Ranch hand advisory committee




НазваниеRanch hand advisory committee
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DR. GOUGH: Well, if we're going to do TEQs on everybody here, it would be probably of some use to do TEQs on the high guys.

DR. MICHALEK: Closer to Vietnam.

DR. GOUGH: Then if I think what is true is true, then there really is going to be a spike for 2 3 7 8. And that would be a useful bit of information. And also tell us something about what I expect is a decrease in 2 3 7 8 and an increase in these other things over time.

DR. HARRISON: Actually, what I would do is, I would use that as the argument for why these samples should be maintained and preserved. Because that's a very useful item that's not a part of this study.

DR. STOTO: It's not part of Cycle 6.

DR. GOUGH: No, and it has nothing   

DR. HARRISON: You should write a grant.

DR. GOUGH: I can always get Ben & Jerry's to underwrite it.

(Laughter)

DR. HARRISON: We don't want to put the dioxin content of Ben & Jerry's ice cream on record.

DR. KAYAJANIAN: It's already on record.

DR. MICHALEK: Thank you. That was very helpful.

DR. HARRISON: Len was saying it would be good to know as soon as possible if you thought you were going to be able to do this. But I'm thinking two weeks is when you've got to respond anyway. That's your turnaround time for the revised statement of work.

DR. MINER: So we're going to go back and have a very long and interesting meeting on funding on what we can afford, yes.

DR. HARRISON: Okay, but the point is that that Statement of Work that's coming back in two weeks will say whether or not you're going to try and do this.

DR. MICHALEK: I'd just like to make a point to anyone who has any influence over funding. The Air Force would simply request that the money, if any money would be added to the study, be given directly to CDC, so that the assays    we don't need to handle the money. What you need to do is fund CDC. They're the recipient; that's where the lab is.

And if money were to be made available, it need not be made available all at once; it can be made available in installments to CDC.

DR. HARRISON: In fact, let me ask you this. Let me point out something that you can do. And that is, you can do the dioxin draw on everybody.

DR. MICHALEK: Yes, and save those serum, and wait.

DR. HARRISON: So I think we could pretty much agree right here today that the Statement of Work will include a dioxin draw and storage.

Now the real question is, will it also include analysis? And if so, which samples will be analyzed?

LTC BURNHAM: 53,000 samples.

DR. GOUGH: Well, yes, incremental.

DR. HARRISON: In endocrinology we have "didja-tubes"; you know, when someone says, well, did you measure this? You go back and grab the tube.

DR. MICHALEK: Shows there's a lot of degrees of freedom here.

DR. MINER: The other issue; you had asked me, we had talked about    Epstein-Barr transformations.

DR. HARRISON: You're right; I did ask. Just to provide some context here, I saw you visited the University of Utah some years ago, and Utah of course has one of the finest genetic programs, as a state, that you ever want to see. Of course with all the genealogical records, it makes it easy to do conventional genetics. But essentially everyone who enters the clinical research center at the University of Utah contributes a sample of blood, the nucleated blood cells of which are then transformed, using Epstein-Barr virus, which then produces cells that divide and grow. Those cells are then grown, frozen and stored for future genetic studies.

The point is that you not only have a DNA sample, but you actually have a living DNA sample if you do the Epstein-Barr transformation.

DR. MICHALEK: So we could end up cloning this whole group a hundred years from now.

DR. HARRISON: We could end up with gazillions of Ranch Handers.

DR. MINER: Don't call it that.

DR. MICHALEK: Make a new Ranch Hand cohort.

DR. HARRISON: So that was the context that I was asking about Epstein-Barr transformations.

DR. MINER: Okay. So I called Dr. Jeffrey   

[Simultaneous discussion]

   and after several weeks of telephone tag, we got    he said, "Well, I'm not quite the one you should be talking to, it ought to be Dr. Francesca Grieder at NCRR," and I finally got ahold of her, and she says "Well, I'm not quite the one you should be talking to," and I got ahold of Dr. Phi Kraus, and he said "Well, yeah, that's a great idea. It's wonderful," but he's not the one I should be talking to. So I have Jeff Cohen and a couple of ours.

But you also asked about costs, and I found on the Internet a place where you can order Epstein-Barr virus transformations, 155 Eurodollars. But they say growth and preparation of a cell bank to inquire. I haven't followed up on that yet.

