Transcript of the January 28, 2004 NCVHS Subcommittee on Populations Planning Meeting

MR. HITCHCOCK: I think that’s true, and I think – makes me think in my mind
that our hearings are sort of show and tell. We don’t have the audience that
comes back to our – meeting to really help us – what we want to do by what we
have learned in the hearings.

DR. MAYS: I think that means a different strategy, because I think – when
you talk about populations, it’s a little different than if you’re talking
about a code set where there is a specific group of people. It is their job.
They are getting paid by their agency to go and watchdog certain –

MR. HITCHCOCK: Right.

DR. MAYS: Whereas, with Populations, that isn’t the case. What needs, I
think, more work in the sense of – when we have a meeting and we are going to
discuss these issues, what would probably be useful is to use the email list
that we have, thin that out as an announcement. Here’s the agenda. People are
welcome to come, because there are agencies within the DC area for populations
in which they have offices, you know, the National Minority This or the
Advocacy Office for – the ATI Health Forum. So, I mean, there are, I think,
those types of agencies in Washington, as there are also, I think, for a couple
of the foundations –

SPEAKER: Yes, the Robert Wood Johnson Foundation, I know for a fact, is
very interested in building momentum, let’s say, in terms of population
approach to health. So I think that they would probably be very interested in
the work that the subcommittee does.

DR. LOCALIO: But we’re not exactly – I mean, they have a representative
with us, so I don’t see why what we are doing should be a mystery to them or
vice versa.

SPEAKER: Uh-huh. Who’s the representative?

SPEAKER: John Lumpkin.

MR. LOCALIO: John Lumpkin is what –

SPEAKER: Oh, right. Okay. But he’s not on our subcommittee, but –

SPEAKER: No, he’s not on our subcommittee.

MR. LOCALIO: But I know he certainly knows what we’re doing.

SPEAKER: Right.

MR. LOCALIO: So I don’t think we need anything more than that, unless he
recommends somebody.

SPEAKER: Okay. Probably right.

MS. BURWELL: Vickie, I think this is going a little bit down on the agenda,
but one of the remarks that Simon Cohen made at the Executive Subcommittee
Retreat is that perhaps we do need to work more with the outside groups, in the
example you gave on the health plans letter, perhaps holding hearings and
workshops to determine barriers to collecting the racial and ethnic data and
exploring methods to do so. So I think that your comment was right on the mark
and there at least was one opinion expressed that we do that.

MR. HITCHCOCK(?): That’s right.

DR. MAYS: I think that’s a point well taken, but I think we could do
hearings forever, but I would also like to see us with consistency, having
people at the table who consistently take an issue to – you know – back, and
they will stay for as long as the issue is there. So, I mean, when we move off
their issue, they’re gone, but what I get concerned about is they come, they
indicate that they are interested, and we don’t engage the mechanisms that we
have to continue to let them know what we are doing.

I think this procedure now for making sure that things are up on the web
earlier, so that people who follow the Federal Registry or who go to our
website with our agendas getting up 30 days before will help. I mean, I think
there’s a series of things. The later that our things are up, also, the less
likely we are to be able to get people to participate. So I think there is a
confluence of that we want to try and work on.

So I guess the suggestion, at this point, would be that we move towards –
and this, to me, is kind of administrative side – that we move towards thinking
through how to extend ourselves beyond just having a small group of us
involved, and I think we need to think about four particular issues. Who should
be the people that we try and ensure are there to hear us as well as continue
to participate?

Now, what would be the mechanism for doing this? Because, again, we have
lots of discussion, but I am trying to make sure these things don’t fall
between the cracks.

MR. HUNGATE: Vickie, Bob Hungate.

A thought. You know, in the quality work group, the rights and ethnicity
issue got talked about a lot, and whether it should go into claims or not was a
question that was left open.

In addressing that, a way to go about it might be to invite health plans to
a hearing to present the issues that are related to that, which then might lead
to a letter to the Secretary talking about what would need to be done, based on
the hearing, and then you’ve got somebody poised on the customer side to work
on it.

So my sense is that picking a specific thing that we would like to see get
to go and then saying who’s got to do the work and have the people that are
going to have to do the work be the testifiers, then you’ve got conditions
similar to what standards and security follows in the way they work, at least,
that’s what it seems to me like they are doing. Make any sense?

DR. MAYS: Makes sense to me.

SPEAKER: Yes.

DR. MAYS: Other people?

DR. BREEN: Sounds like an excellent idea. If there were maybe a – your
group is a work group, rather than a subcommittee, is that right, Bob?

MR. HUNGATE: That’s correct.

DR. BREEN: So maybe a joint hearing between the subcommittee and the work
group, and Bob could help target the people, and it might lead to what Audrey
was suggesting, which is to have these targeted hearings for people who would
actually be implementing it, and, in fact, they could be the testifiers and to
talk us about what their concerns are and it could help us make stronger
recommendations.

I think the workshop is a good idea, too, and maybe it could lead to that
eventually, but that’s a kind of a bigger task.

MR. HUNGATE: Well, Vickie, I’m going to have to run in about five minutes,
and I want to apologize in advance for running out, but the quality work group
is working on its report this afternoon, and one of the pieces in that is the
race and ethnicity – if you will – in the private sector. So I think that is
really set up for action, and the quality work group would be happy to help in
whatever ways appropriate, if that is the right action for the subcommittee.

DR. MAYS: It sounds like, from what we are saying, that that may be a model
to get us started on it, because I think that that will also interest the
people doing code sets also, and so that may be the galvanizing piece across
the groups.

So, Bob, I appreciate that suggestion and what I’ll try and do is chat with
you tomorrow about – after you have had your meeting, chat with you about it.
So I think if you would tell your group that we are interested, then let’s talk
and see how we can make this happen, and I think, again, we need to kind of
look at it –

MR. HUNGATE: Be happy to do that. It’s not clear yet whether we’ll have a
group this afternoon or not, given –

DR. MAYS: Oh –

MR. HUNGATE: We’ll try.

DR. MAYS: Yes. Okay. All right. Thank you very much, Bob.

Okay. So that is helpful in understanding why, for example – because
when I read the minutes in terms of the issue of kind of the effectiveness of
this group, I was trying to get a better sense of it, and this has helped to
capture it.

Are there any other suggestions that people have in terms of changing the
way we approach issues or who we might have at the table?

Jennifer, in terms of NCVHS, any suggestions there in terms of our ability
to be more effective with NCVHS?

MS. MADAN: I’m not exactly sure what you are asking me.

DR. MAYS: What I’m asking is we make some recommendations for NCVHS, but I
think also for NCVHS it comes down to budget issues.

MS. MADAN: Yes.

DR. MAYS: And so things kind of get stuck. I mean, there’s a great
willingness within NCVHS for many of the issues that we raise, but it comes
down to two things. It comes down to budget and it comes down to the resources
that you have in terms of people power to actually do things. So I was asking
you to think about whether or not there is also a different approach for us to
take that could facilitate making things happen.

I don’t know whether it is a matter of we need to work with other groups
that have similar issues to yours that will then make the priorities go higher.
I don’t know whether it’s a matter of we need to take smaller pieces of your
issues. You know, sometimes our goals are a little lofty and it’s like go do a
whole survey and maybe we should at times recommend requesting analysis of data
to present a better case for going doing a whole survey. So that is kind of
what I was getting at.

MS. MADAN: I think you hit the nail on the head. It’s mostly budget issues,
and most of the recommendations are really big-ticket items that either require
expanding sample or – sample or doing something – many of those things are
clearly things we want to do.

So where I see the most impact is being able to use the committee in our
budget negotiations that this isn’t only something we want to do, but that it
is something that is needed. To the extent that you can influence the data –
the department, others that use our data and don’t have what they want to say
so, I think that’s the big picture.

Now, if there are smaller ticket items that would be helpful, then I think
those – you know, that we would do our best – but most of the things that I
have seen, you know, maybe over the last – many years have been really big, big
– big ticket items.

In terms of staff, we don’t have a lot of extra staff. If it’s a smaller
kind of analytic project, that’s one thing, but very large projects, you know,
we are kind of robbing Peter to pay Paul most of the time.

DR. MAYS: Anyone else want to comment on this issue? Virginia, in terms of
NIH?

MR. LOCALIO: Vickie, this is Russell. I would like to comment, but I’m not
going to, not on the record.

DR. MAYS: (Laughter). Okay. Can we go off the record?

MR. LOCALIO: No.

SPEAKER: – puts his pencil down.

DR. MAYS: No, we’re actually being taped.

SPEAKER: Are we?

SPEAKER: Oh, yes. Oh, yes.

DR. MAYS: Yes.

MR. LOCALIO: So for future meetings –

THE REPORTER: We can turn this off.

MR. LOCALIO: No, for –

DR. MAYS: Yes, that’s the request I’m making.

MR. LOCALIO: Do you want to turn it off?

DR. MAYS: Yes.

(Comments off the record).

DR. MAYS: Whether or not that might be a time for us looking at some of the
specific recommendations to say – to then have a discussion with you about that
and what the costs would be and what a strategy might be in terms of our group
responding to the disparities report.

MS. MADAN: Yes, I think we could probably put together a briefing kind of
maybe not explicitly on those recommendations – but, as I recall, they are kind
of general, in terms of populations covered and so forth – with estimates we
have come up with about various changes to the surveys that would meet – and
different ways of meeting some of the subgroup estimates is really what we are
talking about, and you don’t even have to go as far as the new reports. You
just go back to healthy people. It’s all over the department, so those kind of
issues are – I think are very appropriate for us to be giving you some
estimates on.

DR. MAYS: Okay. And –

MS. MADAN: When is that meeting?

DR. MAYS: March 4^th and 5^th.

And, Audrey, can you call and get our arc(?) partners at this meeting? That
would be Kay Felix Arend(?), Harvey Schwartz. Did we have a third person – I
can’t remember who it is. The guy from quality, Eduardo.

SPEAKER: Ortiz – Eduardo Ortiz.

DR. MAYS: Edward Ortiz. Thank you. Yes. I think we should ask them, in
particular, to attend. They’re very aware of the committee activities, and I
think that would be a good group of people, because then they can tell us any
plans they have in this area, too.

MS. BURWELL: I just also wanted to ask that there are other departmental
data-collecting systems, such as SAMSA, and do you want to hear from them?

DR. MAYS: No, I want to do this piece by piece right now.

MS. BURWELL: Okay. I mean, you know, we are getting to – if it gets big,
it’s a whole hearing. This is a report that came from – apparently may have
some plans as to what it wants to do. We also know that they are asked now to
do this annually. So I want to kind of take this piece, which would be to deal
with that particular report, and, hopefully, there will be energy around the
department for dealing with that report, given what is going on in the media
right now.

DR. MAYS: Um-hum. All right.

Okay. All right. Anything else? Can we wrap up this particular issue about
the – I think this is very good because it really addressed issues that I had
planned to address in a different way. I think this is a good way to deal with
the subcommittee and its work and really getting it to engage in a leadership
role that I think it can engage in, as opposed to just a – I think – a response
role.

DR. BREEN: Vickie, I think that I really like the direction you are taking
this in as well, and I just wanted to bring up one other issue which we have
brought up again and again around data collection, and I don’t know if NCVHS
has estimates on this or if it would be Census or another meeting, but I just
wanted to remind us of the desire and the need that we have targeted,
identified from collecting concentrated samples in small areas, and that, I
think, is a pretty expensive endeavor, but I don’t know.

Is that one of the things, Jennifer, that you were thinking of – that you
have made estimates for that you could incorporate in that meeting or is that
something separate?

MS. MADAN: You know, for HIS, all of our – we work pretty closely with
Census on the estimates, but we kind of are using some generic costings here,
and the – we can talk in global terms about what these various different
approaches would be.

You know, they will be estimates. They are not going to be something that
you can say it’ll cost this exactly, this amount of dollars, but – give you an
idea of the order of magnitude. Exactly how you do it can make some
differences.

The kind of basic cost factors are pretty standard, and it is actually, in
some ways, steeper to do a bigger concentration in one area than it is to do
lots of areas. So if you want to just expand the sample in a particular area
that is really cheaper than trying to just expand the entire HIS.

So we can talk about general things like that and tradeoffs and what you
get and what you don’t get and how these kind of focused subsamples effect the
totals, if you want to make estimates about the total country. So it might be
useful to have some of that discussion as well as part of this presentation.

DR. MAYS: Nancy, that is a good point. What I would suggest is that if we
want Jennifer to talk about that, that the people that we add to inviting to
the table to hear the presentation would be the foundation, because I don’t
think it would be unlikely that you could see Commonwealth or Kaiser or
potentially Robert Wood Johnson actually doing that kind of work.

As I said before, I think, in some instances, it’s a matter of there are
other partners who also might get this work done, or, as I also understand, CDC
has this foundation, and sometimes when they are looking for additional
resources, that is one of the ways that these outside agencies can partner with
them to ensure that these things get funded.

So, Jennifer, are you comfortable with – if you are doing that kind of
presentation? Because, again, these are people that I think we need to partner
with anyway, because they do have interest, and they have, in the past, been at
some hearings.

MS. MADAN: Yes, I think I’m fine with it. Let me check some dates and let
me talk – also want to talk a little to Dale about how to best do this,
but I think it’s – we don’t need to assume everybody lives in our little
sampling. Maybe we need to provide some of this basic information about how we
do what we are doing, and maybe people have some ideas about how to do it
differently. Be fine.

DR. MAYS: Okay. All right. So, Dale and Audrey, I will work with you about
these other invitations, and we’ll look at, with Jennifer, the time, whether
it’s like the subcommittee breakout or whether it’s the day before. So let’s
look at that also. Okay. Great. Thank you, everybody.

Virginia, did you want to comment at all on anything else in terms of the –
the Executive – in terms of like the travel or the – can’t remember. There was
something else in this item.

