Ranch hand advisory committee




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It's not just in the Department; but this committee and the number of the committees that the federal government is to have is not support.

DR. HARRISON: That historical perspective is I think always helpful to me, and I suspect it's helpful to you, too.

MR. COENE: You've really got a battle. I'll be honest with you, I don't think the solution is to move it up there. We thought CDC was the appropriate place, and I'll put that on the record, too; CDC was assigned their responsibility as their fair share of    because it had been at NIH, it had been at FDA; CDC, one of the agencies of HHS, it was their turn to    because it's uncompensated. It's unfunded, okay? It's unfunded.

DR. HARRISON: It's an orphan committee.

MR. COENE: And CDC said No. It's unbelievable, the track record. If you did a case study on just trying to make this work. It's, I think    I put that on the record only because a year from now or whenever, or now    three months from now, where there's support.

DR. MICHALEK: I thought we had settled all this at the Shays hearing. Remember? You were grilled by Mr. Shays.

MR. COENE: Oh, I know.

DR. MICHALEK: Was there no outcome to that hearing? Was there any sequelae --

MR. COENE: Well, no.

MR. WEIDMAN: In defense of Ron, we have --

DR. MICHALEK: Yes or no, was there any sequelae to the Shays hearing?

Nothing, huh?

MR. WEIDMAN: Pete Mazella retired, and that was the sum total of the support out of the HHS building, was Pete himself. And we have gone through eight years of an extraordinarily bright woman as Secretary of HHS who could not spell the V word, and was not interested in the V word. And it may turn out that past performance and commitment will not count in future performance with the current Secretary, the new Secretary, but we think that unlikely.

And it's amazing how reasonable people can be in those middle and upper echelons when their attention is focused by the boss.

DR. STOTO: And this is the exact time to ask, too.

MR. WEIDMAN: And if it's not done immediately, and even if it is done immediately, we have been working on legislation, because it's not just this committee that we need a veteran's office within HHS, it has to Rehabilitation Services Administration, with lots of other things that there needs to be a strong veterans office that provides an omnibus person and service function within the Health and Human Services and the various entities within that comprise Health and Human Services Department. Which is the, I guess after VA it's the second largest. Or excuse me, after DoD, in the federal government. I mean, it's a huge agency, or a huge department made up of many, many agencies, many of whom not only don't talk to each other, don't want to talk to each other; and I think that's a fair summation, and I see from some knowing smiles around the room that that's a perception that squares with the perception of some veteran hands in the audience, because it takes the boss's commitment from the top and/or a mandate with oversight function to get people focused and keep them focused on the mission.

The upshot of all of that is, and I want to stress, reiterate something that I believe I covered before    it was not a shot at Len and it wasn't a shot at Barbara or Ron, what I had to say. The problem is that the overall support of this committee has been lacking, and is not provided the kind of cotton-batting and spotlight functions that should be for a committee of this caliber. In other words, the Secretary ought to be doing everything possible to make it A) easy for your work, facilitate your work, draw heavily on your expertise as much as possible within the limits of your time, and not within the limits of an artificially-imposed budget; and to do so in such a way that it spotlights your public service but magnifies the impact of every hour that you put into this effort. And we will do our best, from Vietnam Veterans of America, and I'm quite confident we'll be joined by other veterans service organizations, the American Legion and others, in that effort to make sure that for the remainder of the time of this project that that in fact occurs one way or the other.

And Joel, I should have asked you directly yesterday, and I apologize for presuming that because we hadn't heard anything about it that you hadn't been able to make that commitment, but I'm delighted to hear that you did and I shouldn't be surprised that you did; and we will do our darndest to get out our own press release since the Air Force doesn't seem to want to trumpet the fact that this data is available and do everything that we can, working with our good friends on the Hill to get the information out within the academic and research circles as well as within the veterans community that it's there, and start to go ahead and mine the data. That will be a significant function.

I'm sure that, once again had we had notice, that both Linda and George would have been here with many specific comments having to do with the Statement of Work. And I would ask leave, Mr. Chairman, if they can submit something in writing to you. I know you have to make a decision this weekend, but those may be    we'll submit them to you and with a copy to Joel, that may prove to be helpful as you move forward, because as you write the Statement of Work and actually try and take all the notes from this meeting, there will be some editing process, I would assume, and the SOW will be sent out to committee members for final review.

And so would by our leave sir, would like to ask if we could come up with such comments.

DR. HARRISON: Any comments that you all have would be welcomed by me. I don't know what Joel's deadline, editing deadline is, but I suspect that it's measured in weeks rather than months. And that might be kept in mind.

MR. WEIDMAN: I also think that one of the things, just to share a bit more perspective, and this is not specifically having to do with the Statement of Work, and I know we're overtime so I'll try and make this brief.

What has happened in the past is a combination of lack of support from the Department as a whole for this committee, and of various and sundry entities for the Ranch Hand study per se, coupled with a lack of other studies.

Now, has put an inordinate burden on Joel and on the Ranch Hand researchers, and therefore by extension, upon this committee. What I mean by that is this: Too much is expected from the results of this committee without enough support to get where you need to get, even within the limitations of the sample size and the fact that this speaks only to Air Force personnel and not to ground pounders such as Camacho and myself.

And that's a sticky wicket; we need those additional studies. We're keenly aware that we need those additional studies, and we will be redoubling the efforts. We did in fact get    and we have been working closely with the State Department and with Senator Daschle and others, and Lane Evans, and Pete Peterson, our ambassador to Vietnam. And the first negotiating session has in fact taken place between the Vietnamese and U.S. scientists, led by the National Institute for Environmental Health Sciences, and with CDC representatives, EPA representatives, et cetera. It happened at the end of November in Southeast Asia to begin the process towards working towards a protocol to do research in Vietnam, with both U.S. scientists and Vietnamese scientists. And that's an important step.

