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PUBLIC TESTIMONY

DR. SHAPIRO: All right. Well thatís obviously unanimous. All right. And weíll have to leave that now and go to the public comments. People have signed up and I want to make sure we donít keep them here longer than necessary. Okay. We have three individuals who have signed up for public comment. I just want to remind all of those who will be participating that the rules of the Committee are five minutes; when you get to five minutes, Iíll try to remind you, and then please bring your comments to a close. First is Ms. Marcia Pines from Baltimore, Maryland. Ms. Pines, are you here? Thank you very much. Thank you for coming today.

MS. PINES: Thank you very much, Dr. Shapiro, Dr. Childress, and Dr. Meslin, members of the Commission. I am Marcia Pines from Baltimore. Iím pleased to have this opportunity and I donít know if Iím going to speak for three minutes or five minutes but youíll give me the clue and if I could speak longer, I have other comments. I am the mother of a 50-year-old woman who has been severely disabled with mental illness since she was 17. I was a senior staff member of the Johns Hopkins School of Hygiene and Public Health, where I spent 22 years directing the IRB. I retired in 1989 but I am still very much involved in public policy. I attended the meetings of the previous two commissions, which studied and made important recommendations to Federal government on biomedical research policies and standards. In my capacity as director of the Committee on Human Volunteers at Johns Hopkins School of Public Health, Iíve prepared the policies and procedures under which the committee functioned. These became the standard for the university back in the early 70s. After many years of working with outstanding people like Charles McCarthy, then director of OPRR, and others, I have been there, Iíve done that, and I had grassroots experience in reviewing research protocols on almost every detail for ethical issues regarding appropriate language, procedures obtaining informed consent as well as protecting the confidentiality of research subjects and weighing the risks and benefits in research protocols which came became before our distinguished Johns Hopkins School of Public Health IRB. As a parent of a person with severe mental illness, or brain disorder, as we say today, Iíve also had great experience. Our daughter had her first hospitalization in 1968 at one of the most prestigious private hospitals, where she spent 19 months. And we as parents received no information regarding her diagnosis. Out of frustration we sought the consultation of a prominent psychiatrist from Johns Hopkins and heard for the first time that our daughter had schizophrenia, and were jolted into the realization that the rest of our daughterís life would be paved with peaks and valleys. Unfortunately, the valleys have overtaken the best part of her life. However, through this journey, Ellen was invited to participate in a research program at the Maryland Psychiatric Research Center. She agreed; my husband and I agreed. She had suffered for so many years with devastating illness that we felt that through research, perhaps we could find an answer to her misery and if not, perhaps it would provide answers for future generations. Our experience with the Maryland Psychiatric Research Center was excellent. Ellen received excellent care from a competent and caring staff. She and we were kept well informed at every step of her involvement in each new protocol. And as family, we attended family meetings, which were held as a group. We were being well informed by the inpatient director and other staff about current research protocols as well as new breakthroughs in clinical research on brain disorder. These meetings provided me with a foundation of knowledge that could have never been exceeded if I attended medical school in those days. Although, I must add, that after joining the Alliance for the Mentally Ill, I had the benefit of learning a great deal from other professionals around the country and from researchers at NIMH. So as family members, weíve become very well educated in this field. I know you have heard from several individuals who have had other experiences with family members who have been involved in research, but I think it is important to understand that we as families must realize that our loved ones are suffering with a serious brain illness for which there is little known, and only through research are we going to open the gates of knowledge. We must be certain that every line of protection for these folks is in place. But at the same time, we must not impede the progress of research nor limit or discourage investigators into new horizons. Thereís a serious flaw in a system when accusations can be made, I should say unchallenged accusations can be made, by families, but the researchers are bound by confidentiality and thus are unable to respond to their accusers. I commend the Commission for the time you have taken to study this issue and to listen to testimony. I have reviewed the proposed recommendations and acknowledge the staff for listening and responding to comments, which have been submitted by many knowledgeable and experienced people. I would hope that this Commission does not propose an infrastructure for institutional IRBs which will make it so difficult to approve valuable research. It is clearly necessary to build in protections for research in all brain disorders. In fact, for all clinical research. But we must not throw the baby out with the bath water. As a member of the NIH panel, which met last December to consider the IRB role in reviewing research with people with diminished capacity, I know the thought and the considerations which went into this final report, which I know you are considering. In closing, I want to relay a comment that I heard only yesterday from one of the prominent AIDS researchers at Johns Hopkins. Unfortunately, I was there for a very sad memorial for Jonathan and Mary Lou Clemonsman who are like our family. This researcher said to me, "Marcia, you can not believe how difficult it is to get a protocol approved these days. There are so many obstacles, so many hoops to go through, and valuable research requiring approval from the JHU IRB, the NIH IRB, the CDC IRB and then other collaborating institutional IRBs has caused over a yearís delay in furthering our studies in Africa. And then I received a letter in the mail yesterday from the Institute of Medicine stating that there is a serious decline in research protocols. I donít know how much time I have sir, but, I think, Iím up?

