Male Speaker: Okay, we've reached the ever popular council
initiated discussion phase.
This is, I guess, Terri’s coined a new phrase back to you portion of the council meeting,
where we turn over the agenda to the council members, and we ask you to bring issues to
our attention.
This is a good opportunity if you want to hear in a future meeting a report on a certain
topic or want to engage us in a conversation, and give us a chance to collect some information.
So the floor is yours.
Any topics you want to hear?
We try to anticipate in thinking about speakers and thinking about things to cover, looking
ahead to February.
Anything brewing?
[laughter]
Yes, we're still in the PG rated part of the program, so we're not quite at the R. So just
hold on to some of your thoughts, but yes.
Male Speaker: Well, something in the -- at some point, we
probably ought to hear something in the personalized medicine initiative space.
Male Speaker: You mean precision medicine --
Male Speaker: Yeah, that, too.
You know, I --
Male Speaker: Yeah, see --
Male Speaker: --I'm sorry, I used the wrong term, but I
still think --
Male Speaker: Yeah, yeah.
Male Speaker: -- mine is right, but --
Male Speaker: We will -- yeah I think that'll naturally
happen as soon as we see as it develops what we can say and but absolutely.
I think that'll be a regular update.
Male Speaker: I was going to make the same point, but I
think maybe this is what you mean is but moving beyond the obvious and the cliché is, you
know, what can NHGRI be doing?
What should the genomics community be doing to either promote precision medicine or to
be more fully engaged in the precision medicine initiative.
I mean, you know, I sort of waffle back and forth.
Someday, you know, this is what we do in terms of genomics.
And that is -- well, it's not exactly new.
But on the other hand, it's a wonderful opportunity for us to move it forward.
And so, whenever it comes up, it just seems like we should focus more on the role of NHGRI
and the role of genomics in general to precision medicine, because my guess going forward,
we're going to hear a lot.
There's more to precision medicine than genomics, right or I hope there is.
Male Speaker: Absolutely, a lot more.
Male Speaker: But on the other hand, we have a responsibility
around this table to this institute to see what we can do to help promote this.
Male Speaker: Amy?
Female Speaker: I guess we haven't heard from the large scale
genome sequencing Fenderson [spelled phonetically] faith kind of been retooled, have we?
Male Speaker: Well, they're about -- the largest centers
are going to be a topic of or a discussion at the closed session of this meeting.
Female Speaker: Okay.
Male Speaker: So --
Female Speaker: But I mean, but I mean down the road --
Male Speaker: Beyond -- down the road.
Female Speaker: And --
Male Speaker: Probably February might be too soon --
Female Speaker: Yeah.
Male Speaker: --but yeah, we'll obviously want to keep updates
about them.
Yeah, Val?
Male Speaker: Let me just -- Amy, are you thinking more
about like the -- for us to bring you an annual report from the common disease centers?
Would there be value in doing that?
Female Speaker: No, but maybe --
Male Speaker: Mike.
Female Speaker: Okay.
I mean, we can hold this till after the closed session maybe, but I was thinking more just
future directions a one-time thing of how they fit into directions.
Male Speaker: Yeah, I know we had this -- we got some report
on this a few sessions ago, but I think we need to maintain close contact with the FDA,
particularly in the events of the precision medicine thing.
One of the big obstacles is actually at our institution is getting approval of things
which I think should be easily approved because, you know, gene directed therapy and such using
vectors that are already being utilized.
And if you're just using a different gene, but the same, you know, viral vectors and
certain things, I think the process still needs to be worked on to be much streamlined.
Male Speaker: Sorry, I forgot which council meeting we had,
the FDA.
I’m looking back last February.
So we had last February.
So it is about a year.
That's okay.
Wow, that was a lot.
Meanwhile, I would say we've -- we have ongoing interactions with them, better than ever.
And we could report on that almost anytime.
And then, meanwhile, with wow, maybe we should just go from the top.
We should try to get Rob [spelled phonetically] here.
We could use our Duke colleague to help persuade Rob to find time on his -- what'll be an incredibly
busy schedule.
Maybe we could even get --
Female Speaker: [unintelligible]
Male Speaker: So Arty [spelled phonetically] can put in
a plug.
Maybe we could Rob Kayla [spelled phonetically] to come, but he would probably I'm sure bring
his staff that are working on the -- in the genomics area, that staff we have relationship
with.
So, again, I think that's a great suggestion to shoot for maybe for February.
There's always stuff.
I mean, there's a lot -- again, we know because we're interacting with them frequently now.
Female Speaker: [unintelligible]
Male Speaker: So that's a political question.
