Tip:
Highlight text to annotate it
X
Cecili Sessions: Good morning. I'm Lieutenant Colonel Cecili
Sessions from the Air Force Medical Service. I'm a physician, pediatrician, and prev-med
by training. I am not a geneticist, contrary to popular belief among some of my own leadership.
But I want to thank in particular my surgeon general, Tom Travis, for extending an invitation
on which resulted in so many uniforms being present today. In particular I'd like to acknowledge
Admiral Doll and Admiral Dollymore for being present. I know you are extremely busy, so
thank you for taking this time out of your schedules. I'd also like to acknowledge the
literal army of clinical geneticists who responded to this invitation who are hopefully listening
to us or watching us online.
Next slide, please. Oh, sorry. Okay, so our program is called Patients under Precision
Care, PC2-Z. In the Air Force, we use the Z ending to indicate that we're doing something
that we think is innovative and cool, so genomic medicine research falls into that bucket for
us. It's our comprehensive effort to prepare infrastructure for genome-informed personalized
medicine, and collaborate with academia, industry, and federal partners to achieve those goals.
At the top of the slide, you see the quadruple aim for the military health system: readiness,
better care, better health, and best value, and some of the things that we're doing in
the PC2-Z program that align with those goals.
PC2-Z is intended to be a comprehensive approach, and we have four pillars that we're addressing
through the program. One of those is bioinformatics. Another is education. Research: we're actually
doing research projects, and I'll give you a list of those shortly. And then we're also
addressing ELSI and policy issues in the fourth pillar. Our overall long-term goals are to
enhance military readiness, improve health care in our system, and to mitigate additional
costs, either through reducing duplicate of testing or realizing the benefits of genome-informed
medicine in our system.
Our surgeon general's vision for personalized medicine is to galvanize research using seed
funding because the Air Force has only a small seed of funding compared to some of our sister
services; to model collaboration and create a strategic body of clinical knowledge that
can be used throughout our healthcare system; to demonstrate the translation of omics into
clinical practice. And General Travis feels the third one is most important: to anticipate
the translation that's happening in this rapidly advancing field, and to create evidence-based
state of the art care for our entire beneficiary population. Along the way, we hope to develop
strategies that complement our current primary care model, which is the patient-centered
medical home, and to work in partnership with sister services and other partners to make
sure that we can do this in an effective way across our health system.
Just a sidebar comment, and whenever I do my sidebars, as you know, these are my own
opinions and do not represent the official position of my department or the DoD. We mentioned
that we're moving towards actually integrating those systems, and I think Dr. Cheatham alluded
to that earlier. The Defense Health Agency will be standing up on 1 October this year,
and I'm excited to see what kind of transformation we can see with that officially taking place,
which is what my recruiter told me when I signed up 20 years ago.
[laughter]
That that would already be in place, so it didn't matter which uniform I wore because
it would all be purple anyway. So I'm glad to see I'm still alive and in uniform to see
that happen.
So one of the shared services under that Defense Health Agency model is research and development.
So I've been trying to make sure that this topic is on the minds of our leadership so
that it's considered as we are standing up that function. In addition, we are trying
to utilize our unique capability, which I know Teri was alluding to and trying to get
-- garner some support for that because I do think that we have, although we don't have
an entirely cohesive system, we do have an electronic health record. We do have a central
repository for that data, the Armed Forces Health Surveillance Center. And we do have
about 9 million or so folks who are enrolled as beneficiaries of our system.
So, just again, as an aside, my opinion. We have that electronic health record, we have
central repository, but there are plenty of things that fall through the cracks as I realized
in preparing for my next assignment. My daughter is seeking care at Bethesda. My husband and
son seek care at another facility on the same campus as Walter Reed. Their records -- their
immunization records are in the system, so that when I go into my readiness portal I
can actually download my son's shot records. I can't download my daughter's because she's
seeking care at a facility that's Navy and Army, and they didn't put it into the Air
Force immunization record system. So I had to print out a copy from -- get a hard copy
from Bethesda, and walk that over to an Air Force immunization clinic so that that information
can be, as we say, fat fingered into the Air Force system. So we do have a record. We do
have centralized storage, but, of course, there are always things that fall through
the cracks.
So I mentioned that I would get into detail about what we have in our research portfolio.
The big one, the one that I'm constantly defending, is at the top. That's our involvement with
the Coriell Personalized Medicine Collaborative, and our clinical utility study. This one is
-- we're at about 80 percent of our enrollment goal right now. We have been exclusively enrolling
folks who are part of the healthcare team for the Air Force Medical Service under the
assumption that hopefully we're a little bit better educated about what's going on genomics,
and that we will reach out to our colleagues to get those questions answered or educate
ourselves rather than pushing a panic button. But this study allows for individualized risk
reporting back to the participant only based on SNPs, self-reported family history, and
self-reported personal and health lifestyle choices.
So that one is supposed to be a longitudinal study. It allows the Air Force Medical Service
to be an arm of an existing study, something that's been going on since 2008, that has
about 6,000 folks enrolled in what we call a civilian cohort. And our goal is to enroll
2,000 Air Force Medical Service providers.