But we need more domestic studies of U.S. veterans that cuts across sections, which will frankly relieve some of the pressure on y'all, number one. But number two, the most significant thing    one of the major and of the most significant things about the Ranch Hand study will be that database and the blue book as Joel calls it, both of the adjusted and the unadjusted data. And as a veritable mother lode, if you will, of data that is much more extensive than exists anyplace else.

And even though it is a small sample size, noplace else has that kind of longitudinal data in this depth. And therefore, it can be mixed and matched, if you will, with data from elsewhere to do comparison studies between Air Force personnel to match it up with Air Force personnel who served during the Vietnam era but who did not serve in Vietnam. And therefore, at least do some kinds of further research and publishable studies based on this data that will be, has now been made available to folks and on the last protocol.

So that on that protocol is any and everything that looks promising and that looks operational, whether it be    I wouldn't take a stand because I just frankly am not nearly enough of an expert on it, on the pulmonary function or whatever it may be; is that when in doubt, we would urge you to include it as long as it does not throw a monkey wrench in to the overall progress in order to get it on the record, if you will. Particularly in terms of replication of things. And if there isn't money for things but you think that it needs to be done, we would encourage you to go ahead and put it into the Statement of Work and then let the green eyeshade people take it out instead of being intimidated to not put it into your statement as scientists about what needs to be included based on what the green eyeshade boys tell you. If that makes any sense.

And so I would encourage you to approach it from that public trust and that scientific trust basis and let the budgeteers and the new secretary of the Air Force say "Oh, no, we don't want to do it right." So that would be the sum gist of my comments.

DR. STOTO: Did we make a decision yesterday about the dioxin measurements?

DR. HARRISON: Well, yes, we actually did. But one of the comments that I would make is that, you said that a group from NIEHS and CDC met with Vietnamese officials about performing studies in this general area. And I may be naive in this, but I think of the Air Force study and I think of the people who have performed the Air Force study, Joel and others, as having more expertise in this particular type of study than anyone else that I know of.

On the other hand, we can't hardly get anybody from NIEHS to participate in the committee. So I don't know why they're over in Vietnam getting ready to set up a new study, without at least using this group as their advisors. And I've seen the same thing happen with the VA Chemical Corps study, set up not optimally at all, and often without regard to lessons that have been learned from this study.

DR. STOTO: I was going to ask, what has happened? At one point we were advising that group as well, and I haven't heard.

DR. HARRISON: They only    I don't know.

MR. COENE: He was invited to participate; he being the project officer, Dr. Kahn, but they had nothing to report. They also were made aware that we thought we would possibly have another meeting of this committee and we'll talk about that more tomorrow. Later on this spring, and that he might at that time be prepared to report the progress on their study. But they --

MS. JEWELL: They were invited to San Antonio.

MR. COENE: Yes, they were invited to San Antonio, too; and they chose not to participate at that point. They didn't have anything to bring before the committee.

DR. HARRISON: Well, that means that they're off doing their own thing.

MR. COENE: I know what they're doing, but that's another matter. That's a resource issue, too, and it's the Persian Gulf stuff that their limited epidemiological staff is focused on that.

DR. HARRISON: That's one other thing that I    I don't know if I mentioned this, I think I mentioned it to Mike, but I'm not sure I mentioned it in general. That is, it seems to me that while it may not be within our designated purview, then we might at least, not this morning but maybe this afternoon, discuss briefly how much better this study could have been done if there had been a prospective plan in place for assessing environmental hazards during wartime.

If you had to do that, what would be the kind of information that you'd want to, you'd want the Armed Forces to have on its personnel in order to assess something that you may not be -- you know, depleted uranium. I think it was Mike Gough that mentioned the uniformed services don't even know where the men were in Vietnam. In many cases, they don't even know who was there.

DR. GOUGH: You're exaggerating the second part.

DR. HARRISON: Okay, all right. Don't know where they were, and that being a bit of information that would be terribly useful, for almost anything.

So in addition to analyzing the present problem    which includes not just Vietnam but the Persian Gulf War and the European limited conflict --

DR. GOUGH: Peacekeeping.

DR. HARRISON: Which would be only limited if you and I aren't being shot at.

MR. WEIDMAN: Only limited if you're not under fire.

DR. HARRISON: Exactly. But prospective consideration, prospective planning. Now surely there must be someone doing this somewhere.

MR. WEIDMAN: A lot of thinking has gone on our part and with friends on the Hill. And sometime during the 107th Congress we would anticipate that there will be two separate bills introduced. One is to create a National Institute of Veterans Health as part of NIH, that would gather a lot of what has happened to veterans of every generation, and research and reporting on that, in an entity that is not fiscally liable for those actions. And NIH would be the place; in other words, not DoD and not VA, because there are all kinds of pecuniary impacts on the study, and you need to free it from that in order to have an objective viewpoint based on the science.

The other recommendation that we have made to numerous folks and have had discussions time and again has to do with creation of a National Institute of Military Medicine. And the same thing for predeployment, to study what is going to likely be the impact of various weapons systems and other mechanisms on a large scale on our own people, as well as on the civilian population.

DR. HARRISON: Well, you've got a military medical school.

