Ranch hand advisory committee




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RANCH HAND ADVISORY COMMITTEE


Department of Health and Human Services


Tuesday, January 23, 2001


Day II


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

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

Mary Lambert, DHHS

Bill Chism, EPA

Rick Weidman, VVA

C O N T E N T S


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


Clinical Category Analyses (Continued)

General Health Data 214

Neoplasia Data 236

Neurological Data 254

Psychological Data 269

Gastrointestinal Data 277

Dermatologic Data 288

Cardiovascular Data 290

Immunologic data 299

Hematological Data 303

Renal Data 310

Endocrinological Data 310

Immunological Data 349

Pulmonary Function Data 352

Open Public Session 356


Discussion of Dioxin Study Disposition 394

Section 3.7 465

Addendum A General Physical Examination 498

Agenda and Future Meeting Dates 507

Discussion of Report Writing 517

P R O C E E D I N G S

[8:55 a.m.]

DR. HARRISON: Shall we try and start where we left off yesterday?

DR. GOUGH: I have a problem, a minor problem.

When you did the spousal questionnaire, originally, every answer was followed up for medical evaluation, wasn't it?

DR. MICHALEK: The spousal questionnaire --

DR. GOUGH: On reproductive health?

DR. MICHALEK: Yes. On anything to do with the children, yes, they were followed up by medical record review.

DR. GOUGH: Are we opening the door to that again?

DR. MICHALEK: No, because what we've asked them to do here is tell us: Is there a period of time where you tried to have a baby and weren't able to have a baby? And they tell us the dates. And we get that information from the mother and from the father. The purpose of this is simply a paper on fertility.

DR. GOUGH: Okay, all right.

DR. MICHALEK: We've already published the papers on the children.

DR. GOUGH: I was concerned, because I remember it took so long to do that.

DR. MICHALEK: No. That's another   .

DR. GOUGH: Okay.

DR. HARRISON: All right, now I'm not exactly sure where we left off last night. I think we were somewhere around General Health Data?

DR. FAVATA: I just had a few comments on that.

DR. HARRISON: General Health Data is 3.6.4.

MR. COENE: And I think Paul had already talked about his comments. He got some clarification yesterday. He was the other reviewer on that section.

DR. HARRISON: Okay.

All right, Dr. Favata?

DR. FAVATA: Really, it's very limited; one is just an editorial, line 6 down at 3.6.4.1.1, to remove erythrocyte sedimentation rate.

DR. MICHALEK: I'm sorry, where is this now?

DR. FAVATA: In 1.1, Joel.

DR. HARRISON: Oh, the sixth line down.

DR. GOUGH: 3641.

DR. FAVATA: The only question I have is, what is the significance of the issue of a participant's self-perception compared to bla-bla-bla, being adjusted for hostility? Why was hostility chosen, and the question is, how are you going to measure for that?

DR. MICHALEK: Those are two good questions; I don't have an answer. Except that early on in the study someone thought that personality type was an important covariate. Well, since then, we've stopped measuring personality type and replaced that with a measure of hostility as recommended by I believe someone on this committee, and we've tasked the contractor with finding a good measure of hostility.

So that's really all there is to say. If you think this is not an appropriate adjustment, then that's important.

DR. FAVATA: I guess my question is, why was that particular personality trait or personality problem noted, and how do you actually measure for that?

DR. MICHALEK: There are probably a series of questions in the literature that people use to assess hostility. Someone's going to have to do a literature review on that, on how to measure hostility.

As to why we would adjust for hostility or personality type, the intuition I have is simply the demeanor of the individual; you know, he could be --

DR. HARRISON: This represents a departure, though. I mean it was personality type before and now it's hostility. So --

DR. MICHALEK: Yes. The reason we're in this problem is that the instrument we've used to measure personality type is no longer applicable to this group. Because the scenarios in the questions refer to employment. Most of these men are retired, and actually they've become very irritated, many of them, at taking this Jenkins questionnaire.