DR. CAIN: Well, we had raised the issue – the issue came up about the
travel, and we discussed it. This is for committee members to attend hearings
and the fact that it really primarily falls on the individual departments or
agencies right now to support that travel, and I think that there – through the
discussion – came to be – well, I think certainly starting out, I don’t
think that there was exactly an awareness of how it didn’t have individual,
say, branches budgets, but it really – at least at NIH – does not come from
some central point, and the sense was that there should be an investigation of
how there might be the possibility of raising some additional funds centrally,
but there was certainly no guarantees, and the hope was, through these letters
to the various agency heads highlighting the importance of the work of the
committee, that there might be some additional support from the individual
agencies, but I don’t think that there was a real resolution as to how we are
going to move from the current situation to something where there might be some
kind of a central fund for it. Really, that would be the way to go, but,
realistically, it doesn’t seem like that is going to happen, to a great extent.

DR. MAYS: Is this something we can put at the level of the Director’s
office, something that either a request or your having a discussion with
Reynard or Zerhouni would be a way to go on this?

DR. CAIN: Have a pool of money from OD(?) set aside for travel –

DR. MAYS: Yes, that what happens is that there’s a recognition that when
individuals participate that the budget structure of NIH is such that the
monies are typically put in branches for travel specific to the research agenda
and research mission, but that, at the same time, there is a greater
departmental relationship to the issues that are being discussed, but there are
not the resources for individuals to travel, and so, therefore, it might be
through the Office of the Director that when there are not funds within the
branch that the request can be made to the Office of the Director to travel
members to meetings or hearings.

DR. CAIN: I think it is certainly possible to initiate that discussion. I
think the response might be that there would be an NIH representative then
which would –

DR. MAYS: No.

DR. CAIN: – not necessarily get the committee members there that would like
to participate.

DR. MAYS: Oh, okay.

DR. BREEN(?): I think that’s right.

DR. MAYS: Well, maybe we better leave that alone then. (Laughter). We’ll
lose on that one.

DR. BREEN: There is another travel issue, though, that I wonder if it was
discussed, Virginia, and that is getting people who give testimony there,
because, similarly to what we were discussing before with some of the
committees standards or what not, there’s industries that are interested in
these standards that have money and employees and resources to send people to
the hearings. Whereas, Populations don’t necessarily have those resources, and
so was there any discussion of a travel budget for this group to bring people
who need to testify?

DR. CAIN: I don’t recall a discussion of that issue. Dale or Audrey –

MS. JACKSON: Hi, this is Debbie. Just that Marjorie indicated that the
standard number of testifers we bring in are about three or four, and we ask
that to be justified in the language, so that we have information when we have
to prepare our own committee management budget and accountability that way. So,
generally, the hearings have kind of stayed in that ballpark. If there have
been any additional people, then, that’s kind of taken on a case-by-case basis.

DR. MAYS: See, that’s the problem that we encounter is that we never know
until the last minute, and it’s a bunch of stress, as far as I’m concerned,
that enters into the planning process that – you know – something needs to be
done about it. You know, usually, three people coming in is a one-day – it
could be even only an afternoon. When we put a hearing together, typically, we
have more people than that, and the problem is is that people that we bring in
are either data users, community folks and sometimes the agency, and they don’t
have the resources.

Now, what is fascinating to me is that we can spend the money in travel, in
the sense that one of the reasons we don’t do it in DC as much is because of
that rule, so then we start traveling, all of us, someplace, so that we can
hear from people in those places, because, otherwise, it’s too difficult to
bring them to DC, but I guess I am just uncomfortable with the fact that we
have to sit and wait to know whether or not we can have Person X and Person Y.
When you say it’s a case-by-case, I just don’t know if there’s some other way
we can do this that –

We can spend X amount of money on travel. So then we would sit down and
say, okay, for this hearing, we are going to have 10 people. For this hearing,
we are going to have four people, but that we can just plan, is there not the
capacity for a committee to have at least an operating budget that it can think
about – I don’t say it has to be in our hands, but I say that we have some
sense of a budget at least, in terms of being able to make plans? I mean, I
don’t know how others feel about that. I don’t know if that’s even –

MR. HITCHCOCK: I think it’s a good idea – talked about this before and we
never really followed up on it. I would like that – to have that sort of a
travel budget as far as subcommittee, I guess even an approximate one, like you
were saying, Vickie, something, as Debbie – could probably help us or Katherine
or someone.

DR. BREEN: And the trick here, I think, is that – I’m not sure if we want
an actual budget or if we want an average number of people to give testimony,
because I think one of the things we have observed is some of the outlying
areas in this country are very, very far away, and travel from the Marshall
Islands, I mean, we worked out a phone call last time which worked extremely
well, but –

MR. HITCHCOCK: It worked well for us. For them, it was like 4:30 in the
morning.

DR. BREEN: So, you know, travel could be very cheap or it could be very
expensive, and so I think it’s just important to have an adequate number of
people there to provide the testimony we need, and that is really – we need a
lot of flexibility around that, I think, in terms of money, what it is going to
cost.

DR. CAIN: I think it goes back to the earlier question when we were talking
about the – recommendations for the report on health disparities that we were
given a charge for a certain task, but without the resources, how is that going
to happen? How can we fulfil our mission?

So unless we have access to some resources for travel, either for committee
members or for persons to come and testify at hearings, I don’t see how we can
do an adequate job of really getting the information that we need adequately.

MR. HITCHCOCK: Even if we knew how much we spent last year in terms of
traveling our own members and staff in bringing in speakers will be helpful to
know how much we were allowed.

MS. JACKSON: Hi, it’s Debbie –

SPEAKER: That’s a good idea. That would give some kind of benchmark.

MS. JACKSON: Keep in mind that – this is Debbie. Keep in mind, we are
looking at several accounting line items in talking about bringing in NCVHS
staff and the cost of the room. That is one area. We have – it’s a different
line of bringing in speakers. So what we can do is look at the last couple of
hearings, get a ballpark of the number of speakers that were brought in and the
cost for that and give you more of an average, so you can look at it in terms
of figures.

I would like to think that the hearings that you’ve had and the speakers
that they have been successful in that you had not – you didn’t have to make
any decisions where someone did not come because of a number of speakers on the
panel or the hearing. I think if we look at the agenda from last year that,
generally, from what I recall, those that you needed to have there to make your
presentations, there were accommodations made so they were there either by
phone or in person. So just so that you are not caught at the end trying to
determine who can or cannot come depending on funds, we can look at the number
of people you’ve had at the various meetings and just kind of use that as a
balance.

DR. MAYS: I do think that there were times in which we made different
decisions based on struggling with this issue, and I also think, for example,
in the last hearing, we were flying by the seat of our pants on costs, and then
Audrey stepped in and really assured us to not worry about those things,
because her office, for example, was going to help.

MS. JACKSON: Right. That’s true.

DR. MAYS: I mean, if we raised that we want to have a phone call from the
Marshall Islands, we get people going ballistic, and in this last hearing, it
was very different, because Audrey was able to get Dr. Simpson to say that – we
planned freely, regardless of what happened as to who was there or who was not
there. What Audrey was able to do was to move forth with the recommendations of
what the subcommittee wanted, because we had the knowledge that we were not
going to have any barriers about if somebody from Palau wanted to – Audrey was
– making that happen, even if it meant flying here with a $3,000 ticket. That’s
very different – I’m telling you, it was a very different way to work than
when every time we come up with a name, we instead try and find somebody –
well, are they with a state? Are they with the Federal Government? Maybe we – I
mean, we don’t get to choose who we think will provide the best testimony. We
were choosing by who is the cheapest, and that, I don’t think, is the best way
for us to do our business, and I think that is what we are really saying,
Debbie.

I mean, so don’t think that because we had the people there that those
would have necessarily been our first choices, but those choices were made
within a constrained budget environment, and I don’t say that we would just
decide – if we knew our money – that we would just decide to bring everybody
from Hawaii in. I mean, we are not doing that, but it does make a difference in
how we plan. We start changing our first-level name to other names because we
become concerned about, well, who can do this and it would be less money.

So I guess I’m wondering, in this discussion, whether it would be helpful
to have Marjorie present or not or whether we want to continue this at another
time. What is the group will on this? Because Marjorie is just upstairs in
another room?

MS. JACKSON: That’s right, and she can come on down.

DR. MAYS: Yes, we can actually ask her to join us and – you know, because I
think we’ve gone around and around, and it is just time we either make some
decisions or that – you know – we have to just move on. I mean, because this
committee has asked for this several times –

MS. JACKSON: Right. Quite aware of the requests.

DR. MAYS: So what would you like? We have said our piece. We could either
wait for Debbie to give us some information or we could talk with Marjorie now
or we could talk with Marjorie after we have some information.

MS. JACKSON: This is Debbie. You can go on on the agenda. I can give her an
update of what the request is and then she can always join us sometime in the
morning, if that is information you want to get from her.

DR. MAYS: In the morning?

MS. JACKSON: I mean, later on this morning. You’re going to have a break
–

DR. MAYS: Oh, oh, oh, today. Today, you mean. Is that what you mean?

MS. JACKSON: Yes, later on, after a break, just find out where a window
would be for her to plug in and give you her response.

DR. MAYS: Okay. What do people want?

DR. CAIN: Well, I think it would be helpful to just reiterate exactly what
the request is. Is the request to have a specific budget and then be able to
live within that, making the decisions as to who the best people are?

DR. MAYS: I guess I was hearing Nancy say that it’s not so much we want
specific numbers, but that in the sense of having kind of ballpark – because I
don’t – again, I think that we can’t say we are going to do exactly what we did
before, but having some ballpark idea of a framework that we can operate in.

Like, for example, what are the ranges of the cost of hearings? I mean, it
might be useful for us to even get a – some of the other subcommittees have
three-day hearings. I mean, we have rarely had a hearing for that long, but
they have three-day hearings. So what is the cost of putting on a three-day
hearing? And then, separately, you know, something about the ranges of travel,
because I don’t think we are trying to live with a specific budget, but I think
we are at least trying to get some idea of if there is X amount of money, we
may want to – or some range of money – we may want to spend it as opposed to we
don’t know, so we don’t spend it.

DR. HEURTIN-ROBERTS: Yes, this is Suzanne. I agree, and I think also,
rather than a specific budget, what we are looking for is some sort of
mechanism and assurance by which we can travel people when we need to in order
to do the work of the committee. I think that, right now, we just scramble
around, ad hoc, each time we have a hearing, and if there were some mechanism,
some process, an assurance that there would be a positive response when there
was a need to travel persons for testimony, then that would go a long way, I
think, to solving our problem.

SPEAKER: I guess – I mean, I agree, but I just think – I’m afraid the
response would be, well, we can’t really tell you until we know how much it is
going to cost or something like that. So I think it’s good to get the
information and it might be followed by a more specific request.

MS. MADAN: I think that’s right, because I think we need more information,
and I think the idea of finding out what a three-day hearing or some of these
top-of-the-line hearings actually cost, because Vickie and others on the
subcommittee have been really outstanding in terms of finding other conferences
that we could go to and – speakers from, and then all the agencies have
subsidized these conferences by us traveling to them rather than them coming
here. So those are the ways in which we have subsidized these hearings, and so
I think we need to factor that in, and then just point out that we need a
larger budget in order to have more flexibility and to get the best people in
for these hearings.

DR. LENGERICH: Vickie, this is Gene. I guess I would also wonder if
comparing our hearings to the other subcommittees’ hearings is the appropriate
place to begin, because the people we are often inviting are those who are
employed by public agencies or are members of voluntary groups who may have
very limited travel budgets of their own, and so, therefore, we do pick up the
tabs on those, but some of the other subcommittees may be inviting members of
well-funded, private organizations to handle the travel on their own.

MS. MADAN: Actually, Gene, what I was thinking is that we factor in the
costs that those companies are spending.

DR. LENGERICH: Well, we didn’t say that explicitly, so I think that we need
to –

MS. MADAN: – because that is exactly what I was meaning, what the total
cost is, not to the government, but the cost of those hearings.

DR. MAYS: See, Gene, that’s what I meant is that, for example, when – a
three-day-hearing, this is in line with what Debbie was saying – that is a
different line. So putting all the travel aside, what does it cost them to do a
hearing for three days? That means the taping, the rooms – because they travel
in their hearings also. They’re in hotels sometimes, very similar to the way
that we are, and we just have exercised such caution. I mean, you know, we are
operating from a poverty model. We’re kind of at two days and then that’s about
it, but that is actually not the way that some committees have worked. They
have actually had three-day hearings if they needed to, and they have traveled
around. So it would be useful just to see the cost.

I think the travel thing is a little different, and I think Nancy’s point
is well taken. For example, NCI subsidizes us. So that travel doesn’t even get
considered, to some extent.

So I think when we start looking at it, it is with trying to think about,
for some of the other hearings, the difference between what is paid for and
what is subsidized, which is very clear that I don’t think we have in
Population the kind of built-in audience for subsidies, and I think that is the
recognition that we need to put forth, that this rule of three may not be as
useful of a rule for Populations as it is for groups in which it has the
capacity for greater subsidy.

DR. LENGERICH: Yes, I understand. I just think those who are testifying are
probably traveling on different budgets for the Subcommittees on Standards, as
opposed to the Subcommittee on Populations, and if that all has to come out of
the budget for NCVHS, if the travel is allocated equally between the various
subcommittees, then it is not going to be represented appropriately.

DR. MAYS: Oh, I don’t think the travel is equal.

DR. LENGERICH: Yes.

DR. MAYS: Yes. So I agree with Nancy. I think we want to figure in some of
these subsidies.

SPEAKER: Well, maybe Gene’s other point is that they are traveling in
luxury accommodations that we wouldn’t use. Is that your other point, Gene?

DR. LENGERICH: I don’t know that that is the case.

SPEAKER: Oh, okay.

DR. LENGERICH: I’m just thinking that the people who are coming from
health-care organizations – data-standard organizations for private health-care
industry, their companies are picking up their travel and not being charged to
the committee.

SPEAKER: Right. So we would need to add in those costs in terms of what a
hearing would cost.

DR. LENGERICH: For our group, correct.

SPEAKER: Correct, yes.

MR. HITCHCOCK: Let me just say – make a couple of points here. One is that
I think a lot of information is probably going to be readily available in the
business report that – does every year with how much we have – the committee
has spent on meetings – so forth. I wish you had a copy of this.

DR. MAYS: Oh, okay.

