We now have some commentators on this who will be a part of our discussion, our discussion leaders. First we will be hearing from Todd Ensign, Citizen Soldier.

MR. ENSIGN: Thank you.

Well, I hate to the be first this morning to inject a note of real, real skepticism into this. And I apologize if it is seen as adversarial. But, the fact is we are talking about some pretty important questions here and it maybe that we are adversaries. You be the judge.

I would like to present this to the Interagency Working Group and to the two gentlemen, who both spoke, one from FDA and the other from the other group, which does the monitoring. It is good to hear that we have today this informed consent rules in place and that informed consent is, at least on the surface appears to be an incremental part of our government=s process.

I would like to inform you all that earlier this month the Food and Drug Administration, who this gentleman represents, it was leaked really, that they have written a permanent set of regulations that would permanently give the Department of Defense the authority to determine whether informed consent is feasible, given military necessity, battle field conditions. Now, as you know or guess the history of this comes from the Persian Gulf. And as you may recall, I think I mentioned it briefly yesterday, in the early days before the ground war began, the military was understandably and reasonably very concerned about the possible use of chemical or biological weapons in the Gulf, after all Saddam Hussein had used them against Iranians, of course, at that time we had no problem with it. We were happy to sell them a lot of the chemicals. But, anyway, we knew that that was a risk. And so the Pentagon went out and they undercovered, found an experimental drug which had only been used in the treatment of mysteingravtis(ph) and it is called pertigmebomine(ph), it happens to be made by the Hoffman & Roach Chemical Combine. At any rate, they went to the FDA, they said we have got to have, you have got to waive the informed consent rule, it is an experimental drug. We can=t give it to humans unless you waive the rule. And a long story, I can=t go into, the Nader group went into court, and stood up for all of us really said, AYour Honor, we can=t have this drug being used over there. It is too dangerous. We don=t know what it will do to people. It has only been used in very limited clinical settings. It is not safe.@ And the judge was told, ANo, military necessity requires this. We must have this weapon. We have got it, it is national security, it is protecting our troops.@ The judge passed, dismiss the case, and it went up to the Court of Appeals, where none other than Clarence Thomas wrote an opinion saying that the lower court was right, this was a military issue. We couldn=t have courts interfering and meddling in this and needless to say, the Supreme Court denied review.

So, today, five years later, out of the blue comes the FDA saying, AWell, we are going to make that interim rule permanent.@ And I think that this is something that should be addressed by the two gentlemen on the panel because I mean, it really, not to put you on the spot, maybe you can=t answer it, but it really makes, you know, if you know this and you sit here and you wonder, what are we talking about, informed consent, all these rules, the eight ground rules, the three legged stool, all that stuff. And here is the DOD and the FDA working together to get a permanent rule allowing them in the future to say, ATo hell with it, we need it. Don=t ask questions, we will worry about it later.@ And we have got 60,000 people in this country, right now, or probably more, in the VA hospitals, in the military medical centers, asking, AWhat is wrong with me? Why do I have these unexplained ills? Why do my children have birth defects?@ And there is a substantial body of question, does pertigmebomine, is it a culprit in this? We don=t know. Maybe we could find out.

MR. HOLLOWAY: Thank you very much.

Our other commentator here is -- I am sorry. Oh, yes.

MR. CHADWICK: Yes, in 1990, the FDA did issue that as an interim rule. And it has been under discussion since 1990. This isn=t out of the blue. It is a problem. The Agency aware of that any time that you waive informed consent. We consider that a major weakening of the protections that Gary explained. So, for the last five years it has been debated within the Agency, within DOD. And it is a partnership between DOD and the Agency. But, as I think you appropriately pointed out, that when you have biological chemical weapons being used against troops, you have to use the best thing that you think has a chance of saving lives and that is the basis that that rule was promulgated in 1990.

They are working on making a final rule. The DOD is interested in having a final rule. That is in process. It has not been issued. It is not yet a final rule. I don=t know whether or when it will be issued. They have committees that are currently working on it. And beyond that I really can=t comment. It is being taken seriously. And it is not just going to be something that is just done because, why not.