Wow.
Male Speaker: The February meeting.
Male Speaker: It could be.
Well, yeah.
Male Speaker: Their CTO is also awesome or CIO to HASS [spelled
phonetically], the --
Male Speaker: The FDA?
Male Speaker: Yeah.
Yeah, he's been working on their open FDA project and alternated their release.
It's actually an incredible model for how to control the happening.
Female Speaker: What data
are they releasing?
Male Speaker: Almost everything.
Everything they handled, they're releasing in their [unintelligible].
Male Speaker: All right, is that better?
Male Speaker: Yeah.
Male Speaker: So they're trying to release as much information
as they can that isn't, you know, privileged information from the filings, but they've
got, you know, ton of -- adverse drug reaction responses that they're releasing.
It's a pretty interesting data set, open FDA.
Female Speaker: And there was an article coming up describing
the whole process.
It should be out this month.
Female Speaker: I don't know.
I seem to remember maybe February, we talked about the CER [spelled phonetically] RFA.
And I would like to hear an update about the status and the outcome of the review.
Male Speaker: So that will be reviewed in the fall and it
will be coming to February.
Female Speaker: So it won't probably be for next council meeting,
but you know, once we have a new director for NLM, it would be great if we could get
them to come to council to give their vision.
Male Speaker: Right.
So certainly, I completely agree with you.
I think unlikely May, hard to say.
May would be unlikely.
Maybe possible.
Certainly not February.
I would say the same thing about the directorship of the precision medicine initiative cohort
programs.
It's acting director now, but I mean, that search is going to start at -- I'm sure it'll
be also placed in a very fast timeline, but both of those would be extremely appropriate.
Are there any other, probably been thinking about it, are there any other institute directors?
Are there any other leadership positions at NIH?
I'm just trying to think out loud.
I mean, we can be monitoring this -- for people you want to hear from that we could be -- those
are easy.
The locals, yeah.
Female Speaker: I would actually like to hear from the director
of NIMHD.
Male Speaker: That's a great suggestion.
Brand new.
I just -- I've only been across the room from Height [spelled phonetically].
We actually haven't even met yet, but he's coming to see me.
I think we're going to arrange meetings.
He's going to come around, but he's only been on the job I think two weeks, three weeks,
but that's a great suggestion, Peggy [spelled phonetically].
Yeah, yeah.
Bob?
Male Speaker: I was going to suggest we hear the director
of NIMHD.
Male Speaker: Oh, okay.
Male Speaker: That's exactly what I was just going to suggest.
Male Speaker: Great minds think alike.
Male Speaker: And I know Alecio Perstabla [spelled phonetically] pretty well.
Male Speaker: I bet.
Male Speaker: From UCSF.
And it actually leads to something else, which is not very well formed in my mind.
I'm not sure how we would go about this.
But thinking about precision medicine and the general mcmedicine workgroup, there is
a certain amount of pushback against genomic medicine and precision medicine out in the
academic community from people who are really, really focused on the social and behavioral
determinants of health, and also, people that are really public health focused.
And I really think that a -- some sort of a meeting of the minds between precision medicine,
genomics, and social behavioral health and public health people, because I actually don't
think they're antithetical at all, but it's being posed as being possibly antithetical.
Female Speaker: I'm interested in hearing you say more about
that.
I mean, I'm curious how that view comes and how you have that view.
Male Speaker: How I have the view what?
Female Speaker: That there's a disconnect or a tension between
public health researchers and precision medicine?
I guess I wouldn't see it that way at all.
Male Speaker: Yeah, I guess I get the view, particularly
from public health researchers and social behavioral researchers at UCSF who say -- who
said to me things like, you know, this is really a lot of resources being spent on stuff
that affects a very small number of people, and yet, we could use these resources much
more effectively, if we study things that involve many more people at the same time,
and also, that it's an overemphasis on genetics and genomics as a determinant of health, and
that there are many other factors that are as or more important that we're not spending
money on.
So that kind of thing.
Male Speaker: I could -- you're right.
And it's not from everybody.
It's just -- there are some -- I've given many talks on precision medicine initiative
over the last, you know, 10 months or something like that.
Nine months in particular, I remember -- one of them I gave was at a public health meeting.
And they were very unhappy that it was being called precision medicine, as opposed to precision
health as an example.
So, you know, again, these are just -- [unintelligible] disagree over many aspects of this, including
cosmetic aspects like the name, but yeah, Gail?
Female Speaker: Yeah.
And I agree that I've -- that there's a lot of tension.
And I think one of the other things that people -- that people who have critiqued this argue
a lot is that it will exacerbate health disparities.
