Ranch hand advisory committee



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RANCH HAND ADVISORY COMMITTEE

Department of Health and Human Services

Monday, January 22, 2001

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

Elissa Favata, M.D., Robert Wood Johnson Med School

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

Richard Ogershok, U.S. Air Force

Dr. Judson Miner, Program Management Support

Manuel A. Blanca, Program Management Support

Meghan Yeager, SAIC

William Grubbs, SAIC

Maurice Owens, SAIC

David Banks, SAIC

Bill Chism, EPA

Rick Weidman, VVA

Gary Kayajanian, Ph.D.

Kim Penland, FDA Week

C O N T E N T S


Introductions 4
Review of Minutes from October 19-20 Meeting

Committee 7


Review and Discussion of the SOW for the 6th Cycle of the AF Health Study
Statistical Models 40-55

Covariates and Interactions 140

Analytical Planning 140

Clinical Category Anlyses 177

Open Public Session 104
P R O C E E D I N G S

[1:10 p.m.]

DR. HARRISON: Good morning. I'm Bob Harrison, chair of the Advisory Committee meeting. We'll go around the room and introduce ourselves, I guess starting with the people here at the table and then proceeding to the representatives from the Air Force and the contractor, and then those members of the public who are here.

I've already said I'm Robert Harrison, I'm Professor of Medicine at the University of Rochester, with no particular expertise that lends itself to this committee.

MR. COENE: I'm Ron Coene, and I currently am a contractor to NCTR. I served as the exec sec to this committee, and former exec sec and a few other things. But I have retired and I'm here to help out for the next day and a half, two days.

MR. SCHECHTMAN: I'm Leonard Schechtman, I'm the new Associate Deputy Director, NCTR-Washington operations, and I'll be replacing Ron in his position as Exec Sec to this committee. That's a big pair of shoes to fill, and I've got some real little shoes right now.

DR. GOUGH: I'm Michael Gough, this is my second stint on the committee; I was here for five years, from 1990-95, and this is my second meeting, second time. What else is there to say?

DR. STOTO: I'm Mike Stoto from George Washington University, I'm Professor of Epidemiology and Biostatistics.

DR. HARRISON: Paul?

DR. CAMACHO: I'm Paul Camacho, I'm a sociologist at the William Joiner Center at U-Mass-Boston.

DR. HARRISON: Thank you.

However you all want to do this; let's do the Air Force and then the contractors.

LTC FOX: I'm Lieutenant Colonel Karen Fox, one of the physicians at Brooks Air Force Base.

LTC BURNHAM: I'm Bruce Burnham, Director of the Air Force Health Study.

DR. MICHALEK: Joel Michalek, Principal Investigator of the Air Force Health Study.

MR. OWENS: Maurice Owens, I'm with SAIC, supporting contractor.

DR. GRUBBS: Bill Grubbs, SAIC.

MR. OVERSHOK: Richard Overshok, program management of the Air Force Health Study, plus other things.

MS. YEAGER: Meagan Yeager, SAIC.

DR. BLANCAS: Manny Blancas, OP-TIK. I'm a contractor providing program support to the Air Force.

DR. MINER: I'm Jay Miner, I'm a contractor with Operational Technologies, also working in support of Mr. Overshok.

MR. BANKS: I'm David Banks, I'm a subcontractor with SAIC.

MS. : My name is Kim Penlan, I'm with FDA Week.

DR. KAYAJANIAN: And I'm Gary Kayajanian, I'm an independent consult, and I've published in the area of dioxin.

DR. HARRISON: Great. Welcome.

I've already mentioned that Dr. Elissa Favata is on her way here, and will hopefully make an appearance fairly soon. But while we're waiting, why don't we go ahead and begin our review of the minutes from the October 19th and 20th meeting.

We've received one set of comments on the agenda from Mike Gough.

Do you want me to read them, Mike, or do you want to read them?

DR. GOUGH: Well, they're rather extensive, but let me introduce them by saying I think these minutes are atrocious. I mean, I don't know what we expect in the minutes, but this is a project that's probably going to cost a billion dollars before it's all finished, it's going to take 25 years to complete.

I can imagine in two or three years a history student or a policy student or a public health student is going to be interested in what this study did and in what the Ranch Hand Advisory Committee did, and if they read this set of minutes, with atrocious    I mean atrocious English, I think it's the only paragraph in the history of the world where the first, second and third person are used in the same paragraph, when they all should be third person.

Plus factual errors. And I think, as I understand it, this is a machine transcription and it is put together by people who probably don't have much information or knowledge about the field, and I don't hold anybody responsible, I don't blame anybody; but I would refuse to sign off on these minutes and would dissent from them, and I have a lot of notations about them.

