National Cancer Institute Director Dr. Norman Sharpless on the Future of Genomics, Prevention, and Personalized Oncology

Dr. Norman Sharpless

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Margaret Flinter: Welcome to Conversations on Health Care with Mark Masselli and
Margaret Flinter , a show where we speak to the top thought leaders
in health policy , health innovation and technology , and the great
minds who are shaping the health c are of the future. This week , Mark
and Margaret speak with Dr. Norman Sharpless , Director of the
National Cancer Institute at the National Institutes of Health. He
discusses significant changes ahead in creating a more personalized
approach to cancer diagn osis and treatment based on one's own
genome and the need to foster more sharing of research across
institutions ar ound the country and the world.

Lori Robertson also checks in , the managing editor of FactCheck.org ,
looks at misstatements spoken about hea lth policy in the public
domain , separating the fake from the facts .

We end with a bright idea that ' s improving health and well - being in
everyday lives. If you have comments , please email us at
[email protected] or find us on Facebook , or Twitter @chcradio .
We love hearing from you . Or find us on iTunes , SoundCloud , or ask
Alexa to play the program , Conversations on Health Care.

Now , stay tuned for our interview with Dr. Norman Sharpless,
Director of the National C ancer Institute on Conversations on Health
Care.

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Mark Masselli : We're speaking today with Dr. Norman Sharpless, Director of the
National Cancer Institute at the National Institute s of Health , leader of
the National Cancer Program , the world's leadi ng cancer research
funder. Dr. Sharpless served as Director of the University of North
Carolina Lineberger Comprehensive Cancer Center. Dr. Sharpless is
also chief of the aging biology and cancer section in the National
Institute of Aging 's Laboratory of G enetics and Genomics. Dr.
Sharpless earned his medical degree with honors from the UNC
School of Medicine, completing his residency at Mass General
Hospital .

Dr. Sharpless, welcome to Conversations on Health Care .

Dr. Sharpless: Yeah. Thank you for having me.

Mark Masselli : Yeah. Since you've taken on the reigns of the National Cancer
Institute , much seems to be possible , given the increasing in data
computation, more scientific discovery around genomics , machine
learning , and personalized medicine . What a re you most excited
about in terms of the case of research and discovery ? What do you
see as some of the big challenges you ha ve to overcome?

Dr. Norman Sharpless

Dr. Sharpless: Well, I think, you have to sort of have two statements in mind about
cancer research and cancer car e in the United States at present. The
first one is that we're making progress in cancer research and cancer
care at a pace that is greater than at any point in my career as an
oncologist . New discoveries, new therapies, new ways of treating
patients , t his has been built on decades of elegant basic science,
understanding how cancer works . Now those scientific endeavors are
paying off . We're developing new therapies and better ways of
treating patients and better ways of preventing cancer at all the time ,
so a pace and progress that is really breathtaking .

At the same time, while we've made a lot of progress, that progress is
not good enough. We still have a long ways to go. There's still too
many people dying of cancer in the United States . Then particularl y,
the progress has been uneven . We've had a lot more progress in a
disease like melanoma, skin cancer , than we've had in the cancer, like
brain cancer, like glioblastoma.

Against that background , I'd say something that is very exciting right
now is, as y ou mentioned, the ability to aggregate large datasets and
learn from every patient , because we realize that cancer are very
personalized and precise entities and each person's cancer is
somewhat different, even if they all look a little bit under the same
microscope. The ability to learn from every patient by aggregating
data is very exciting as is these new the rapeutic modalities like
immuno - oncology and new ways of doing radiation and surgery , and
chemotherapy.

The challenges though are that there are so me cancers where we still
need a better basic science understanding. There are some barriers to
implementing successful cares that are problematic. We have
therapies that work, but getting them in widespread use is still a
problem . In some areas , we have s o much success. We have so many
different ways of treating things that a real challenge is how to put all
those things together and use them. How to integrate care and make
comprehensive care for patients is becoming a challenge.

Margaret Flinter: Well , Dr . Sharpless , when you stepped into the role as Director of the
National Cancer Institute , you identif ied four key areas of research
that you felt needed to be paid particular attention to at NCI in order
to improve the research landscape. What are these fo cus areas and
how are they driving the institute's overall research agenda and I
assume w e ll over the next several years?

