Articles, Blog

The White House Hosts a Precision Medicine Initiative Summit

December 12, 2019

James Hamblin: I want to get things started by asking you, Mr. President to kick things off. You’ve been talking about precision medicine since 2005 but a lot of us are still new to it. So could you fill us in on the background and what brings us here today? The President: Well, this is
an incredibly exciting time in medicine generally and
the biological sciences. And a lot of this traces
back to the incredible progress that we’ve made
with the human genome — oops, I’m sorry, my mic —
I’ve got to talk with a mic — we’ve made less progress
when it comes to the audio sciences. (laughter) Let me start again. This is an extraordinarily
exciting time for medicine and the biological sciences,
and a lot of this traces back to the work that was
done in mapping out the human genome, which was
an enormous endeavor. There are some people
here in the room who were involved in that process,
including our own head of the NIH, Francis Collins. And at the time, it was
enormously expensive for us to do that. With the advance of
computers, big data, we are now seeing a rapid
acceleration in making that process cheaper. It is spurring on a whole
new set of understandings about how diseases operate
and how the human body — how cells operate, how areas
like cancer show that each cancer may be unique, even
if it’s in the same organ. And so all these insights
promise the possibility of us being able to cure
diseases that, up until now, we couldn’t figure out. We could oftentimes, with
real blunt instruments, treat, but it was
very ineffective or, in some cases at
least, inefficient. And what we’re now seeing
is the possibility of us identifying diseases,
targeting them, individualizing treatments
for a particular patient, and operating with the kind
of precision that promises to reduce costs, provide
much better care, make our entire health care
system much more effective. And the key to all this is
for us to be able to build up databases. And because all of us
potentially could have electronic medical records
that voluntarily — with strong privacy protections
— we pool together so that researchers, practitioners,
scientists can share, we may be able to accelerate
the process of discovering cures in ways that we’ve
never seen before. And our Precision Medicine
Initiative has been designed to get all these various
building blocks brought together so that the whole
is greater than the sum of its parts. So that, for example, the VA
— which has been gathering genomic data on a large
number of our men and women who have served this country
in order to serve them better within the VA system
— can make them connect with researchers at a
particular university who are focused on a
particular disease, and can we use big data to
accelerate the research process much more rapidly. Those kinds of
opportunities are there. And the good news is, is
that over the course of the last year that we made this
announcement about PMI, or Precision
Medicine Initiative, what we’ve seen is huge
interest from the private sector, from the
public sector, from the
non-for-profit sector, from the medical community,
from researchers. And today, what we’re able
to announce is that 40 more organizations — a
large number of other organizations are joining
us in this process. There are a whole new set of
initiatives that are going to help to drive
this even faster. And my hope is that this
becomes the foundation, the architecture whereby 10
years from now we can look back and say that we have
revolutionized medicine in areas like cancer,
or Alzheimer’s, or some of the diseases
that cause so much pain and suffering for so many
families all across the country. And there’s no better place
to do it than the United States of America, where
innovation and R&D has been the hallmark of driving not
only our economy but the improvements that we’ve seen
in the life expectancy and the quality of life for
people all around the world. (applause) Dr. Hamblin: I want to
start by talking about some successes we’ve had from
people on the panel in the realm of precision medicine,
and then go to some of the challenges that we face
moving forward — starting with Sonia. So several years ago, your
mother was diagnosed with a rare prion disease
and passed away. The disease is known as
Fatal Familial Insomnia. You have essentially devoted
your life to making that name obsolete. You chose to get tested
yourself for the gene. How have you been motivated
to be so proactive? Dr. Vallabh: It’s
a great question. I would say deciding to get
tested once I learned that my mom had died of a genetic
disease and that I had a 50-50 risk of inheriting
the same thing — which was mid-life onset, very rapid
degenerative decline, these diseases
are always fatal, they are currently
untreatable — once I had that knowledge in my hand,
–these decisions were all made hand-in-hand
with my husband, Eric, who’s here today —