DR. SHAPIRO: Your time is up so if you could draw your comments to a close, I would appreciate it.

MS. PINES: Well, as you explore this critical subject, please do not allow the voices of a few to impede the process going forward. Please do not let us turn the clock back. I would implore that the guidelines for more education is critical. Guidelines for educating IRBs. Guidelines for educating researchers. And, Iím sorry I donít have more time because I would like to comment on the item number 3 but I can write you comments. Thank you for the time.

DR. SHAPIRO: Thank you very much for being here today and we would welcome any other written comments you have and we would distribute them to the entire Commission. So youíre welcome to submit any further comments you would like. The next person on our list is Ms. Irene Lynch, from Coltís Neck, New Jersey. Ms. Lynch, thank you for coming today.

MS. LYNCH: Good morning. I would like to thank the distinguished members of this Commission for the chance to give testimony today. Iím Irene Lynch from Coltís Neck, New Jersey. In light of the current frenzy in the national capital, it is refreshing to be here. I see this as government at its best. I come to you as an expert witness. I am an ex-mental patient. The mother of six mental patients and the wife of another. I have participated in field work, as a field worker in several research projects about mental patients. I currently work tirelessly as an advocate for mental patients, most often without pay, as do many of the thousands of mental patients with whom I work and share the stories of our lives. To have been a mental patient and to have recovered is a growth experience; is a journey through hell and back. It is an uneven path fraught with emotional distortions and extremes and yet with a painful awareness of the depths of what we do to one another in the name of treatment, a word for which I prefer to substitute the word control. But interspersed with these elements of fear, anger, humiliation, understandings, and isolation are moments of insight into the very best of human nature and how we could help one another. We have carried our knowledge into the self-help movement, which has grown tremendously with our interconnectedness, now worldwide through the Internet. We are historically, as you well know, an impoverished population and e-mail is affordable. The Executive Order that gives you your mandate states that government departments and agencies shall review the protections of rights and the welfare of human research subjects, and I note the very use of the word subject was an issue for this panel. It is difficult for me to understand how you can segregate someone and protect their rights and welfare at the same time, particularly when you deem them lacking in decisionmaking capacity. My concerns are these. The real nature of what society terms mental illness. The proliferation ad nauseam of labels known as diagnoses, especially as they relate to our children. The high use of doses of drugs at the onset of emotional distress and the combining of chemicals without a clear knowledge of their interactions with one another or their interactions with other environmental elements. The treating of symptoms instead of looking for causes. The misdiagnosis of mental illness in cases of the presence of infectious diseases, and lastly, the gross negligence of the medical professions in treating the many and varied physical problems of mental patients. All of which leads to my recommendations to you. That you seriously consider as human beings, you individually, that the basic assumptions of much of todayís research involving persons with mental disorders is faulty. That the emphasis ought to be on wellness and recovery, not on bean counting beds; not on outcomes fashioned by managed care to cut costs; not on changing the chemistry of human beings, refashioning their behaviors, leveling the differences that makes some folks uncomfortable but which differences are really an important part of who the person is. That youíd include ex-mental patients in your deliberations, especially requesting that they sit with this body and that sufficient numbers of mental patientsí experts determine the research protocols and the accountability thereof. I sincerely hope that this Commission will be instrumental in ameliorating the lives of some very wonderful people. I thank you.

DR. SHAPIRO: Thank you and thank you very much for coming here today to share your thoughts with us. Next, letís hear from Dr. David Shore. Dr. Shore.

