DR. SHAPIRO: I think there is a way to do it if one favors it, but let’s wait until we’ve got it written down so we don’t discuss it any further right now. Okay. Now we have scheduled in just three or four minutes from now public testimony. We have four people who wanted to speak to us. I’m going to suggest that if they are here now, that we begin right away because we really can’t take on other cases in that short period of time and I don’t want to keep them longer than our scheduled time. So let me just see, is Ms. Judith Brundin here? I just want to remind everyone, step forward to the microphone here if you’d like to. Just to remind everyone of the rules under which we operate in this area. That is, everyone has five minutes to present their material. If they have any additional written material that they’d like us to consider, they’re more than welcome to submit it. And there is, of course, you did submit something in advance in writing, and every Commissioner has copies of what you submitted.
MS. BRUNDIN: You’ve given my name: Judith Ann Brundin. I’m from Union City, New Jersey. I am grateful today for the opportunity to give testimony before this Commission because I believe its research objectives to be of extraordinary importance and the passage of John Glenn’s legislation, a significant step toward unraveling human rights abuses within our own borders. My father worked as a space systems division senior administrator with Astronaut Glenn in the late ‘50s in Los Angeles. I grew up in what was known as the Air Force’s "elite class" amongst a highly educated military group of Ph.D.s and Master’s degrees. But by my mother’s recent admission on audiotape and my own recollection, I was a victim of the Monarch mind control programs of the Air Force. And this occurred, in part, while my father was working with Senator Glenn. Because of this brutal mind control torture, I have become toughened, resilient and determined to bring out what has happened to me regarding this brutal assault and the continuing ongoing situations that I have suffered, especially since 1993. I am well educated; I have two Master’s degrees. I am an author. I got past the Monarch brain control programs and I have done well until recently. In brief, in 1993, three men, who I know, with the involvement of government agencies, carried out mind control assaults upon me at work, in my Federal facility at the Smithsonian Institution in New York City. This included the implanting of an experimental device in my body, which is seen on X-rays. And, the man responsible for that in part was a Canadian paramilitary man named Robert McDonald. He has admitted to involvement with government agencies and was paid to set this up. This is the beginning of a brutal, high-tech community war which I have endured, which has included the use of chemical weapons and frequency weapons. I have suffered permanent physical illnesses in very short and quick time. The complete loss of four fetuses for unknown reasons. The chemical assaults have included toxic food poisonings consistently in my residence. I own a beautiful Victorian house. Arsenic was found in my foods on my desk at the Federal job, and that was by lab reports that me and my attorney did. Triphenylphosphine, a highly toxic chemical, was found on my steering wheels to my cars consistently—has been now for four years still found on the car. I wear gloves driving my vehicles. I have been used in Monarch-style mind control programs in those Federal facilities in 1993 and I was used further in sessions in Paris in 1996. The evidence I have includes toxic and exotic lab results of poisons found on Federal premises for which I had no access to. They were obtainable only by qualified chemists. Audio reports I have, some supportive eyewitness testimony, photo documentation, some police reports. I am still subjected to criminal syndicate cell assaults in and around my residence and food poisonings. I filed five court complaints in an effort to obtain a thorough investigation. This includes an Office of Special Counsel whistle-blower complaint to Janet Reno’s office in D.C., which is still pending and mentions McDonald in four affidavits. Law enforcement agencies repeatedly ignore my pleas for safety and assistance. In lieu of my attorney not appearing here today, I am going to provide the Committee with a package of materials that includes a summary of my court litigation and newspaper articles which I have published in The Washington Post and many other articles that I have written about what’s occurred to me. The research I now know that there is a mind control victim profile. Often, victims experience long histories of abuse, including abuse by family members. Their residences are nearly always surrounded by neighborhood perpetrators. Victims suffer intentional sabotage in terms of economic situations. I have endured $150 in damages of vandalism to my house in three years. After the abuse that these victims have endured, their ethical sensibilities are often extraordinarily high. I found probably four or five dozen victims like myself of experimentation—government experimentation and medical community experimentation—to be the brightest and some of the most moral people you have ever met. Who is paying for this system of human torture and genocide? It appears to be your tax dollars, people. Who is carrying out these vicious games of slavery and violent assaults in communities, because they are going on in this country? It’s probably your government and, I’m not sure, crime syndicates is the next possible answer. It would appear that the corruption and mental illnesses in these scenarios have very little to do with these victims and a great deal to do with an ineffectual politic. As a supplement to my testimony, I submit to you the following resource materials, including summaries of my situations, information about my court cases, and the evidence and documentation I have been able to put together. I have lost my job, my career. I am dealing with violence now and ongoing in my life. It’s very real, people. I feel that the mind control horrors our society has so quietly accepted through legislative inaction includes the loss of a great deal of life. This has got to stop and these policies have got to change and these stories have to come out. They have to hit the front pages. Thank you.
