Ranch hand advisory committee




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RANCH HAND ADVISORY COMMITTEE


Department of Health and Human Services


Wednesday, January 24, 2001


Day III


Meeting


Parklawn Conference Center

Conference Room K

Parklawn Building

5600 Fishers Lane

Rockville, Maryland

ATTENDANCE

Committee:

Robert W. Harrison, M.D., Univ of Rochester, Chairman

Michael A. Stoto, Ph.D., George Washington University

Michael Gough, M.D., Consultant

Paul R. Camacho, Ph.D., Univ of Massachusetts-Boston

Ronald F. Coene, P.E., Consultant [former staff]

Leonard M. Schechtman, NCTR, staff

Barbara Jewell, NCTR, staff

Attendees:

LTC Karen A. Fox, M.D., Brooks Air Force Base

LTC Bruce Burnham, Chief of Population Research

Dr. Joel Michalek, Principal Investigator

Dr. Judson Miner, Program Management Support

Manuel A. Blanca, Program Management Support

Robert Newman, House Sub on Nat'l Security and VA

Mary Ellen McCarthy, House Veterans Affairs

Dr. Gary Kayajanian

C O N T E N T S


Review and Discussion of the SOW for the 6th Cycle of the AF Health Study (Continued)


Drafting Letter 539


Agenda 566


Future Meeting Dates 576


P R O C E E D I N G S

[8:53 a.m.]

DR. HARRISON: (Reading draft letter.)

(Discussing the wording of the letter.)

DR. HARRISON: I just put another sentence in here. I just want to read it. You know, what will happen is that when I send this around, if I put in something that you haven't heard before, it'll be kind of out of context, and you won't really quite know why it was there.

But I just put in there as a last sentence: "Please also realize that inertia is such that this is an urgent problem that needs immediate action" -- underline immediate -- "to avoid loss."

That kind of addresses what Len was saying, and that is to point out that if planning is left until 2006, that that guarantees loss of sample, that something needs to be in place now.

DR. CAMACHO: You know what I would like to do also, I would like us to either informally or formally as a Committee outline the difficulties that we talked about yesterday; the ethical difficulty, the possible need while we're on that issue.

DR. HARRISON: All I put down here was we would like --

DR. CAMACHO: Not in that letter.

DR. HARRISON: -- we would like this meeting --

DR. CAMACHO: Not in the letter.

DR. HARRISON: -- "we would like the VA to determine the ethical and scientific issues at stake." I included that as part of the letter, because --

DR. CAMACHO: In general.

DR. HARRISON: Yes.

DR. CAMACHO: Okay.

DR. STOTO: Maybe we could add that, you know, we'd be happy to work with whoever takes a responsibility for doing this, considering these issues.

DR. CAMACHO: Yes. I wasn't referring to the letter, Michael, I was referring to

the --

DR. STOTO: That may be self-evident.

DR. CAMACHO: -- to the points that we talked about yesterday.

DR. HARRISON: Well, let's see. "We feel strongly..." (reading).

DR. STOTO: I think it's self-evident.

DR. CAMACHO: I'm not referring to the letter.

DR. HARRISON: All right. So this is a first cut. This is not a commitment by anything, and I would certainly -- you know, I won't do anything until we're all satisfied that it's appropriate.

I've got down that this goes to the Secretary. It gets cc'd to the VA Secretary. It's going to have as attachments right now the previous letter as well as a copy of the Public Law.

DR. CAMACHO: Would you throw in the sheet of his Powerpoint? That won't make sense, though.

DR. HARRISON: No. No.

Should this also go to the Air Force Surgeon General? That's a committee question.

DR. GOUGH: I think so. Because it's the Air Force study.

DR. HARRISON: We wouldn't want the Surgeon General to be blindsided by a letter that they're not aware of.

Going once? Going twice?

LTC BURNHAM: So you'd be happy if there's a repository for the samples and records? Is that what you're --

DR. CAMACHO: That's a minimum.

DR. HARRISON: Well, I'm not saying what I'd be happy with because I'm not sure I have the expertise to say that. I think what I would be happy with would be to have people that I would respect; epidemiologists like Mike, and ethicists. I would be happy to know that they met and seriously considered this, that they invited you all, that they made sure that they were well aware of what had gone before, and then decided, you know, "This stuff is worthless. Can it."