DR. SHORE: Thank you very much. Having encouraged a number of investigators to read and respond to your draft during the July, shall we say, open season, and having seen a number of those responses to the draft and seeing some improvements, I certainly want to express my appreciation to the Commissioners and Executive Director for responding to many of the issues raised. I do, however, want to raise a couple of questions because there are several issues that have been discussed on which it is unclear to what extent the field is being heard and exactly what the Commission is saying. And rather than give a speech, I would like to simply ask four questions and try to get some clarification about these issues because the people with whom I have previously spoken are going to ask me these questions when I get back to the office and Iíd like to be able to try and answer them. First question. Would IRB waivers of informed consent for those with questionable capacity explicitly be allowed or forbidden? Yesterday afternoon, the group spent considerable time discussing the three major criteria for waiver of informed consent and I presume you would not have devoted that amount of time to that subject had you planned to throw it out the window. But, this morning, the discussion seemed to focus on the assumption that there will always be informed consent and I think it would be helpful if the group would explicitly say whether or not informed consent might be waived so that people would understand the implications of your recommendations of, in particular, for research deemed not greater than minimal risk. The second question has to do with an issue you discussed this morning. Would people with mental disorders, that is 20 percent of the American population currently, automatically be singled out as requiring competency evaluations? Clearly the discussions about more flexibility on that and perhaps rewording Recommendation 3, I think, would be welcomed. Number three, would studies be permitted comparing people who have one particular medical disorder comparing them with those who have another mental disorder? People who may be on similar medications, who may be in similar treatment environments, who may have similar degrees of impairment or, as I read the recommendations currently, could we only compare such individuals with healthy, non-mentally-impaired controls? As you probably know, there is a long history of research demonstrating differences between patients and healthy college students. That research has not gotten us very far because of the multiple confounders. And of course, Iím sympathetic to the desire to ensure that individuals with mental disorders are not exploited but, of course, distributive justice is already covered in 45 CFR 46. Final question. Will those who have progressive and gradually deteriorating disorders be allowed to have a surrogate enter them into studies that will be scientifically relevant when, several years down the line, that person does subsequently become incompetent, or will they only be permitted to agree to studies that are now relevant which in all likelihood be considerably less valuable by the time the individual would be likely to participate? Will legal proceedings be required even if the intervention to determine competency or a durable power of attorney is more traumatic and time consuming than the research intervention itself? Those are my four questions.

DR. SHAPIRO: Thank you very much for your questions. We will not respond to them all at this time. Some of these will be taken up this afternoon but we will certainly respond to all of them directly to you over the next few days. Thank you very much. The final person I have here today is Michael Sesco from the Citizens for Responsible Care. Thank you very much for coming this morning.