through the two of us, the decision to pursue
testing and resolve that was clear. We made that decision
instantaneously. Because we knew there was no
going back to a time before we knew about our risk. So we wanted to know
what we were up against. What I couldn’t have
predicted is what would happen next. So, as you mentioned, I’d
been trained as a lawyer; Eric had been trained as a
city planner and engineer. And I don’t think either of
us went into this test with a vision of how it was going
to change our lives one way or the other. But when we came out with
that positive test report, my life broke
into two pieces. There was before,
and there was after. And what happened after is
we set about trying to learn everything we could
about these diseases. And like everyone
looking for answers, we started with Google. We started with Wikipedia. We read what we could
find on the Internet. We read papers. We called up researchers out
of the blue — some of them were kind enough
to take our calls. We started attending
conferences. We started blogging. And eventually,
we changed jobs. And four years later,
we’re both Ph.D. students at Harvard
Medical School. And day to day, we work
side-by-side in Schrieber lab at the Broad
Institute in Cambridge. And there we’re devoting
ourselves to developing treatments for
these diseases. I’m so proud to
be doing this. But I have to say we’ve
been just immensely lucky. The Broad Institute has
basically adopted us. We have had some brilliant
people take risks on us, like Eric Lander who advises
the President on science — sometimes advises us, too. (laughter) Amazingly. Amazingly. But even with the best
people backing us, there is no guarantee that
we will be successful in my lifetime. We are running this
race day by day, and we still have to
see where it takes us. I would say in terms of
redefining the disease as you mentioned — the
diagnosis that was handed to me was fatal familial
insomnia and that’s like this particular genetic
variant in the prion protein gene has acquired that
clinical designation over the years. So that name was given to
it in a time when we didn’t know what was at the
root of these diseases. What we knew was what
doctors saw in the clinic so some genetic prion diseases
were named for symptoms like insomnia that some patients
have honestly and some don’t. And some genetic prion
diseases were named for the doctors who observed
these symptoms. But I think it’s really —
it’s symbolic of the era that we’re in now that I
think we can — we can rename these diseases on
the basis of what they are. So now we know the molecular
mechanism of our disease. This is like our
greatest weapon. Like we’re coming in
knowing what our enemy is. We have molecular resolution
on our target and I think we do ourselves a disservice
by clinging to names that obscure the mechanism of
these diseases and the things that unite patients
with quote unquote “different” diseases that
have flown under different names for many decades. So, I think of us as
patients with genetic prion disease and I think that is
the patient cohort that I identify with and those are
the people who I want to help. James Hamblin: So at once,
while you’re studying a disease that effects 100
people worldwide you’re also studying this entire
mechanism that can tie into many diseases as people
continue to share their data and their experience? Sonia Vallabh: Absolutely. The President: I know that
you’re supposed to go next but I’m going to hijack
this just for one second. (laughter) We’re in my house. (laughter and applause) But there’s something that I
should have mentioned that Sonia’s story I think
highlights, and that is, so often what we label as
a health care system is actually more of a
disease-care system in which the patient is passive, you
wait until you get sick, a bunch of experts
then help you solve it. And one of the promises of
precision medicine is not just identifying — or
giving researchers and medical practitioners
tools to help cure people; it is also empowering
individuals to monitor and take a more active role
in their own health. Now, in Sonia’s
case, obviously, there’s a very particular
genetic variant that she’s got to worry about. And the extraordinary
strength and tenacity that she brings to this makes me
really optimistic that she’s going to help drive for a
cure in this particular area. But for many people who
may not have such a clear, specific concern, may still
have genetic variants that alter how you think about
your blood pressure, your likelihood
for diabetes, a whole range of potential
markers that if we get this right, if we do
precision medicine well, and we get that information,
that data to consumers, gives them the ability
to stay healthy for long periods of time. And that’s hugely promising. And it’s good for
those individuals; it’s good for
society, generally, because it will save on a
whole lot of health care costs if we can prevent
diseases from manifesting themselves in