That's all I have right now.

(Laughter)

LTC BURNHAM: Other than that, they're okay.

DR. GOUGH: Well, I was glad to hear it wasn't a person who did it; it's a machine.

DR. HARRISON: I think that one of the first questions that you ask is really a good one; as someone who is probably not good at process, I thought "Well, my, that's really nice"; and that is, are these minutes supposed to be a record of our deliberations or just what purpose are these minutes supposed to serve?

Should they be a checklist of things that we've recommended to the Air Force so that we can check back and judge whether the checklist was done or not?

DR. STOTO: I think there's probably a law that describes the purpose of the minutes and what they need to do, and so on. I'm sure it's covered by the Federal Advisory Committee Act.

DR. GOUGH: Let's ask our former executive secretary.

MR. COENE: And we have    they're supposed to be what they are, is a summary; because we have a verbatim copy of what's taken place at the last meeting. So this was an attempt to summarize those. Obviously we've got some work to do on those.

Both are available to the public, if requested.

Joel?


DR. MICHALEK: I'd just like to say that, at the end of    a parallel. At the end of every congressional hearing we receive a verbatim set of minutes, which are full of errors and double-spaced, and we're asked to proofread, and we do.

But I have not seen the minutes from the previous meeting. If you would have sent them to me I would have proofread them for you and sent them on to the Chairman through the secretary.

DR. GOUGH: I think that would help a lot. Somebody, particularly you, Joel, because in the first example I give of accuracy, you're quoted as saying concerns developed after the war. Well, the concerns developed during the war. And we'd look just silly as hell if that stayed in here.

Why couldn't it just be a process record, say that Dr. Michalek reviewed the origins and the progress of the study; make references to the written documents, make references to the URL, and be done with it. And then have conclusions and recommendations.

MR. COENE: And that was the type of minutes we had in the past, was process. And I guess we got    that's just a fact, we did have process minutes. If you go back and read them, that's    you know, we said that certain people discussed certain things, and didn't go into a lot of detail beyond that.

We got somewhat gun-shy, I guess, and so we decided to go to the verbatim trip and then the summary; and quite frankly, we ran out of resources to do anything more than that    and so we probably made an error in doing that. But that's the fact.

DR. HARRISON: It's really interesting at this point in this committee's lifetime, we're still trying to decide how to do things. But it seems to me that some content is helpful in the minutes because of the sort of erratic way we meet. Some attempt needs to be made, at least to jog my memory about what we actually said the last time and what the issues were the last time, not just that we met and things were said.

So I think I would be in favor of something with a little more substance, and I guess that the real question is, having pointed out that the minutes have problems, maybe the real thing to do is not focus so much on the specifics of the problems in this set of minutes, but discuss what kind of process we can have in place to ensure that the next set of minutes, and maybe even this revised set of minutes, is more reflective of what happened, even though it's now several months after the fact.

DR. STOTO: I think one thing we have to recognize is it takes a lot of effort to get good minutes, and this goes to the resources issue. I don't want to demand something of the staff that's impossible for them to do.

Maybe we should say how important it is to get good minutes, and that could be communicated in terms of the amount of resources that are available for this kind of effort.

DR. HARRISON: Well, I was feeling kind of funny about it myself, because obviously my job is to review the minutes as well and make corrections, and when I look at an extensive set of minutes, it is quite time-consuming and requires quite a bit of an effort; and I've been trying to decide whether I really want to place myself in the position of feeling obligated to do that; but I think I probably should. Joel can do it because he's good at stuff like that, but it takes me a lot of effort.

DR. MICHALEK: Well, you would send those minutes to me; e-mail them to me, and I'll proofread them and send them back. We'll circulate in our office and send back to you.

DR. HARRISON: Paul, do you have any ideas?

DR. CAMACHO: Well, I like the idea of the standardization. Maybe we could flesh some parameters out and then have what we have in front of us now as a kind of an appendix idea, if people wanted to go into it. So you had a summary of standardized issues; what we voted on, key topic, or however we wanted to arrange this. And then have this kind of summary of the exact    the tape as a kind of an appendix.

DR. HARRISON: Maybe we could standardize on the, essentially each minute, each set of minutes would have the equivalent of an executive summary that would serve the purpose that Mike and Ron were talking about, and the different actions that took place. That would be fairly easy, I think, to accomplish.

DR. CAMACHO: Yes.

DR. GOUGH: Well, I think it would be a good idea to have a    at the end or the beginning, say "the following votes were taken." And then I think if we did that, whoever wrote it, he could key the minutes to that, because those are clearly the more important things we discuss, and that might help a lot.