So merely by administering the questionnaire we're making them hostile, or we're changing their personality type. And we've examples of them just    you know, doing diagonal patterns down the page on the multiple choice responses; they're not responding in a reasonable way to the questionnaire. So we're going to drop the Jenkins, which means we do not have a clear measure of personality type at this physical.

We were told that    someone told us, and I've seen it in the literature, that the appropriate covariate would be a measure of hostility, but we're talking cardiovascular endpoints here. And the question posed at the time we talked about this was "If we're not going to measure personality type, what covariate or corresponding covariate would we use for cardiovascular endpoints?" And the answer was "hostility."

Well, I simply replaced personality type with hostility in this section; may not be appropriate?

DR. FAVATA: Why not anxiety? Or.

DR. MICHALEK: Yes. We have anxiety.

DR. STOTO: In the past has the personality type ever made a difference when you adjusted for it?

DR. MICHALEK: Probably not.

DR. HARRISON: Certainly it's said to make a difference. I mean, in terms of cardiovascular disease and so on.

DR. STOTO: This is the General Health section.

DR. HARRISON: I don't know that there's any evidence of personality type changes.

DR. MICHALEK: Well, if you want to use past measures of personality type, you're going to miss about 10 percent of the group. You know, they're going to have about 10 percent of the people come this time that didn't come last time.

DR. HARRISON: They haven't been any time?

DR. MICHALEK: Well, I don't know; what percent   

DR. GRUBBS: I'm not sure that --

DR. MICHALEK: We're going to lose a few percent.

DR. GRUBBS: Relating to that question, we looked at '87 classification of personality types versus 1992, on the same subjects, and about 25 percent switch from A to B in terms of their answers to their questions, which was real interesting to us.

DR. HARRISON: But you're also talking about men that have already gotten into the situation that Joel is talking about, where the questions aren't relevant. If you had an '82 test or something, you'd really almost have to go back to there.

DR. STOTO: That may be the most relevant.

DR. HARRISON: And may be the least generally available, too.

DR. MICHALEK: I think the more general question is, should we do any adjustment at all? Maybe this is a question for Paul, because these are kind of socioeconomic types of things and personality types. I don't know.

MR. OWENS: I have a comment. In going back over the history of using the Jenkins for personality type, the Jenkins test is going out of favor and very few people use it, and it was weakened; and we came into, we were having difficulty accessing the test, and we always asked the question, "Well, what other measure of personality type could we use?" And the questions would come up, "Well, what do you want to do with it?" You know, the second level questions would come to play, and the answers really    really didn't have the answers or we went back to, "Well, we used the Jenkins before."

So that led us to gravitate towards the Jenkins test for the purpose of continuity. But if we put the Jenkins test aside and go for a new measure, that's going to open up whole new ground, and unless we know where we're going, it's going to be difficult   .

DR. HARRISON: I'm suggesting that we retain this for discussion when Paul gets here, and ask the question of whether there should be any personality assessment in this round.

DR. GOUGH: Can we ask the Air Force to let us know if the adjustment did make a difference or not?

DR. MICHALEK: We can get an answer to that in a few minutes, as soon as I get to the phone.

DR. GOUGH: Okay. Why don't we do that, too?

DR. MINER: I've got the report here on disc, if you want to --

DR. MICHALEK: Oh, yes. We've got the report on disc, or anyone who can get to the Internet will see the report on the web page. But since you have it on disk.

DR. STOTO: Why don't we look at it during the break or something.

DR. GOUGH: Well, they can set it up; we don't need to look at it.

DR. HARRISON: While Joel is looking for that, let's go on.

What else?

DR. FAVATA: There's nothing else.

DR. GOUGH: I have a question on the section.

DR. HARRISON: Go ahead.

DR. GOUGH: On 3641a, the comparisons made to other people of the same age, are these the other patients in Scripps?

