said as well, is that no one except the stakeholders in doing the experiments were involved. There was no transparency whatsoever.
AMY GOODMAN: What hospitals were involved?
VERA SHARAV: Oh, you have — most hospitals in the City of New York, the major hospitals. That includes both the city hospitals and the private hospitals.
BILL PERKINS: You know, it seems to me that when you have something this sensitive and this important that there should be some sort of independent entity that is charged with overseeing this type of activity, so that there can be given some sort of confidence, some sense of credibility that there is integrity, there is a true need in some sort of transparency and some sort of accountability. We have not gotten this from ACS. That raises very serious questions as to whether or not we can trust their leadership and their decision-making process in terms of investigating this matter.
AMY GOODMAN: Finally, what would satisfy you that would be an independent investigation?
BILL PERKINS: At this point, I think the Department of Investigation has a responsibility as the city agency to look into these sort of matters. I think the federal level is important, as well, and I believe that’s going on, as has been stated. But I think there needs to be an expeditious movement on the part of the Department of Investigation to look into this. I think that delay is very bad in terms of the credibility and in terms of the community’s concern about what actually took place.
AMY GOODMAN: Well, New York City Council member Bill Perkins and Vera Sharav of the Alliance for Human Research Protection, I want to thank you both very much for being with us. When we come back from our break, we’ll get response from the Commissioner of the Administration of Children’s Services. Thank you.
AMY GOODMAN: We are joined by the Commissioner of the Administration of Children’s Services in New York City, John Mattingly. Welcome to Democracy Now!
JOHN MATTINGLY: I think it’s very important that I be here, so I’m glad to be here.
AMY GOODMAN: When did you become Commissioner?
JOHN MATTINGLY: August 16 of 2004.
AMY GOODMAN: And what did you find? What is your response to these charges of the abuse of children in clinical trials?
JOHN MATTINGLY: Sure. Well, I think there’s a question of the present, and there’s a question of the past. The present I know about, at least since I have been here, and I’m quite certain of. The past, of course, is going to take a great deal of research and investigation and review to find out the details. In terms of the present, I can say to the public of New York City that there are no children in approved clinical trials involving ACS, foster children, at all. The last individual child who was a part of a clinical trial because of her special needs, and she’s doing well now, was approved for that in 2001. The last formal trial that I can find so far that was approved was in 1998. So the present involves where we are with children now, and there aren’t children in clinical trials, number one, and number two, it involves a policy that we have just sent to the state, which requires a great deal of review and consideration before any children in the future should be involved in clinical trials. The most important thing to remember is that these children are foster children, that they are therefore in the custody of the City of New York, so we need to be absolutely certain that we do right by them, because they are in our custody, and it’s my intention to make sure that we do that.
AMY GOODMAN: What about these questions that have been raised? Let’s begin with the numbers of kids involved. City Council member Bill Perkins just said they were told originally that the number was 78; now you have come on board and you’re now saying that the number of kids is 465, kids in foster care that were involved in these experimental drug programs.
JOHN MATTINGLY: Well, it’s important to remember that most of these trials occurred in the late 1980s, early 1990s, mid 1990s, that ACS didn’t exist then. ACS was founded in 1996. So there was a separate organization now called the Human Resources Administration that was responsible for all child welfare. It’s a different building, different offices and a whole different agency. So when I arrived and heard these concerns I was really quite concerned that this is too important to just leave to the past, that we have to look at it ourselves now, because these are foster children. And if we lose the support of the community as a whole, if our childcare and Head Start programs are seen as run by an agency that can’t be trusted, or if our child protection people can’t be expected to intervene appropriately to protect abused and neglected children, then we can’t do our work. There’s a sense of mutual trust that I think we have to have with the community, so it seemed to me at the time that we should look as hard as we possibly could to find everything that we could in the past — from the past. That’s what we did, and that’s how we turned up the additional cases. We’re not stopping there, however. I’m convinced that we have to leave no stone unturned, so we’re going to not only — we’re going to look at all the archives filed away in boxes all around the city. We’re going to look at all of the case records that we can possibly find to make sure we find every last one of these kids’ cases, and secondly, we’re going to see to it with Vera’s help that we run down these children and find out how they’ve fared. It does seem to me that it is our responsibility to know how they did, and I want to know that personally.
