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MS. McCARTHY: That's all right; they can be mad at us, that's fine. But you need about $2 million --
DR. MICHALEK: About $2 million.
MS. McCARTHY: to go to CDC, because drawing the blood is really not going to cost you much more.
DR. HARRISON: Let me run through because we did it in levels. We said, number one, that everyone should have a dioxin draw, whether there were funds to do the assay or not, because and you missed this, this was earlier, we are concerned about future archiving of these, and maintenance of these samples; and a letter is being prepared for the Secretary of Health and Human Services asking that a process be put in place to resolve that issue.
So we want the samples drawn. The committee recommends that as the first cut.
MS. McCARTHY: Okay.
DR. HARRISON: There are two possible assays to do; dioxin and total dioxins, TEQs; and it turns out that the CDC will do the total thing for the same price as the dioxins, as dioxin itself.
So we would like all of the, the entire cohort to have an additional assay performed. If for some reason there is insufficient funds for that, there is a cohort whose dioxin levels were still high, that we would say that would be if we had to select a group, the subgroup of the cohort, it would be those with high dioxin levels.
So we've made recommendations. And the justification --
DR. GOUGH: No, I thought we were going to do the people with only one point first.
DR. HARRISON: Well, I'm glad I reviewed this, because I thought it was pretty clear that it was felt that adding additional point to the high values that still had first order kinetics would come first.
DR. GOUGH: I thought other way around, actually.
DR. CAMACHO: What was the last thing we --
DR. MICHALEK: All right. First priority was to do everyone; if we couldn't afford that, then we would get at least two points on everyone.
DR. HARRISON: Okay.
DR. MICHALEK: And finally, we do above ten only.
DR. HARRISON: Okay. I'm glad I --
MS. McCARTHY: So the third one is everybody who was above
DR. CAMACHO: Above ten.
DR. MICHALEK: And that's about 500 people.
Getting a second point on those that already have one, will be about 1500 people, and doing everyone would be about 2300 people. And we think the current price at CDC is about $800, in round numbers. So $800 times 2300 will be the maximum cost, which would be about $2 million.
DR. HARRISON: And the reason for doing the TEQs rather than just dioxins is the possibility that there may be the unlikely possibility but still finite possibility that there would be a confounding other dioxin that might actually had a health effect. And this would be one last chance to rule that out as a possibility.
And if you all could get another ten thousand or so just sent directly to me
MS. McCARTHY: Sorry, we don't take requests.
DR. HARRISON: My real complaint is that I didn't get to fleece.
DR. CAMACHO: There's also a disposition of I thought we talked about having some kind of a forum about just bringing the --
DR. MICHALEK: There are two conversations in the room and it's hard to concentrate.
DR. GOUGH: Mike?
DR. CAMACHO: I thought there was also a concern of getting some kind of a panel together among ourselves with the Veterans Affairs committee and others that are interested, to just brainbust and discuss the closing of the study. And I think that's important from my point of view, that all the committee members get it in their head what's going to happen here. So we're not just yanking a plug out of the wall in 2006.
There's a lot of ideas, legal issues and ethical issues.
DR. HARRISON: Paul, what we agreed was that I would send a letter to the Secretary of Health and Human Services, Secretary of the VA and Secretary of the Air Force, expressing the concern of the committee that plans be made for disposition well, for maintenance and preservation of what really is an irreplaceable treasure trove of scientific material.
And we discovered that there's a basis for the VA being responsible for organizing the discussion of this; because there's a Public Law 104, Section 8 says that the VA should be doing this.
VOICE: 1024, Section 8.
DR. HARRISON: And if you'd like to have a copy of that letter when it's prepared, I'd be happy to forward it to you. Because we've agreed that the public itself, and our previous letter to the previous Secretary of Health and Human Services would be included in this new letter.
And we'd be happy to bring you up to speed on that as well.
DR. STOTO: It turns out that what Bruce and I were talking about was the same issue. And I think the point that we've got to be clear is, because of the budgeting cycle in the Defense Department, decisions need to be made soon about what might happen in '07. And I hope that we get that in the letter.
DR. HARRISON: Well, I didn't spell it out that way; I said that this is an urgent problem that needs immediate, and I was going to underline "immediate action" to --
DR. STOTO: Maybe you should say because of the DoD's budgeting cycle or something like that.
DR. HARRISON: Okay.
DR. STOTO: I don't think we need to say the specifics of it, but just to say that--
DR. HARRISON: To meet the budgeting cycle and avoid loss.
MS. McCARTHY: You need this money allocated for FY 2002?
DR. MICHALEK: For the assays?
DR. MINER: We start them in '03 and probably will finish them up either that year or for '04.
DR. MICHALEK: FY.
DR. MINER: FY.
MS. McCARTHY: FY'03?
DR. MICHALEK: FY'03 and 4.
MS. McCARTHY: But you basically need some kind of commitment now because you're getting ready to do your --
DR. MICHALEK: To start.
For the record, I'd just like you to know that what we just heard just now was the content of a hone call I made to Mr. Darryl Dero and to you last week; and it was the reason why we wanted to meet with you, and we still do, to show you in detail, to flush out some more detail.
MS. McCARTHY: Actually Joel, Dero and I aren't actually the right people. We're the benefits subcommittee; we really don't I cover these because of my boss's long standing interest in Agent Orange and its side effects, and the importance it had on the com side.
It's really probably it's probably more appropriate in the Armed Services arena, because I would probably sit in on a meeting that took place. It does make sense to have a meeting at some point, possibly; but I need to talk to you about who the right people are.
DR. MICHALEK: Good. And of course I called you and Darryl because you're the only two I know personally.
DR. HARRISON: But you don't write the purchase order?
MS. McCARTHY: I don't write the purchase order; I just pass on the information to
DR. HARRISON: Understood.
MS. McCARTHY: My boss ranked member of the Committee on Veterans Affairs, is both on Armed Services and the ranking member on the Veterans Affairs Committee. And he has a liaison in his office that's actually half time staff to the committee and half time with DoD. So we have overlapping functions. Usually Tom O'Donnel in Lane's office takes the lead on that, and I did inform him of our conversations.
But I know that has to get cleared through all the DoD bureaucracy and that kind of stuff, but if something needs to happen, we'll just make sure we got the proper information.
DR. HARRISON: Okay. Anything else?
So the agenda for April are the review of the four scientific studies and a VA update, and the agenda for September will be hopefully a fuller VA review of the Chemical Corps study and an update on the Air Force's scientific publication process.
DR. GOUGH: I just want to put on the record, after the criticisms we heard about the committee support yesterday or the day before--
DR. HARRISON: Yesterday.
DR. GOUGH: And the man who had the criticisms also said it wasn't directed at the FDA staff. And I want to underline that while I was chairman of this committee, and so far as I know while Bob's been the chairman of this committee, Barbara and Ron have been always a pleasure to work with and responsible, and it's not their fault, any shortcomings. I think it's far higher up in the Department than you guys.
DR. HARRISON: I agree. The only thing that I've ever noticed is that Barbara and Ron bust their butts to get everything done, and it's you can imagine, they're like that person in the circus with the rings on both feet and both arms it's a shame to hear so much frustration from the representatives of the veterans organizations and from us, and to know that it's not, we're not getting the kind of support that this project deserves, I think.
DR. GOUGH: I'm finally finished.
DR. HARRISON: Okay. Going once, going twice -- sold.
[Whereupon, at 10:23 a.m., the meeting adjourned.]
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