MR. HITCHCOCK: The other part is I worry about the subsidy issue, NCI and
others, because I think the general feeling, as reflected in our notes from the
Executive – retreat, is that agencies should be picking up the expense to send
their staff to the full committee meetings or to the hearings that we have in
other places. So I’m just worried about talking about being subsidized by other
parts of HHS.

SPEAKER: Do most of the other subcommittees meet in Washington most of the
time or do they do a lot of flying around like we do?

MR. HITCHCOCK: It depends on given place and time – the vision for health
statistics – so they’ve got to have a lot of travel going on about that.

I think, in general, another topic that came up – at the – retreat is we
really probably should stick to Washington as much as we could, and we probably
really should meet in Federal facilities and not in hotels, not be hidden away
in Silver Spring, is one of the examples that they used. I think it was a
standards and security meeting had met a couple of times in Silver Spring, and
people had trouble even hearing about the meeting and finding it.

DR. EDINGER: Vickie, also, this year, the APA – meeting is here in DC, so
some of the groups that might come to that, that might be a good time to have
them in, since it’s here anyway.

DR. MAYS: Yes, I was thinking that this next one is – if we do something,
it is very easy, because it’s there, but, I mean, we have traveled, again,
because of cost, where, you know, like the targeted populations are in
geographic areas. So we went to those geographic areas or we took ourselves to
meetings that were being held –

MR. HITCHCOCK: I think we were justified.

DR. MAYS: Yes.

MR. HITCHCOCK: I don’t think – I think we were certainly justified.

DR. MAYS: Yes. Okay. All right.

MR. HITCHCOCK: There were a couple in the year, one or two, when we did a
lot of travel.

DR. MAYS: Okay. Let’s summarize what we are going to do on this, so that,
again, it doesn’t fall between the cracks.

Debbie, I guess a request for you would be that it would be helpful to us
to get some information on costs, and that would be to give us a sense of the
cost, for example, of the travel for hearings. I think we want the costs on
site, off site, you know, when it’s there, if a committee has a hearing for
three days, what that is like. I think it would be useful to give us, because
you can’t estimate when you are looking at those hearings in terms of like say
– I don’t know – privacy or standards and security the testifiers and how many
of those testifiers, on average, you are paying your travel for, because I
think we are going to find out that, for some of these, it is probably few, and
that that is the difference for us is that it’s many more.

Anything else that we want from Debbie?

DR. EDINGER: We want to look at the possibility – depending on where the
hearings and the groups are – like using an HHS regional office, because
there’s 10 of those around which wouldn’t cost us anything. The Federal
facilities or maybe a teleconference or something from a university or
something where the group of people come to one place it might be cheaper to
pay for one place or a Federal facility of some sort somewhere than actually
going somewheres. I mean, I don’t know who we are going to have and when, but
we might want to look into some of those possibilities.

DR. MAYS: Yes, and, again –

SPEAKER: We’ve been doing that.

DR. MAYS: Yes, I was going to say, again, I think we have been trying, to
some extent. The question is probably if you compare us maybe to some of the
other groups whether or not the other groups have also been doing that.

I mean, one of the things I want to make sure of is that, as we talk about
these cost-saving measures, that all of the subcommittees are doing that, as
opposed to just Populations. So if we are suddenly going to be in the Federal
facilities, then I would expect that all of us are doing that, if we are
suddenly expected that we are bringing in people from Federal agencies, that we
are all doing that kind of thing.

So – but I do think it may be worthwhile for Debbie to take back some
thinking about the ability to be able to facilitate that. I mean, my experience
of our hearing when we did move to a university with great technology that our
contractor was not able to really facilitate these things happening in the ways
in which it should have been able to happen. So, I mean, that is the other
thing, and it may be that we need to also look at the services that we get from
our contractor, but I think that is out of the scope of us as much as we have
already commented on that, and that that may be something when it comes to
costs for Debbie or Marjorie or somebody to also look at, whether or not
services that we would need are being best provided in the context that we are
asking.

So – okay – anything else or we’ll move on?

MR. HITCHCOCK: Vickie.

DR. MAYS: Yes.

SPEAKER: I do want to move on a bit, but I want to also relate to ask a
question.

A while back, we had talked about writers for reports, and –

DR. MAYS: Your voice is dropping, at least for me. Can you –

SPEAKER: I’m sorry.

I was wondering if there had been any discussion at the Executive
Subcommittee about writers for reports that the committee might be wanting to
produce.

We had talked about – as a subcommittee, we had talked about several
reports, and I think we were desirous of having a writer contribute to that,
and I’m just wondering if that topic had come up at the Executive Subcommittee.
It also had budget implications. So I was wondering if there is any update on
that?

DR. MAYS: I think for some of the reports, we were moving towards a
contractor, but – a contract. I’m sorry – but maybe you all could comment. I
don’t know if that was discussed at all.

MR. HITCHCOCK: I don’t remember it being discussed.

DR. MAYS: Did they ask – I mean, sometimes, at the retreats, they want to
know what projects are underway, because of the budget implications. So were
any of our projects discussed?

MR. HITCHCOCK: Audrey? Debbie?

MS. JACKSON: Just your ongoing hearings and plans to develop your reports
from the hearings.

DR. MAYS: Oh, okay. So we are on your budget radar, right?

MS. JACKSON: On the accountability for the reports, yes. That’s right.

DR. MAYS: Okay.

MS. JACKSON: I think we have already had the contracts. We have had several
writers contracted for populations. So it’s just kind of compiling the material
and getting your statements as to what you want to prepare in your report.

SPEAKER: Good. That is gratifying to hear. Thank you.

DR. MAYS: Okay. All right. Let’s move on to our letter, because I want to
make sure that we get that – oh, sorry.

MR. HITCHCOCK: As I said, there are very limited notes that I took and it
had to do with our subcommittee encouraging the collection of reporting – data
at the provider level. This is something that Simon Cohen talked about quite a
bit. He suggested that we look at best practices for collecting plain data on
race, ethnicity, and he talked about at the time of enrollment.

Other than that, the group talked about that’s not really the easiest way
to convince people of – origin to give us this data, because it’s sort of –
they are suspicious of how it might be used at the time of enrollment.

But, anyway, in any event, Simon was thinking that we ought to look into
this, and a fresh, new look is needed, and I had written here that it is clear
that the subcommittee needs to involve – the private sector – and providers,
and we talked a little bit about what was going on at Aetna, for instance.

DR. MAYS: Right.

MR. HITCHCOCK: In getting the point of view of the providers – this is sort
of an issue – a couple of different committees, something that, I think, the
consensus of the Executive Subcommittee was that we ought to be doing more of
this.

DR. BREEN: Could that be incorporated into the joint hearings that we
discussed with Bob Hungate’s group?

MR. HITCHCOCK: I would think so.

DR. MAYS: I was going to say that is the kind of example of a three-day
hearing where you bring both of those in and what you try and do is have Bob’s
group for one and maybe Simon’s groups for another.

MR. HITCHCOCK: Right.

DR. MAYS: And then a day of discussion. So that – I think we may want to
think about that, Nancy, relative to structuring what we just talked about
would be to involve the other committees in it, and that might be something out
of which we would want a report to come where we would want to have a writer at
the start, and not at the end, I agree.

Okay. Let’s have some planning time to talk about this. So I am going to
ask Audrey to – as a followup for us to be able to have a subcommittee
conference call and to ask Bob and Simon and John to join us. I want John to
join us on it because of his role relative to – Robert Wood Johnson has had a
hearing, I think, or – I’m sorry – a meeting with the people at the
planning. John is quite interested in this. So let’s see if we can have them
join us for a call where we can get a sense of the broader landscape of what
they are thinking about, and then we can plan a hearing.

Okay. Thank you very much, Dale and others who were at that Executive
Committee retreat. It sounds like, at least from the Population side, that I
have a greater understanding of comments that were made, also, the suggestions
that they made to, I think, kick-start us in a direction. If we could just take
care of some of our structural issues, I think we’ll do well.

Agenda Item: Review Draft Letter on the National
Children’s Study Recommendation

DR. MAYS: So okay, can we turn our attention to the letter?

Gracie, are you there?

MS. WHITE: Yes, I am.

DR. MAYS: Is Leslie – can you call and see if there’s any – I know
Leslie’s branch is having a meeting. So I don’t know whether it’s possible or
not possible for her to join us.

MS. WHITE: All right. I’ll give her a call.

DR. MAYS: Thank you.

But let’s start by – I mean, I can give you much of the background of the
letter, and many of you were at the presentation that was given to the full
committee.

I think everybody on line is aware of the study that NICHD, CDC and ETA – I
think that’s – is that right? Are those the three, Audrey?

MS. BURWELL: Those are the three prime –

DR. MAYS: Yes, the three primes that are organizing, in terms of the
National Children’s Study.

We had Peter come in and we had a series of questions that we had, many of
which were addressed by Peter, and some of which, I think, there has been some
subsequent conversations with him about.

The choice for the subcommittee was to write a letter expressing some of
this – areas of interest, ensure that, because the study is so early in the
formative stages that it would be useful to get our concerns on record, and so,
hence, you see the letter before us, which was worked on by a smaller group of
people before it went out to the full committee for – I’m sorry to the full
subcommittee for comment.

The discussion that ensued about the letter really has more to do with the
direction and what we want to do with it, and that is do we want to just
present these points as we have learned them from the hearings, and here are
the things we want you to think about or present them in a way in which we are
asking them to actually respond.

Now, Jennifer, are you on line?

MS. MADAN: Yes, I am.

DR. MAYS: Oh, okay.

I do think that, again, it is kind of apropos of our earlier discussion
this morning that – you know, some of this is pie in the sky and it’s – the
survey then does everything. So I think the point is well taken that we can’t
expect one survey to be able to answer all – I forget how many points there are
in there, 10, 12, 15, something like that – but that, instead there is some
thoughtfulness that are given to those points might be an addition that we want
to make to this letter.

But I think what we need to talk about as a committee is what we hope to
achieve, because, again, if it’s going to be a marker later about did we hit
the mark on things that we are sending, we ought to have a clear sense of what
do we want to see happen as a function of this letter, and I think that that
may be a broader discussion for the committee.

My perspective of what I think would be useful to have happen as a function
of this letter is that it really promotes a discussion about the importance of
these issues and that the issues are discussed early in the study. The study
can be clear about what it can do and what it can’t do and that everyone who
participates is well aware whether or not the study, for example, will include
significant numbers of which racial and ethnic groups that will be available
for analysis, whether or not, for example, the study is going to look at the
issue of health disparities, whether or not the study is going to ensure that
there are variables that allow them to do social determinates, whether or not,
for example, the study is well aware, as we are, of the kind of privacy and
confidentiality concerns that racial and ethnic minorities might have that need
to be planned into the recruitment and retention strategy for this study. I
mean, I have heard little about retention. In a longitudinal study of this
magnitude, there are certain populations that retaining them is quite difficult
for the amount of time that they are talking about.

So that would be what I see as an important role, so that we don’t find
ourselves four or five years down the line that this group is worrying about
the same things that it worries about with some of the other surveys that are
already on line.

Other goals, comments?

DR. CAIN: Well, I’m trying to find my copy of the letter right now.

Let me express some of my general concerns about the study and some of the
directions that it is taking that I think that we might be able to help with,
and one of them is that this seems to be a move to only include things in the
core hypotheses that require the sample size that they are talking about. So
some of the more general behavioral and social issues that you could answer
with questions, that you could answer with a smaller sample size may not make
it into the core hypotheses.

However, I think that when we are talking about trying to get some of these
racial and ethnic subgroup estimates, that even that 100,000 quite quickly
turns out to be not as large a number as it initially starts out to be.

DR. MAYS: Oh, without a doubt.

DR. CAIN: So if we can really emphasize the point that to get some of the
answers that we want for racial and ethnic subgroups, even on some of the
hypotheses that, in theory, you could use a much smaller sample size, but we’ve
really gone a long way to helping get some of the more basic behavioral and
social-science questions in there.

And I know other people at NIH, certainly, are well aware of the study and
they may have some other thoughts.

DR. MAYS: Any other comments from others?

DR. BREEN: I had a kind of a general comment about the organization, and I
was trying to think about this from the point of view of the reader as well as
what we are saying, because I think we want to know about these items that are
bulleted, and I think they are important. So –

DR. MAYS: Before you go to that, let’s see if we can get some comments on
Virginia’s recommendations, because I want to get a sense of –

DR. BREEN: I think she’s right.

DR. MAYS: Let me ask, because I’m not clear, Virginia, are you arguing that
there be more social and behavioral-science questions in the core sets?

DR. CAIN: I’m concerned that a lot of it is going to be lost.

DR. MAYS: Yes. Okay. I just wasn’t clear what sort of the results was that
you were arguing for.

DR. BREEN: You know, Virginia, one thing I’m wondering, is this going to be
a public-use data set? I mean, is this going to be data that is collected and
available so that people can formulate and answer their own questions with it
or are we going to be limited to the findings that the group of researchers who
are working on this ask and answer?

DR. CAIN: Well, I think that there is discussion on that. Now, there’s many
people that believe that it makes absolutely no sense to collect something of
this magnitude and not have it widely publicly available, but there has been no
mechanism that has been worked out. There’s no set of rules as to how that
might happen.

DR. BREEN: That should be among our concerns, shouldn’t it?

DR. MAYS: Oh, yes, but I thought that – and, again, I always find it
fascinating what rules we would be held to if we were applying for this versus
kind of its structure – that when something is over 500 K that there are a set
of data-sharing plans that are included. So I guess I assumed that this study,
given – and I just focus on data sharing – that that would have to be the case.

DR. BREEN: Well, the thing is, Vickie, that unless mechanisms and money is
appropriated to put this up as a public-use data set, there is a lot of work in
cleaning the data and setting up – like, for example, Ask Chis(?), that took a
whole – a staff person and quite a lot of staff working with him in order to
come up with that. So that has to be a focus and that has to be all planned for
along with the data planning for the public-use sample to be developed and
available to the public in an easy-to-use way and in a timely way, and I think
that the issue is complicated by the fact that this is a panel survey, a
longitudinal survey, and so how often would it come out, and the researchers
who work on this are going to want lead time with the data. They are going to
want to be able to use the data first, I bet.