the first place. Sorry to interrupt. (laughter) But it’s an important point. James Hamblin: It’s a
perfect segue to Howard who is working not just
as a patient advocate. Your own daughter was
diagnosed with Type 1 diabetes but in terms of
data sharing you have worked to create a platform for
data sharing and you recently built, for your
daughter, a pancreas. Which is especially
impressive for someone with no training in the
medical sciences. (laughter) How did you manage that? (laughter) Howard Look: No
training required. (laughter) It turns out I’m a geek dad
and when my daughter was diagnosed in 2011 the first
thing I realized was, “Wow, here are these medical
devices — a continuous glucose monitor that
measures her blood glucose every five minutes, and
insulin pump that delivers a deadly hormone which you
walk this tight rope when you have Type 1 diabetes
of just a little too much insulin and you can have a
seizure or go into a coma. Or even one in twenty people
unfortunately will die over the course of their lifetime
from nocturnal hypoglycemia or too much insulin
while they sleep. And what I realized was we
just couldn’t get the data out of the devices
easily enough. Each device came with its
own proprietary software and it was just too hard
to get the data out. It’s kind of like imagine
you bought a digital camera and you had to use the
software that came with the camera in order to view
your pictures, right? James Hamblin: I
would never see them. Howard Look: It
was like that. Right. And, so we founded a company
called Tide pool which is open source and non-profit. And a bunch of other people
also built open source efforts. There was a gentleman named
John Costik who reverse engineered that continuous
glucose monitor so that we could read data
off that device. And another gentleman named
Ben West who reversed engineered the insulin pump. And there are other people. Dana Lewis is here with her
artificial — her open APS — Artificial
Pancreas System. And this community came
together and wrote software that allows those decisions
— those precise decisions about insulin delivery —
to be made in software. So now I put one of these
together for my daughter. There are many other people
who put it together for themselves and what it means
is that she gets those precise doses of insulin in
a much safer and much more effective way. So basically what happened
is by liberating the data from the device we were
able to come up wit ha much better way to
deliver therapy. And I think it just shows
the power of engaged patients and how important
it is to liberate the data. Not just electronic health
record data but also device data, right? Patients with Type 1
diabetes shouldn’t have to outsmart the very companies
that they depend on for these life saving devices
and I think that’s what we’ve seen the community do. (applause) James Hamblin: And I want
to move to Dr. Linehan. You have been for decades
doing research in renal cancers. And when you trained as a
urological surgeon there was only one disease — kidney
cancer — it had the same treatment. And you came in and
said that, “You know, this isn’t working. These are — these are
different diseases.” Half of which you basically
discovered yourself. You were doing precision
medicine before it was cool. (laughter) How — I mean, what
led you to that? What was your moment of
saying we need — something needs to change? Marston Linehan: It was —
it was very each in a way. So as you said, I’m a
urologic surgeon and so if a patient comes to someone
like me with a small kidney tumor we can cure 95
percent of those patients. But if — but if they came
certainly 34 years ago when we started with advanced
disease 82 percent of them died within 24 months. So I said, “You know, we’ve
got to do something about this.” So we decided to try
and identify the gene. We thought it was a
gene for kidney cancer. We had no idea what a
mountain this would be to climb. And so we started out to
look for the gene for kidney cancer. There was no human genome
project at the time. It took us 10 years to
find out first gene. We worked on one thing for
10 years to find that. We now know that kidney
cancer is not kidney cancer. It’s a number of different
typos of cancer that just happen to occur
in that organ. They look different
under the microscope. They have very
different courses. Some are very indolent. Some are very aggressive. And they respond different
to therapy and we know they’re caused by
different genes. And we use that now in our
management of patients all the time. I’ll give you an example. We started with studying
patients who had kidney cancer. And again, as I said,
it was very difficult. There was no technology to
really do it at the time so we started studying families
with rare forms of kidney cancer and our hope was that
those genes would be the main genes for the
non-inherited kidney cancer. That turned out to be the
case for our first gene is the main gene for the
non-hereditary main type of kidney cancer. But, I’ll give