MR. HOLLOWAY: Gary, any comment? The other Gary.

MR. ELLIS: As you may be aware, the President appointed a Gulf War Veterans Illnesses Advisory Commission. That Commission issued its interim report on February 14th, and I believe that report addressed this issue. I can=t quote it verbatim. I don=t have it in front of me. But, if you have not already made your views known to that commission, that would be a very good thing to do, I would think.

MR. HOLLOWAY: Other comment?

MS. KITTRELL: I have one. I have one. I think we can see just from Todd=s example, that if there had been an adequate advocate on the institutional review board or whatever group within DOD and FDA, made that decision, specifically to waive informed consent, there might be a really different decision. I would note that the Advisory Committee did say that it was not good to waive informed consent at any point in time.

I am sorry, this is Jackie Kittrell.

MR. HOLLOWAY: Thank you.

Sandra Marlow, who by the way represents CARS. I am afraid I --

MS. MARLOW: I need to tell you what CARS is. CARS represents the Center of Atomic Radiation Studies. An acronym that I am not fond of. It started because I could not find in the Boston area a single doctor to help give an objective diagnosis of the veterans who were concerned about what was happening to them because of their experience at various nuclear weapons test like my father. We could not find any legal counsel who would help us file the forms for Service connected disability because most of the agencies could not represent us, understood the effects of atomic veterans. And I believe there is the Farris Bill, which prevents us from paying, what is it, more than $10.00 to get an independent lawyer, to represent us, to help file a claim. And we are not allowed access to the courts to present any of our concerns for injury. We needed support psychological and counseling for widows, and wives. We have been writing all over the United States to agencies for help. No agency that represents us, helped us.

And that is why Donnel Boardman, who is luckily retired, and decided to help us and get people to help others, to understand what the effects of radiation on people were. And why Dan Bernstein practically gave up his practice, pro bono, and represented widows, a Mrs. Brown, whose husband flew through the clouds in the 1995 test called Teapot.

So CARS represents professionals, just like some of you with a different kind of expertise. But, what was interesting and important in terms of consent and the future and the past, was we learned from each other. The doctors and the lawyers were informed by the people who have gone through the experience because there was a passion and a dedication to know about the past, and to bring those documents that we had looked for and paid out of our pockets, to copy.

This is the kind of help and commitment that those of us, who for 20 years, have been going through libraries all over the country to get information.

And I address a couple of questions to the Panel about informed consent. Because I did not know what I would find at the Walter E. Fernel State about the people that were committed there. And how many doctors believe they had their consent and the consent of their guardians, who did not understand science. It did not understand national security and the need to know about the effects of fallout on food. Who represents people who are in experiments? If there is an effect, do they pay out of their own pockets? Where is the legal counsel? Must we beg lawyers, pro bono, to help us? Should the Department of Justice defend us or the agencies? I ask that because we need to know that.

MR. HOLLOWAY: Thank you very much.

Are there comments from the Panel on this issue?

MR. ENSIGN: Yes.

DR. SHAMOO: Thank you very much. I am Dr. Adil Shamoo, I am a professor and former chairperson of our department at University of Maryland School of Medicine and I am data entry chief of eight year old journal, which has been quoted in three congressional commissions, government commissions, called AAccountability and Research@. We deal with issues of ethics in research.

One issue which to me is greater than the radiation experiment, Debacol, is the issue of the use of cognitively impaired people, that is the mentally ill in research. This still goes on right now all across the country. I have documented and the paper was suppose to be out a year and a half ago, through a lawsuit was stopped its publication. It will appear in two months in another publication. There are a series of papers which will document to you that there are thousands and maybe 10s of thousands of mentally ill patients used in research in very high risk research, where not only physical harm to their brain is done, but rather the dignitary harm to themselves, they are used as guinea pigs.