I mean, as long as it's given serious consideration, I don't think you can -- you then have to go with whatever the decisions are.

DR. GOUGH: The letter says, it's a storage while you make up your mind about what to do with it.

DR. HARRISON: Right.

DR. GOUGH: There's two parts.

DR. HARRISON: But if you think about it, you can't store something unless you're going to figure out, try to figure out, at last make a commitment to try to figure out what to do with it.

DR. GOUGH: I think you underestimate the government.

LTC BURNHAM: No, that's true. CDC has thousands of serum samples just in freezers in case someone wants to use them in the future.

MR. COENE: You've given a solution, Bob. I would suggest, as you put it down, look at Section 7 and Section 8 of the law, and that contains tissue archive system and scientific research and feasibility studies program, that we want the Secretary to know that this needs to be implemented.

DR. HARRISON: Okay. I'll tell you what. What would be the best way to do this?

Can you all produce a word processor version of this text with appropriate sections underlined, so that what I'll include in the letter is, I'll say "see this attachment, especially underlined portions."

That way, again, it won't be a part of the letter. It won't detract from the punch of the letter.

MR. COENE: That is on the web. You can download it from the web.

DR. HARRISON: It's in Joel's database.

DR. MICHALEK: I'll email it to you.

LTC BURNHAM: Does it have the site on the top?

DR. MICHALEK: The web site? No. What happened was I downloaded it from the web, put it into a Word document and printed it, so I will e-mail it to you when I get back.

DR. HARRISON: But you see what I'm saying? Instead of having it in the letter, some way --

MR. COENE: By the way, I told you wrong. Our web site's not public yet, or at least NCTR isn't public, and therefore you can't get it. Otherwise, it would have a date of this meeting and the Minutes of the last -- not this last meeting, but --

Dr. MICHALEK: That's another point. I'd really like to have a copy of the Minutes of this meeting for my folder, for my record.

MR. COENE: Okay. That's something we need to do anyhow because that's one of the action items. Okay.

DR. STOTO: When I get your draft, I'll see whether I might be able to correct a sentence or two that says a little bit more about what the law says that might fit in there.

DR. HARRISON: Okay. All right.

Gary, good to see you again.

DR. KAYAJANIAN: Thank you.

DR. HARRISON: We just finished discussing our concern for disposition of the Air Force samples at the scheduled end of the study and our desire that the appropriate agencies begin making plans of how to maintain and preserve these samples for future scientific use.

The last item of business -- Jay says that there are a couple of left over things. What do we have left over?

DR. MINER: We didn't ever finish the serum dioxin testing for everybody versus not.

DR. MICHALEK: We'd like your opinion.

DR. MINER: If we can open that up again.

DR. MICHALEK: In the hypothetical case that we did have the funding, does the Committee think we should do the TEQ or the dioxin again on every subject?

DR. HARRISON: Okay. Mike's comment was that TEQ was not -- he felt it wasn't useful, as I recall, because dioxin was the contaminant de jur in Agent Orange.

DR. STOTO: The dioxin measure in this study is a measure of exposure to the herbicides. That's presumably better than --

DR. MICHALEK: Do you think that we should do a dioxin measurement again on this subject?

DR. HARRISON: And then Mike thought, the other Mike thought that everybody should have two points.

DR. GOUGH: I was initially opposed to that; but he's right. If you're trying to do individual elimination rates, you need those  .

DR. HARRISON: So I think, that was actually my understanding of the committee's position. Was that dioxin should be measured, not TEQ, and that those individuals who only had one measurement, attempts should be made to have two measurements made, whether they were Ranch Handers or comparisons.

DR. STOTO: That would allow people to do some more sophisticated statistical modeling to get at some of these things.

DR. MICHALEK: Then my opinion would be that you should do a dioxin measure on everyone. Because if you were to do only those that only had one point, you would be not taking advantage of the very last time you're going to see these individuals. And there would be a benefit to measuring every single subject.

You're talking about skipping about 400 people if you don't. This is your last time.

DR. STOTO: I think having the point separated in time is --

DR. HARRISON: That's fine. That's fine. Well, is it this below-quorum committee's consensus that --

DR. STOTO: I think that if it turns out they can get some of the resources but not all, then we need to consider what    but I think that it would --

DR. HARRISON: So our first priority would be to have two points, the next priority would be to have everybody, and the very wasteful priority would be to do TEQs on everybody.