MR. WEIDMAN: UHUHS is not really set up to do it, and it would have to be separate from that, in our view. We've talked with folks over there, we've talked with numerous physicians who are very familiar with that institutions, and it would be giving them a mission that they're really not set up to meet. And therefore although they would be there in consultation and they could draw on the expertise, but a National Institute of Military Medicine that is housed at NIEHS could draw on many resources in the Greater Washington Area including Bethesda Naval, National Medical Center at Bethesda, and Walter Reed, and some of the top physicians from the Uniformed Services.

But it really has to be independent of the services in order for people to have confidence in their findings, either for predeployment or for postdeployment, look-back if you will, and recommendations for the future based on what happened in Korea, to the veterans who were exposed to radiation, to the Vietnam veterans who were exposed to the toxicological soup, or to Gulf War veterans and many things to which some of them somewhere or all of them may have been exposed, whether it be serin gas, heavy metals, from the oil well fires or depleted uranium or whatever the case may be.

The problem with all of these things is many people had so many multiple exposures we're never going to tease out exactly what was the triggering agent that would elevate the rates of certain diseases. We propose to    the acting secretary    well, then Secretary West entered a petition having to do with in-country effect, based on the fact that you're probably never going to be able to tease out what was that silver bullet that caused X, Y and Z elevation in terms of adverse health effects in veterans who served in Vietnam.

I'll give you just a mundane example: Central cereus retinopathies, which is    I'm sure most of you know, the physicians anyway    is a leaching of plasma through the back of the eyeball that causes bubbles under the retina. It is the one eye disease that is connected and related to stress, to acute stress. Well, you know, for some people who've done dioxin research, they believe that central cereus retinopathy is due to the exposure to Agent Orange, to 2,45T.

Well, you're talking about the same folks. How are you ever going to be able to tease out what was the silver bullet that did it? And in the end, does it necessarily matter for some purposes anyway, having to do with access to health care and to compensation.

What we were suggesting to Secretary West was, and will be coming back around the horn to the new secretary, Tony Principie, is that if you establish a baseline of people who served in a combat theater of operations, whether it be Bosnia or Vietnam theater of operations, or wherever the case may be, or Southwest Asia for the Gulf War vets, and you have an elevated level of whatever. In other words, establish a baseline of health right across the board, comparing to the cohort group of the civilian population. And anytime you have a blip you do the same thing that is done generally in the industrial medicine model; is you move to compensate and to treat insofar as you're able to at the same time that you have ongoing research to try and tease out better treatments based on what in fact might have been the causal agent.

So those are the three steps that are not done for the men and women who serve in the military. That happens very quickly in a Monsanto plant, I can assure you, and those of you who are familiar with and I see a smile in the back there from the designated responsible adult from SAIC, that this is in fact what happens at an industrial plant. Because they know that if they don't move quickly like that, that they're going to have a liability that won't quit. But we have a little thing called the Ferris doctrine where Paul and I can't sue the government for damage done to us during the military service. On the theory that the benefits and health care system is set up and will meet all those needs; and therefore the Supreme Court has upheld that we cannot sue.

So this young lieutenant colonel here, if something happens to him in military service, he can't turn around and sue the Air Force or the Secretary of Defense for the damage done to him in military service on the theory that the military will take care of its own through our extensive service of veterans health.

Sometimes that's true and sometimes that ain't true. So it's    we believe that in the future that's the way to go, and end all of the slogan    firing slogans at one another over entrenched positions over each separate element having to do with Agent Orange -- each disease whether it be diabetes, whether it be you name it, that we need to move to essentially look at things from a macro level right across the board and then move forward.

That does not negate, in any manner, shape, or form that value of what you folks have been doing and will do over the next five years in the Ranch Hand study, nor any of the other particular studies having to do with Agent Orange or any other aspect of it. What it does is put an overlay on that that moves forward to provide the assistance to the men and women who have been harmed by virtue of military service to country when they need it, not 15 years down the line but now, when they and their families need it.

DR. HARRISON: Okay. Joel?

DR. MICHALEK: I only ask that you stick around, because I have some slides to show on the disposition of the study, and you should probably see those slides.

MR. WEIDMAN: Okay. Will that be right after lunch?

DR. HARRISON: We can change that around if that will suit you better.

When will Caldwell --

MS. JEWELL: There's a Gulf War conference or something with a conflict, and that's where she was yesterday and this morning.

DR. HARRISON: So we're not sure.

MS. JEWELL: She said after lunch, so I would guess 1 or 1:30.

DR. HARRISON: So that might bring all the parties together at the same time.

Why don't we break now. Let's not rush lunch; let's be back here at 1:30.

Whereupon, at 12:24 p.m., the meeting recessed for lunch, to reconvene at 1:30 p.m., this same day.

A F T E R N O O N S E S S I O N

[1:35 p.m.]

DR. HARRISON: Paul, we still have psychology to do, because there are some questions about it that we thought you could help answer; and we've been trying to make a list of recommendations, so we have some things that we need to go back and ask you to agree to so that we have a quorum voted on that, in that order.

Once we've done those things, then we'll go through whatever else is remaining on the agenda.

So Joel, go ahead.

DISPOSITION OF THE AIR FORCE HEALTH STUDY

DR. MICHALEK: Briefly put, we are concerned about what to do with the study, from many different points of view. The immediate concern, which we've expressed at previous meetings, are the disposition of 51,000 biological specimens collected from these men since 1982, and they reside in these freezers in our building at Brooks Air Force Base.

These were all collected under informed consent, and include    I have a chart here to show    they include serum, urine, semen and a few specimens of body fat but not much, and there you see across the top, you see the years of collection.

Last year, Dr. Harrison wrote a letter to Donna Shalala recommending that a peer review panel be set up at NIH to solicit proposals to address the Agent Orange question with these specimens, which was the intent of the protocol, and the informed consent we received from the study subjects.

