Ranch hand advisory committee




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DR. MICHALEK: But I gave those proposals to Ron several months ago.

DR. HARRISON:    so --

MR. COENE: But the record    okay.

DR. HARRISON: Can we at this point    at this point what should we do? Shall we take the nerve conduction study addendum   .

DR. STOTO: It's not like reviewing a proposal at this point. It's reviewing a protocol to see whether or not it is clear enough and appropriate, so on.

DR. HARRISON: Well, I'm not real pleased with this.

DR. STOTO: Well, I understand.

DR. HARRISON: I just have to say that I think this is a good way of avoiding scientific review. And I think it's    I can't think of anything that I feel so dissatisfied about.

MR. COENE: Let's back up. There was a point when we thought we were going to have another meeting in March, and it was my understanding that it would be at the March meeting then that we were going    that's why I questioned you yesterday.

DR. MICHALEK: Sorry, I forgot that.

MR. COENE: Yes, that we were going to meet in March, and that the meeting in March was to conduct this review, and that I didn't bother Bob about identifying reviewers, because you talked about reviewers. I do have them, but they weren't to be done at this meeting.

This meeting was to address the scope of work.

DR. HARRISON: But, see, the thing about it is that they really    they've essentially been integrated into the Statement of Work   .

DR. MICHALEK: Well, we were waiting for you to tell us your impression.

DR. GOUGH: Can we pull them out if we don't like them?

MR. COENE: Yes. Well, I mean --

DR. GOUGH: No, no, no. I mean it's in the Statement of Work as it is now. If we meet in March and decide there's no scientific justification for them, can't they just be pulled out of the Statement of Work?

DR. MINER: Yes.

DR. GOUGH: That won't create a great deal of trouble, will it?

MR. COENE: Well, now --

DR. MICHALEK: They can be taken out later.

DR. HARRISON: I'm just thinking.

DR. GOUGH: That would be a suitable solution to me, but I do think we need outside reviewers. Because Landrigan, if he ever comes to a meeting, and you are the only clinicians, right?

DR. HARRISON: Well, now that Elissa's gone.

MR. COENE: And Osei.

DR. HARRISON: Oh, yes, Kwame Osei.

DR. GOUGH: So he would be a good one.

DR. HARRISON: Actually, even Sills is a pathologist.

MR. COENE: Yes.

DR. HARRISON: I mean, he's an animal pathologist, but at least he, you know, knows that red blood cells don't have DNA in them.

DR. GOUGH: Large animals, or?

DR. HARRISON: So we have four proposals. We need at least    of those four proposals, we need to inquire as to which committee members feel they have sufficient expertise to judge those proposals.

Where there are less than two reviewers available from the committee, not necessarily who will be able to attend the meeting but who will be able to review the proposal, then we need to find an outside reviewer who can receive some honorarium for performing the review, and we need to meet in March and as early in March as possible.

DR. GOUGH: I'm with you.

DR. HARRISON: Does that   ?

DR. OGERSHOK: That sounds better.

DR. HARRISON: Okay. So   .

MR. COENE: We have to go to the Federal Register next week.

DR. OGERSHOK: Yes, but that's only four weeks.

MR. COENE: We, you, somebody has to go to the Federal Register next week, the first of February.

DR. HARRISON: Actually, do you know what I have down here that's interesting? I have March 18th, "hold for Agent Orange."

MS. JEWELL: That's because when we put a calendar out there, several people were available.

MR. COENE: You told us to do that; we did that.

DR. STOTO: That whole week I have as a possibility.

DR. HARRISON: All right. Well. I'm just    you know.

[Simultaneous discussion]

DR. HARRISON: Okay, let's travel on the 11th and meet on the 12th.

MS. JEWELL: You have to check with your Exec Sec.

DR. HARRISON: Yes, he said the first part of March.

MS. JEWELL: First week, he said.

MR. SCHECHTMAN: First week in March is my only open week in March.

DR. HARRISON: That's too soon.

MR. SCHECHTMAN: The week of the 5th.

DR. STOTO: I'm tied up on Thursday and Friday.

DR. CAMACHO: So you're talking about one day?

DR. HARRISON: Yes, we could do this in one day. But you've got a travel day. and you've got   .

MR. SCHECHTMAN: You could do it two half days. A travel day and a --

DR. HARRISON: Well, Len, when do you open back up again?

MR. SCHECHTMAN: After March, do you mean?

DR. HARRISON: Yes.