DR. MICHALEK: No, this is an instruction to the doctor. This the physician answering: Compared to other people of the same sex and age, would you say this man is older than or younger than --

DR. GOUGH: Okay. So it's very subjective.

DR. MICHALEK: Yes, it's subjective.

DR. HARRISON: Before we go any    is that all for General Health Data.

DR. MICHALEK: I'm sorry, this is the self-perception.

DR. HARRISON: If that's all on General Health Data, I realize I've got a couple of things I want to ask about that don't fall into any of these categories; and I just want to make sure that I don't forget.

Where are we with IRB approval, both the Scripps IRB and whatever you all use. Are we able to get a copy of that for our records that --

DR. MICHALEK: The answer is Yes. What will happen is, the sequence of events will go like this. Out of this meeting will come a set of opinions, and we will use that, your opinions to revise the Statement of Work. And after we revise the Statement of Work and we're pretty much settled on what we're going to do at Scripps, then I will approach the IRB. And the IRB will want to know, what are we doing this time that we didn't do last time? And conversely, what have we stopped doing this time that we did last time, and why?

And after that presentation and I obtain IRB approval for the current Statement of Work, at the same time I'll present to them consent forms. That's the other piece that they have to approve.

There's usually an editing process on the consent forms that may go on for two or three months.

After we've received formal IRB approval for the study and for the consent forms, then if you'd like I can communicate those to you.

DR. HARRISON: I think we should have that.

` DR. MICHALEK: For the record.

DR. HARRISON: The other two things that I had down here was, could we have a complete list of the previous contractors and subcontractors? That is, for the 19 --whatever it was.

DR. MICHALEK: '97

DR. HARRISON: '97.

DR. MICHALEK: Sure. A complete list of contractors.

DR. HARRISON: And the list of the specialists, medical specialists used in preparing the various chapters?

DR. MICHALEK: Okay, you've put your finger on something new, actually. We will get you those lists.

DR. HARRISON: Which part is new?

DR. MICHALEK: What's new is that last time we had a single physician who did all of the interpretations and discussions, summary paragraphs across all the chapters. But this time we're going to have specialists in each chapter write the overall interpretations.

DR. HARRISON: That's one of the reasons I was curious, because I've been dissatisfied with the chapters; and somewhere in here I've got a notation that, wherever you spell out that you're going to use specialists, I wanted to ask you if you could change that to say that you'd use experts.

DR. MICHALEK: Okay.

DR. HARRISON: The point being that a fellow right out of his endocrine fellowship may not write the kind of balanced review of the endocrine chapter that would satisfy me.

DR. MICHALEK: Okay.

DR. STOTO: Better than one doc writing the whole thing.

DR. HARRISON: I was amazed.

A couple other things that I wanted to must make sure    you've got in there that there's a, you've got a toll-free number for people to contact. Is that accessible 24 hours?

DR. MICHALEK: No.

DR. HARRISON: I think that would probably facilitate things; and you also have that there's a number for the family to contact the Ranch Handers when they're out being studied, and I think it would be a nice gesture if they were able to make free calls for that, and it probably won't cost you that much. It would be good --

DR. MICHALEK: You mean free calls to their family while they're at Scripps?

DR. HARRISON: In other words if mama wants to call up daddy and see how he's doing, she should be able to call an 800 number and be connected to him, and not have to pay three dollars long distance.

DR. MICHALEK: We'll have to price that out and see.

DR. HARRISON: Do you have a problem that, for some of the    you have two groups of examinees in per week, if you do it like you used to. Do you have a problem with them not filling, some people canceling at the last minute?

DR. MICHALEK: Yes; NORC is very good at that. They're our schedulers, and they keep up with it.

DR. HARRISON: I was just wondering, do they keep a list of people who are    you know, like every time I go on the plane and they want to know if anyone is willing to be bumped, somebody always jumps up because there's always somebody who's really very flexible. You might keep a sub-list of very flexible people who could come at the drop of a hat; they could help fill out your groups.
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