MR. HITCHCOCK: And it’s not as simple as it used to be to hang onto data
like that. I forget the name of the – Julie may remember this – and Wendy
Baldwin had a lot to do with this when she was at NIH, but it’s – those sorts
of data are what we call – just can’t hang on or contractors just can’t hang on
to data like they used to be able to, and I think it’s a good point that we
would be making that they ought to prepare for this, that they ought to build
into whatever contractual funding arrangements are made the capability to put
together something that at least passes as a public-use data file.

MS. BURWELL: It’s my understanding that they are going to use the ad
health-study model –

MR. HITCHCOCK: Yes.

MS. BURWELL: – for dissemination of public-use data, but, like
Virginia said, I haven’t heard any specifics worked out.

SPEAKER: What model did you say, Audrey?

MS. BURWELL: The adolescent health study that was conducted a few years
back from the Carolina Population Center.

SPEAKER: Okay. Is that data easy to use?

MS. BURWELL: I have tried to use it, but –

SPEAKER: Is it as easy as any –

MS. BURWELL: Yes.

SPEAKER: Okay.

MS. BURWELL: They have a big public-distribution plan, and as far as the
National Children’s Study, in some ways, part of the problem is that it is so
big and there are so many things that have to be attended to that it is hard to
get a sense of what any particular – or even for the people who are renting it
to focus on one aspect of this, such as data release, which is going to come
fairly far down the road, but maybe the kind of thing that we can ask for is
some assurances or an outline of a plan or just really emphasize the need to
come up with a plan well before the data are at the point where they could be
distributed.

DR. MAYS: Now, does that address your concern? Would that address your
concern, Virginia, or does it run deeper?

DR. CAIN: I have many concerns.

DR. MAYS: Well, no, no, no, but you expressed that you – you thought that
there were some questions that were being neglected in this data set because we
have already answered them for the general population, perhaps, but in this
data set, we could answer them for targeted populations that we haven’t been
able to answer them before. That was my understanding of the concern you
expressed.

DR. CAIN: Well, yes, that is certainly one of my concerns. I mean, I also
think that even – regardless of the targeted-population issue, to do something
of this magnitude and not include or ensure that there is adequate collection
on kind of the basic context that kids are growing up in would really not be –
end up with a not very useful data set that you might get. You would get things
like exposures to particular chemicals, but that is a very narrow range of what
is effecting the daily lives of kids.

DR. MAYS: Well, what about – I mean, we have here explore the complexity of
race and ethnicity and the interaction of the environments where people live
and the impact on health disparities and health outcomes –

SPEAKER: Is that two bullets or one? Should it be.

DR. MAYS: Oh, should it be. Maybe it should be two. Explore the complexity
of race, ethnicity and the interaction in the environments where people live.

SPEAKER: Maybe physical and social environments.

DR. MAYS: And action of the – okay. Let’s –

SPEAKER: Is there a list of those hypotheses that are being honed in on
right now?

SPEAKER: I think it’s probably on their web site. I don’t have the list
right now.

SPEAKER: But isn’t it –

MS. BURWELL: On the portal it’s – 144 hypotheses. Some have been
adopted and some have not. So they are in various stages, and that’s on their
portal, not exactly the public website.

DR. MAYS: I was just going to say, I don’t think that we all can get to
them. It has to be someone who has access.

SPEAKER: My problem with this survey is that it kind of doesn’t – it’s
kind of like Jell-o. It moves around, and it’s hard to get your arms around,
because it hasn’t formed enough for you to say this isn’t enough in this area.

So I think the committee would be much more effective if it had something –
if it were ready to reply in that critical period when there is something being
decided before it gets solidified, but there’s something there to talk about.
Because all this stuff where you bring it up – and everyone’s bringing it up on
this call – I know it’s all been discussed, but it’s been discussed with
3,000 other issues. Until certain basic things are – kind of come into some
focus, it is really hard to know whether there’ll be enough of any one kind of
person to do any analysis on.

DR. MAYS: But do you think that the letter pushes them to come to some
resolution? Because I agree with you is that things are fuzzy, but the problem
is I can’t see them taking a focus in which they are deciding these things.
It’s like the notion of how this occurs and you’re going to come out with a
scientifically-driven set of hypotheses is beyond me, because this is like a
weird way to approach doing this. There’s a lot of input, but I don’t know in
terms of decision making and tracking –

SPEAKER: I think that’s kind of the issue. I don’t have a problem with
listing the things that are of interest to the committee, but then what? And
maybe there needs to be more – if the committee wants to have a role, you know
–

DR. MAYS: Well, maybe –

SPEAKER: – ask for the role, but I think if you just lift 15 things you
would like to see, it almost – it dilutes all of them, because there are so
many of them in there and you really need to kind of pound in one thing or
figure out a way that when these decisions are made you are at the table making
your point.

DR. MAYS: Yes, I think that is what we really need, and that is where it
was getting fuzzy. Some people wanted to send it forth and it’s like, well,
here is what we have learned, and I guess I’m trying to say we need a response,
but I don’t understand structurally – because it seems vague to me – the ways
in which to impact that group, other than to say we need a response, but how do
we make sure that before these decisions are made we are able to weigh in?

SPEAKER: Well, one of the things that strikes me about the bullets here is
that they are pretty general, and I think, from the point of view of this
committee, they are very bottom-line concerns that almost – if we had our
druthers, no survey should be – no large, national survey should be done
without these things being taken into consideration.

DR. MAYS: Right.

SPEAKER: So – particularly no modern one that is going to be with us for 10
or 20 years, for goodness sake, and so these should be expressed as bottom-line
concerns, perhaps, and then a request that there be representation from this
committee on their committee, and then, after that, it is just force of
personality. So, I mean, Vickie, do you want to get involved in this?

DR. MAYS: What I was trying to avoid is that, when we send something forth,
that in order for it to happen that we actually have to do it, as opposed to
there is some reporting mechanism where we are alerted to this occurring and
then we keep commenting.

SPEAKER: Right.

DR. MAYS: I mean, normally, we would comment at the level of the Secretary,
but we didn’t think we needed to go that high. So, right now, we are saying –
this to an institute director, and, Virginia, is that an effective way, if this
goes before Duane Alexander, that he then understands that he should – the way
in which to then involve us with the progress on the issues that we put on the
table?

DR. CAIN: I mean, part of it is that this is – the process is not, as I can
tell, the way would be run. I mean, there’s – the decision-making board is a
group of people with representatives from the three agencies, and the
recommendations seem to go back and forth between that group and the steering
committee, but I still think it’s the coordinating committee that has the
ultimate decision-making power.

Now, a letter to Duane, I think that he would assure you that all this is
going to be taken care of, but what happens is this thing moves. I mean, a year
ago, there had been no requirements that a core hypothesis had to be something
that required that sample size. That is something that just came out of their
last advisory committee meeting or their last – I can’t remember what they
call them –

DR. MAYS: – assembly.

DR. CAIN: So things change all the time, and they kind of evolve. If we
could get a handle on it, we will be the only group that has done that.

SPEAKER: Is there a way we could do this in several phases, rather than
thinking that one letter will do it, that we can send a letter, perhaps to the
– is it the steering committee, I think you said?

DR. MAYS: I think there’s – what? – a coordinating committee –

SPEAKER: Or whoever. Whatever –

DR. MAYS: I know. See, this is the problem. The management of this thing is
like crazy.

SPEAKER: Well, anyway, we could send a letter – this initial letter –
urging them that this is something that needs to be addressed in the planning,
because I don’t think we want to wait until something is done to respond to.

I think the idea that it is fuzzy is actually a good thing, because maybe
we can help them focus, at least in terms of our needs, and then tell them that
we would be happy to look at any response that they could send us as to how
they plan to incorporate these issues or address these issues and we would be
happy to look at it and advise them and help them with it as a committee, so
that we could try to build the relationship between, not necessarily an
individual, but the committee.

DR. MAYS: I like that.

SPEAKER: The subcommittee and them.

DR. MAYS: What do others think about that suggestion?

SPEAKER: I like it.

MR. LOCALIO: This is Russell. I have a question. Who on NCVHS participates
in the – what you call the –

SPEAKER: Coordinating committee.

MR. LOCALIO: – coordinating committee of this survey?

SPEAKER: I don’t think there’s anyone – Jennifer?

MS. MADAN: Well, I keep forgetting which committee is which. We have
someone on detail to NICHD, who is working on this, and I thought that either
John Kiley – or is it Ken?

SPEAKER: Yes, Ken Showendorf(?).

MS. MADAN: Showendorf. Yes, he’s working on it. He’s detailed there, but he
may be our person on that committee. You don’t know if –

SPEAKER: – some CDC on the committee. There’s Marsha –

MS. MADAN: Marsha Lynn.

SPEAKER: Right. Marsha Lynn, and I can’t remember the other two people.

MS. MADAN: Yes, there’s someone – yes, but I think they’re with Ken. If
that is the committee you’re talking about, that is the committee that Ken is
on. I’ve gone a couple of times when he couldn’t a few years ago.

SPEAKER: Yes, and the name they have on the sampling, Randy –

MS. MADAN: Right.

SPEAKER: Well, the decision making is within the coordinating committee.
There are three representatives from each of the agencies and they don’t want
anybody else on it.

MR. LOCALIO: The decision making is done by the coordinating committee, did
you say?

SPEAKER: Right.

MR. LOCALIO: And that is composed of members from the three agencies and
they don’t want to have anybody else on it. Now, who are the three agencies?

SPEAKER: EPA, NIH –

MR. LOCALIO: EPA?

SPEAKER: And CDC.

SPEAKER: Right.

MR. LOCALIO: What is the third one? EPA, CDC and – no.

SPEAKER: EPA, NIH –

SPEAKER: NIH.

SPEAKER: – and CDC.

SPEAKER: Because it’s NICHD and NICHS, right?

SPEAKER: Right.

SPEAKER: Is it EPA or NICHS?

SPEAKER: Both.

SPEAKER: EPA is the third agency. NICHS would be one of the NIH –

SPEAKER: NIH, right. And then CDC has several centers. So it’s NCVHS and
the Chronic Disease Center and the Birth Defects Center.

SPEAKER: For NIH, at least, is there one person from each institute or is
there only one representative from NIH?

SPEAKER: Well, I’m trying to remember. There’s certainly not one from each
institute. Eatshy(?) is the person who kind of runs the whole thing and he’s
NIH, and then I think there’s an NIHS representative. I’m trying to find the
website right now, so I can get more specifics.

SPEAKER: But in terms of the decision making, the ICC is sort of like the –

DR. MAYS: Wait. Say what it is. These initials don’t help. Say what ICC is.

SPEAKER: Interagency Coordinating Committee.

SPEAKER: This is the Interagency Coordinating Committee, and they are like
the last layer of advice to Dr. Alexander, then he makes the decisions.

DR. MAYS: By himself?

SPEAKER: Through all these layers of advice.

DR. MAYS: Oh, my –

SPEAKER: I mean, he relies on Keith(?) heavily and the recommendations of
the coordinating committee. I mean, in some ways, I think he’s a titular head
more than an active participant in it.

MR. LOCALIO: One more question. Does the statute that authorizes this
survey stipulate who has the authority to make these decisions? How did the
Interagency Coordinating Committee get formed and get the authority to make
recommendations, and how did Dr. Alexander get the authority to be the final
arbiter of decision making?

SPEAKER: Russ, I sent you that legislation a little while ago.

MR. LOCALIO: Yes, I know, but that’s a long time ago. I know I saw that. It
was only a little tiny short piece.

SPEAKER: And that doesn’t get as specific as to what you’re asking. It
usually says the Secretary through, you know.

MR. LOCALIO: Okay. So it’s the Secretary who is making all of these
decisions.

SPEAKER: No, no.

SPEAKER: – an agreement between the Secretary and the EPA Administrator.
That’s a long time ago, and that’s the way it started, and then it got into
legislation where they put it in NICHD, but it is supposedly a joint project,
and I would – you know, I agree. I think – it may be because it’s in his
budget, but I don’t know if he would consider that he is sitting around making
these final decisions, but –

SPEAKER: It seems to me that Peter is probably the most important decision
maker in this project. Is that right?

SPEAKER: – certainly controls the purse strings, as I understand it, would
that there were any.

SPEAKER: Right. But, in my office, the way it works – and I’m putting this
out here as – maybe it doesn’t work that way everywhere, but the person who is
in charge of the project is the one who knows more about it than their boss,
and they will make recommendations, and, usually, the boss will go ahead with
it, maybe with some modifications, but that is usually how the decisions get
made.

So it wouldn’t be Dr. Alexander who is thinking through everything and
making the recommendations. He would approve or modify the recommendations
being made. Is that the way it happens in other agencies?

SPEAKER: I think, certainly, that that is true. On any particular
controversial issue he would be more involved in the decision making, but on
day-to-day – you know, what questions are going to be included in the survey,
he is not going to get into that.

SPEAKER: Right.

SPEAKER: He wouldn’t need to be involved at all in that. Okay.

SPEAKER: Right. Right.

SPEAKER: So, there, we’re back to Peter.

DR. MAYS: But what I was surprised about were the questions that Peter
couldn’t answer, but yet there was quite a bit of activity in that area going
on. So that was the only thing that’s surprising to me.

SPEAKER: You know, one thing that strikes me is if we could have the ear of
– you know, a direct communication with some member of the board who was
sympathetic to our concerns and willing to listen to our suggestions for how to
address those concerns, that might be what we need. I don’t know who that
person would be. I mean, I wasn’t at the data committee meeting to know whether
– you know, what Peter was like or if he seemed open to the questions, even
though he couldn’t answer them.

DR. MAYS: Well, I think it’s a difference between do we want to do this
informally or formally be on the record and be able to have a response back.

DR. HEURTIN-ROBERTS: Well, I think we want to do it formally, but I think
informal actions to support our formal actions don’t hurt.

DR. BREEN: I agree with Suzanne.

DR. MAYS: Okay. Nancy, I thought you were suggesting –

DR. BREEN: No, no, not at all.

DR. MAYS: I get it. I get it. Okay.

All right. Here is what I am going to suggest, which is let’s try and see
if we can get a letter, because – as kind of our formal response, and then work
on the informal response. If we can get a letter that we are okay with, then
this can – we can try and get this through the full committee tomorrow.