A subsequent letter was sent to Ken Olden at NIEHS, not very strongly, directing him to set up such a committee. Ken Olden responded back to me saying that he's received such correspondence, but no funding, and that was the end of it. And that correspondence and activity stopped sometime in June last year; never heard a word since.

That's why we need Rick Weidman here, because he may be able to exert some influence on this process. The point being that this material was collected under informed consent, number one; number two, it is irreplaceable. Once you use it up, it's gone forever. And there is the unique biological specimen database for Vietnam veterans that sits in those freezers.

We also had, we're using those up as we speak, 313 Adipose tissue specimens which are being analyzed by Dr. Fumio Matsamura, University of California - Davis, and we recently shipped him 100 of those specimens; we're going to have a meeting with him I believe next month.

DR. FAVATA: Joel, what is he studying?

DR. MICHALEK: He's studying the diabetic intermediaries such as glucose transporters and biological parameters that I cannot recite, but he can. If you'd like to hear that, I guess we could arrange maybe at a future meeting to have Dr. Matsamura summarize his work.

I have a copy of his protocol, if you'd like to have it. We can e mail that, or send that out to everyone.

DR. CAMACHO: Yes, run that to us.

DR. MICHALEK: Let's back up.

MR. COENE: Let's see that intro thing again.

DR. MICHALEK: Rick Weidman. [Mr. Weidman returns]

DR. HARRISON: Rick, look on your seat over there.

MR. WEIDMAN: Thank you.

DR. CAMACHO: Rick, this is for you.

DR. MICHALEK: This is especially for you, Rick Weidman.

MR. WEIDMAN: Are you commenting on my disposition, Joel?

(Laughter)

DR. MICHALEK: I'm commenting you and the VVA and the whole world, really.

We, as executors of this study, are concerned about its disposition; in particular concerned about this study at large, but we're also concerned primarily, right now today, about these specimens that were collected under informed consent from the outset of the study in 1982.

We have 51,000 biological specimens collected under informed consent from these men, beginning with the first physical in 1982, for the express purpose of answering the Agent Orange question. They remain in our freezers as Brooks Air Force Base.

Last year, Dr. Harrison    and this was discussed at the committee    decided that Dr. Harrison would write a letter to Donna Shalala, which he did, suggesting that NIH set up a peer review panel with appropriate funding authority to receive proposals from the scientific community in the United States or elsewhere to answer the Agent Orange question with these specimens.

A correspondence was sent from Shalala's office to Ken Olden at NIEHS, suggesting    and I can get you copies of these letters -- suggesting that this be done. Soon thereafter, a letter from Ken Olden was sent to me saying that he had received such correspondence but no funding. And that's where the processed stopped. It stopped sometime around the middle of last year.

I bring this up because we who have experience with administering and soliciting research know that even in the best of circumstances, I believe that if this were to start today you would not see results until maybe five years from now. So five years from now will put us at the end of our study. This is not optimal from the point of view of the use of these resources to delay this much further so that the results of these analyses, if they are ever done, would come in after we all leave. There would be no one here to synthesize the results, if that happened, there would be no way to assemble it all together and ask whether these results have to do with what we found in our reports.

So from the point of view of technical optimality and scientific efficiency, and there are so many other things, it would be a really good idea to launch this effort as soon as possible so that the results can be realized before the study ends. Another reason is, that if you wait much longer and decide we're going to do this, but "We'll do it sometime in the future, say the year 2005," now you're talking about results that won't come in until roughly the year 2010, which may be too late for all the Vietnam veterans.

You see, we're at a critical point here in terms of getting these specimens used in the way they were intended to be used. Now it can be argued    here's the rest of the summary. We have 313 adipose tissue specimens that are being analyzed as we speak at the University of California-Davis, to study glucose transporters and other chemical intermediaries and dioxin as they relate to diabetes.

At the time we did these slides, we had some specimens still outstanding at CDC; I'm not sure that's the case anymore. Small number of adipose tissues.

So that the rhetorical question is, should these specimens be used for their intended purpose before the study ends, simply put? There's my guess: Four to five years. If you believe this should be done and it's going to start now, today, I believe that's what we're going to be, four to five years from now you will see results.

Later may be too late for the veterans. You put this off much longer, I think it's clear to all of us or many of us in the room, you're not going to see the results in time to help anyone who was in Vietnam.

There are many hypotheses outstanding in the study; many questions to be answered.

DR. HARRISON: I think there's another point that you might be missing there, too, Joel, just to interrupt. And that is that the effects of dioxin are very species-dependent. So you can't reliably test a hypothesis in a rat to prove a relationship in man, at least that's my impression. Nor can you prospectively administer dioxin to human subjects in order to test a hypothesis.

So the inadvertent presence of these samples are again difficult if not impossible to replace, because, for those two reasons.

DR. MICHALEK: That's right. They are unique. This is the only biological specimen bank on Vietnam veterans, let alone exposed Vietnam veterans, because for every one of those specimens we know the dioxin level. And we know the dioxin level multiple times, for about 350 Ranch Handers, their specimens in the freezers. This is an irreplaceable and unique dataset that's sitting in the freezers and the question that's begged here is, what should be done with these specimens? And should they be used for their intended purpose before the study ends?

LTC BURNHAM: You could mention what happened to the West Point study.

DR. MICHALEK: Of course. We have an example of another study that literally fell through the cracks and was just, specimens allowed to thaw in the freezer, and become spoiled simply because the funding was cut off. It can happen.