DR. STOTO: Something like that. But I think that we can consider the priorities on every stage if we need to.

DR. MICHALEK: So the first priority is two points on every subject.

DR. CAMACHO: Second one is every subject.

DR. MICHALEK: Second one is do everyone, whether they have multiple points or not, and the last priority is to do a TEQ.

DR. HARRISON: Don't even put that in. Because Mike's argument was that that was wasteful anyway.

DR. MINER: We have asked you to do fiscally unrestrained recommendations. Now we'll have to go back and look.

DR. HARRISON: The science says there's no way to use the TEQ.

DR. GOUGH: The only place it would be of interest is if we had a lot of guys in the comparison group or a lot of guys in the Ranch Hand group who had unexpectedly high concentrations. And I would expect them to have really different profiles, because they have 2 3 7 8 and then they have all those pintas and octas. But I think that's a minor gain because we don't have very many people like that.

DR. MICHALEK: Well, we don't know.

DR. GOUGH: Well, we do know. The highest comparison --

DR. MICHALEK: We've never measured the other congeners.

DR. GOUGH: What's the highest comparison guy?

DR. MICHALEK: 50 parts per trillion.

DR. HARRISON: But you know that    okay, you're making a point, though. You're saying that it could also be looked at, if you had the funds; it would be looked at as surveying that group with the possibility that there's some oddity that's producing elevations of other forms of dioxins.

DR. STOTO: That makes it a different study.

DR. HARRISON: Yes, but it would be a way of    if you did that and there weren't other congeners, it would give you, your statistical analysis a little more    it would give you a little more confidence because you would have ruled out a possible unexamined confounder.

DR. MICHALEK: That's right.

DR. GOUGH: How much more does it cost?

DR. MICHALEK: Not much. In fact, I talked to CDC and they'll produce the entire panel of 36 congeners for the same price as they'll produce the TCDD.

DR. HARRISON: Oh, gees.

DR. STOTO: Then do it.

(Laughter)

DR. MICHALEK: So there's no issue on cost.

DR. HARRISON: But the other thing is, we now have identified a possible use for the measurement, so   .

DR. MICHALEK: What you've done is extended the use of the data to humanity after we all leave and the Agent Orange issue is closed. You'll be able to use the data for other purposes.

DR. STOTO: Can I give another thing in this hierarchy of possibilities? The best thing would be to get everybody. The next thing would be to get a measure on the people who only have one, so far. The next thing I would say is get the people    if you can't afford that, get the people who have elevated measures.

DR. MICHALEK: Okay, those Ranch Handers in the pharmacokinetic study. Those are the ones above 10.

DR. HARRISON: Okay, to get another point that is very likely on the first order --

DR. STOTO: If their first measure was below ten, getting another measure is not going to be all that valuable.

DR. MICHALEK: Do above ten only. That's going to be about 600 people.

DR. STOTO: It's best to get everybody, and it's next best to get --

DR. HARRISON: The problem with those low numbers is, how are you going to analyze it? Either numbers above ten will follow first order kinetics; the ones below ten are following some life cycle of the sun and --

DR. STOTO: That's why I suggested this intermediate position.

DR. MICHALEK: We believe the ones below ten are in steady state, although we don't have any data to show that. But this would give us the data to show it.

DR. HARRISON: But you said they weren't in steady state, because the level keeps dropping.

LTC BURNHAM: Dropping.

DR. MICHALEK: That's true; and if it hadn't been for environmental cleanup and the whole population coming down, they would be in steady state. But this is your chance to know and to eliminate an assumption.

DR. HARRISON: I'm not opposed to it; I was just --

DR. STOTO: But it's clearly more valuable to have the second measures on people who had a higher level to begin with.

DR. MICHALEK: Right.

DR. KAYAJANIAN: If you want to look, you want to look, for example, in the below 10, you look at 8 to 10 or 6 to 10, because they have a chance of coming down. I sort of sense a somewhat different --

DR. STOTO: I don't want to make distinctions in there.

DR. KAYAJANIAN: No, no. I'm simply saying if you have to.

DR. HARRISON: I don't think that's going to be necessary. Joel will write a check for this himself if he has to.

DR. MICHALEK: Don't worry.

DR. GOUGH: This is beyond the scope of work I think right now, but we have archived serum samples, right?

DR. MICHALEK: Yes.
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