Now, Virginia, I want to ask, this issue about the core hypothesis, can you
– and you said you had some other concerns, and I take it that your concern
about the core hypothesis I don’t think is in this letter, and it would be a
question of making sure that it gets included.

The letter, as it stands – I’m hearing different things – that all
these bullets may be too much or that we leave the bullets in. Let’s decide
what we want the letter to be, and then we can decide what we need to work on.

But before we do that, I want to make sure – Virginia, any other comments
that you have about concerns? Because it may be that those concerns would
change how we would write the letter. Do you have some others?

DR. CAIN: Well, I have many concerns about the whole study. (Laughter).
Kind of – just the organization and how – the structure of how it is run
and things like that. I’m not sure we can tackle that, but I think –

DR. MAYS: That has been my concern throughout, because it just – I
think that that is part of the fuzziness is that how this thing is structured,
even though it has all these committees, it’s – in my opinion, it’s very
difficult to see how that leads to the best science, but I’ve said that several
times. I decided that maybe that wasn’t in our purview to tell them to
restructure themselves. So I left it alone.

DR. CAIN: Exactly, but I think that two issues that really would be within
our purview, of ones that had been raised, and, one, making sure that we get
adequate data to answer questions within different racial and ethnic subgroups
and bring up the question of the public use of the data set and how that would
be worked out.

DR. MAYS: Okay. Okay. Let’s talk about the structure of the letter. I would
like to hear from those who think that maybe, at this stage, having these – I
don’t know, I guess maybe 15 bullets or so might not be the most effective way
or that reducing the bullets might be more effective.

SPEAKER: I have a suggestion to kind of focus more on the big pictures in
the letter and then put the bullets in an attachment, like more specific things
of interest. So you don’t lose them, but whoever is reading it is not going to
drown in them.

DR. MAYS: Okay. What do others think?

SPEAKER: I think that’s a good idea, making me wonder which ones would be
the big ones and which ones would be the small ones, and I’m a little concerned
that this has to be ready by this afternoon or tomorrow afternoon? When is it?

DR. MAYS: Well, I have to fly this afternoon, so, for my input, it would
have to be either when I got there in the morning it was ready or as of maybe
about three hours or so I’m out of here. So, I mean, it would be –

SPEAKER: But you wanted to present this to the subcommittee tomorrow
afternoon, is that right?

DR. MAYS: To the full committee tomorrow, yes.

SPEAKER: Tomorrow at 8:30 or at 1:30?

MS. JACKSON: You’re on at 1:30 for the – I’m sorry – 2:30.

DR. MAYS: I have 1:30.

MS. JACKSON: Oh, I’m sorry, 1:30 is the claims adjustment and then 2:30. So
you’ve got a little time.

DR. MAYS: We’re in the afternoon we’re on.

MS. JACKSON: The afternoon.

SPEAKER: Well, so what are the bottom-line concerns that we would have? The
public-use data set seems like it is an important one.

DR. MAYS: I think the – data set, the adequacy of the sample of racial and
ethnic minorities. I think that the population health perspectives to examine –
the third one, to examine relationships and interactions among environmental,
social, psychological and biological factors in health disparities. Can I live
without these other things?

SPEAKER: We can put them in the appendix.

MR. HITCHCOCK: I don’t know if we actually need them in an appendix. I
don’t think I would go with 2, 3, 4, broad recommendations, and one of those
might be the one – translation and –

SPEAKER: Is it the last two?

MR. HITCHCOCK: Yes, probably some combination of those two.

SPEAKER: That would be a fourth one that you would add to the important
bullets?

MR. HITCHCOCK: I think so, yes.

SPEAKER: And then you would just not include the others at this point?

MR. HITCHCOCK: Yes.

DR. MAYS: Wait a minute. Dale, can you go through and then say which ones
you’re talking about? I didn’t quite get it. The first one you were saying 2,
3, 4. I didn’t know if you – I was trying to number these, and I realize you’re
actually just talking about the numbers you want to see. Can you go through and
say which ones you’re saying?

MR. HITCHCOCK: You asked me – My phone’s cutting out a bit. What did you
ask?

DR. MAYS: Oh, which ones are you saying should be in?

MR. HITCHCOCK: I’m talking about the public-use data files – issues.
The one that you brought up as the third one about pulling together
environmental sources.

SPEAKER: Population health perspectives?

MR. HITCHCOCK: Yes. And then the bicultural aspects of this.

SPEAKER: The fourth one he would add were the last two bullets combined.

DR. MAYS: Okay. So let’s walk through in terms of what we have and say what
we would just dump.

We would dump this issue about the definition of health disparities or
should we talk about it in the letter itself or should we put it in an
appendix? Just so that I understand, are we talking about that these four are
in the letter and then we have an appendix or are we talking about that we just
totally get rid of this other stuff?

MR. HITCHCOCK: We could put that as a sentence in the letter, I think.

DR. BREEN: Why don’t we work on a sort of hypothetical that let’s try it
with the four bullets that you and Dale developed as the key ones, and then we
could keep these others in reserve – you know, they would be in our notes – as
possible things we might want to bring up as details later on? Because what we
are hoping for is ongoing communication with this committee.

MR. HITCHCOCK: You’re right, Nancy, and I think Peter is very willing to do
that.

DR. MAYS: Okay. But let me just ask about one that I am concerned about,
and that is this is an agency-wide problem, that is, the definition of health
disparities. Do we need them to define health disparities?

SPEAKER: I think HHS is working on a definition of health disparities.

DR. MAYS: Oh?

SPEAKER: They are – working on it, right, Suzanne?

DR. HEURTIN-ROBERTS: What’s that?

SPEAKER: They are.

DR. HEURTIN-ROBERTS: Yes, they are. I don’t know where they are with that.
I know NIH is participating in that, but I don’t know where the process is
right now.

DR. MAYS: But I guess I was speaking for – that really determines what they
should be measuring.

SPEAKER: I think at this point, you’re really concerned not so much about
how you are going to describe the data once you get it, but that you – so that
you can identify certain differences, however you – you may have to come down
with how you are going to measure that, but I think, at this point, you are
talking about design issues. I would focus this letter on design issues. That
is what they are doing, and so I think if you say to them definition of
disparity, they are not going to know what you are talking about.

I think you really need to – and when you talk about the group, you’re
really talking about sample sizes. You want them to get a large enough sample
size so that you can pick up important differences and whether you are going to
measure – however you are going to measure the disparity. I don’t think you
have to get into that in this letter. That may be something you want to talk to
Peter about, but the real issue is sample size for me.

And I also think that number three may help address that, too, because we
talk about environmental, social, psychological and biological factors, and I
would add in there economic, and I think by doing that and having the bullet on
racial, ethnic subgroups, then we are asking them to design a survey where
people can examine health disparities regardless of how they might be defined
for purposes of this study.

DR. MAYS: Okay. All right. So we are going to dump one, dump two. We just
modified three to include economic.

MS. BURWELL: I need to ask a question. I’m sort of doing this – and they
can edit on the computer now. So I was wondering if Dale or someone else is
doing that so – to prepare the final letter, the final draft?

MR. HITCHCOCK: I haven’t been doing it, no.

MS. BURWELL: Okay. Well, then, I’m going to try to follow what you’re
saying and do it.

SPEAKER: Is that Audrey?

MS. BURWELL: Yes.

SPEAKER: And just ask qualifying questions whenever necessary. Thank you.

MS. BURWELL: Okay. All right.

SPEAKER: Thank you much.

DR. MAYS: All right. So we’ve got – we are going to leave three the way it
is.

It seems like we need not – whatever – four and five, including the sample,
ensure that – we need maybe a new sentence here – I mean, a new bullet here –
right? – rather than writing it the way it is. Something like ensure the
sample size is sufficient to allow for the analysis and meaningful
interpretation of data for geographically distinct and small racial and ethnic
minority populations?

SPEAKER: I would say the analysis and robust estimates of.

DR. MAYS: Okay. Jennifer, does this get what you just said?

DR. HEURTIN-ROBERTS: Yes.

DR. MAYS: Assure that there is –

SPEAKER: And then you can jump to data, I think, in that second bullet,
data for geographically distinct and small racial and ethnic minority
populations.

DR. MAYS: Okay. So let me see if I have this correct now. Audrey, are you
with me?

MS. BURWELL: Yes, I’m trying to catch up. So –

DR. MAYS: Okay. Ensure that there is sufficient, and then you want me to
drop down to data.

SPEAKER: No, I would say ensure that the sample size is sufficient to allow
for the analysis and robust estimate of – and then drop down to data.

MR. CURTAIN: Excuse me. This is Randy Curtain –

DR. MAYS: Hi.

SPEAKER: Hi, Randy.

MR. CURTAIN: I just want you to be aware of one very basic design issue
that is being – is somewhat controversial, and that is the use of the term
national in scope for this study, as opposed to a nationally-representative
sample for this study, because one of the major controversies in the design is
whether this should be viewed as the type of multi-site clinical study where
the clinics are selected based upon their excellence and ability to carry out
the study and they take their patients and enroll them in the study versus a
national probability – and so there’s issues of coverage and how – the
geographic distribution that is all tied up in the controversy, the national
probability design versus multi-centered clinical-trial-type design.

MR. HITCHCOCK: I was wondering about that –

SPEAKER: Have you decided?

MR. CURTAIN: That has not been decided. There is a workshop scheduled March
21^st, I believe, where there is going to be a presentation. I
believe this is open to the public, but probably limited seating is available,
but it is going to discuss the issues of probability versus non-probability
sample, alternative design, put this before a group who is then going to make a
recommendation back to Peter and then up to Duane on the overall design of this
stuff, then you can tweak the design within that framework.

SPEAKER: And, you know, until the decision is made, almost everything else
is up in the air, because you would do it so differently –

SPEAKER: Exactly.

SPEAKER: – until you do that.

And a little bit of background, there was a contract that NCVHS had awarded
a couple of years ago to Weststat(?) to kind of go through some of these design
options. I’m assuming, Randy, that that will be part of that workshop, but
–

MR. CURTAIN: That report was not received very favorably by several people.

SPEAKER: They’re not talking about it?

MR. CURTAIN: I don’t know if they are going to make that particular output
available to this group. They have Betel(?) as a contractor now, putting
together a paper on design options which is using the Weststat report input
into their report.

SPEAKER: What didn’t they like about the report? I mean, if it’s a long
answer – Weststat usually does very good work.

MR. CURTAIN: Yes, I think there is a long answer to it, but the short
answer is that there’s statistical considerations and then other considerations
involved in the design of the study in terms of the Centers for Excellence
wanting to be fully participants in it and they might not necessarily feel like
– go in there through a probability design. So there’s some – hate to say
political ramifications, but that’s the term I would use.

SPEAKER: The Weststat report was really about statistical issues.

MR. CURTAIN: It was primarily statistical issues, and it didn’t really
address the pros and cons of – see, part of the intrinsic controversy here is
that they are not producing national estimates – prevalent national estimates
of conditions. They are looking for causal relationships in these data. They
feel that they are intrinsically biological or could be modeled appropriately,
so they’re – now have to be concerned about how the sample is selected per se.

SPEAKER: And that has implications for the issues you are talking about,
because if they are intrinsically biological, then the sample design may not
need to be over sampled and you may not need to be making estimates. Those
things are very basic.

MR. CURTAIN: Right, but, on the other hand, you have the social and
behavioral sciences aspect of it, which may not have been heard well enough
yet, that would say, well, you know, there’s other sources of variation that
have to be considered, and many are not, in terms of the biological concerns.

SPEAKER: So it’s very complicated.

MR. CURTAIN: And part of it is the fact that they haven’t really taken
their core hypotheses and prioritized them to say – you know, because certain
designs would be good for some and certain designs would be good for others,
and they haven’t prioritized those – yet.

SPEAKER: So would you be concerned with the bullet that is under discussion
now, the geographically distinct? Do you think we should take that out for the
moment?

MR. CURTAIN: Well, the question I would have to you is to interpret what
you are doing in light of this controversy. If you do any probability design,
that implies a certain geographic distribution. However, a lot of these
hypotheses are related to environmental exposures which have different
geographic gradients to it. A probability design for organo-phosphates is
something different than palites(?) and things like that. So you have to be
concerned – one of the design concerns is that there may be very small pockets
of exposure, and a broad-based probability design may not pick up those
pockets, because probably the selection is too small.

SPEAKER: But you do want robust estimates for small populations, don’t you?

MR. CURTAIN: All right. Well, that could be interpreted two ways. Robust,
in that a very design consistent needs probability design in order to ensure
the robustness, and the other is that if they had a properly-specified model
and had the – composed a variation delineated in a properly-specialized model
that would provide the robustness. So you give them wiggle room there on terms
of the design options. From a lot of social behavioral and health disparity
context, you would probably factor in more of a probability design, because you
can’t – I mean, those occur at random throughout the population or very
geographically related, and so you won’t be able to address that.

SPEAKER: I think – if you really want to look at environmental exposures,
where this started, you use a very, very different design than if you want to
look at social, and if you’re – and kind of generic development kind of
issues.

You can overlay the social on the design that is going to be looking at
exposures, but it is only going to be in that context. It’s not going to be
generalizable, and, at some point, this study is going to have to come down on
what it is trying to maximize, and some people aren’t going to be happy, and so
the committee probably needs to think about what side of that argument they are
on, and I don’t know even – you know, I wasn’t at the meeting where Peter
talked, but I know enough of these issues – really make a seasoned
recommendation about where – what you want this study to do. Perhaps after the
workshop would be the time to make those recommendations.

DR. MAYS: The only reason we were really moving ahead is because, according
to Peter, that if we wanted to have input that could help resolve this it
needed to be sooner rather than later. So that was why, because we get more – I
think we learn more as we have discussions with others than I think we did from
Peter that day. That’s why I was a little concerned that – you know, there’s a
fair amount of activity going on, but I just didn’t get a sense of he was
really presenting all of that and presenting the dilemma as we actually have
come to learn about them.

I mean, this is a critical issue for the committee to think about, and that
is kind of where you do land on this, whether if we are comfortable with the
study being kind of biologically driven and then you derive what you derive
from that versus ensuring that – you know – it’s kind of on an equal footing in
terms of like these kind of social behavioral issues.