DR. SHAPIRO: Thank you very much. We very much appreciate the time it took to come today and if there are any supplementary materials you have, we very much appreciate having them. Any questions from any members? Thank you very much. The next person to address us at this time is Mr. John Cavanaugh O’Keefe from the American Life League. Mr. O’Keefe?
MR. O’KEEFE: Thank you Mr. Chairman. For the record, my name is John Cavanaugh O’Keefe. I’m the Director of the American Bioethics Advisory Commission, a project of American Life League. I want to thank you very much for the decision on the fourth initiative, the fourth paper you are undertaking. I think that was a great decision. I think the topic does matter greatly and I’m grateful to you for the decision to go ahead with it. I do have several concerns that I just wanted to raise about it. In testimony yesterday, there were a couple of concerns that would obviously be of interest to Pro-Lifers and folks on my side of the issue. The suggestion that the Commission should explore population control or throw its prestige behind population control efforts would be of great interest to us and I wouldn’t suggest it. If I understood Professor Dickens, he was also urging you to push ahead implementing the decisions in Cairo and Beijing. I think that that, too, could be a red herring. I think it would be a mistake. I think it would be divisive and unnecessary. I was fascinated by the material, by the suggestion that you explore further a new paradigm for research and inclusion of subjects in research. Subjects have a right to be included or a right to be protected. It seems to me that it’s a little premature, perhaps too suddenly optimistic to adopt an inclusive paradigm now. That just seems too optimistic to me and the fourth concern coming out of yesterday was that I think that a public health model rather than a medical model raises a whole series of issues about dealing with a collective rather than the rights of individuals. Questions that go back right through the entire history of the public health system in the United States. All of the issues there have to do with eugenics. Frequently, watching the work of the Commission, I have this feeling that I have this five minute message tied to a rock and I’m trying to toss it over a 40-foot wall. Perhaps the easiest thing to do is if I just back up and point to a paper that does lay out the concerns really clearly. It’s a paper by Major General Frederick Osborne published in The Eugenics Review in 1956. I will make it available to you all, but do want to just note three things about it. In his paper, Major General Frederick Osborne, a member of the American Eugenics Society, talked about restructuring the eugenics movement after World War II. And Osborne is usually credited in histories of American eugenics, as the reformer of the movement, in particular, that he drove out the white supremacy that had tainted the movement for 50 years. But doing this so called "reform," Major General Osborne was the president of The Pioneer Fund, which was a secretive, white supremacist group. And if he’s the reformer, then what you’re going to be left with is that white supremacy could remain, but it’ll be secretive rather than open. If he’s the reformer, the reform is a sham. I think that it’s worthwhile when looking at his paper, looking at two things in particular. One, his description of what he called crypto-eugenics and looking what he urged as a new policy of voluntary unconscious selection, pushing for the eugenics movement in the second half of the 20th century. And I think that his ideas show up, in particular, in two places that are worth looking at in American-funded research overseas, the concern of this new paper. I think his ideas show up, in particular throughout the Agency for International Development. His work, I think, shapes a great deal of it and, in particular, I think it’s worthwhile looking at Norplant. I think that the testing of Norplant overseas in American-funded projects does provide a rich source of problems and questions that should be dealt with as we think about how to protect human subjects. I will provide more material in the mail as soon as I can. Thank you very much.