These patients, they are subjected to what is called washout. That is they functioning patients, who are on medication, washout, remove them from medication and watch them suffer for somewhere between few days up to one year through psychosis, delusions and depression.

Let me quote to you from published record, from hundreds of papers, what they say in their method section. AWe have recruited 400" and I am quoting, AWe have recruited 400 schizophrenic patients, who are psychotic and delusional and they all voluntarily signed informed consent. That is their methods section.

Now, how could a homeless schizophrenic patient, who does not even know his name, can sign an informed consent? The informed consent has been a charade to those people who are mentally ill. As you know all the codes, whether it is the AMA or the Nuremberg Code, says you have to have sufficient knowledge, and comprehension. I have a mentally ill son, and he has been sick for 10 years with schizophrenia. So I know how much sufficient knowledge and comprehension he will have at any given time, if he wasn=t, and he has never been, because his father is a scientist, never let him, if he was a subject of research.

The IRBs, Gary talked about, they are well intended, but he knows and I know and I am a professor in a university, that members of the IRBs are my colleagues. They sit in my promotion committee and tenure, I sit in their committee. They approve my grant, I approve their grant proposal, etc., etc. To have one citizen member from the community and it is one in five, that is what the federal regulation, but in general they are somewhere between 15 to 25 members and one vote from the citizens, you know, simple majority, what that means. It is totally irrelevant. These are our -- they should be removed from institutions, they should be a community based institutional review board, because the community standards of all society should determine what risks our citizens should take for the common good. The common good should not be supreme to the individual human rights of the patient.

Thank you very much.

MR. ENSIGN: Lincoln, do you want to speak?

Todd Ensign, Lincoln Grafhis.

Oh, the Panel?

MS. SZETELA: Yes, if you don=t mind, I would like to just respond to the comments that just came up.

MR. ENSIGN: Identify yourself first.

MS. SZETELA: Carrie Szetela, Caroline Szetela.

And I am very concerned about the issues that this gentleman presented as well. And I would like to ask if the Interagency Working Group can give us any suggestions as to what kind of a forum this community discussion will take place and where the community will say what kinds of risks and benefits we want to subject ourselves to and our children and our fellow humans to, what price for research. This is an issue that has not been addressed at the community level sufficiently. And it seems germane that we answer this question before we empower other people to make these decisions for us.

Do you have any responses or suggestions on this?

MR. HOLLOWAY: We certainly hear your question and we will make it a part of our considerations.

Oh, Harry Holloway.

MR. ENSIGN: I think Lincoln Grafhis has the floor next.

MR. GRAFHIS: Okay, my name is Lincoln Grafhis. And I made a presentation yesterday in which I referred to recent research that I had done and I am always impressed by the fact that my study was based on interviews and questionnaires. And it was done under the sponsorship of the University of Michigan. And they ran me through their review board for human subjects research, ran me through an awful lot of hurdles before I could do that. And certainly, I agree with that. The kind of research we are talking about has much more serious implications than what I did. I would suggest.

And I am impressed by what I heard about all of these guidelines and regulations and so forth. I think many of us are a little bit uneasy by virtue of the fact that there are people in power who kind of ignore the regulations. And I heard reference here to what was it, compensation for people who are injured. I would like to go one step further and say when people ignore these regulations, or override these regulations, and somebody is injured, there ought to be criminal sanctions.

MR. ENSIGN: Okay, next we have Linda

Price-King has asked to speak. Could you go up the microphone please and identify yourself.

Oh, all right, Darcy Sollars, then.

MS. SOLLARS: This is in, Jackie Kittrell brought up an issue today about having survivors, victims or someone who lives in a community to be able to participate in the groups. I believe that is very important. And I would like to say that I really appreciate that DOE paid my air fare and helped pick up a lot of the expenses while I am here. And I learned something last night that really shocked and offended me. I learned that yesterday inbetween two of the panels, speaking that the other downwinder, was told by Dr. Tara O=Toole, that the Hanford downwinders were not going to be addressed. I would like to know if that is so and why were we brought here and why were we at least, the two representatives of that particular group, not listened to before this comment was made? I am puzzled.