You know, this design issue really – once that decision is made, you then
have to work with how to maybe integrate those two perspectives, but one is
going to dominate.

SPEAKER: Well, one of the things that maybe we need to bring in here is
there’s a fairly new area within social determinance that is trying to figure
out what are the biological mechanisms that are linked between social
determinance and physical outcome related to health, and stress is a leading
contender, but there are other things, because environmental modification can
change biology. It can even change genetic structure, and we don’t know much
about that and we would like to know a lot more about it, and this might be an
opportunity to do that, but I think maybe social determinance and biology need
to be more explicitly linked, but there is a possibility out there there are
hypotheses and that that should be something that these data allow for testing
of. Would that help, do you think?

SPEAKER: Well, I’m not sure. I mean, there is a gene environment
interactions working work that is generating hypotheses and feeding them up
through the system, but what I’m not sure is how – as are many of the other
working groups, but it is not clear to me how the decision was – that is going
to be made as to what surfaces as part of the core.

SPEAKER: So then maybe we should just focus on what social groups need to
be part of the core and not – you know, with some specificity, but not enormous
specificity. What do you think?

MR. LOCALIO: This is Russell. I just have a comment, and I am very happy
that Randy is on the call, but, Randy, are you still on the call?

MR. CURTAIN: Yes, I am.

MR. LOCALIO: Well, the point you brought up is no secret, the controversy
is no secret, but I am reading back from my notes of our meeting in November.
On November 6^th, I have a note, how will NCVHS be included in the
design process? And what I would say the letter should say to Dr. Alexander is
just that: How will NCVHS be included in the design process?

What we are talking about now is specific issues that we can’t really
address because we don’t have sufficient information about what is going on,
and we are out of the design process, and I think the focus of the letter is we
have these concerns and we want to be in the design process, and that is what I
would recommend. So that would be much more of a blunt letter than I think
you’ve got proposed here.

DR. MAYS: But the question is – let’s make sure we don’t create something
we can’t do. It’s like being involved in the process, what – I mean,
specifically, is it that we are now attending all the meetings? We’re just
another voice, yet the decision gets made at a very different level. We’re
advisory to the Secretary. So I think where our value lies is in our ability to
not necessarily be fully in the process, but to be fully informed about the
process in order to do what is our charge.

SPEAKER: Intervene when needed.

MR. LOCALIO: Well, I agree with that, but we need to say that then. If that
is the point, we need to say it. How are we going to be included? What is the
mechanism by which we are going to be included? You know, how are they going to
put this together? Because from everything I have heard about this process,
there is no – I don’t think anybody has thought about NCVHS down there. I don’t
think they care, and –

DR. MAYS: Well, I don’t think they knew about us either.

MR. LOCALIO: Pardon me?

DR. MAYS: I don’t think Peter knew about NCVHS.

MR. LOCALIO: Sure. I would agree with you. So I think we have say, look,
you have to consider these other issues and you have to consider that this
committee exists and has this mandate, and so, I mean, the committee needs to
be involved in the decision making.

DR. MAYS: Okay.

MR. LOCALIO: But, by the way, and that would also be in the decision making
of this very fundamental distinction between whether this is going to be a
longitudinal survey that is similar to other longitudinal surveys or whether
this is going to be an elite medical-center-based study that is very similar to
just a multi-center study that goes on in other endeavors, and that is a very
fundamental distinction, and would you agree with that, Randy?

DR. MAYS: We do have people sitting on here who are wearing a different hat
who are at the level of receiving this information, but what does the group
think about making that request?

MR. HITCHCOCK: Well, let me just say one thing – this is Dale – that when I
talked to Jim Scanlon very early on about this letter, the letter is fine, but
he thought he also could handle it with a couple of phone calls. So we got to
sort of keep that in mind. I mean, he probably could handle a couple of phone
calls on sort of what Russ has been talking about, letting people know that
there is a new CVHS, for instance, if they don’t already know what it is that
we do, and how can we best have regular input into the design of the study.

I mean, we go all the way from a long letter with a list of recommendations
to the possible option of just having a phone call. I just wanted to point that
out –

SPEAKER: Can we do both?

MR. HITCHCOCK: Excuse me?

SPEAKER: Can we do both, have the letter and the phone call?

MR. HITCHCOCK: With both.

DR. MAYS: Okay. I think – I wasn’t aware. I think that is a good idea is
that, if that is that informal that people were talking about that, if Jim
could do that, then, you know, one becomes much more comfortable about
shrinking down a letter. I mean, I’m in a different headset now if we are going
to say that Jim will make these phone calls that I think we really do go down
to our few bullets and drop everything else.

SPEAKER: Also, we might – I think Russ’ idea was good, in general, but
I think we have to come up with a specific way in which the committee would be
participating on the committee or being informed or whatever, and that might be
something that could be discussed on the phone and then written in a letter, a
confirmatory letter, just as a followup, so that everything that needs to be on
paper would be on paper.

DR. MAYS: Yes, I think that – yes, I think we have to have a discussion
about that, probably with John Lumpkin and Jim and kind of move on from there
with that. Is that what you think, Dale, about how to work with them at
something that gets worked at?

MR. HITCHCOCK: Sure.

DR. LENGERICH: This is Gene.

I guess I would go back to Jennifer’s comment also in that I could envision
different mechanisms to work with that committee, depending upon which side of
the coin they come down on of how the sample is drawn, and so – and I think
that is the critical thing that we have to get across at this point, that we
are probably in favor of some sort of population health sample design and that
we need to be engaged in that kind of discussion first, and after that kind of
issue is resolved, then we will be more clear about how and to what degree our
involvement should look like.

DR. MAYS: I’m not sure that we are definitely 100 percent behind that
design, because if it is population based, depending upon how it is structured,
you could end up with very few racial, ethnic minority.

DR. LENGERICH: I didn’t say population based. I said population health, and
so I think that maybe that is the place where our discussion needs to happen. I
think that you could still explore disparities with a population health
approach.

DR. MAYS: Okay.

SPEAKER: I think we do need to emphasize that the social, the economic, the
environmental context that we have discussed needs to really be made a part of
it. This is much too large a project to focus only on the biological, I think.
I think it would be such a wasted opportunity –

DR. LENGERICH: I agree.

SPEAKER: – to not consider –

DR. LENGERICH: I agree wholeheartedly. I think our point number three there
sounds –

SPEAKER: Yes.

DR. LENGERICH: – somewhat like what we want to put forward and make
sure that – for them to consider us as being supportive of it.

SPEAKER: Yes.

DR. MAYS: Yes, I think three is turning out to be our – it’s almost like
once you got that in place, a lot of other things –

SPEAKER: Right.

DR. MAYS: – do fall into place. So that is definite.

Let’s revisit this sample size – while we have Randy on line – to make sure
that we don’t box ourselves in a corner with it.

DR. BREEN: I was also wondering, the people who are doing the
gene-environment interaction, are they all geneticists or are they a
combination of geneticists and social scientists? Who’s – could you give us
some sense of – Randy – of who is working on that subcommittee?

MR. CURTAIN: Unfortunately, I don’t know anything about that one.

DR. BREEN: Okay.

DR. MAYS: Virginia might.

DR. CAIN(?): I have the list of people. I don’t recognize the names, but I
could read it very quickly, maybe other people would. Melissa Bondee, Arvinee
– I’m sorry. I can’t pronounce that name – Checkravartees, David Ditz,
David Eaton, Sharon Cardia, Maximilian Nunkees, Andrew Alshands, Nate Rockman,
Robert Wright, Molly Bray, Stephen Channock, Janice Dorman, David Hunter, Fred
Ledley, Robert Nusbaum, Sonia Rasmussen and Shalom Wakholder(?).

SPEAKER: I know none of them.

SPEAKER: I think Shalom Wakholder works at NCI. He’s a statistician.

MR. HITCHCOCK(?): Yes. He’s a statistician at NCI. A couple of other ones
are with the people at CDC, the labs at CDC.

SPEAKER: My guess is that there would be a good number of psychologists on
that group, if they are looking at – is this biology –

DR. LENGERICH(?): I think one of the questions is how do they define
environment.

SPEAKER: Yes.

DR. LENGERICH(?): Is it a purely toxicological definition or does it
include the social environment, for example, as well?

SPEAKER: Right.

DR. MAYS: True.

I think that maybe some of these are things that – this is the informal
work. For example, it would be useful to find out whether or not an effusion on
these committees is necessary, because of the – as I understand it, the people
that are on the committee – that much of this was driven by the cochairs which
are from the institutes – I mean, represent the various institutes – CDC, EPA
and NIH – and so a lot of the environmental – as I understand this – is really
more a reflection of kind of the toxicologist approach as opposed to
environment, the way that we might think of it more broadly, and so it may be
that at the informal level that may be the opportunity to say this is a point
at which to add some different people to these work groups.

DR. CAIN(?): Yes, now, I’m sorry, I left off the two cochairs. One was
Jeffrey Murray, who is from Iowa, and the other is Paula Um(?) from CDC. I
don’t know if anyone knows them.

SPEAKER: Yes, Paula a little bit. I’m starting to work with her, but I
don’t know her well, but she’s from their genetic – I don’t know if it’s this –
division or what it is, but she has quite a good reputation, but I don’t really
know her work. So –

DR. MAYS: Okay. Okay –

SPEAKER: But that group is quite good.

DR. MAYS: Do we want to try and – let’s see if we can try and finish the
bullet that we were working on that Randy was just commenting on to make sure
that we can capture – Audrey, can you read what we have?

Does Randy sit on that committee? I mean, is he a good liaison for us?
Isn’t Randy on detail? Randy, you tell us.

MR. CURTAIN: Well, I’m not on detail. I’m on sort of – I’m serving as an
informal consultant to Peter on statistical issues, including design issues,
and when the planning came up for the workshop on the sample design issues, I
started sitting in on that workgroup. I don’t think I’m formally a member of
the workgroup, per se, but I show up a lot.

SPEAKER: And Peter asked you to join.

MR. CURTAIN: Peter – talking to Peter, he views me as a consultant to him
in the program office on their decision making and how to structure the format
of the workshop and what will be discussed there. I don’t think I’m a member of
the workshop. When they have a closed session, I do not participate in it.

SPEAKER: You certainly have his ear, though.

SPEAKER: The study-design working group?

MR. CURTAIN: I didn’t hear the question.

SPEAKER: Are you talking about the study-design working group?

MR. CURTAIN: Well, the study working group is a larger group, and then a
subset of that is a sample design working group that has just a few select
members of it. I have never really understood totally the interface of these
people. Some of them are working groups and some of them are also the
interagency coordinating committee, and then there’s this external review
committee that provides input as well, where university people and other people
sit on it.

DR. MAYS: Aren’t they hiring a sampling person?

MR. CURTAIN: Well, I suggested that they do that.

DR. MAYS: Yes.

MR. CURTAIN: But, right now, they have a contract with Betel and they are
having Betel pull in some consultants and put together some working papers on
draft-design options, on recruitment and retention issues, estimation issues
and various things like that, and these working papers will be presented at the
March 21^st workshop.

SPEAKER: Is Ken on that, too?

MR. CURTAIN: Ken, he might be on the – he’s not on the subgroup for the
design, per se. He might be on the other study group, but because Ken works
directly in Peter’s office as well, it’s hard to say who is on the group.

SPEAKER: I just pulled it up. Ken is the ICC liaison for the study design
working group, and among the group members are a number of people that
certainly I recognize – Ty Arbuckle, Colleen Boyle, Brenda Eskinozi, Lynn
Goldman, John Tiley, Weez Math, Steven Redd, Ink Spicer, Ira Tager, Jeanette
Thomas, Gertrude Berkowitz, Onus Ellenberg, Fran Ferstenburg, Elaine Cullen
Hubel, John Lynch, Gregory Pavlov, Paul Sorley, Mervin Susser, Mary Jane Teeta
and David Williams(?).

MR. CURTAIN: And then the sample design is a smaller group within that. I
don’t think it’s listed anywhere, but it has Jonas Ellenberg, Frank Spizer, the
guy from Chicago – I forget his name, Bob something – the guy from
Emery University and somebody from EPA on it. So it’s a smaller group that’s a
subset of that group.

SPEAKER: Well, now, are you talking about Bob Michael?

MR. CURTAIN: Yes, Bob Michael.

SPEAKER: He’s on the advisory committee. He’s not on the working group.

MR. CURTAIN: Right. But he’s also on this little subgroup that is looking
at the design of this workshop on the sampling issues.

DR. MAYS: What is interesting is even in that list, I recognize few of
those people who have expertise relative to racial and ethnic minority groups.

SPEAKER: Well, David Williams is the only name I recognized on that score,
though there were some other people who do good work at population health.

DR. MAYS: Right.

SPEAKER: John Lynch, a couple of other people.

DR. MAYS: Right. And then you have to make sure that David – he’s on lots
of things right now –

SPEAKER: Yes.

DR. MAYS: – whether – you know, if he misses a meeting, we miss the issue.

So okay. I think we are learning a lot right now which is useful, but I
think we have to decide what we want to do, whether to proceed with the letter,
whether to wait and do this at another time or to have the letter and also the
informal process that we talked about – what would you like? I’d like to get us
– if we are going to do this letter, I would like to get it finished, so that
we can actually present it tomorrow.

SPEAKER: I think both the letter and the informal process, because the
response that we will get to the letter will be a formal response, but I think
that since our discussion today has really shown how much goes on at an
informal level and how much goes on very rapidly and things change and it’s –
you just have to have more of that informal contact to be able to – a handle on
what is going on.

DR. MAYS: Now, how can we achieve this informal contact? I mean, while Jim
will talk about us being involved, as you can see, you need to be almost in the
upper level of this to have the bigger picture, I mean, because it is not being
in one of these small work groups, and it’s not attaching yourself to just one
issue. I mean, our committee is concerned with several issues that cut across.
So just so that we can offer Jim some idea of as he makes these calls what
might work, what is your suggestion?

MR. HITCHCOCK: Yes, that’s right. We need to do some – what I would think
of as talking points with Jim – in addition to whatever else he wants to say he
can make some of the points that we want to have made.

DR. MAYS: Right. So do you have a sense, in terms of this structure, the
level of – at which we might best be informed? And it sounds like for sure it
has something to do with the ICC.