It will re-defy categories of race that are mainly social in origin anyway, etcetera.
So and I know there was a call for proposals.
And what was the institute?
Might have been the one with a new director that, but U-54 proposals about, you know,
that were looking at precision medicine and disparities?
Huh?
Yes.
Male Speaker: NIHMD.
Female Speaker: So and -- yeah.
And oh, sorry, but I just wanted to say that I imagine that those -- that those will be
reviewed and maybe even some awards made before the next meeting, but maybe not.
But I guess there's a lot of energy in the community about sort of addressing this in
a really thoughtful way, addressing the ethics of it, addressing some of the critiques.
And it would be nice to hear about genomics and health disparities in the context of precision
medicine.
And go ahead.
You had a response?
Female Speaker: Thank you very much.
I would just echo that I think it's really important to have people who have diverse
views about it.
I don't -- I think just as there are people who might criticize it and be critical of
the focus on genomics and sort of the way in which it might be conceptualized and operationalized
at different institutes, I think the U-54 in particular really encourage a wide range
of disciplines to be engaged in the precision medicine effort.
So I think it'd be really timely to have that director and someone who works, you know,
in the space of genomics and health disparities come and present.
Male Speaker: So one suggestion along those lines.
And I, for one, am, you know, love precision medicine.
It's what I'm very interested in.
Also very concerned that precision medicine could widen health disparities, right?
Like all kinds of technologies can.
And so, I think it's a really important problem.
And it's one of the things that we spend a lot of time at the meeting that Vince [spelled
phonetically] organized last week.
You know, so one potential strategy is to kind of understand where our colleagues in
population health are coming from, right.
They're getting attacked in lots of different directions in terms of their funding.
The National Science Foundation doesn’t receive funding from National Science Foundation.
You know, is constantly under attack for behavioral research.
And so, they look at -- those of us who do genetics and precision medicine and say, how
come those guys are getting a -- you know, all the resources.
And so, maybe one model could be the NHGRI model of having a set aside for LC research
in those aspects.
And I think, you know, that should be a big component of precision medicine.
And to also broaden the definition as my understanding is that it includes those behavioral determinants.
And so, in fact, it should be seen as a rising tide lifts all boats, and that this is going
to be broad and inclusive, both in terms of research and population, but you know, maybe
Eric [spelled phonetically], you as someone who's been on the throttle of the PMI can
speak more to that.
Male Speaker: It is absolutely intended to include that.
Jay [spelled phonetically], do you want to make a comment as a member of the working
group?
I mean, there was plenty of discussion about social determinants also being factored in
to the precision medicine initiative, in addition to genomic data and various other --
Male Speaker: Being socioeconomic kind of -- yeah.
So I think there was -- throughout the entire process, there was, I think, a constant sort
of awareness of the possibilities of this increasing disparities and issues like that
and the notion that it was something that we not only had to be cognizant of, but also
built in -- build in kind of a response in the way this was structured.
You know, how that comes to be executed, I think, remains to be seen, but --
Male Speaker: Maybe the Pony Express has been broadened
out to the West Coast.
But, you know, on our side, I definitely have gotten a lot of concerns from colleagues also
at Stanford on the population health side about, you know, how could this -- you know,
could this precision medicine initiative end up, you know, sidelining a lot of the things
that they think is important.
And I think it's a mistake.
I think they're intimately aligned, right.
Male Speaker: Yeah, I think basic -- to make it as oversimplified
as possible, you talk about end of one studies to population health researcher.
And they look at you like you're a lunatic.
I mean, how can you do an end of one study on anything?
Male Speaker: Okay, great suggestions.
Other suggestion?
Topics or future presentations?
Male Speaker: I'll just add as a further response of that.
You know, I think the way people think about precision medicine is, you know, everyone's
got kind of a different conception of it in their head, but the way this might actually
come to pass, I think, it could end up broadly enabling exactly those same folks that you're
talking about, right, if it all works.
Male Speaker: I'll just add one more comment about a possible,
like I would just thinking backwards and also forwards, I would love to see some more basic
science in kind of some of the presentations in the future.
So I don't know if that would be in code or GGR or something like that, but --
Male Speaker: And so, give us a little more detail what
you're looking at?
Are you interested in program highlights?
Are you interested in -- from program staff, are you interested in members of the community
who are grantees, who could describe their work or?
Male Speaker: Yeah, I would be more interested in members
of the community, but that's --
Male Speaker: Okay, yeah.
Male Speaker: Okay, we just need to get you started and
then, it's hard to stop you.
So thank you very much.
[end of transcript]