A scenario that we've seen happen in other studies is that the funding is ended on a given day, and at that point literally the staff walks out of the office, and it's over. There isn't even enough money to keep the electricity going to keep the refrigerators and freezers going.

You see what you've got here are 22 institutional freezers that must be kept at -70 degrees, there can be no power failure, there can be no mistake; and every one of those specimens is tied to a consent form and that's tied to a patient record.

In other words, there is a chain of custody here and there are logistical issues associated with simply maintaining the specimens without even using them for anything. They have to be kept under lock and key, they have to be kept linked to the folders and the consent forms, and I believe they're all bar coded and labeled with case numbers so we can connect them.

This is a major issue, in other words. It's important and needs to be addressed, needs to be discussed. And in that connection, I received an e mail from Paul Camacho a few weeks ago that he attempted to talk to a staffer at the House Veterans Affairs committee.

Do you want to make a remark about that?

DR. CAMACHO: Yes, Darryl. I asked him about, I brought up to Darryl that we had these issues about, how are we going to dispose of the study? He got excited, and he said "They're out there" he goes "Out there, there are very specific rules. These were set out. There's very specific things they absolutely by law have to do." But he couldn't, he said "I can't tell you where that is right now." But he was referring to some rules, regs, somewhere, something in the law about all federal studies and where the --

DR. HARRISON: All federal studies?

DR. CAMACHO: Well, that's what he was implying. Federal studies where the disposition of this is supposed to go.

I didn't know what he was talking about at all in that, but he was adamant that something --

DR. STOTO: Maybe it's this.

MR. WEIDMAN: Mary Ellen McCarthy will be here tomorrow morning, and I would urge you and encourage the committee --

DR. HARRISON: We may not be here tomorrow morning.

DR. MICHALEK: We might quit today. But I'm going to be here tomorrow morning.

MR. WEIDMAN: You might want to call her, then, and let her know that.

DR. GOUGH: I have a couple questions. First of all, I don't know what the limitations are on the use of these samples. You have this word 'intended purpose' there. It is an intended purpose to find somewhere?

DR. MICHALEK: They were collected to provide collateral information to the physical exam data that we're talking about today.

DR. GOUGH: Okay, so do we need a legal opinion about how broad that intended purpose definition can be expanded in case, say somebody applies to NIH, gets research funding to use these samples?

DR. MICHALEK: For what purpose?

DR. GOUGH: Well, that's just it.

DR. MICHALEK: As soon as you entertain that idea that these samples could be used for any other purpose than Agent Orange, is that what you're saying?

DR. GOUGH: I can say Agent Orange and I can make Agent Orange a tiny little part of a bigger research project.

DR. MICHALEK: That's why there has to be a gatekeeper; there has to be a panel. There has to be someone responsible.

DR. HARRISON: Wait a minute.

DR. STOTO: No, no. I don't think we know the answer to this. I don't know the answer to this; I think that Mike is right, that we need some consultation from people --

DR. MICHALEK: I have consulted with the IRB at our facility.

DR. GOUGH: I think it's a --

DR. STOTO: A broader question than that.

DR. HARRISON: Yes, but in point of fact, your facility's IRB does have the right of making that determination. They're not going to be overruled by some other institution's IRB. So to that extent I understand what you're saying, but I'd like for us to make sure we don't get too excited, because we do have time to solve this problem; and we can discuss it.

DR. CAMACHO: In terms of funding, was there something that's been lost way back when when they originally appropriated money and oh, authorized, when they originally authorized this study piece that indicated that the appropriated funding, the disposition was to be included in any game plan? In other words, they would say to you "We've already paid for you guys to dispose of this study. It's supposed to be locked in your budget."

DR. MICHALEK: Good point. Someone might say that.

DR. GOUGH: There's never been a congressional authorization for the study, has there? It's just been appropriations, because the Air Force --

DR. OGERSHOK: There's been public laws issued where the study would continue, there's been public laws --

DR. GOUGH: All right, because I remember there was an Air Force initiative.

DR. HARRISON: Let me ask a question as chair here, about what it is that we're trying to discuss right now. As a member of a scientific advisory body, are we discussing the desirability of retaining these samples and someone organizing a mechanism for their further use, or are we trying to decipher what laws apply? What is the purpose of this discussion?

DR. CAMACHO: I thought we were talking about the disposition of all these study materials, the samples. In other words, how do we close this study? It's like a computer program, I can close it properly or I can yank the plug and shut the machine down.

DR. HARRISON: Let me review something. Joel mentioned that I wrote a letter, and I wrote a letter at the direction of the committee. And the substance of the letter was that the committee felt that the Air Force had demonstrated a relationship between herbicide exposure and diabetes. As I recall, I don't have the letter in front of me, but that's what I think we wrote.

And we said, we felt that that information should be, that correlated information should be followed up by studies intended to understand what possible relationship there might be between herbicide exposure and diabetes. And the samples that are a part of the Agent Orange study are an important resource for people who think about these kinds of problems.

So we wanted that information made public and we wanted somehow there to be some collaboration between the Air Force and an appropriate    the problem that the Air Force has is they have neither the money nor the review capability to determine if one idea is just crazy or of it's just innovative.

So my point is that we've already said that we think that these samples are important. We've already said that we think collaboration is needed with other appropriate agencies; that's a part of this committee's, if you will, judgment about what the disposition of the samples in the study should be.

So what's the question?

DR. MICHALEK: I guess the purpose of these slides is to inform you that there has been no action based on your committee's decision, and to remind you that this is still an issue.

DR. HARRISON: Okay. All right.