DR. SHAPIRO: Thank you very much, and thank you for being here today. We look forward to receiving those materials. The next person to address us is Dr. Adil Shamoo from Citizens for Responsible Care in Psychiatry Research.
DR. SHAMOO: Although we recognize that the draft of research involving persons with questionable decisionmaking capacity—
DR. SHAPIRO: Excuse me, if I could just interrupt you for a minute. I do want to thank you and remind Commissioners that there is a letter that Dr. Shamoo provided us with. You may want to consult that. Excuse me for interrupting.
DR. SHAMOO: Although we recognize that the draft of research involving persons with questionable decisionmaking capacity are working paper of NBAC, is but a work in progress, we must express our extreme disappointment in what is lacking in this working paper and offer some of our concerns and recommendations. One, a fundamental principle of public policy and government business and academia is independent oversight and accountability. The absence of such independent oversight in human subjects research is especially harmful for mentally disabled human subjects, who are incapable of protecting their rights or their welfare and who have no representation on any public policy boards, including NBAC. We urge the Commission to recommend establishment of an independent Federal human subject oversight authority, such as a laboratory animal has, not NIMH. Independent oversight is the only method of improving safeguards. Unless the Commission recommends the addition of independent oversight, including independent capacity assessment and independent physicians to provide ongoing medical monitoring and independent onsite inspection of the subjects of research, not just the paperwork, it will have failed to make any improvement to protect disabled human subjects. Nothing short of independent oversight will protect vulnerable human subjects. Two, if the Commission is reluctant to recommend the establishment of a Federal human subject oversight authority, our organization offers a plausible alternative: a no-fault personal injury insurance requirement. Every human subject of research should be protected in the event of harm by a no-fault personal injury insurance in the amount of, let’s say, $250,000, with premiums to be paid by research sponsors, investigators or their institutions. Three, the draft working paper is silent about documented evidence of ethical violations, which has been presented to the Commission by individual families and patients on September 18, 1997. It is silent about published evidence submitted by our organization documenting 1) the absence of full disclosure of risks on consent forms, 2) evidence that consent forms are presented to acutely psychotic patient subjects, 3) evidence of violation of protocol exclusion criteria, 4) evidence that experiments are designed to exacerbate these evident psychotic symptoms by abruptly withdrawing medication and/or chemically provoking relapse. Amphetamine, apomorphine, ketamine ("Special K"), L-dopa, methylphenidate, MCPP, PCP ("angel dust"), cocaine, and fenfluramine are not therapeutic medications. They are dangerous psychosis chemicals. Yet, the consent forms we have examined mislead disabled subjects by stating the opposite. In no field of medicine are severe symptoms of chronic disabling illnesses chemically exacerbated for the sake of scientific progress. Patients suffering from multiple sclerosis or muscular dystrophy are not subjected to symptoms provoking challenge studies that are likely to exacerbate their symptoms. Diabetic patients are not subjected to insulin withdrawal experiments followed by glucose analog injections to inhibit the delivery of sugar to vital organs for purposes of studying the path of the physiological course of the illness or to see who would relapse. Why are such symptoms exacerbation experiments permissible in psychiatric research? The Commission cannot ignore the evidence; it must address the obvious. Why are uncomprehending, disabled patients easily recruited into experiments which clearly conflict with their clinical best interests? Is their mental disability being exploited? 4) The working paper ignores evidence of the inordinate difficulty for the public to obtain information about human subject research, even from NIMH, the agency entrusted with the responsibility of evaluating and funding such research. We have submitted a copy of a list of published troubling, possibly unethical, nontherapeutic experiments for which we were seeking informed consent documents under FOIA from federally funded institutions and from NIMH. Our original request was September 30 and subsequently February 12. To date, NIMH has not forwarded a single informed consent document for its own experiments and those it has funded. What are they hiding? 5) If the Commission presents a premature report to the public, a report that does not reflect relevant information known and available to the Commission, it will not engender public confidence in the Commission’s recommendations. We hereby submit in 1997, a published report of a federally funded experiment conducted at New York State Psychiatric Institute, fenfluramine was infused into 34 6- to 12-year-old—I repeat, 34 6- to 12-year-old inner-city, minority boys, of whom 44 percent were African Americans and 56 percent Hispanic. The dubious purpose of this experiment in which the subjects were innocent brothers of convicted felons—they have no illness, they have no disease—was to prove that, and I quote from their paper, "biological factors, abnormalities in the serotonergic nervous system" predispose them to aggressive behavior. This experiment, conducted by the Department of Child and Adolescent Psychiatry and Biological Study Unit of New York’s premier psychiatric research center, is being examined by Lawyers for the Public Interest and civil liberties attorneys in New York. Thank you very much.