Now I do think that we should pass it by Joel for factual comments; and if you redline it, it's not a problem for anybody to go back and say "Well, that's not what I said." Even though Joel said it correctly and I said it incorrectly, that's not what I said, which is going to happen.

MR. COENE: Application, are you talking about the transcript now or this summary document?

DR. GOUGH: No, whatever the summary is. The transcript    everybody's used to reading these transcripts and finding out that    at least I've found out I've never spoken a complete sentence in my life.

(Laughter)

MR. COENE: There lies    summarized.

DR. HARRISON: So would this sound like the sense of the group, not just the committee but also of the Air Force participants, that we do have concern about the accuracy and intelligibility of the minutes, that Joel will review the minutes in terms of the accuracy of the Air Force statements. I think that I should review the minutes, and particularly with respect to the accuracy of the committee's positions, and that there should be a summary of the minutes, to include the actions recommended and votes taken, either at the beginning or at the end of the document, to the extent that FDA resources allow those things to be accomplished, that's what we would like to see done.

Yes?


LTC BURNHAM: We'd really like that list of actions recommended, because in the past we get a lot of different responses and there's a lot of discussion, and we never get any finalization, consensus.

DR. HARRISON: Okay. So the Director really does want that list.

I think a good point was made, though; and that is that the FDA has allocated a certain level of resources for this, and obviously they have to do what they can within the limits of the resources allocated.

LTC BURNHAM: Hasn't that changed, though. recently? Hasn't HHS   ?

DR. HARRISON: Resources are always allocated. There may be more --

LTC BURNHAM: I thought part of the deal is you were going to continue doing it, but they were    that didn't happen.

MR. COENE: This is it, I'm finished.

DR. HARRISON: No, what he's saying is, doesn't the committee have more money now than it used to?

MR. COENE: It has resources; it was given resources for last year and this year, yes. It has some resources.

DR. HARRISON: So at least we can do it this year. Whether we can do it next year is another question.

MR. COENE: It's in dollar resources and not in people resources, and the issue becomes one of having somebody that understands and understands what he's reading or she's reading and makes some sense out of it, and therein lies where we're shorthanded; we don't have anybody that    you know, I come as close to it, and even then. See, I would not have picked up that, and we need   .

Look at the Air Force    I mean, you guys sit over there and I'm going to take you on a little bit, with resources that goes beyond us, and you can recommend a lot of things. HHS doesn't even come close to having those kind of resources to put to bear on this.

I'll tell you something, I'll go on the record here a little bit, I'm a little bit concerned, I deal with a new document    and I'm going to take off a little bit    I get this new document here and it's different than the one I had in September that I had to give to the committee. So when I put an agenda together, I find new sections that weren't there when    what you gave me in September to send out to the committee.

I mean, come on, guys.

LTC BURNHAM: Those aren't different? I mean --

MR. COENE: They're different, yes.

LTC BURNHAM: That's the writeup. I mean, that's the reworked    the second one was the reworked --

MR. COENE: Yes, I know. But here I'm asking the committee to respond to a scope of work, and you keep changing    it's not a steady target.

I got two different drafts, and even as late as last night I was going through and I said, Okay, I want to try to organize today to get to your point, Bruce, where it says, you know, 'we reach some conclusions on specific things'    I find two new sections in the clinical section that weren't there when I put the agenda together back in December.

LTC BURNHAM: Those are different than the rewrite? What you've --

MR. COENE: The January rewrite, the January    the September rewrite and the January are different.

LTC BURNHAM: The last one that we sent you was intentionally different because you wanted the updated --

MR. COENE: The marked up one.

LTC BURNHAM: The marked up one, yes.

MR. COENE: Right, and I assigned, Bob assigned sections to the committee, and there are two new sections.

DR. HARRISON: And when the marked up one had new sections   

MR. COENE: And it's not a big deal, but    I just --

DR. MICHALEK: I can respond to that; I get your point, and that's just the way the process is at this point. We're running out of time. We're trying to give you the latest material, and you're right, the document changed.

DR. STOTO: I think the issue is having enough staff resources at the HHS end.

MR. COENE: You're not going to get that. I'm a private citizen. You're just not going to get all of the resources --

DR. STOTO: I'm not saying that you personally should do it.

DR. HARRISON: NO, what he's saying is the office receives a very small budget, there's not a funding line for an editorial assistant, and so what are we going to do about it? Shall we --

DR. STOTO: Is there no possibility of transferring funds from the Air Force to do it? It certainly would be in their interest to get good records.

MR. COENE: They have    in their behalf, it's awkward to do this. And the appropriateness of that is --

DR. HARRISON: We talked about this once before.

MR. COENE:    and the fox in the chicken coop --

DR. HARRISON: Yes.