MR. SESCO: Thank you. Yes, my name is Michael Sesco and I guess my background is that Iíve worked a lot in the field and at psychiatric halfway houses. I now presently, Iím an outreach worker with homeless people so Iím very much in the trenches. I edited a book taking first-hand stories from people who actually had been on the streets or in psychiatric hospitals, vulnerable populations. Many years ago I had my own experience of being in a psych hospital but wasnít treated with the aggressive sort of heroic treatments of neuroleptic drugs and allowed to go through the experience. So I come with that sort of background, in the trenches with very high antennae, if you will. I guess I come today because I had given some written testimony to the Commission, Iím not sure whether people have the time to read it so I came all the way from Baltimore to give you a sense of where Iím coming from. I think that most people who are actually in the trenches working firsthand with these people, not as researchers, and the actual people who are of these vulnerable populations would be very suspect or very wary of any aggressive sort of treatment thatís sort of in the neuroleptic line. Which a lot of this research is, if not shock treatment or psychosurgery, which has come back. These are very strong treatments. People who have been through this stage of vulnerability are very fragile and itís hard to imagine unless youíve been through this type of process, the impact of these types of treatments. So itís in that context that I come with, you know, very high antennae, very much awareness. One particular issue I think is egregious is that most people would recognize that it is a problem are the psychiatric challenge studies where the profession, these are federally funded researchers, are actually inducing psychiatric illness in order to make discovery and gather exploratory data. Theyíre giving PCP to induce psychosis with people in psychiatric hospitals. Thatís in, I have the cites on that if the people want it. Theyíre inducing panic attacks in veterans in the veteransí hospitals. All of these studies. Thatís the end that weíve come to and itís hard to believe; most people when I tell them they donít believe it, even some neuroscientists. Physicians are deeply disturbed when I tell them. Most people get a very visceral reaction. How have we come to this? Well, thereís lots of reasons but before I go into those reasons, another thing that disturbs me in the discussion today is that the use of language. Iím a writer. We talk about minimal increase over minor risk and all these different phrases but whatís a suicide, whatís a real death? Those are real things and I grieve the death of friend who had been in the psych system. Itís an enormous thing when somebody dies, takes their life and dies. This language doesnít capture it and I fear that this use of language lowers our antennae and gets us away from our heart and whatís really happening at times. Why we come to this pass, where I think thereís a historic erosion of the Nuremberg Code, enormous profits involved and the fear of dealing with the actual pain in peopleís lives. These treatments basically subdue people, basically tranquilizing. They used to be called heavy tranquilizers. They block receptors in the head. So we fear to deal with the real pain and the solution is to use drugs to stop it, use force to control it. We have a research subculture. Maybe somebody should study them, sort of people who want to be on the cutting edge of research that becomes the bleeding edge of research often. I think a type of scientific mania where to be a professional you have to have real low antennae and you become a success and publish the papers, but what happens to real people? Footnote. Does this all really work? Is the system very effective? I think when studies have been done and there have been few studies where they didnít use these aggressive heroic treatments that are in our contemporary culture here. Where theyíve just provided healing homes, let people express the pain in a safe environment. Their rates of success have been very much higher than when using these other types of treatments. I can refer to the Agnew double-blind study by John Ware Perry. There are a number of such studies. Theyíve only been allowed in an isolated instances and because itís not politically in the mainstream. So thatís just my overview. Itís hard to do in five minutes but itís a little bit. Thereís another whole universe out there aside from this one that you need to sometimes examine your assumptions. I would end with simply a question thatís somewhat rhetorical but itís a serious one. If weíve had a five-year moratorium on cloning to protect potential life, why canít we do a five-year moratorium on psychiatric challenge studies that actually induce the illnesses that the profession has said to not want to, to want to stop or to deal with. Why canít we protect people who are living? Thank you.

DR. SHAPIRO: Thank you very much and as Iíve said to others, if there are other things that youíd like to share with us, you could put into writing and we would be glad to look at them carefully and distribute them to all members of the Commission. Well that brings an end to our public comment session today.

Professor Capron: In line with the public comment in distribution of writing, we had at our place this morning a statement from Robert Aller, previously here, when we were in Los Angeles, I gather, and maybe he also came when we were one time in Washington. I donít remember the times that he has been there. But he raises a number of points about our report and one question about a point on which he is, I think, suggesting we will be criticized in alliance among our consultants, on people who had financial conflicts of interest and I wonder whether this was something which you, Mr. Chairman, was aware of and you can reassure us that this was taken into account in obtaining or using their information. And as a more general question, whether we have in place a method which will inform us. I mean a conflict of interest is not necessarily disqualified in thereís somebody we have some reason we should turn to. But, I guess as a Commissioner, I would like to know about it rather than learning about after the fact where I do think weíre sort of open as an ethics commission to a concern that something is going on and the woolís been pulled over our eyes.

DR. SHAPIRO: Iíve not read this yet, so I canít answer anything specific with respect to this but be glad to do so later today after I have a chance to look at it. But we do attempt to look at those issues and consider them when we hire people and I donít know if weíve had all the information or not. I just canít answer that question right now but Iíll ask the staff about that and report back. Yes, Eric.

DR. CASSELL: In the public comment, I donít remember the gentlemanís name but the question about waiving informed consent. I think it should be made as though that was also true, that also might be true in this category of research. So it ought to be made perfectly clear that occurred in the research on tissue sample situations that are bearing no resemblance whatsoever to research on living subjects.

DR. CHILDRESS: That is something we will be considering in the lower right-hand box. It is something we have to talk about in this context for minimal-risk research. That will come up this afternoon.

DR. SHAPIRO: Well, itís not quite twelve yet but weíre going to adjourn in any case. Please everyone try to be back here at one oíclock.