LTC BURNHAM: Let me read something real quick out of NAS update of '98. It says:

Section 7 of the law, that public law, calls for the establishment of a system for the collection and storage of voluntarily contributed samples of blood and tissue of veterans who served in Vietnam.

Balancing the strengths and weaknesses of stored biological samples and clinical data for research purposes, the committee feels that systems of the sort have scientific value, but only to the extent they are components of specific well-designed studies. In the absence of a clear study design to guide such activities, and without resolution of important design, quality control and ethical issues regarding tissue banks, the committee does not recommend the establishment at this time of the clinical data and tissue archiving systems described in the law.

In other words, they want us to have an idea of what to do with these things.

DR. STOTO: That's a very important point, because the Ranch Hand is the one    there's an exception mentioned there, that there needs to be a study plan, and in the Ranch Hand in fact, there is a study plan. So --

DR. GOUGH: This was done the way it was --

DR. HARRISON: I'm treating this as a public discussion rather than a committee discussion.

MR. WEIDMAN: I guess I had a question for Joel.

Did you actually talk with Dr. Olden?

DR. MICHALEK: No, I have not. I simply received a letter from him.

MR. WEIDMAN: That said they didn't have any --

DR. MICHALEK: They said they didn't have money.

DR. HARRISON: I will say, though, that I know Ken personally, and I placed three calls to him within around the same period of time and didn't get an answer, didn't get a return phone call.

MR. WEIDMAN: Well, I'm seeing him tomorrow; that's why I'm asking him the question.

DR. HARRISON: You can tell him I said that.

MR. WEIDMAN: How much do you estimate it will cost or have you talked with Portier or any of those guys about how much it would cost, Joel?

DR. MICHALEK: Well, Dr. Harrison put an estimate in his letter. I forgot the number.

DR. HARRISON: I don't remember either.

DR. MICHALEK: We're talking 40 funded proposals at a cost of what?

DR. HARRISON: A million, 1.2 each or something like that.

DR. MICHALEK: $40 million.

DR. STOTO: I think that we chose the wrong way to go last time when we did that. And actually, I knew about this stuff that Joel handed out, the 102-4, but I had forgotten all about it. And there really are three sections that are potentially relevant here. 7 and 8 I think is the most relevant, and 9. But the 8 one says that the VA should have a whole series of studies going on, about the health effects on Vietnam veterans, and explicitly says they need to consult with the National Academy of Sciences about the conduct of those studies. And the tissue samples could be one of them, and the IOM recommended against that, except for things like the Ranch Hand study.

I think that we need to be talking to the VA about convening a group from the Institute of Medicine to think about the disposition of these studies.

LTC BURNHAM: Why don't you finish your slides, because this is part of the bigger --

DR. MICHALEK: Okay. Well, of course the larger issue is what will happen to the study in the year 2006? Are we talking about a scenario such as the West Point study where they literally pull the plug and material is destroyed and wasted and lost, or are we talking about something else? Or what are we talking about?

Certainly scientifically there are going to be many open questions remaining in the year 2006. Every position, as we could understand it as you see from our notes, it could be debated. One would be just to stop the study completely. A skeptic would say "Well, we've spent enough public money on this. Let's do something else with our tax dollars." Another would be, "Well, there are many open questions remaining and there's a big resource here and it shouldn't be wasted, and we've just reached the point of technical optimality where we have scanned all of our records into a system that we can point and click and reach any document. We can do great things with the existing database, and that should continue.

So there are many pros and cons, and it can be argued both ways, and that debate should begin, in our estimation, should begin soon. And should take place until the day comes in the year 2006 when we all leave.

There are many issues. Funding, of course, what's the performing organization? Who's going to do it if it is to be done beyond 2006? Who's going to be responsible for the patient folders containing approximately 8 million documents on the children, on the wives, their sexual partners, other sexual partners and themselves. Who's going to be responsible for the specimens? What is the chain of custody and what are the rules regarding informed consent? All that has to be worked out.

Even if the study is not going to actually stop dead in its tracks in the year 2006, exactly what will be done with all this material? Is it going to be burned, is it going to be handed back to the study subjects? That all has to be worked out and discussed in a slow and thoughtful way over the next five years and not done hastily in the last few months. Because in my experience, what can happen in the last few months is that the staff will start quitting; they're all looking for new jobs, and the place will contract. We're already going to lose a lot of staff in the later years because our scanning will be finished. And as soon as the funding stops, at that point we have no control whatsoever about what happens.

So the point is to put a lot of thought into this and exert as much control as we have so that the outcome is something we can all live with in the year 2006.

Did I miss anything?

DR. HARRISON: No, you didn't. Go on.

DR. STOTO: I think one point that needs to be clear, somewhere in here, in these issues here, is that there's value in these data to understand more about Vietnam veterans. What might have happened to Vietnam veterans. There's value in these data for people interested in the effects of dioxin, separate from whatever happened to Vietnam veterans, and there's also value to people interested in the aging process, in white men, having nothing to do with dioxin or Vietnam veterans.

DR. HARRISON: But the problem is those samples were not collected --

DR. STOTO: Clearly you need to look at the issues involved with using it for other purposes. I don't know that these problems are insurmountable; they may be, but I think that we need to have someone who really understands those issues look at them.

The guy reaction of the guy who runs the IRB at Brooks will say "Oh, no." But I think that the VA might see the value beyond that; and in fact the law gives them some authority here.

I think that if people at NIH understood the value of this beyond the specifics of the Vietnam veterans, they may find it very interesting, too, and it's a way that the Ranch Hand veterans can contribute to society, take advantage of what's happened to them --

DR. HARRISON: Make another contribution.