LTC BURNHAM: I don't know if that would go over real good with --

DR. STOTO: Well, as a member of this committee, I make an investment in this, we all make an investment in this; we want the investment to pay off. And that takes a kind of effort that I'm not able to do, myself.

DR. HARRISON: I don't believe that it would affect any of us if the Air Force contributed funds to the operation of the committee. But it would certainly seem like it to somebody who wasn't a participant. And that was the concern that I felt was most important; that is that if we ever appear to lack a level of independence in terms of at least what we expressed, whether it gets expressed clearly in written form or not, then our usefulness as a committee is gone. And it's hard to launder the money well enough   

(Laughter)

DR. STOTO: No, I don't think it should be in any way laundered; I think it should be above board. I mean, the Air Force is doing the study; it's well-recognized in a lot of other areas of scientific research that to do a good study you need to have external advice, peer review in one form, and that it's part of the cost of doing business. And we have a committee that is set up and is staffed by an independent agency, so I think there should be no question about whether or not the conclusions that we come to are appropriate or inappropriate or are fairly represented, but I don't think it is inappropriate for the Air Force to pay for it.

DR. HARRISON: Well, I respect your opinion. But in terms of what we're going to try go do, in terms of    what we can do as a committee is, it seems to me, is to say what we would like the minutes, how we would like the minutes to be structured. We can complain if they're not structured that way.

I don't know that we can    if you have something in addition that you think we can do, then --

DR. STOTO: Well, I guess if it were up to me, I would say explicitly that it takes resources to do this well, more than apparently exists in HHS, and that we should try to find a way to get money transferred from the Air Force.

DR. HARRISON: So the criticism    and Mike's certainly got an extensive critique of the minutes here, is that that's a direct consequence of inadequate funding of the FDA staff.

DR. STOTO: Inadequate staffing. I don't know what the budget looks like, but it's certainly inadequate staffing.

DR. HARRISON: Inadequate staffing, and needs to be corrected.

Are you okay there, Paul?

Did we lose you, Paul?

[No response.]

DR. HARRISON: So is anything more to be done with the issue of the minutes right now?

DR. GOUGH: Well, I want to ask a couple of specific questions. Is it okay then if we send, as part of the process    I mean, I think it's okay if, as part of the process, we review the minutes, we send them to the Air Force. I just want to be clear.

[Reconnecting speakerphone to Dr. Camacho]

DR. HARRISON: But my point is, I think that    I think we have to recognize though that, at least I think it's fine for Joel to correct what the Air Force says; I don't think it's fine for Joel to correct what I say.

DR. GOUGH: No.

DR. HARRISON: That was all I was    but in terms of    so I think that any corrections have to follow two tracks. There has got to be a committee, the committee has to be involved somewhere in the corrections, and the Air Force has to be involved.

DR. GOUGH: I think if we do that    how much does it cost to get an editor for getting verbs to agree with nouns and things like that? That doesn't cost very much, does it?

MR. SCHECHTMAN: If I could add something here.

DR. GOUGH: Yes.

MR. SCHECHTMAN: I think we're not only dealing with that level of modification of the minutes. We're talking about expertise that's lacking in the individuals and the HHS staff that are capable of recording the factual material in the way that you would like to see it down on the record.

And that certainly is a reflection of say lack of funding, or the funding requirements that are just not there to support such a staff. And we wouldn't necessarily need such an individual full time on the NCTR-HHS staff; however, if that expertise is available say through the Air Force, that could work with us in recording the factual material, because we're using the verbatim transcript to do the first cut, do the second cut, wind down to some level of minute-taking that is at least comprehensible by people who don't have the expertise, don't have the background to do this kind of reporting. But working in conjunction with those folks that do have the expertise, we could probably give you the kind of record that you want. But that person has to be actively engaged in the note-taking.

DR. STOTO: I think that as long as we as a committee review everything, and take responsibility for the final minutes, the final product would be a lot better if it's done that way.

DR. GOUGH: Me, too.

DR. HARRISON: Why don't we leave it    well, first of all, to try to work out the details of this operation as a committee is probably not the most efficient thing. I think all the committee members have expressed their concern about the minutes; I think here have been several excellent suggestions made about how we can improve the minutes. Why don't we give our Executive Secretary a chance to demonstrate his expertise   

MR. SCHECHTMAN: Or lack thereof.

DR. HARRISON:    and put together a mechanism for us to do this. It may mean that we're going to have to work out a way for me to spend a half a day or so on a telephone call, a teleconference or something, going over the minutes with you. Maybe they should go to Joel first, and then you and I can go over them. Maybe we can do something like that.

I'm just saying I think we have reached a level of granularity here that we don't need to go below.

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