I also found on the Web a request for a Statement of Work, actually, on the Crohn's-Colitis Foundation, requesting applications for a DNA cell line repository to receive and process peripheral blood cells or to establish cell lines; and if I would change the verbiage in this to Ranch Hands instead of Crohn's, that's what we want done. So I'm going to try and contact these folks over the next couple of weeks and see what kind of bids they got in to do that.

DR. HARRISON: But you never talked directly to the University of Utah people?

DR. MINER: No, I didn't get led down that path.

DR. HARRISON: Well, that might be worth    if that's something that you all are, you think is even feasible to consider --

DR. MINER: Well, we collect the white blood cells anyway. We just throw them away now.

DR. HARRISON: Yes, but this is a whole different level of consent.

DR. MINER: Yes, that's correct.

DR. STOTO: Is there even time to do this now? The Statement of Work.

DR. MINER: Yes.

DR. GOUGH: What's the justification for this?

DR. HARRISON: It's the ultimate didya-tube. Really. For instance, yesterday we were talking about    we were talking; I was talking --

DR. GOUGH: That's why I don't remember it.

DR. HARRISON:    about the differences in the repeat elements and exons and how that has been discovered to relate to prostate disease; or put another way, to any androgen-sensitive activity. So it's an 'if' kind of thing. I don't know that there's a specific study.

LTC BURNHAM: Well, the best thing, you mentioned about cirrhosis. Some people are going to get it where others aren't. We may find a gene that someone is sensitive or resistant to --

DR. HARRISON: It wouldn't surprise me if someone were interested in looking at polymorphisms of the AH receptor.

DR. MICHALEK: That was one of our    it's in the addendum. That's Longnecker's proposal that we've included in the Statement of Work. We're going to save red blood cells. Well, save cellular material; we're going to save cells.

DR. HARRISON: Red blood cells don't have nuclei.

DR. GOUGH: I'm in favor of that.

DR. HARRISON: So the idea here is, if you save white blood cells, you're saving a finite resource.

DR. GOUGH: Yes.

DR. HARRISON: If you Epstein-Barr transform white blood cells and freeze them away, you have an infinite resource.

DR. GOUGH: I'm for you.

DR. HARRISON: So it's the sense of the committee that this is at least an acceptable addition to the biological sample? On the one hand, think of it, this is really silly. On the one hand, think of it, this is really silly. On the one hand we're worried that this stuff is going to be destroyed in another few years; on the other hand we're thinking about how to immortalize a sample.

DR. GOUGH: But it increases the intrinsic value of the rest of the samples to do this, because if people do want to come back and look at polymorphisms, they'd like to have all this other stuff.

DR. HARRISON: Good point.

DR. GOUGH: Whoever is taking minutes, notice I used the word "intrinsic."

DR. HARRISON: Anything else, Jay?

DR. MINER: No, that's enough.

DR. HARRISON: If you want to give me a call and have me call the people out at the University of Utah and see if they have a protocol. I don't actually know them. I can tell you, though, one part that's interesting, and that is that that group is almost entirely Howard Hughes Medical Institute investigators, and if there's any group that could crank up a quick half a million dollars to do something fun like this, it would be them. I mean, I used to be a Howard Hughes investigator, and around November they'd call up wanting to know what I wanted. I've never had a granting agency do that.

(Laughter)

Anything else from leftover stuff. Let's see, we've done that, we've done the letter. So all we have to do now is agree on the    when we need to meet next, and I have one suggestion to make for this.

- That is, I think SAIC should include the Advisory Committee meeting as part of its program project planing. It would make contextual sense. You all know, they know when you need advisory committee responses, and you have the stuff planned out for the next five years.

DR. OGERSHOK: We also do our own overall project plan. Actually, they're integrated into our plan.

DR. HARRISON: Well, in fact, when I said SAIC, I take that the back. I'm just suggesting, though, that the advisory committee meeting schedule be thought of as a part of the project. I don't think anyone on the Advisory Committee has a vested interest in whether we meet in June or August; the real thing that we have a vested interest in is that we meet in a timely fashion.

DR. STOTO: Right. And that we know far enough in advance when it's going to be so we can keep the dates.

DR. OGERSHOK: One time we did that; but when things started to fall apart, then we stopped doing it.

DR. HARRISON: Well, I think --

DR. STOTO: That's why you need it in the plan, so that --

DR. HARRISON: I would urge you to keep it in the plan, because what falls apart, as we've said before, is support for this committee. And I think that if I were you, I would keep it in the plan and make the failure to meet the responsibility of some other agency other than our lack of planning.