you one example. We saw a young lady came
up from — a young girl — young woman. Came up from Charlottesville
— 18 year old — and she had a big kidney tumor. She came up with her mom and
I took out that kidney and that tumor on May 23, 1989. And even with my — with our
surgery we still lost her. She died on February 1,
1990 — seven months later. And her mom died 14 months
after that of kidney cancer. It ran in the family. It took us 18 years to
figure out actually what she had. We now know what that is. We now know that gene. We now know that disease. We manage those patients
very differently than we manage patients — excuse
me — with other types of kidney cancer. So, we saw — I saw a woman
yesterday who was a very nice woman. Forty-two years of age. She and her husband went
to — she had a very large kidney tumor. Went to a very well known
medical center in the south and they looked at that
and they said, “Gee, that’s a big kidney tumor,”
And that tumor has spread to her liver and different
parts of her abdomen. And they said, “You know, we
don’t think surgery’s going to help here and there’s
not a lot we can do to help you.” And actually then they
contacted us because they knew we had an
interest in this. And we saw this lady and we
agonized over what to do and we decided to go ahead and
do surgery even though we knew we couldn’t get all the
tumor out but we had seen people like this do well. So we did that and we
took out a lot of tumor. There was still a lot of
tumor left in her liver and different things. She’s now about 16 weeks on
the therapy targeting — we know the cancer gene that
causes her cancer that runs in her family. And yesterday we saw her and
we couldn’t find any cancer on her in the x-ray. (applause) I’m not saying that
this won’t recur. And I’m not saying we don’t
have miles to go before we sleep. But we are really encouraged
by this and we’re encouraged — we’re seeing with the
other types of kidney cancers the first gene that
we identified, that pathway, the FDA has now approved
seven drugs that target that cancer gene pathway. Now again, we’ve got a lot
of work to do and I couldn’t practice medicine really
without what we now call precision medicine. I really couldn’t do it. It helps us decide
what operation to do, whether to do an operation
or not, what drug to give. But most importantly, our
real goal is prevention. And the President
mentioned this. Once we understand
the genes, the pathways — then
we ought to — well, we hope we’ll be able
to prevent those. And so it’s — it has — it
is incalculable to us what this has meant to how we
manage these patients. And it’s had a huge effect,
on which surgeries we do, certainly what drugs we do. The drugs we gave this lady
we saw yesterday are known in my field not to
work in kidney cancer. But I say to them, “Look,
these are different diseases. This is a different
type of kidney cancer.” So I think we’ve got
a great future ahead. James Hamblin: When you talk
about prevention is there — is there an example? Immunologic therapy, CRISPR,
are we talking about how we could keep that gene from
being expressed or actually remove the gene? Is there an example of
how that might work? Marston Linehan: Well,
there’s a number of potential strategies
like that. But what I was really —
what I was really thinking about here was
understanding that pathway. And then for example, if we
could get to the day — and I say this to
patients every week. You know, that
we’re not giving up. We’re not stopping until
we’ve got a way to prevent this. And to have, you know, I’d
say a nice lady like you that we could
give, you know, if we had a 21 year old we
could give a pill and say, “You take this pill for a
month a year and call us if you need us.” So, that’s one strategy. James Hamblin: And so what
we have found here is that what we thought to be one
disease, even in the 1980s, is how many diseases today? Marston Linehan: We know of
at least 16 different types for sure that cause this. James Hamblin: At least 16? And — Marston Linehan: And we
have more genes to find. James Hamblin: Yeah, I
mean, could it go into the thousands? Is every tumor going to
be its own individual, you know? Marston Linehan: Well, we’ll
have to see but I think so. I think every different
tumor is — I don’t want to say is going to be a fight
to the death each one, but just about. I mean, each gene pathway
for the different cancers could potentially have
a different strategy. So, it takes — we say
to ourselves and to our patients, “This
is a marathon, it’s not a sprint.” James Hamblin: So, the question that raises in my mind then, is how does that not
become exorbitant cost when pharmaceutical companies
need to move away from a drug that can treat many
people to drugs that are treating small groups of
people — just as a matter of scale and production. The President: Well, what
the doctor has identifying I think is the fact that we’re
just in the infancy of all this. we’re just beginning to
understand at the molecular level, at the genetic level,