DR. GOUGH: Do you have any days in the latter half of March?

MR. SCHECHTMAN: No, it's gone.

April --

DR. HARRISON: April Fool's Day?

MR. SCHECHTMAN: First week in April. About the 3rd or 4th of April it opens up again.

LTC BURNHAM: Is it not possible to have it the week of the 5th of March, if it's a one day deal?

DR. GOUGH: We have to find reviewers and get them to review it. Who knows, that's a short period of time.

DR. HARRISON: Let's consider two possibilities. There's the 8th April    sorry, the meeting date would be the 9th of April.

DR. GOUGH: That's no good; I'm gone that week.

DR. STOTO: Okay for me, it's a good week for me.

DR. GOUGH: I can't review any of these things; I'm not a clinician. It doesn't make any difference.

LTC BURNHAM: Got to have a quorum, though.

DR. HARRISON: Yes, but --

DR. GOUGH: I'll send somebody in my place.

DR. HARRISON: We also have to have an Executive Secretary.

So let's consider traveling on the 8th and meeting on the 9th. Let's also consider now going back in March; let's consider traveling on the 4th and meeting on the 5th.

That actually becomes a little difficult for me because Mondays are one of my clinic days, and I'm already scheduled through April. So this means that I'm going to tell my secretary to cancel that clinic and reschedule those patients.

DR. CAMACHO: A Friday-Saturday is easier for me, if you need the quorum person.

DR. HARRISON: Friday-Saturday is easier for you?

DR. CAMACHO: If you need a quorum person, yes. And I'm the least qualified to look at it.

DR. HARRISON: I mean if we travel on a Thursday and meet on a Friday?

DR. STOTO: Those two days, Thursday and Friday are out for me. But again, I'm not the most important person for the subject matter, either.

DR. CAMACHO: You travel on Friday afternoon.

DR. HARRISON: Always gets down to statistics.

DR. CAMACHO: Then you meet on Saturday.

DR. STOTO: I don't want to do that.

DR. CAMACHO: You don't want to do that.

MR. SCHECHTMAN: Can you keep your clinic day on the 5th and travel the following day?

DR. CAMACHO: I've already missed a couple of teaching classes.

DR. HARRISON: Well, actually, I have an even worse clinic on the 6th. Let's see if    let's try for one    if we met on April 9th and if there was something that was really a problem at that point, that would still be    it would still be possible to pull that.

What we're doing is playing spoiler here, right? If everything's okay, then the meeting is okay; if there's something that's a real problem, that either has to be corrected or pulled, that can still be done the first week of April.

DR. OGERSHOK: What we would do, we were just discussing it, what we would do is put out, make them price everything and then just tell them certain things could be dropped out, which is fairly easy to do.

DR. HARRISON: Okay. So instead of really killing ourselves, why don't we try for April 8th, travel on the 8th and meet on the 9th, is it?

MR. COENE: I would like to say the mechanics of running a review of that makes more sense. I mean, we've got contracts in place.

DR. HARRISON: Travel on the 8th, meet on the 9th.

Now what we're going to do is we're going to agree at this meeting    this is what I'm suggesting    we're going to agree at this meeting that that is our next meeting date.

DR. GOUGH: Yes. I just won't be here.

DR. HARRISON: I understand.

DR. CAMACHO: It will be very hard for me.

DR. HARRISON: Well, that's going to be our meeting date. If we have to get Kwame Osei on the telephone to make the quorum work, we're going to meet on that day.

DR. CAMACHO: I could do a telephone -- I've got to be back on the 9th at 6:30.

MS. JEWELL: I have no problems with that where we have to have a quorum, and you have to understand that whether it be by phone or whatever, that's the requirement.

DR. HARRISON: I understand, but one way or another, we're going to have a quorum. We're meeting only to review these four protocols. So we can probably get that done in one morning.

MR. COENE: May I ask the format that you would propose? Everything else being equal, how would you like, who would you like to have?

DR. HARRISON: Everything else being equal, I would ask that reviews be done pretty much in an NIH-type style, that there be a written resume with a critique of the proposal and a recommendation from the reviewer as to whether it should be performed or not.

MS. JEWELL: Back to the reviewers. If we don't have two with the expertise on the Board, we're going for outside reviewers?

DR. HARRISON: Right, and it will be our responsibility, mine and yours and Len's to find the appropriate reviewers. I don't think that will be real hard. These are not such advanced science projects that only one or two people in the world can understand them. So I don't think finding someone    you know, finding a neurologist who understands what's being proposed and can, and has worked with diabetic neuropathy and has some feel for that is, is going to be acceptable, I think.