MR. ENSIGN: Dr. O=Toole, do you care to respond to that? Identify yourself, please.

DR. O=TOOLE: I am sorry. This is Tara O=Toole.

Darcy, could you say some more because I don=t recall saying that. I certainly don=t believe that. So I am not sure how to respond.

MS. SOLLARS: I can say a very little bit more because you did not say this to me. I really wish you had. It make this a lot easier, too. It was Brenda Weaver. And I would like to learn more.

MR. ENSIGN: Brenda, would you take the microphone?

Identify yourself, please.

MS. WEAVER: My name is Brenda Weaver. I am a Hanford downwinder. And in a private conversation after our panel yesterday, I talked to Tara and we were talking, I guess, not officially really, and my feelings that I received from you, Tara and what you said was, AThere is really not anything you are going to do for us right now because we are too difficult to test and too difficult to keep track of and the birth defect issue isn=t and there is not enough of studies that have shown that we are not affected enough.@ And I really felt very discouraged and I felt, AWhy am I here?@

Darcy and I discussed it and I felt, I mean, discouraged, forgotten, not important enough. And I was representing, we are representing the entire communities of downwinders. There are many, many people of us. And I know there are so many of us, we are easy to overlook. Thank you.

DR. O=TOOLE: Tara O=Toole.

What Brenda and I were talking about, I think this was after the morning panel on medical monitoring, was the difficulty given unlimited resources, let=s forget about the money stuff for the moment, okay. We were talking about the difficulty of fashioning meaningful medical surveillance for the wide range of potential effects of exposure to radiation, particularly at low levels. Sandra talked about the perils of limiting health outcome investigations to cancer only. And Brenda was talking about the question that has been raised in a number of quarters, as to whether autoimmune diseases, for example, which comprise of very wide range of illnesses and diagnosis might not be a consequence of radiation exposure. And what I was talking about was my own frustration as a physician with the very limited number of surveillance techniques, available to science, all of science, mainstream science, radical science, call it what you will, that allow you to take a person, who was extensively healthy, i.e. not a sick person on whom you are doing, you know, the diagnostic test your physician would perform if you had symptoms and complaints and so on and so forth. But, take a large number of people, who were exposed to something, and to investigations whether they be questionnaires, or exams or blood tests, or x-rays or anything that you can think of, that gives you a clue as to whether (1) something happened as a consequence of that exposure. And (2) gives you a handle on some kind of therapeutic intervention that would make a difference in those persons= lives.

The American Medical Association and the Public Health Service within the past month, have issued guidelines on what they think constitutes good and useful preventive health care. You know how many interventions they have got? Eight. Eight. And many of them are controversial. We are still having a lot of discussion as to whether or not women over 40 should get annual mammograms. All right, and whether the benefits of detecting cancer early outweigh the risk of the radiation.

Dr. Egilman, yesterday, when Stephen Galson tried to say that, you know, we have to be careful about the possible perils of medical surveillance, Grafhis very amusingly and dramatically and said, you know, what is he talking about? We are not talking about doing biopsies, something dangerous and painful like biopsies. Well, I know of two surveillance programs that are going on in the Department of Energy. One is for workers who are exposed to verilum(ph) and if you have a positive blood test in this surveillance program, then the next step is a biopsy. You put a tube down the person=s lung and you take a little bit of lung tissue. That is a biopsy, David.

Another one is the Hanford thyroid study. And if you have a positive ultrasound and you have got a suspicious nodule, then we do a biopsy. These medical surveillance programs are not without risks. They are not. And everyone with any kind of commonsense would want to make sure that there is a likelihood that the benefit of surveillance would outweigh the risks.

And also, these days, I think it is very important to think about costs, unlimited costs are not feasible. You do want to target our taxpayers= dollars, our money where it is going to do the most good. That has been, you know, the whole point of the last election part. Not all of which I am in agreement with, let me say.