The next few studies all started in FY '12 as part of our broad agency announcement.
Epigenetic biomarkers of stress at high altitude conditions are a mouse study. And I always
smile when I say that, Dr. Miller. But this one looks at a validated model for post-traumatic
stress disorder in mice, and then is evaluating how hypoxia can impact that, and looking for
epigenetic biomarkers that predict that outcome.
The next two studies, GENErating Change: Genetic Risk Testing and Health Coaching, and Genetically-Guided
Statin Therapy, both are in partnership with Duke University -- thank you, Dr. Ginsberg
-- and some of our researchers at Travis Air Force Base. And those will be doing just what
they say, so one is looking at type II diabetes and coronary artery disease, and looking at
genetic risk factors, and then using certified health coaches to guide participants through
what that information means, and how that informs their treatment plans. And then Genetically-Guided
Statin Therapy is looking at using pharmacogenomics around statins.
Cellular Sentinels Toxicity Platform is using stem cells to model toxicity response and
looking for biomarkers that are predictive of that. The next study is not in my portfolio,
but part of the autism research that we have ongoing through the Air Force Medical Support
Agency that began as a Congressional-funded project, and is now something that we're funding.
But this one is looking at modifiers -- genetic modifiers that are predictive of asthma and
obesity. And then the next one is billing on the registry of children with autism and
their parents. That was created through an earlier project, and then going and doing
triad genotyping of the parents and children who are in that registry.
Pending, because of sequestration and lack of FY '13 funds, are the last two studies.
A Rapid Learning System for Delivery of Personalized Healthcare, also in partnership with Dr. Ginsberg
and his Center for Personalized Medicine at Duke, and Implementation Adoption and Utility
of Family History in Diverse Care Settings, which would be another collaborative between
Duke University and Travis Air Force Base, which was something that we pursued through
a NHGRI grant.
Obstacles that I think are unique to our system. So we do have -- I said we have a centralized
electronic health record, we do have biorepositories, but we also have regulatory constraints around,
in particular, the inability to use tests in our systems that are not FDA approved.
So, laboratory-developed tests are not something that we are able to order when we specifically
indicate that we are ordering those tests outside of FDA guidance about how those should
be implemented. National security concerns about biobanking and data sharing: my geneticists
tell me that even if we try to strip identifiers from the data, and if we publish a sequence
in its entirety that there are ways of reverse engineering someone's identity based on existing
publicly-available data about mapping people's DNA to their area code and their surname.
So because of that, every time that we talk about doing one of these collaborative partnerships
where we're sharing data or talk about storing our sequence data in dbGaP, this is something
that we need to make sure that we're mindful of.
Information assurance. This is something that we have been dealing with in a very substantive
way as part of the Coriell project. We've enrolled about 1,600 people into the Coriell
study. We're supposed to be marrying up their genomic sequence data and electronic health
record data from our system, but we can't do that until we have met information assurance
guidance about the IT system where that data will be stored, which is translated into us
needing to purchase and configure that IT system, and then export it to Coriell for
them to plug in so that we can transfer the data to them.
We already mentioned -- I'll just pass over the financial stuff because I don't want to
get myself in trouble. But the more important one is operational versus clinical omics.
Now, I will give the caveat that I'm, you know, I've been in uniform for a little while,
but I'm relatively naïve when it comes to practicing medicine in a stateside military
facility. Also, as a pediatrician, I tend to be somewhat of an idealist. So in my function
in this job for the last couple of years, I have tried to draw a line in the sand between
what I call operational genomics and clinical genomics.
So I like to -- I like very much Dr. Manolio's narrow definition of what clinical genomic
medicine is, which is that we're using that genomic information in the course of clinical
care. There are many other research groups and people who would like to use that type
of data for more operationally relevant concerns. And I do not wish them any ill will, I just
don't want that to be part of my portfolio in this program. Therefore, I have tried to
draw that line in the sand.
However, as Admiral Doll rightly pointed out for this -- for genomic medicine or personalized
medicine to be something that's truly embraced by the military healthcare system, we have
to do it in such a way that it is operationally relevant. So walking that fine line between
-- sorry, I have a frog [coughs] -- that fine line between something that is operationally
relevant and something that is of operational significance, that's really -- that an obstacle
to me. Trying to find out -- thank you -- trying to figure out where we can implement personalized
medicine and genomic medicine in a way that's clinically responsible in a system where,
and this gets to the last one down, privacy concerns -- where it's a standard practice
in our healthcare system that if something in someone's medical care could impact their
ability to perform their job or could impact the mission, we don't have that privacy, that
doctor-patient privilege that normally exists outside of military treatment facilities.
So that's something that I'm not senior enough to navigate. I've only been in the position
of saying that in the Patient-Centered Precision Care Program so far, we've only addressed
the clinical genomics aspect, and tried to distance ourselves from people who were trying
to use genomics for human performance enhancement, as an example.