DR. SHAPIRO: Thank you very much for your comments. We’ll certainly think about these carefully and we will, of course, be reviewing some of these issues this afternoon.
DR. CHILDRESS: I’d like to thank Dr. Shamoo and others who have presented very important information for us and we’ve worked on the report that has gone by various labels, including the draft you’re looking at on persons with questions on decisionmaking capacity. What’s been provided has been very important, including the information we received on September 18. Even though the draft report does not focus on specific cases and discuss them in detail, I think what was provided that day was really very important for the way the Commission understands the problems and also the way it’s going about thinking about possible solutions. So sometimes, even when things are not reflected specifically, they play a very important role in the way the Commission goes about thinking about the problems and solutions.
DR. SCOTT-JONES: What I have to say is similar to what Jim just said, and that is that we feel a great deal of compassion—at least I do, personally—regarding the individual cases that we’ve heard. But my understanding of our task is that we are not to address or look into those specific individual cases. So I believe they have, in fact, affected our thinking. And regarding the study that you mentioned at the end of your testimony, that study involves children and we’re not directly addressing regulations for children in this particular report. We have talked about doing that at some point in the future. And I want to say that I have, in fact, read the study that you mentioned and I am quite horrified by it myself. So your concerns are not being unheard.
PROFESSOR CHARO: Regarding your suggestion of a no-fault compensation fund, are you familiar with any example of its use in another country, an American State, or even an institution that has chosen to go this compensation-fund route?
DR. SHAMOO: No, I don’t.
DR. SHAPIRO: It’s also an example of where the health system in which we are all operating makes a big difference.
DR. SHAMOO: But the independent oversight is available in the Animal Welfare Act and that exists in the Department of Health and Human Services.
DR. SHAPIRO: Just one final comment I’ll make is that we are in the process, in fact, of reviewing a number of cases of direct concern that will make its way as we go along into the court. I’m not reflecting any individual case here, but we are looking at that literature right now. DR. SHAPIRO: Any other questions from members of the Committee? Thank you. The final person that I have on my list is Professor Karen Rothenberg, who is here to address the Commission.
PROFESSOR ROTHENBERG: Good morning. Thank you, David, for raising that case study and I would like, if I could, just to raise three or four conceptual challenges that maybe the Subcommittee has already addressed and maybe it’s in Alan Buchanan’s paper. So I apologize, but maybe I could reinforce them, perhaps. And these comments come from two years of experience of working with the breast cancer community, as well as the Jewish community. In part, it’s a reaction to this study. But the same case study could actually be utilized as well, most recently at Johns Hopkins with the announcement of the colon cancer gene, which also, in part, the data was generated from Tay-Sachs samples. The first conceptual challenge that I wanted to clarify, I think, is based on some of Alta Charo’s points, is that community consultation is helpful after you’ve started, but it really matters before you decide to do this stuff. So you want to get the community involved in the discussion, 1) it will make it a better study; it will make it better for recruitment. An example of that is actually what NIH did in its recent Ashkenazi Jewish study, where they got over 5,300 people in a period of 6 to 8 weeks—unprecedented. They brought the Jewish community in ahead. There are some concerns about whether or not that is the right community, which I think are legitimate questions, but it is an interesting model and you may have already heard about it. If not, I would really encourage you to bring in the people from the National Cancer Institute, perhaps even some of the people from the National Action Plan on Breast Cancer, who were involved as well with that, and to talk to them about how they developed that process. Part of that process included that in the individual consent form, it said at the end, "Can we keep your samples for future studies of cancer?" And I think really is important based on the other point about behavioral genetics and using genetic and DNA samples for other things. So that would mean the National Cancer Institute could not give those samples to somebody who might want to study homosexuality or manic depression or whatever without going back. And they don’t have the names of these individuals, the names have been taken back. So that’s an interesting possible process you might look more into. So first point is, community consultation matters the most before you approve the protocol. Yes, you can continue community consultation while you’re doing this study. Yes, you can continue community consultation after you’ve gotten the results of the study. A critical point is how you present the data to the public once the study is done, and there has been a lot of criticism about the use of the media in this context as well. The second point is, I wanted to clarify some additional facts. The Tay-Sachs samples were gathered by