what exactly is happening in various diseases. And the goal of the
Precision Medicine Initiative is to figure out
how to break down some of the structural or
institutional barriers that prevent us from making the
big leaps over the next several years. So I’ll just give you
a couple of examples. With respect to being able
to map out what’s happening with these different
diseases and what are the genetic similarities,
what are the differences, why are some people
doing okay with it, why are people not, the
more samples we have, the more data we have, the
more we’re going to be able to learn. Part of the problem
with have right now is, is that every patient’s
data is solid — it’s in a hospital here, a hospital
there, a doctor here, a lab there. And so the goal here is if
we can pool and create a common database of
ultimately a million people that’s diverse so that
they have a lot of genetic variation, we can now
take a disease that may be relatively rare, but because
we have a pretty large sample size and start seeing
patterns that we might not have seen before. But a couple things that
requires — it requires, first of all, us
understanding who owns the data. And I would like to think
that if somebody does a test on me or my genes,
that that’s mine. (applause) But that’s not always how we
define these issues, right? So there’s some legal
issues involved. In terms of the model that
we use for health records that hopefully will be
digitalized more and more, companies help hospitals
keep and collect that data. And they should
get paid for that. They’re building software;
they’re building an infrastructure. On the other hand, we don’t
want that data just trapped. So if I am sick and
voluntarily I want to join with other people who have a
similar disease to mine and donate our data to
help accelerate cures, I’ve got to be able to work
with the electronic health record companies to make
sure that I can do that easily. And there may be some
commercial resistance to that that we have to talk
about — although we’re seeing some terrific
participation now, and that’s part of
what we’re announcing, of those companies in terms
of helping that happen. There’s privacy issues. We’ve got to figure out how
do we make sure that if I donate my data to this big
pool that it’s not going to be misused, that it’s not
going to be commercialized in some way that I
don’t know about. And so we’ve got to set up
a series of structures that make me confident that if
I’m making that contribution to science that I’m not
going to end up getting a bunch of spam targeting
people who have a particular disease I may have. And so across the board,
what we’re trying to do is just make sure that all
the various players in the health care system,
including the researchers themselves, are invested in
us building this broader capacity. Because this can potentially
also change how we do research. Right now, what happens is
the best researchers and the best universities,
oftentimes they’re kind of hording their samples
because — apparently — I’m not a researcher, but
that’s — (laughter) Dr. Vallabh: Never too
late, Mr. President. (laughter and applause) The President:
That’s a good point. I don’t think I’m
as smart as you are, so — (laughter) — the
transition may be difficult. Mr. Look: You
can try software. (laughter) The President: But
my understanding is, is that the basic model of
research at universities is having your samples, that’s
really valuable because that’s how you get grants. And on the other hand, if
we’ve got a million samples that are accessible to
researchers from all across the country and all
around the world, and they’re all able to at
least shorten the lines of inquiry and collapse them
so that they can eliminate those things that are less
likely to work and pursue those things that are
more likely to work, before you start getting
into the more detailed aspects of the research —
that ends up being a cost saver. Now, you’re identifying
one last point, which is something that
we’ve got to have some big brains out here figure out,
and that is the economics of treatment. Because right now,
if you have a big, blockbuster drug, it may
work really well for this individual, not so well
for that individual. In the aggregate, it
works pretty well, and as a consequence, it
gets prescribed a lot and the drug company can
make a lot of money. If it turns out that we
start knowing that it really works well for you, but
it doesn’t work well for Francis — Francis is
no longer buying it, and we now have a smaller
group of potential customers, and so there may
be some pause in terms of making that investment. And what we have to be able
to do is to think about — much in the same way that
we have to think about vaccines, and right now
we’re working — we just had a meeting about Zika, where
we actually think there’s a promising pathway for
diagnostics and vaccines on this. It’s not a real
complicated virus, apparently — but how do