AMY GOODMAN: Presumably, Commissioner, as you do this internal investigation before the investigation that you have contracted for, you found out some information. For example, what pharmaceutical companies were involved?
JOHN MATTINGLY: I don’t know the answer to that now. What I do know is we’ve located, and it took a long time to run even these things down, the policies going back to the late 1980s and early 1990s. The policies themselves seem to me to be thoughtful and to consider the rights of these children and their parents very carefully and to be focused solely on what help the children needed basically to survive the AIDS epidemic. Looking at those policies I can see nothing wrong with them. They may not be what we would do today, but they were very thoughtful and thoughtfully considered. However, policies are one thing, and determining what actually happened on the ground are something else. That’s why I’m going to be looking carefully at the whole range of things, and that’s why we brought in the Vera Institute for Justice to help us do that.
AMY GOODMAN: When you were first having to publicly deal with these allegations, the BBC documentary came out in December, we did a story on this, the word from the ACS was — well, it was being denied. And then, the response was the people who are making these allegations appear to be a group of individuals holding the views that HIV does not cause AIDS. Why the denials originally?
JOHN MATTINGLY: Well, we still have no credible evidence that I can find in what I can find that anything untoward happened, that anything illegal or immoral or unethical happened. So our initial responses were focused on that fact. However, once it became clear that there were more cases to be found than we had found before, again without credible evidence that anything immoral or illegal had happened. I still felt like in order to keep the public’s trust, we have to go public, and we have to reach out to both the Vera Institute of Justice people and to a special medical panel of advisers and overseers to make sure that what we find gets public and is heard by everyone, good, bad or indifferent.
AMY GOODMAN: Commissioner Mattingly, the BBC identified pharmaceutical giant GlaxoSmithKline as one of the companies that provided the experimental drugs. In an email to us at Democracy Now!, GlaxoSmithKline stated, “Pharmaceutical companies are not directly involved in the recruitment, enrollment or participation of patients in such trials.” They went on to say, “The FDA encourages studies in pediatric patients. Clinical trials involving children orphans are therefore legal and not unusual.” In the documentary, parents or guardians who refused to consent to the trials claimed that children were removed by ACS and placed in foster families or children’s homes. Then acting over their objections, the ACS authorized the drug trials.
JOHN MATTINGLY: Sure. I don’t know anything about the pharmaceutical companies involved or what they did or didn’t do, so I can’t speak to that. I can say that in my brief review of the individuals involved in that report, that the statement that these kids were removed from families or foster families in order to get them in clinical trials is absolutely false. And I will say that the fact is that if a foster parent won’t provide drugs to a child that will keep that child alive, not involved in a clinical trial, but because the medical experts and the child’s physicians believe they have to be provided, we have to consider carefully whether we need to move a child from that foster family because of their unwillingness to allow the family’s physician to step in and tell families what it is that they need to do. We haven’t, however, as far as I know, and we’ll know a lot more in a few months, we haven’t, as far as I know, removed children from their families solely to involve them in a clinical trial. I know of no such case.
AMY GOODMAN: So no child has ever been removed because a parent or guardian said no to putting them in a clinical trial.
JOHN MATTINGLY: I have no evidence at all that that exists. However, it’s important that we take the time to look at every one of these cases to make sure it didn’t happen.
AMY GOODMAN: Why the Vera Institute of Justice? What City Council member Bill Perkins is saying, what expertise do they have in this?
JOHN MATTINGLY: Vera is widely known and widely respected as researchers in the human services field. So that’s why we called upon them first. Secondly, they have a reputation for speaking the truth, whether the city comes out positive or negative about it. And thirdly, they haven’t been heavily involved in medical issues, and I think that helps with this question.
AMY GOODMAN: I want to thank you very much for being with us, Commissioner of Administration of Children’s Services, ACS, John Mattingly. We hope to continue to talk to you about this process of investigation.
JOHN MATTINGLY: I’d be glad to.
AMY GOODMAN: Thank you.