DR. STOTO: Make another contribution, that's right.

DR. HARRISON: You know, the Food and Drug Administration is responsible for overseeing ethical clinical research in this country. It has, if I understand it correctly, a major office in that area.

DR. STOTO: I think the key office is the Office of Protection from Research Risk, is what it's called.

MR. COENE: There are two titles. There's Title 45 and there's Title 21. FDA is Title 21 and covers clinical research. Title 45 is everything else.

DR. HARRISON: My point is there's an Food and Drug Administration resource that we should be able to tap into to--

DR. STOTO: I think that the other HHS resource is the one that's more appropriate for this.

MR. COENE: Yes, it is. This is not clinical research, and FDA's is just    it's HSRB activities, Human Subjects Review activities, is limited to those studies involved in clinical studies for new product approval.

There's another part of the law, Section 45 of the code, that has to do with everything else that goes on with human subjects, and that's administered by the Department. And that's the level that would play out here.

DR. STOTO: Yes.

DR. HARRISON: I would much rather see us approach it that way than to try and approach it through and interpretation of the law. I would like us not to be in a position in justifying what could be considered unethical behavior by citing a law that says that we can do it.

DR. STOTO: I think we need to look into it. I don't know what can be done and what can't be done; but --

DR. HARRISON: I think that could be one of the functions of our FDA support; we're going to be talking sometime later about the next meeting, would be to request an opinion and request someone to appear personally and discuss with the committee and the Air Force just what the ethics of this are.

DR. STOTO: I think Section 8 of the law suggests or perhaps commands that we work with the VA on this.

DR. HARRISON: I don't care who we work with, as long as we work with someone who has --

DR. STOTO: Well, the thing about the VA --

DR. HARRISON:    the appropriate --

DR. STOTO: They're more likely to put up the money to do the work.

DR. HARRISON: There are two issues, one is money and the other is ethics. And I would like    I want as much ethical coverage as we can get. I'd like as much ethical discussion as we can get; and from whatever sources we can get it. If we can get Billy Graham or his son to come and talk about it, I'd just as soon then.

DR. STOTO: But I think the VA is more likely to give us the resources to even bring the ethics people in.

DR. HARRISON: That's fine; that's something that Len and cohorts can work out.

You had something you wanted to say?

LTC BURNHAM: I talked to the chairman of our IRB before we left about this, and he said that as long as we have done what we    stuck with our protocol, you could actually ethically and with the IRB, you couldn't throw them away. Of course that's not what we    but that's an alternative.

Another alternative is that another agency does the research, within our protocol about Agent Orange, and as long as Joel is a co-investigator, you don't really need a new consent form. But if you look at any other research protocols or another agency does the research, then you need a new consent form.

And then I asked him, "Well, should we get" --

DR. HARRISON: You've already told me this. And --

LTC BURNHAM: What I'm leading up to the last point is--

DR. HARRISON: Okay, because we're supposed to be offering you advice, not your IRB person telling us what should be done.

LTC BURNHAM: Well, I thought they had impact on each other. The last thing is, I asked him "Well, should we try to get a new consent form at this next exam?" And he didn't know.

DR. HARRISON: Well, first of all, I would say that you cannot get consent on samples that have already been given. I know that.

DR. STOTO: I don't know that that's true.

DR. HARRISON: Because an essential part of the consent process is the lack of coercion. The fact that you already have the sample is coercive.

MR. WEIDMAN: It's accurate; there have been court test cases on that.

DR. STOTO: But does that prohibit the new use of these things? Can you get consent about new uses of these?

DR. HARRISON: Yes, it does. The only way you can get out of this is for somebody to say that you can broaden the definition of    I don't know. That's why I'm saying that we need to   

[Simultaneous discussion]

DR. HARRISON: The issue of coercion is    whew.

DR. GOUGH: These can't be passed on to anybody; then we just pull the plug.

DR. CAMACHO: But that in itself is unethical, as far as I'm concerned. Let's bring in some legal counsel --

DR. HARRISON: Let's find out the answer is. That's what I'm suggesting. Or at least what the counsel is.

DR. GOUGH: That's a first step. Before we know that, we can't do anything. We can't recommend anything, we can't advise anything.

DR. STOTO: I think it's not an easy thing to do. I think it needs some very careful thought, get the right people involved, and   .

DR. HARRISON: Can I ask, if we agree that these are extremely valuable samples, we agree that these are unique samples, we agree that it would be a waste to do anything other than to use them in the most intelligent way possible. But we also agree that there's an ethical consideration and a practical consideration.

Can we ethically use it? How can we ethically use the samples, and where can we find resources to use the samples with?

DR. STOTO: And we have to balance all these things.

DR. HARRISON: Yes. And for all those, we don't have the answers in this room.

LTC BURNHAM: Maybe the VA could ask the NAS to answer both of these questions; the endgame and also what to do with the specimens now.

DR. HARRISON: I'm open to any suggestion.

Let's do it this way: Who wants to make, as a committee member, a straightforward suggestion of what should be done next?

DR. STOTO: I would suggest that we contact the VA, we as the committee, contact the VA and say that we're aware of their responsibility under Section 8 of the law, and that we know about something that we think that they should at least get their consideration, and that they consider consulting with the National Academy of Sciences as the law calls for, to discuss some of the practical and the ethical and the legal and the financial issues involved, as well as the scientific issues involved in doing this.

DR. HARRISON: Okay, does anyone else in the committee agree with    like in a second for this approach?

DR. CAMACHO: I would agree with that. We should be casting out our questions now, whether it's before the Veterans Affairs committee and all this, we should get some people    by airing the argument instead of clutching it inside, airing the argument we'll find people that will support "No, this is unethical." "Yes, it's ethical." "This is what we should do."