But, what Brenda and I were talking about was my frustration with figuring out anything that is useful in terms of a surveillance program for the wide range of concerns and complaints that afflict the people who live around DOE sites.

We also talked about her feeling and I gather shared by others, from what I heard yesterday, a feeling invisible, Brenda, I think was your word. And forgotten and part because her plight and that of many of you in this room, was not called out explicitly by the Advisory Committee in the report.

MR. ENSIGN: Thank you. I am sorry.

DR. O=TOOLE: Let me make one, we can=t, if the measure of the Government=s concern, if the measure of the Government=s sincerity in wanting to tell the truth about experiments, is whether or not you get a line or a paragraph or a chapter in one report, that is the beginning of the human radiation experiment story. This is the first installment. This is what that committee could do in 18 months. Then we are in real trouble. This is the beginning of the story, not the end of the story. We have to keep on for years and years. We have to keep getting the records out. We have to keep reviewing them. There have to be more and more committees. They are going to have be different kinds of investigation. Some of those are going to be run by the Government, others aren=t. They are going to be citizen initiated. They are going to be done by state health departments, I suspect.

But, it is wrong to think that I said, you know, we are just blowing off the downwinders. My frustration is that there aren=t simple solutions. There aren=t answers that we can click into place. There aren=t immediate satisfying approaches that the Government can offer as remedies. That is what I had been saying.

MR. ENSIGN: The thing is, I do think that with Dr. O=Toole=s lengthy response, which is necessary, we should take a little more time to allow, because there is a lot of interest in this area.

With the permission of the group, I would propose we take an extra 10 minutes, so that people can be heard. Is that acceptable that we take shorter breaks so people can be heard? And we can drink coffee later, but I think it is important that we really airing of this. We had called on Linda Price-King and she deferred to Darcy, so let=s hear from Linda.

Identify yourself, please.

MS. PRICE-KING: Okay. I am Linda Price-King. I am the executive director of the Environmental Health Network. And I have to take exception to what Tara O=Toole said in quite, many ways. I work with Superfund communities and we have been working really hard to get health care systems, health care services in communities. And they talk about two things. They talk about costs, what it will cost to the Government. And they talk about whether or not it is feasible to do the health care, itself. Well, I will tell you that the costs are already ticking away. We are talking about the system imploding upon itself. We are talking about the Government says that there is not enough money to help the victims, yet, they are paying through this with higher medical costs, useless inconclusive studies, legislation, Social Security Disability, Public Assistance, loss of work, Workers Compensation and public institutions who have to take these people in, when they can=t function in society anymore. As well as children who have learning disabilities in the schools, and mentally retarded children, who were born with birth defects as a result of these contaminations. This is not only going on in the DOE communities, it is going on in the Superfund communities and RCFRA communities and everywhere. This is a public health crisis. And the Government has no right to stand up here and say they can=t afford this. They are paying for it in invisible ways all across the board. But, the people that are paying for it the most, are you and your families.

And what I want to say also is that these useless meetings, over and over again, where there is no action, there is talking and talking and talking, litigation, litigation, litigation. The trillions of dollars that have already been spent and that will be spent, could have already given each and every one of us health care.

The money is there, it has got to be used correctly. And each and every one of you in this room and the communities I represent for the Superfund, need to be standing up yelling and screaming, talking about physical responsibility as to where all this money is being spent. Not on reports and Tara O=Toole just got up here saying, this is the first --

MR. ENSIGN: Linda, if you could try to wrap up. We have got three more people.

MS. PRICE-KING: Okay. The first of many reports, what about health care? And the other thing, too, is that it is very important that we realize the decisions that were many, many, many years ago, during the Cold War, seven generations, the Native Americans believe that it affects seven generations. The decisions that are being made right now will affect seven more generations. If we start health care and preventive programs now, we will have a much better way of dealing with the seven generations to come.

So, that is what I wanted to say.

MR. ENSIGN: Okay, thank you, Linda.

I have, the next one on the list is Cooper Brown, who asks to speak.