SPEAKER: Yes, and it has – and Peter, as sort of the chair – I mean, he –
it’s a group of equals, but he is a little more equal than the others, just
because that is where the money is going, but he really tries to have it a
group decision-making process. So I think Peter is probably the best contact
for that.

DR. MAYS: Okay. Can you tell me where you participate, and, Jennifer, where
you participate? So that we have a sense of also the sources of information
that we might be able to get as input into the committee?

SPEAKER: Well, I work with NIH staff who sit on the various working groups,
and I have staff that attend – I occasionally meet with Peter, and I
occasionally meet with the chair of the advisory committee who is Don Madison,
but, again, it is very informal. I have gone to the coordinating committee
meetings in the past from time to time, but it is not a regular involvement in
decision making, by any means.

MS. MADAN(?): I kind of do my best not to go to any of those meetings,
after having gone to a lot of them early on.

SPEAKER: (Laughter). I like that.

MS. MADAN(?): Well, I would like to – we could make a bet on what happens
at the end of this, but I’m a little cynical maybe.

I do talk to Ken from time to time about what is happening, and John, but,
generally, when they think there is something that is an NCVHS issue.

I have kind of been waiting for a recommendation that you can talk about as
opposed to – at this point, everything is let’s look at all of the
possibilities, and that’s fine, but, at some point, when there is really some
proposal, I think that is when we might – as an agency – get more involved.

SPEAKER: That is one of my concerns. One of my issues with this is that I
am afraid – if you get involved in the beginning or even at this point in time,
it can consume all of your time, and, yet, if you’re not involved, I’m afraid
that things will become cast in stone and then it would be hard to change them.

DR. MAYS: Um-hum. I think that’s been my concern, too, is that it kind of
looks from the outside like there’s not much going on, but, then, you talk to
some people, there is – you know, some people are on a very steady path to
make sure that certain things are being woven into the core hypothesis. They’re
working at the structure. They’re wanting to be in at the gate to make sure
that once this process is out for bid that they are going to be there. So there
is a lot of activity, but, at the same time, it’s like it seems to change every
week.

SPEAKER: Some of these issues are not going to be – are not science issues.
There’s many different designs, many different ways to do this, and it would be
very defensible scientifically. Some of them are more policy, and someone is
going to have to make those decisions.

I think that NCVHS has – that is where their input is most useful, not in
these day-to-day stuff, because, as you say, changes all the time and it is
going to be very much a function of some of these major decisions.

Clearly, there are folks out there who have a lot of vested interest in how
this goes, and that is understandable, and I’m sure they are spending a lot of
time, but once those major decisions are made, other things tend to fall in
place, and it’s not so clear how to best to do this.

DR. MAYS: Well, it sounds like, at least at this point, what we would want
to do is to be on the radar screen, and being on the radar screen is we send
the letter and then we let Jim make some phone calls on our behalf, and maybe
from there the strategy is to see where we can best have input, and if both you
and Virginia and whoever is aware that we then kind of have a more formalized
relationship that we can offer comments on, then you can also let us know about
issues that we should respond to, as well as in our formal role we might be
able to get access to those issues. Does that sound like it might work or do we
need something else?

SPEAKER: No, I think that’s worth a try. That’s a good place to start.

DR. MAYS: Yes. Okay.

All right. So let’s see if we can get our four points. We’ll drop
everything else. We won’t have an appendix.

And I think, Dale, based on the conversation we have had on this issue that
will be helpful to transmit to Jim, so that he knows kind of what our concerns
are, how we want to be positioned and to see what he can work out for us
formally.

MR. HITCHCOCK: Yes, okay.

DR. MAYS: Okay?

All right. Let’s do this – the sample. Audrey, can you read where we are
with this? And then let’s see what we need to change.

MS. BURWELL: Ensure that sample size is sufficient to allow for the
analysis and robust estimates of data, and then that’s where we stop.

DR. MAYS: Randy, you had a – we were just at that point and we stopped, and
your concern was that we not box ourselves into having this be kind of
nationally-represented data. Is that – did I get it correct? Is that what you
were concerned about?

MR. CURTAIN: Even though the national probability sample is best for some
types of studies, this is also a longitudinal study, and one of the major
considerations here is the recruitment and retention problem, and the ability
to, first of all, enroll people in the study and then maintain them in the
study over 20 years. So that is a major issue. The cost of a probability versus
a multi-centered clinical is a major consideration, and some of the measurement
issues kind of preclude doing truly probability-based scattered throughout the
country. It would have to be kind of clustered within a clinic study and to
collect the biological samples. So you don’t want to come too hard on either –
at this point. That is the purpose of this working group is to sort of
delineate the advantages and disadvantages of the different survey designs and
what can be done and what can be excluded under each design.

I think what you probably want to do is – what your emphasis as a committee
would be, in terms of the data, the types of data, the distribution by race,
ethnicity and the need to cover – I don’t know if you want to use the catch
phrase No Child Left Behind – (laughter) – but you could certainly
consider that, that you don’t want to exclude a large proportion of the four
million births(?) by just dividing it into 30 clinics, unless there was
overriding concerns that drove in that direction.

So this robust estimate is a nebulous enough term that it could be
interpreted in several ways, but to the statisticians dealing with this, that
would mean either a design-consistent, robust-model-based or a model-consistent
design robust-based item. So you haven’t excluded anything, but you put in your
emphasis for the environmental and social factors and geography as well.

MR. HITCHCOCK(?): So it’s more a question of adequate statistical power
than it is national estimates, because it sounds more and more like it probably
wouldn’t – and when I hear estimates, I’m thinking of national estimates, and
I’m not even sure what these – could produce estimates. I don’t know whether it
would be their area – or whatever or – I mean, do we want to move away from
saying estimates entirely?

MR. CURTAIN: Well, I know the emphasis of most of the people dealing with
the study is on causal relationships – and, like I say, national in scope, as
opposed to be nationally representative.

The real issue is, if you are doing a causal relationship, are you dealing
with all of the factors involved in that relationship, including the race,
ethnic distribution, social factors, geographic distributions and environmental
exposures and things like that. So the terminal bust(?) estimation still holds
within the context of causal inference.

DR. MAYS: Could we say something like ensure there is sufficient sample
size for analysis of causal relationships that can include geographically
distinct and small racial and ethnic populations?

MR. CURTAIN: You can certainly put that in there. Again, once you get into
the final design phase, the final decision making, there are going to be
tradeoffs, and one of the tradeoffs you always get in a national design
sometimes is geography versus sub-domains. You often can’t do both in a design.
At least in this case you have 100,000 children being entered in, which is a
substantial sample size, but one of the reasons for that substantial sample
size is they are estimating things at one- and two-percent prevalence.

DR. MAYS: Exactly.

MR. CURTAIN: And if you are at those rare conditions, you might be able to
do it across the 100,000, but can you do it by sub-domains within that 100,000?
And I don’t think any design is going to be able to give you too much level of
detail on a 0.5-percent statistic by five sub-domains.

DR. MAYS: Point well taken. I think that what we are trying to do is
emphasize that, as these decisions are made, that what is important to us – it
goes back to almost the first one – that is, the population-health approach –
and that it is within the context of these relationships that we talked about,
but in this one what we are trying to say is that our hope is that the sample
size is going to be sufficient to ensure that we are going to be able to have
some comment about these relationships in these specific groups, because if we
– you know, I’m not sure exactly. If we just kind of leave it, the concern is
always that we end up with black, white differences, maybe black, white, Latino
differences, and then that is about the end of it.

SPEAKER: I guess my concern is that these issues – that they really do have
to have 100,000 people to study some chemical exposure that is not very common
or schizophrenia or I guess some of the less-wide-spread health issues that
they want to look at. They may really only be able to get fairly narrow – or
the racial and ethnic groups, they may not be able to have the diversity that
they would like to see, but I think it is one of the more basic issues. We
don’t have the answers to those questions about family context, neighborhood
context for some of the racial and ethnic groups. Whereas, you wouldn’t need
the 100,000 just to look at that. If you are going to look at the major groups,
you certainly need that if you want to try and look at some of the smaller
groups. So even on more basic questions, we really don’t have those answers.

SPEAKER: Well, on those questions, we don’t have the health outcomes
associated with them, but we do, from the Census, have some information about
household structure and some of the things that you mentioned –

SPEAKER: We do have some of them. We do – but in relation to health, I
don’t think that we have, and I don’t think that we have them for as many
groups as we would like to see, and this would be an opportunity to get –

DR. MAYS: Okay. How would you like to express this in a letter?

SPEAKER: (Laughter).

DR. MAYS: Concerns are there, but we gotta bite the bullet –

MR. CURTAIN(?): I think you probably want something to the effect that you
have concerns about the overall sample size and its distribution by geography
and minority sub-domains, and you would like to see these issues addressed as
part of the decision making in the sample design to see what core hypotheses
can be examined in terms of health disparities for any given particular design.

SPEAKER: I think that’s good – because this committee really should think
about what the implications are going to be if this is a very targeted,
center-based – because you may not be able to combine some of this stuff. You
may only be able to look at this within each of these areas. May be harder to –
you know – what you’re really going to be able to say for 100,000 kids may be –
I think is still up in the air.

SPEAKER: I agree.

SPEAKER: These design issues are really going to be complicated, and the
committee needs to decide what they want out of this. It’s a lot of money, a
big study, and there probably won’t be another one.

SPEAKER: And unlike the big surveys that NCVHS does or the Census, this
seems to be a hypothesis-driven survey, the kind that epidemiologists usually
construct.

SPEAKER: It seems to be going that way.

DR. MAYS: Yes. So what – I think maybe the way to deal with this is to
not try and make that a bullet, but to actually bring this up to someplace
within the letter itself and to just say the committee has concerns about the
overall sample size, specifically in terms of geographic distribution and
overall sample size for racial and ethnic minorities, and that – again – what
we would like is a consideration of these issues in any design that is
considered by the study.

SPEAKER: Right. And it’s not overall sample size. It’s sample size for
specific racial, ethnic, minority populations for whom we don’t usually – we
aren’t usually able to measure anything in these surveys.

DR. MAYS: I don’t know if we want that specific, because that is really
hard then.

DR. BREEN: Well, but I don’t think we just want to say overall sample size,
do we? I don’t think that conveys our meaning. Am I wrong about that?

SPEAKER: No, I agree, Nancy. I think that that is one of the basic issues
we have always tackled, that these large samples don’t provide adequate
representation of some of the groups that we would like to have information on.

DR. MAYS: Do you want to specify what groups you are talking about, then?

SPEAKER: Well, if you use that one bullet that talks about Puerto Ricans
and other island people, that brings it right down, and you might add Asians
in, too, because those are the groups that typically don’t get adequate sample.

SPEAKER: I think if you put that in the letter, it’s going to kind of show
your hand in a way about what you really want, and I don’t know if you have
really talked about what kind of design would give you that and what else you
won’t get because of the 100,000 births. If you really want to make those kind
of estimates for those small groups, it is going to be a very different design
and be very difficult to make any kind of combinations on. You would really
need to have one of these centers, if it goes the center route, in an area. You
would have to put it there, because that is the only way you are going to get
it, and how that works with – you know, if this is a grand process or a
cooperative agreement and – it gets very technical, I think, down the road, and
if you really want to – I’m not sure you really want to say that, if this is
the study where you really want to get those sub-populations.

SPEAKER: I think you have been in on most of the conversations where we
have struggled with this issue, Jennifer, do you have any suggestions on how we
might get the point across without being so specific?

MS. MADAN: I think what Randy suggested is good for this letter, because
this isn’t the final word. You know, you are going to get a formal response to
this letter, and it’s going to be more this is a door-opening letter, and if
Jim makes his phone calls – because these are complex issues, and I don’t
think you can deal with it in a bullet – I would just raise the issue of –
generally, of how race, ethnic groups are going to be dealt with in this
design, and that you need to be at the table.

MR. LOCALIO: Yes, I want to reinforce that last point. You have to be at
the table. These issues are very technical and complex, many, many tradeoffs,
and we can’t really – it is very difficult up front now to make these
decisions. You have to kind of be there and participate in the decision-making
process for these decisions to be educated.

DR. MAYS: Okay –

SPEAKER: So one of the things that is going to have to be discussed on
these phone calls is how to be part of the process.

MR. HITCHCOCK(?): Yes, keeping in mind that we really are an advisory –
because the Secretary, you know, does not make us – equals. I don’t know. I’m
thinking – want to be as much at the table as – to invite representatives of
this study come to our table.

MR. LOCALIO: Before they make any decision that can’t be revisited.

MR. HITCHCOCK(?): Sure.

MS. MADAN: Yes, I think you want to be involved in the decision making, not
in the development. I don’t think you can be, as a group. It would be hard,
because there are so many groups, there are so many people involved in this
that it is just one more person, but if this is truly an advisory committee to
the Secretary, then – and this is a big survey – then it should have some
advisory capacity here.

MR. LOCALIO: And one more thing, Jennifer, I would hate to have to see this
survey take even more money away from NCVHS. I mean, that is what we don’t want
to have happen.

MS. MADAN: Thank you.

(Laughter).

SPEAKER: Is that at risk? Is that a possibility?

MS. MADAN: I have no idea.

SPEAKER: Because I thought this was pretty much funded by those agencies
that were mentioned.

SPEAKER: No, the official position is that it can’t happen unless this
congressional appropriation –

MS. MADAN(?): Exactly. So – and congressional appropriation, health is only
going to get so much.

SPEAKER: So this study isn’t funded.

MS. MADAN(?): No.

SPEAKER: No.

MS. MADAN(?): Not yet.

SPEAKER: Okay.

MS. MADAN(?): I don’t think it’s going to take it out of our budget, but if
there is – you know, how much more money is there going to be? And if you want,
as Randy says, estimates for Populations, which you are not going to get from
this, you could get from some other study, whether it’s one we do or someone
else does, you know, it is competition.