We'll get better parameters by going out and getting other input.

DR. STOTO: What I'm trying to avoid is the Secretary of HHS telling Ken Olden to do it, and then he says --

DR. HARRISON: And then Ken saying "I don't have the money"; yes. Whenever somebody tells you to do something and they don't give you any money, they're not telling you to do anything.

DR. STOTO: Right.

DR. HARRISON: That's pretty obvious.

DR. STOTO: We can't blame Dr. Olden.

DR. HARRISON: No, not at all.

DR. STOTO: But the other thing about this is that, not only does the VA have the authority to do this, they've got the interest.

DR. HARRISON: But they don't have the money.

DR. CAMACHO: Money is a down the road trick.

DR. HARRISON: I understand.

DR. STOTO: I'm not saying they need the money to archive the samples. They can have the money to convene a workshop under the auspices of the National Academy of Sciences.

DR. HARRISON: Can I get your agreement to one other    I'm sorry. Now we've got two people down here.

Do you want to say something?

MR. COENE: I think at least your proposal is to approach the VA.

DR. HARRISON: Right.

MR. COENE: Your responsibility is to the Secretary. You'd probably need to go to    you'd recommend to the Secretary that she communicate with the VA. That's the charter of this committee.

VOICE: The Secretary is 'he' now.

MR. COENE: Sorry.

DR. STOTO: We can work that channel.

DR. HARRISON: Well, if a letter is going to come from this committee, then we need to make sure that we know where we're sending it. So protocol says it goes to the HHS Secretary.

MR. WEIDMAN: Joel, when you said $40 million, are you talking about $8 million for five years?

DR. MICHALEK: We were talking about a number of proposals to be carried out over a relatively short period. We didn't put a time limit on it.

DR. HARRISON: If you did a Request for Proposal, if NIEHS published a Request for Proposals that said that there's 50 some million samples, a mixture of this, that and the other; the following clinical data is already available, request proposals to study the mechanism of action of the increased incidence of diabetes secondary to herbicide exposure.

All of us in academic medicine would be trying to figure out how we could write a proposal to get funded under this, and it would have to be reviewed, so you'd have probably    50 different study sections would have one or more grant proposals from this; and out of those, we were presuming a certain number of grants to be funded, and we were figuring that a five year proposal runs total cost somewhere around $1.2 million.

And those are all just    very puffy figures. Obviously very puffy figures.

LTC BURNHAM: I thought it was 20 grants.

DR. HARRISON: My point is, who cares? You know, when you actually get down to doing the RFA, people who are much keener than us in terms of the appropriate cost are going to, having a much better idea of what the actual cost is going to be; but that's an order of magnitude. It's not going to be $400 million, and it's not going to be $4 million.

MR. WEIDMAN: It's unfortunate that    and I know you've touched on this before -- but it's unfortunate that this contacting the VA didn't happen after the San Antonio meeting, because the head of VA Research is here. The VA, after what happened in West Los Angeles, has tightened up and has all sorts of safeguards, particularly with    at this point when it comes to any research with human subjects, they're like Caesar's wife: purer than pure and appearing to be purer than pure.

How long that will last is anybody's guess, but that's the way they are right now. But the head of research is solid, and it would have been good to have him here at this meeting, and I don't know if it's possible to get him over for tomorrow morning or not. But the real question is, is that chain of custody, is VA even potentially willing to do so? I'm not sure that they would be, because of the inherent conflict of interest that the results of any study then come back from NAS to the Secretary of Veterans Administration.

I don't know if I'm making any sense on that.

DR. STOTO: Well, they don't necessarily have to do the studies or pay for the studies in the long run. What I think they ought to have an interest in doing is organizing an activity this year to think about this issue, and to sort of lay out the possibilities and evaluate the possibilities. In fact, Section 8 says they've got the responsibility.

MR. WEIDMAN: Tony would be open to that kind of thing, I'm quite certain, and would work with Secretary Thompson.

DR. HARRISON: So what we are proposing to do is to submit a letter. We'll do it the way we did it the last time, a draft goes out by e mail and people get to jabber over it, to point out that this is an impending problem of major proportions; that it's our understanding    this is pointing out to the secretary, that it's our understanding that serious scientific and ethical considerations are present and need to be dealt with in the widest forum possible; that there appears to be a legal mechanism in place to provide that type of advice through the public law, whatever it is and section, whatever it is. And that as a committee, we urgently propose that the Secretary act on this and request the VA to coordinate a sufficient number of meetings to determine what should be done. That's a rough kind of idea.

DR. STOTO: I'd be happy to volunteer to help to talk about this with the National Academy of Sciences; and if it would be helpful, with the VA folks.

DR. HARRISON: I think that would be a good idea. The other thing that I would like to ask if it's acceptable to the committee; as I recall, the last bit of correspondence was also copied to a number of interested parties. This is a public thing.

DR. FAVATA: I think we need to raise the awareness of the scientific community of the availability of these specimens. How do we do that? It's kind of a backwards fashion. I think that clearly we need the ethical, legal and scientific guidance and we need to have a time line to move this forward. We don't really need to bring it to closure, but we need to move it along faster, and I think a time line is important. for us to achieve that.

But I think making the scientific community aware of the presence of these specimens might stimulate a backward reaction; and an investigator could have an interest and then find funding instead of us finding the funding and then get --

DR. HARRISON: You know, I mentioned to Ron a month or so ago, I got asked    I don't know why, but I got asked a little while back by the editor of
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