DR. STOTO: Are these proposals to collect data during Cycle 6, they're at least that, do they also include money for the people who work in their lab?

DR. MICHALEK: No.

DR. STOTO: Or for their time, or?

DR. MICHALEK: No.

DR. STOTO: So it's only for data to be collected.

DR. MICHALEK: To be collected at Scripps Clinic. These men are not going to benefit in any way from this.

DR. GOUGH: How can you review that? How can that possibly be reviewed?

MR. COENE: The IRB, where's the IRB?

DR. GOUGH: No, no. If we don't know what, the analysis of the samples is going to be, how can you review the proposal?

DR. MICHALEK: You have already seen the    nerve conduction velocities will be used in the assessment of peripheral neuropathy, and you saw that in the Neural section of the Statement of Work.

DR. GOUGH: So what are we looking at?

DR. MICHALEK: You're looking at the actual clinical procedure to assess nerve conduction velocities. This is a routine procedure, according to Jim Albers, University of Michigan.

DR. STOTO: But we need to have a justification for what new you will learn by doing this, how the data will be analyzed --

DR. MICHALEK: I presented that in a justification that I gave to Ron Coene. I wrote a paper explaining why this method is important for the study.

MR. COENE: You asked for that and he has provided that.

DR. STOTO: Did he see it?

MR. COENE: Yes. I mean, I have not shared any of it with anybody since it was not on the agenda for today.

DR. MICHALEK: I also wrote material justifying the IMT, the intimedial thickness. The reason there is we're seeing a trend of increased thickness with increased dioxin. And that presentation I couldn't make today because I wasn't ready. But we're also seeing an effect on peripheral neuropathy with dioxin that seems unrelated to diabetes, whether we include diabetics or not in the analysis; and that's also part of the justification.

DR. STOTO: I think that what we need, and maybe it exists to some degree already in this document, is a proposal for why it would make sense to study a certain thing.

DR. MICHALEK: That's exactly what I wrote.

MR. COENE: He's done that.

DR. STOTO: Good. Let me say more. I think what we need is a proposal that says basically, why does it make sense to study this thing. And that includes a background on what this thing is and what we know about its relationship to dioxin or the different outcomes we're interested in and so on. The second thing is a protocol that says exactly what would be done in terms of gathering the data and how the data would be analyzed.

DR. MICHALEK: Everything you have described.

DR. STOTO: Good. That's what we need. And if it's there already, that's fine.

DR. MICHALEK: It's done.

DR. HARRISON: What I'm trying to do, or at least what I'm interested in, and it's pretty late in the whole study for this, but you've got what's-his-name off in California doing adipose tissue samples; you've got some guy down in Arkansas doing glucose clamp studies; and they're all a part of this    it's a way of adding science projects to this study that seems ad hoc to me; and I've been trying to figure out how we can bring some more reasonable review into that process.

Rather than just what's being said, you know, "Nokamura out at such-and-such has got five adipose samples." The fact that those adipose samples have already been obtained is not sufficient justification to just allow somebody to use them. There needs to be someone who looks at    who knows what they're looking at, who looks at the protocol and says "I think this is worth doing."

It would be even better    this is one of the reasons for the letter last year, it would be even better if there were 50 or 100 competing applications and you could say "Well, this is the best one." And that's not what we have right now.

What we have are one or two people who happen to know that there's an Air Force health study and that there's a little treasure trove over here, and get together and say "We want to do, we want to study these hangnails."

DR. MICHALEK: That's not how it happened.

DR. HARRISON: Yes, it is.

DR. MICHALEK: No, it isn't.

DR. HARRISON: It's not happening with an RFP, it's not happening with a review of scientific peers --

DR. MICHALEK: That's true.

DR. HARRISON:    and the Advisory Committee is not acting like an NIH advisory committee which sets direction and determines what the priorities should be in terms of what should be looked at next. It's none of those things.

DR. MICHALEK: That's true.

DR. HARRISON: So at the very least I think that we should just make sure that the new things that are added    I consider carotid artery thickness to be a new thing, really. Is    I'd like to see that, that at least someone can say "Yes, this is the right way to do it."

DR. GOUGH: Or, "this has really shown to be of value."

DR. HARRISON: Yes, as opposed to someone saying, "Jesus, we stopped measuring that ten years ago."
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