we figure out a production cycle that makes sense. We’re going to have to
make some decisions. And this is where
Senator Lamar Alexander, who is taking great interest
in this — this is going to be part of the legislative
process that we’ve got to think about. Are there ways where the
government says we step in — not to pay
for every drug, but there may be areas where
we subsidize drugs that are really effective for a
small group of people, and there ends up being some
cross-subsidies with other drugs, we create markets —
there’s a whole bunch of complicated questions that
we’re going to have to answer. The final point I’ll make
is over the long term, we can save a lot of money,
rather than make this more expensive, if every drug we
prescribe actually works. If the doctor with his
kidney patient knows that this is not going to work,
and that’s not going to work, he’s not going to be
wasting a huge amount of time, effort,
surgery, et cetera, on a path that’s less
likely to succeed. He’s going to be saving
money and focusing entirely on those pathways that we
know are going to work. Dr. Hamblin: And to kind of
piggy-back on that and note that CDC announced
last month that 47,000 Americans died in
2014 of drug overdoses, the majority of
which were opioids. That number has
doubled since 2000. Do you see a role for
precision medicine in addressing that, what
they’re calling an epidemic? The President: Well, it’s
a complicated question. Part of the problem that
we have with the opioid epidemic is that, in 85
percent of rural communities we don’t have mental
health or drug treatment facilities. So I want to make sure
people understand precision medicine is not a
replacement for making sure people have just
basic health care. (applause) And we have to make sure
that that’s still in place. But we don’t yet know the
genetic basis for addiction, for example, in ways that we
may discover 10 years from now or 15 years from now. And so it could end
up having an impact. I think, short term, the
opioid problem really has more to do with the fact
that a lot of people don’t have basic health care. They put off getting
help on pain management. The easiest way to do it
initially is just to get some pills; the pills
run out and then, sadly, it turns out that heroin is
a cheaper way to refill your prescription and people
are getting hooked. So I think that’s actually
a different category of problem. But what it does speak to is
the fact that the more we know about how to treat
a particular problem, the more effectively
we treat that problem, over time, the more
efficient and cost-effective the health care
system will be. James Hamblin: Can I turn to
Sonia and Howard who are — this’ll be my
final question. Talking about
barriers to sharing. You’ve both been very open
advocates for donating data. What has — how do you
encourage people to donate data and feel safe about
it and understand the importance? And what are the barriers to
people feeling safe about that going forward? Sonia Vallabh: I think it
continues to be a challenge in the sense that
we’ve come a long way. I’m so grateful to the
people behind Gina and the people who are working to
make sure that people with genetic variants like mine
don’t fear discrimination. But they still do. And I hear from patients
all the time who are really concerned about even letting
their PCP know that this disease runs in
their family. It’s tricky with a disease
where the phenotype is sort of lurking. They don’t have a health
problem right now. And they kind of want
to coast and, you know, hide among the general
healthy population as long as they can. And what I hope to convey to
people when we talk about this is the sooner — we
don’t have a treatment now. But the sooner they become
plugged into a system that is working on one I think
the better for everyone, right? Having baseline data about
what is your particular body like today will help
enormously down the road if we have a treatment
and want to ask, “Is it making a difference?” Or if they think they’re
having onset and they think their disease is beginning. And, you know, in rare
diseases I think we depend so much — all research
depends so much — on patient participants. In rare diseases every
person who comes forward to participate is like a
quantum leap in the amount of data we have. So, I hope that we keep
working on the sort of legal framework behind celebrating
patients who come forward. And I think we’re headed
in the right direction. Howard Luck: So, in the Type
1 diabetes world fortunately finding people who are
willing to donate their data is not a problem. There are plenty of
people who say, “I’m in. Just tell me how to do it
and you can have my data because it’s for
the greater good.” The challenge is
really two fold. One is with both device
makers and also cloud service providers who house
the data there’s this fear where they may say, “Well,
we don’t know what people are going to do
with the data.” We’re worried about the
liability if that data gets out. So, I think one thing we