DR. OGERSHOK: Okay. It makes sense.

DR. HARRISON: So when are we going to meet next?

MR. COENE: What's on the agenda? What needs to be    and I know one subject, and that's    well, one is a response to Mike's request and the second is the research proposals. The review of the research proposals.

DR. MICHALEK: What was Mike's request again?

MR. COENE: The outstanding --

LTC BURNHAM: The carotid artery stuff.

DR. MICHALEK: That's what I meant, sure. And I would call that the science presentations. I would say that we'd be ready to give you an in-depth science presentation within six months. So I was hoping to have a meeting around September, October of this year.

DR. HARRISON: The science that you're discussing is a part of the Cycle 6   ?

DR. MICHALEK: No; it's just an update on diabetes and carotid artery and anything else we're doing. Because we will not have collected Cycle 6 data yet. Cycle 6 data won't start to come in until March or April of 2002.

DR. HARRISON: Let's back up for a minute. There are science projects that are associated with the upcoming Cycle 6    that have not been reviewed, that have not been assessed for scientific credulity.

DR. STOTO: We looked at them in very brief form last time.

DR. MICHALEK: Oh, I'm sorry, I misunderstood.

MR. COENE: We were going to put reviewers on them.

DR. MICHALEK: I thought you did that already. You haven't done that yet.

MR. COENE: No.

DR. GOUGH: Well, we haven't even seen them all, I don't think.

MR. COENE: You actually went back, you remember they were buried? Some of them were buried?

DR. MICHALEK: Yes, and I reduced it to four. I sent you four proposals.

MR. COENE: Right, but we weren't going to take those up today.

DR. HARRISON: So we have proposals, you're saying?

DR. MICHALEK: Yes. There were four proposals I sent to the committee.

DR. STOTO: Are they proposals or are they paragraphs?

DR. MICHALEK: No, no, these are proposals; these are full blown writeups.

DR. HARRISON: So we need to select some reviewers. If there's not appropriate reviewers on the Advisory Committee --

DR. MICHALEK: That has to be done soon.

DR. HARRISON: -- and that was my concern, is now we're all    because the Statement of Work gets driven into granite when?

DR. MICHALEK: What's the deadline?

DR. MINER: The proposal is supposed to go out the 2nd of March. Now, it can take some minor tweaking.

DR. HARRISON: We can't possibly --

DR. GOUGH: Review proposals.

DR. HARRISON: I mean, this is --

DR. MINER: Up until about the middle of March.

MR. COENE: How will these research proposals impact on the scope of work?

DR. MICHALEK: Well, there were four of them. One was the IMT, the intima media thickness measurement, and that's an onsite procedure; it will be done right at Scripps by Dr. Dwyer. And so that's written into the Statement of Work already, it was an addendum.

DR. HARRISON: That's the carotid artery --

DR. MICHALEK: Carotid artery thickness. Then there's the blood pressures, peripheral blood pressures, and that's in the Statement of Work currently, and that's another one you were to review; and then there was Matt Longnecker's proposal to look at AH receptor polymorphisms by simply saving white blood cells, to be done some time in the future; that's in there.

Then the last one was the electrophysiological measurement; the neurological function, namely the nerve conduction velocities, and that's in there.

DR. GOUGH: So if it's in there, what are we   ?

DR. MICHALEK: Well, I assume --

DR. HARRISON: Well, the problem, though, see, is that when you look at this    for instance you look at this carotid artery thickness study, and I know that carotid artery thickness studies are being done, that that's an endpoint that seems to be used by people; but as I expressed yesterday when we were going over it, I wasn't real happy with the explicit description of how it was going to be done.

DR. HARRISON: Okay. Then if you tell us more about what you need, he'll rewrite the proposal.

DR. HARRISON: We have no neurologists at all; you know, I    I have no idea. I can look at the neurological section and I can say   

DR. MICHALEK: It's in the addendum.

DR. HARRISON:    that it's consistent; you know, I know nerve conduction studies, what neurologists do. But I feel certain that any neurologist is going to say "Well, you know, are you going to do it the XXX way, or the YYY way, or the ZZZ way?" And if the question is nerve conduction problems secondary to diabetes, you look at one form, and --

DR. MICHALEK: It's in the addendum, in the Statement of Work. Unless I gave it to you separately, as a separate document.

DR. HARRISON: But we don't have a reviewer.

DR. GOUGH: And we got the addendum the day before yesterday.

DR. HARRISON: I don't care when    we don't have --
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