So privacy concerns, I mentioned, and lack of coverage under GINA. This is not to say
that we want GINA amended to include us. Simply to say that, in its current configuration,
it does not apply to members of the U.S. military seeking care in our system through TRICARE.
It does not apply to veterans obtaining health care through the VA, or for people who are
seeking care in the Indian Health Service. So I think everyone's familiar with it. It
protects individuals from discrimination by health insurers or employers. It doesn't cover
disability or long-term care insurance, but it does not apply to folks in my situation.
So Senator Kennedy said it was the first civil rights bill of the new century of the life
sciences. There's a lot of confusion. And when I talk to my colleagues in uniform about
-- they think sometimes that the N is for nondisclosure when it's, in fact, for nondiscrimination.
There's a big difference there. So in practical terms, it has really contributed to the fear
factor around folks who are considering participating in research projects that we're engaging in
because they don't want that information to be disclosed to their employer, insurer, healthcare
team, which, for us, is all a single entity, if -- you know, when you boil it down. So
as I mentioned before, readiness and operational concerns can trump confidentiality, and that's
another concern that is unique to service members.
So partly to address that issue and partly because it was part of the original vision
for this program, we have been meeting informally as the Precision Care Advisory Panel. At the
time, General Travis was the Air Force Deputy Surgeon General. He invited his counterparts
to appoint representatives, so we had Air Force, Army, Navy, Health and Human Services,
VA, and Health Affairs/TRICARE medical authority representation. At the beginning of this year,
I had the opportunity to present this information to Dr. Warren Lockette, who is the Deputy
Assistant Secretary of Defense for clinical programs and policy, and he invited me to
make this presentation to the Clinical Proponency Steering Committee; all that to say we are
being formally chartered as a work group that reports to his office. That is up for a vote
virtually, not that I'm advertising, very shortly. And I'm hoping -- I'm hopeful that
our charter will be formalized in the next couple of weeks.
In that charter, the proposed objectives are seen here: gathering evidence about translating
genomic-based personalized medicine into the clinical workflow in our system, and then
providing policy, scientific, and operational recommendations and approaches to support
genetic screening, counseling, and healthcare services for service members and beneficiaries.
Our deliverables: the first one is what I was alluding to earlier with the slides about
GINA. We need to draft genetic information nondiscrimination policy for DoD and/or the
VA if they'd like to partner with us on that. We need to create awareness of genomics and
omics within our system, not only for the healthcare team but also for beneficiaries,
and then review the existing constraints, some of which I outlined in this presentation.
And deliver recommendations with respect to genomic-based personalized medicine implementation
in our clinical system.
So some of those strategic partnerships that this program has initiated: Dr. Manolio and
others mentioned the eMERGE Network, and we're extremely pleased to be affiliates of that
organization. We also are on the Institute of Medicine Genomics Roundtable. And thank
you, Adam, for your support of that. Integrator for our program has been the Johns Hopkins
University Applied Physics Lab. They have facilitated our outreach with academia, an
industry in their position as a university-affiliated research center. I mentioned our study with
the Coriell Institute for Medical Research, and the ongoing study that we have to look
at omics and provide kind of a train-the-trainer situation with hands-on access for providers,
and learning about how to interpret our own genome-informed risk reports. I mentioned
several collaborative research products that we have ongoing with Dr. Ginsberg and the
Duke University Center for Personalized Medicine. Also thank you to Joan for her support of
our last two symposia through the National Coalition for Health Professional Education
and Genetics. And I mentioned in great detail our Precision Care Advisory Panel. And thank
you to Dr. Cheatham and others who've been supportive of that effort.
Opportunities: we've talked with Dr. Ron Prescosky and several members of his team about collaborating
more closely with the Million Veterans Program. I mentioned to Dr. Coopersmith, when I saw
him at the PMC luncheon the other day, that I have initiated a data request to share historic
EHR data from the DoD system for a cohort of folks who've enrolled in the Million Veterans
Program so that you have some phenotypic data from when they were with us. I also mentioned
the stand of the Defense Health Agency and that opportunity for shared services in research
and development. The Joint Program Committee set up at Fort Detrick, and my limited understanding
of them is that that they are in charge of joint research dollars for the military medical
system. We have less of a presence there, but as part of this transition that's been
happening over the last few months and that's continuing, we will -- the Air Force will
be developing a larger presence there, and trying to preferentially put our good projects
up there rather than funding the projects that we think are really worthwhile with blue
money, with Air Force money, and then sending the leftovers up there, which is the way we've
done it so far.
The barter system: this is my way of imitating the fact that, as Dr. Ginsberg and Dr. Manolio
alluded, we have EHR capability. We have a large beneficiary population. We have a relatively
standardized system of care. That's what we bring to the table. We're less able to bring
large amounts of money to the table to fund research projects, but we do have a community
of researchers who are willing and definitely eager to work with partners in terms of leveraging
those capabilities. And I want to thank NHGRI for welcoming us with open arms over the last
couple of years, and making a lot of these opportunities that you see on these slides
possible.
Any questions for me?