individuals in part, not all. They didn’t consider themselves a research subject. They went in for clinical testing for Tay-Sachs. This is a really important point that I would really like the Commission to think hard about, and this is the issue of trust in research. And I didn’t hear that today, maybe again, the subgroup has discussed it. Ninety-nine percent of the public, and probably many people in this audience, maybe, don’t realize that when you go in for clinical testing 20 years ago, that doesn’t necessarily mean they’re going to throw your sample out when they’re finished with it. And 20 years later, that same Tay-Sachs testing sample that many of us may have given when we were pregnant or thinking about getting pregnant is now being used in studies for predispositions to cancer and other sorts of diseases. Now, is that good public policy? Maybe it is, but I would challenge us that we really need to educate the public that this is going on and to win their trust to support it. Because if not, there will be a backlash in the community, "Hey wait a minute—we didn’t go in as a research subject." The individual that goes in as a research subject, that to me creates fewer issues because you can plan ahead and they’ve already assumed themselves to be a research subject. But many of these people did not. So that is the second issue that I think is very important to talk about. And then third, I think somebody mentioned this about keeping our conceptual framework in the context of protection—I think this was Chairman Shapiro. I think there is a real challenge here again, and that is under our existing regulations, if we approve a protocol and we rely, as Alta Charo has said, perhaps on individual consent, there is nothing that speaks to telling the individual that there may be implications for their group, for their community. Now some people might argue, "What good is that?" If we get enough people to consent to it, it’s going to have an implication with respect to group stigma or discrimination or whatever harm you’re concerned about anyway. But if you’re going to, in the end, decide that that’s where you’re going to place all your decisionmaking, then at least you could say that in addition to group benefit—which you do include when you’re talking about why somebody should be in a research study, particularly a phase one research study has no direct benefit to them—you could also raise that maybe you need to include something about group or community harm. And it isn’t just life insurance discrimination or employment discrimination or health insurance discrimination. To me, that’s the easy one. We could try to pass laws to address all those things. We’re doing okay in that area. I think these other issues, if you ask communities. If you ask the Native American community, and there is some research in that area, and we’re now asking the Jewish community as well. They are not just discrimination issues, there are stigma issues independent of that. And that’s very hard to get a grasp on. So those were the three main points that I wanted to raise and if anybody has any questions, I’d be happy to answer them.
DR. SHAPIRO: Thank you very much and thank you for coming. The issue you raise with respect to trust in research is something that we have discussed over time and is an important issue. Indeed, I saw Carol’s graph, which dealt with future collected materials, and it distinguishes clinical and research subjects, in part, for that reason. Part because you face the problems that you have articulated. But the points you have made have been very helpful. Let’s see if there are questions from members of the Commission. Alex?
PROFESSOR CAPRON: Karen, the position that you articulated here is one that some of us pushed three or four meetings ago. Trying to say that there was a difference—you put it in terms of trust, I would expand on that, but it’s the same idea. Between knowing that your sample has been collected for research, rather than some kind of consent form where it was just in the background, that you’re in there for a clinical purpose and they said "blah, blah, blah" and you weren’t focused on that. It was very strongly argued to me by a lot of people here that I was wrong in that. The central point that made the strongest impression on me was that being a research subject is often very situation-dependent. And the notion that, let’s say, you didn’t go in when Tay-Sachs was a well established clinical entity in terms of the test being developed, but when Michael Kaback or others were first developing the test. And so at that point the sample was collected for research purposes, but the research was on something which you thought of as relevant to, as you said, the reproductive decisions you were going to be faced with and the safety for a child and so forth. And now the researcher is proposing to use it for the cancer research. Is there, would you say, for two next-door neighbors who, reading the newspaper, that samples were used by scientists at an anonymous research institution in Baltimore. That in order to use these Tay-Sachs samples to find out something about the prevalence of a cancer gene, would you say that the two people you would expect to have very different responses, the one who knew that her sample was taken in that early phase of the Tay-Sachs research program and the one who was taken a few years later when they came back to groups and said, "Would you like us to conduct a screening program at your community center or your temple," and the data were for "clinical purposes."