can do is just make it very clear that by publishing
your data protocols you’re not accepting any
new liability. It is up to the people who
take that data downstream to make sure they’re using it
in a safe, effective way. Another challenge — and
this is an easily fixed one — is just making the
interfaces available. Device companies could
publish the data and control protocols for their devices. And cloud service providers
can use very simple well-known APIs — Application Programming Interfaces. The President and I are both
wearing out FitBits today, right? There are APIs that let
us pull our FitBit data. There should be APIs just
like that that let us pull our diabetes data. These are very
solvable problems. James Hamblin: One last
thought from Dr. Linehan. Marston Linehan: You know,
you mentioned about — actually the President
mentioned about things like tissue banks and things. My assistant the other
day said to me — said, “Our clients have said, ‘You
work with 140 people.'” On this kidney — on from 29
different labs and branches at the NIH — National
Institutes of Health. And over the years our
approach has always been the same. That you shouldn’t be
surprised the progress people can make working
together if you’re not quite so concerned about who
gets credit for the work. And I think that — (applause) And that’s all
I — you know, you get so tied up and
then but we all think. Those of us in science or
those clinicians all think, “Why did we go in this
field in the first place?” It was to help patients. And then you got involved
in all these things about promotions and who knows
what — publications or something. But the leadership
comes from the top. The good news is we
have great leadership. The leadership comes from
the top and I think we can change the culture. It’s going to take a little
bit of that but we can do it. The President: One of the
charges I’ve given all the federal agencies working
together on this is looking at the regulatory framework
we have that was designed for another era of medicine
and making sure we update it. And that’s where I think
the work that we do with Congress can be very
important here. And there’s good bipartisan
support for how we think about that. So, for example, we’ve got
a new FDA Commissioner, Robert Cardiff (sic) — congratulations, Doctor. (applause) But the FDA traditionally
has thought about protecting the public health in terms
of these are medical devices and these are drugs,
and there are certain categories, and here’s
certain protocols that we go through. And when it comes
to gathering data, disseminating data, making
sure it’s accurate and valid, figuring out how it’s
communicated to the patient or the individual who’s
interested in it — sometimes we’re fitting
square pegs into round holes, and we may have to
re-conceptualize how we think about this to
open up this space. I mentioned
researchers earlier. Well, part of the reason
that people are worried about getting credit is
because research dollars and grants flow in the direction
of who gets credit. And so rethinking how we
design — the NIH and other agencies redesign their
grant-making to encourage collaboration
rather than siloing, that’s going to
be important. So there’s going to be a
whole range of areas where we may need new safeguards
— for example, in terms of privacy and
security of the data that’s being disseminated. There may be other areas
where we need to break down regulations that might have
applied and made sense in another era of medicine but
aren’t going to apply now. And that’s the kind of
evaluation that we’re doing. Because ultimately, this
is going to be successful because everybody in this
process starts rolling in the same direction. This won’t work unless we
have the private sector coming up with innovation. And that includes
the drug companies, and that includes
manufacturers of — ultimately something that’s
just tracking your heart rate may be able to track a
whole bunch of other stuff that is giving you a
constant flow of information on a daily basis to
keep you healthier. We want to encourage
that kind of innovation, and we don’t want to have
bureaucracy stand in the way of that. On the other hand, we also
know that there’s going to be possibilities for abuse,
and really making sure that we have private sector
providers, researchers, doctors, academics,
government officials, agencies all figuring
out what’s the basic architecture and having an
open mind about continually updating it, modifying it —
if we get this right now — and this includes,
by the way, the Cancer Moonshot that
Vice President Biden is initiating, because a lot of
the progress is going to be in this same space, making
sure that we’re all working in the same direction
— if we do that, I’m confident that, at
least for Malia and Sasha’s generation, they’re going to
be able to make progress in ways — and live healthier
lives in ways that we could not imagine. (applause)

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