DR. MAYS: Okay. Let’s go to second page of the letter, the first paragraph,
where it talks about the NCS study as shared by – and what we do is talk about
the kinds of things that we are concerned about, that these include, but are
not limited to da, da, da, da, da, da, da, and it might be after that sentence
that we say something in particular about the committee finds itself
particularly concerned about the sample size – let me see. What did I do in my
notes here? Scratched them out a couple of times. I want to capture what Randy
said here, but before the sentence on guided by our hearings, maybe we can say
something about the committee is particularly concerned about an overall sample
size – oh, we don’t want overall. I forgot. Is concerned about a sample size –

MR. HITCHCOCK: I used the word design.

DR. MAYS: I’m sorry?

MR. HITCHCOCK: Is it size that we are concerned about or the design that we
are concerned about?

MR. CURTAIN: I think what you are concerned about is the sample
distribution.

MR. HITCHCOCK: Yes.

SPEAKER: Thank you.

MR. CURTAIN: Given a sample size, how it is distributed across different
characteristics.

MR. HITCHCOCK: Very good.

DR. MAYS: Okay. So the percent will be the committee is concerned about the
distribution –

MR. HITCHCOCK: Distribution.

DR. MAYS: – of the sample.

MR. HITCHCOCK: Distribution of sample, I guess.

DR. MAYS: Distribution of sample across – how do we want to do this?

SPEAKER: Racial, ethnic and socio-economic characteristics?

MR. HITCHCOCK: And geographic domains –

DR. MAYS: The racial, ethnic, geographic and what else?

SPEAKER: Socio-economic.

DR. MAYS: And socio-economic characteristics.

MR. HITCHCOCK: Geographic sub-domains.

DR. MAYS: Geographic sub-domains?

MR. HITCHCOCK: Yes.

MR. CURTAIN: I wouldn’t start mixing characteristics with sub-domains. Use
one term or the other.

MR. HITCHCOCK: Why? Because they are sort of competing –

MR. CURTAIN: Yes, it’s just a translation that you wanted to – for whoever
is reading the letter, you know –

SPEAKER: How would you put it, Randy?

MR. CURTAIN: I would like to say the – by different types of
characteristics, including the race and ethnic composition, the geographic
distribution and the socio-economic status of the study participants.

DR. GREENBERG: This is Marjorie. I’m really sorry to interrupt.

SPEAKER: Hello, Marjorie.

DR. GREENBERG: Hi. I’m also sorry I couldn’t be in two places at once. I
still haven’t figured that one out yet.

SPEAKER: Cloning.

DR. GREENBERG: There was a discussion going on upstairs that I really
needed to contribute to as well, but I don’t want to interrupt you while you
are working on this letter. How much longer are you planning to be on this
call? Because I understand there are some issues you wanted to discuss with me,
and I’m happy to respond to them, but I don’t want to barge in here, but this
was – I got this little opportunity to come down.

DR. MAYS: Well, what I would like to do is to see if we can finish this up
in the next 30 minutes or less.

DR. GREENBERG: The next what?

DR. MAYS: Thirty minutes or less.

DR. GREENBERG: Okay.

DR. BREEN: Vickie, I’m going to have to go at noon. I just wanted to let
you know.

DR. MAYS: I’m sorry?

DR. BREEN: I’m going to have to go – this is Nancy – at noon. I just wanted
to let you know.

DR. MAYS: Okay. All right. Let’s see if we can finish the letter then.

MR. CURTAIN: I think the main point of the letter is just getting the basic
point across, and then you can rely upon the telephone conversations to further
illuminate the points and what you really mean by it.

DR. MAYS: Yes.

Okay. So let me see if I can do this and do this efficiently. The committee
is concerned about –

MS. BURWELL: The distribution sample.

DR. MAYS: – about the sample. No, that’s not the word I started to –

SPEAKER: The distribution, sample distribution.

DR. MAYS: The committee is concerned about the sample distribution by
different characteristics – concerned about –

SPEAKER: Randy had the wording, if he could repeat it.

DR. MAYS: Yes, he had sample –

MS. BURWELL: Let me read what he said.

DR. MAYS: – by different characteristics, racial, ethnic distribution, but
I don’t have at the beginning of the sentence –

MS. BURWELL: Hold on a sec.

DR. MAYS: – different characteristics.

MS. BURWELL: The last sentence that I – when Randy was talking, it says,
the committee is concerned about the distribution of sample across different
types of characteristics, and then by race, ethnicity, social, economic status,
geography, and then that’s where we stopped.

DR. MAYS: What else?

MR. HITCHCOCK(?): Did he say sample? I forget – I can’t remember.

DR. MAYS: Yes, he did say something about sample –

SPEAKER: Study participants, I think he said.

MS. BURWELL: Study participants?

SPEAKER: I think so.

MS. BURWELL: Okay. Of study participants. So then I heard him say something
about –

MR. CURTAIN: Yes, I prefer to use the term study participants, because it
gets away from that probability sample versus the clinic-based sample.

DR. MAYS: Good.

Okay. Read the sentence, Audrey. Let’s see if we can get it.

MS. BURWELL: All right. The committee is concerned about a distribution of
sample across different types of characteristics by race, ethnicity, social,
economic status and geography of study participants.

DR. MAYS: Okay.

MR. HITCHCOCK: – was saying distribution of study participants by those
characteristics, and did not say anything about sample.

MR. CURTAIN: Right.

DR. MAYS: Randy, can you run your comment again?

DR. GREENBERG: I’m going to have to go. Bye-bye.

DR. MAYS: – sample in terms of different characteristics, and then it was
racial, ethnic distribution, geographic. I mean, I’m one that does not do
wordsmithing well –

SPEAKER: I thought it was something like the distribution of study
participants across characteristics of race, ethnicity, geography and I forget
what the other things on the list were.

MR. CURTAIN: I think you need a second sentence as well to tie in what you
mean by that, but the first study would basically introduce the concept that
you are concerned about the distribution of study participants – distribute or
however the words – the characteristics of SES, race, ethnicity.

DR. MAYS: Right.

MR. CURTAIN: And that introduces – since you have a concern, I think you
need a second sentence to say exactly what your concern is and that is the
ability to do causal inference so that the core hypotheses are related to those
characteristics of importance. So you want to tie in the fact that these
characteristics are related to the core hypotheses and are intrinsically part
of the core hypotheses.

MR. LOCALIO: Randy, you want to get the message across that the association
between some environmental exposure and outcome is influenced by somebody’s
geography, SES, ethnic background. Is that correct?

MR. CURTAIN: Right.

MR. LOCALIO: Yes. Okay.

DR. MAYS: Okay. I do not believe that it is in our best interest to try and
wordsmith this right now on the phone as much as we need to get it written
down, then work on it or else we are going to do this for like 45 minutes, and
I’ve heard from you all now several times and you don’t think that is the best
use of your time to get the wordsmith on when our face-to-face meetings are on
the phone.

So, Audrey, maybe while we’re talking you can give us the sentences, and
then we’ll revisit them at the end, and then we’ll make our corrections,
because I think, without a specific thing to respond to, I’m just concerned
we’ll not be able to do this.

MS. BURWELL: Okay.

DR. MAYS: Okay?

And then, let’s see, there’s – what were the four things? The population
perspective – we have that in – the sample size. The last two, which are
concerned – something about the language – we have translate instruments into
all languages necessary for the broadest participation of racial and ethnic
subgroups in the study. Use bilingual and bicultural interviewers where
appropriate. Do we still want that?

MR. HITCHCOCK: I’m willing to drop that out of the letter and have it be
part of a phone conversation.

DR. MAYS: I agree. I was just going to say I think the informal – that that
may be for informal.

And what else did we want in as kind of a fourth point?

MR. BURWELL: Public-use data.

DR. MAYS: Yes, public-use data. How about something as simple as assurances
or outline of a plan for public-data use?

SPEAKER: Sure. That sounds good.

DR. MAYS: Okay. So that’ll be – we can have that as –

MR. LOCALIO: I would expand that to – broad access to the data, because we
are not just talking about a public-use –

DR. MAYS: Oh, yes –

MR. LOCALIO: We are talking about something much more than that.

DR. MAYS: Assurances or outline of a plan for public-data use which is
broad in its accessibility and easy in its access. How’s that? Oh – which is –

SPEAKER: How about which is broadly accessible.

DR. MAYS: Thank you.

SPEAKER: Okay.

DR. MAYS: Which is broadly –

MR. CURTAIN(?): And timely accessible?

DR. MAYS: I’m sorry, and what?

MR. CURTAIN(?): And timely.

MR. HITCHCOCK(?): That’s a good one.

DR. MAYS: Okay.

SPEAKER: Time and broadly accessible.

DR. MAYS: Okay. Timely and broadly accessible. Okay. So we have that one.
All right. So that is our four points.

So how do we end up? It says, currently, the NCVHS remains committed to the
importance of da, da, da, da, da. We will follow with great interest.

We need to ask for something specific. I think Marjorie gave us a little
specific language – get Marjorie’s letter. Marjorie, are you on the line?

SPEAKER: Marjorie had to go back to the meeting.

DR. MAYS: Oh, okay.

MR. HITCHCOCK(?): Russ gave us – Russ talked about this, too. Russ, do you
have some thoughts on this?

MR. LOCALIO: I don’t have anything in front of me.

MR. HITCHCOCK(?): Okay.

DR. MAYS: Okay. Let me go to Marjorie’s letter and – the NCVHS would
appreciate feedback on these issues and welcomes continuing dialogue with the
Subcommittee on Populations on how these issues might be addressed. The NCVHS
remains committed, and then da, da, da, da, da. So she asks very specifically
for feedback and continuing dialogue of how the issues might be addressed.

MS. BURWELL: Okay. You need to read that to me, so I can stick it in here.

DR. MAYS: I’ll just send it to you. I mean, this is Marjorie’s letter. So –

MS. BURWELL: Okay.

DR. MAYS: I just want to know from the committee if that is strong enough
or they want something else –

MR. HITCHCOCK: Given that there’ll be phone calls, I think it’s strong
enough. I don’t think we want to be overly assertive on paper here.

DR. MAYS: Okay. All right. So I sent that to you, Audrey.

MS. BURWELL: Okay.

DR. MAYS: Okay. Anything else?

MS. BURWELL: The rest of the text you are leaving?

DR. MAYS: The rest of the text, meaning the beginning of the letter, the
paragraph of the letter?

MS. BURWELL: The paragraph.

DR. MAYS: Yes.

MS. BURWELL: The paragraph. Okay.

DR. MAYS: And what we are dumping would be bullets, other than the four
that we agreed upon.

MS. BURWELL: Okay. Now, there is the one that you talk about examine a
causal relationship between social, economic and biological factors which
contribute to health disparities and their impact on health outcome. That goes,
too?

DR. MAYS: No, that’s our first one, user population health perspective to
identify and examine – that is the first one.

MS. BURWELL: All right.

DR. MAYS: Okay. What I’ll do is – Audrey, if you can pull that together,
why don’t we send that to people as soon as you finish it, have them look at it
and send the comments back to you and to Gracie, and, then, Gracie, if what
you’ll do is have them fax them to my hotel, and then when I get there today I
can look at them, and then we can make sure we have a clean letter for in the
morning.

MS. JACKSON: Audrey, are you at your office?

SPEAKER: Audrey’s at home.

SPEAKER: Audrey’s home.

MS. JACKSON: We are trying to work out the logistics. Maybe they can plug
into a CDC line here at the Humphrey Building. Right now – generally,
we’re off line when we’re in the meetings.

MS. WHITE: Because Dale is not here for his computer to be on.

MS. JACKSON: And you need something coordinated to –

DR. MAYS: Okay. Can we – let me finish with the committee and you all can
do the logistics on the end of this. How’s that? Because I’ve got people who
are going to get off very soon.

MS. JACKSON: All right.

DR. MAYS: All right. Let me just look and see what else on here that we
definitely need to do.

Can we get Marjorie back, Gracie?

MS. WHITE: I don’t think so, Vickie.

DR. MAYS: Oh, I thought she –

MS. WHITE: I told her I’ll try to set up something with you next week,
maybe –

DR. MAYS: No, did Marjorie go back to the meeting?

MS. WHITE: Yes.

DR. MAYS: Can you ask her to come down?

MS. JACKSON: I did give her the – I prepared a spreadsheet, Vickie, based
on the request that people were looking for, the various subcommittees, the
number of meetings, the hearings, the cost for accommodations and speakers,
things like that that you were looking for, and so she does have that request
and she does know what the matters are.

DR. MAYS: Oh, okay. I thought, since she came down and she was asking us
that we could talk with her, but that’s okay.

Anything else that we want to bring up at this point? I mean, the only
other thing that is on our agenda that we didn’t really deal with, and I’m not
sure that we should jump into it, is really to talk about where things were
relative to the discussions in the San Francisco hearing. I think that is
something we might be able to do at another time.

MS. JACKSON: Hi, this is Debbie. As well as status of any upcoming reports
from the committee.

DR. MAYS: Any things we want to bring up now? Anything else?

MR. HITCHCOCK: I don’t think of anything that we need to cover today, and
my battery is starting to flash at me.

SPEAKER: Yes, I need to get going.

DR. MAYS: Yes, I figured we were hitting the magical hour here.

SPEAKER: Uh-huh.

DR. MAYS: I am absolutely very appreciative that you all were able to be on
a call for this amount of time and that you have the stamina and endurance to
do a telephone call for this – (laughter). I mean, I’m not – I go nuts –

SPEAKER: My ear is numb at this point.

DR. MAYS: I know.

So – Okay. I will be there tomorrow for the full committee meeting. We will
try and get this letter approved and through.

And the other thing that I want to do is I will attempt to work with the
staff on coming up with a work plan to kind of distribute and attend to all the
things that we have on our plate, so that we can figure out how to get that
done, and to look at who the additional staff are I think that also will be on
board to work with us, as well as whether we have any new committee members.

So I think some time after the meeting, we will sit down as a group and do
that, and then we’ll be back to the full subcommittee.

Other than that, I think that’s it.

MS. LUCAS(?): Excuse me, Vickie.

DR. MAYS: Yes.

MS. LUCAS(?): Hi, this is Jackie. I just wanted to let you know I’ve been
on the call. I haven’t said anything, but I have been here.

DR. MAYS: (Laughter). Well, thank you, Jackie.

Okay. All right. If there is nothing else, then I think we should be
adjourned, and I will see you all in D.C. tomorrow.

(12:07 p.m.)

* * *