PROFESSOR ROTHENBERG: Well, I think in both situations, probably with sufficient amount of education and understanding, unless there was some strong commercial stuff going on, which I think Bernie made a good point is a whole separate issue, it might not matter. However, it does matter under existing regulations, doesn’t it? Because in one situation, somebody came in. Whether their expectations were different or not, if they are coming in as a research subject, there are certain protocols—
PROFESSOR CAPRON: As I understand it—let’s assume that the data have now been passed through a repository where they are not linked to any identifiers. So we have unidentified data and the person is doing exactly what David described. This is, to use Steve Holtzman, they only care about the meat. That is to say, they don’t need clinical information; they just want to know in a population about whom we know one characteristic, that they are of Ashkenazi Jewish descent—that’s all we know—what’s the prevalence of this gene? And the researcher says, "Well, I have two pools. One with the people who came in originally for Tay-Sachs research screening and the others who came in for clinical screening. Do you want them both?" And the present cancer researcher says, "Yes, I’d like to have them both." And the result, I was convinced after all this, that the decision to have been "a research subject" in that first protocol, yes, does indicate some small willingness to help science to find answers. But it’s not the answer to the question the present researcher has asked, and therefore that that commitment to research, that extra willingness to help research is so attenuated that it probably doesn’t really differentiate. And I would understand under present regulations that if that’s unidentifiable information, existing samples, that you don’t need consent from either of those. And I was asking if whether you, having raised the issue, really think that the two next-door neighbors when they open The Washington Post and read about this and speak to each other over the back fence, one of them is going to say, "I was shocked. I went in for clinical studies and now they’ve used it." The other one is going to say, "Oh, I wasn’t bothered because I knew I was in a research protocol."
PROFESSOR ROTHENBERG: Well, I don’t have a definitive answer, but I will say I’m in the middle of a quantitative study that is asking that very question. We’re putting people in different situations, not only in the context of where they originally got their sample, but we’re also asking them whether it matters as to what they then are studying. And I think that the stigma associated with cancer and the stigma associated with manic depression and the stigma associated with homosexuality—go down the list—are different for members of a community. Different communities may have different feelings about different issues. That’s why some attempts now, prospectively, in the Jewish community to develop these panels of prenatal tests, clinically, are now including at the end a question—gets to Alta’s concern about you would be stupid not to do this in the future—they’ll say, "We would like to ask your permission to keep this blood sample for future studies that may have an impact on the Ashkenazi Jewish community—check yes or no." Okay. In the study that was done at NIH, I think it was 97 percent—and you could get this exactly from NCI - that checked "yes" that you could use those samples for future cancers. So the question really is in the clinical context if you ask that research question, would you get that percentage? I don’t know—
PROFESSOR CAPRON: And that’s not data that your study will show us.
PROFESSOR ROTHENBERG: No, ours is really an attitude study.
DR. SHAPIRO: Have you any other questions?
DR. MIIKE: I’m beginning to get a little impatient. We start rehashing everything all over again. I feel like I’m in a deposition where someone wants to ask every possible thing so we can extract certain things out of it. I’d like to get a little bit more focused. We’ve been going over these things over and over again and so I’d like to move on.
DR. SHAPIRO: I just want to remind us all we’re in a public comment section, that’s if you don’t mind. In any case
DR. MIIKE: But the public comment is going on and on and on.
DR. SHAPIRO: Unless there are any other questions... Well, we in fact are not going to get back to eugenics because we’re going to break for lunch. But we’ll be back—let’s try to reassemble in an hour.