Dr. Sharpless: As I entered federal service, having been an academic , I ' d spent a lot
of time taking stock of how the NIH works and th e NCI works , and
some things that National Cancer Institute does well and other areas
where we can make improvements . That involves a learning and
listening tour where I went and spoke to people for , those patients

Dr. Norman Sharpless

and doctors , and scientists , and advocate s , about where we could
make progress more rapidly.

From that exercise, I did identify four areas . The four things that we
came up with refers to a real focus on workforce development, on
training the future scientists and doctors that will take care of
p atients with cancer in the future. I would argue this is possibly the
most important thing the NCI does, is we have a large amount of
spending on training grants and training exercises , and making sure
doctors and scientists are well equipped for the futur e of cancer
research.

The second is a steadfast commitment to basic science. While we've
made a lot of progress in our scientific understanding of cancer, we're
not done yet. We still need to do these very detailed and careful and
in some cases elegant ba sic investigation of cancer to understand
exactly how it works because that's where the ther apeutic ideas really
come from.

A third is this focusing on how we use data. We have a lot of data on
oncology. We get data from patients , from scientific studies, from
outcomes , and prevention trials . All these different datasets are not
well linked and they're not easy to research for s cientists to go into
these data sets , and understand what's happening to patients with
cancer . Getting aggregated and shared data , that's useful.

Then the fourth is we really have to sort of reimagine, if you will, how
we do clinical trials in cancer research. Every therapy that we use
successfully in cancer right now is the result of a successful clinical
trial . At the same time , be cause of a variety of issues, making progress
through clinical trials has become more difficult in cancer research
over the last two decades. I think we're really focusing on how to
make trials efficient and ethical for the patient , so that we can provide
everyone with the best care .

Mark Masselli : Dr. Sharpless, I think the public , when they think about the progress
that we're making , is looking for this cure for cancer . We ' re really
looking at more than 100 different related diseases and possibly
thousand s , and all of these are influenced by this complex network of
factors. I'm wondering how you're viewing the role of personalized
medicine in this context as well and how that will benefit the direction
that you and your colleagues are headed.

Dr. Sharpless : Right. I think the appreciation that cancer is very heterogeneous that
even -- we have two breast cancers . They look the same under the
microscope. We thought of them as the same disease . Really we've
become to understand that even tumors that look quite similar
microscopically to a pathologist can be very different in their
molecular underpinnings of the tumor . That appreciation that what

Dr. Norman Sharpless

we used to think of as being similar things like lung cancer or breast
cancer , really are very heterogeneous entities , w h ere almost every
patient needs a personalized or a precision approach.

I believe that's one of the major advances in cancer research in the
last few decades . It's really changed how we do things . It's changed
the clinical trials enterprise. It's chang ed how we take care of
patients. It has really had a widespread im plication in all areas of our
field.

What it means for patients who have advanced cancer is that the
doctors who are taking care of them will want more studies of their
tumor th a n we used t o do . We use d to sort of just look at the tumor
under the microscope and say, ye ah , that's cancer . You need this and
that. Now , we have to do additional work , where the pathologists are
asked to molecularly classify the tumors in terms of their expression
of various proteins . Then that information is used to provide a
therapy for the patient that is intended for them.

This is good news for patients in many ways because it means they
get a therapy that is more likely to work, that is less toxic . Using this
approach , we are starting to cure patients. We really can say now as
opposed to just prolonged remission that we're curing cancers that
we used to consider untreatable . That's great progress . At the same
time , that fragmentation of cancer research , realizi ng that we're not
dealing with 10 diseases, but thousands of diseases , makes the cancer
research enterprise much more di fficult. We really have to not
aggregate them into groups . That is a much more complicated
endeavor for a clinical trial, for example.

Precision oncology has provided a means , whereby we can make
progress in lots of these individual diseases that we take them one at
a time . It's also proven that there's no sort of magic silver bullet that
will cure all cancers. We realized that that now w as a vain hope of the
past. Really what we need now are very effective therapies for each of
these different kinds of cancer . Using that approach , we're making a
lot of progress.

Margaret Flinter: Well , Dr. Sharpless , talk a little bit about screening and early
detection. We have taken ownership in the public health and the
primary care world of trying to start with prevention, right? This
whole arena of screening and early detection remains an area of
some controversy . We follow the evidence - based guidelin es , w hat to
screen for , given the availability of access to people's genetic profiles.
What do you think we might see in the coming years over , any major
changes around how we think about screening for the purpose of
early detection?

Dr. Sharpless: Yeah. T his is a fascinating area . Some of the major victories in cancer

Dr. Norman Sharpless

care o ver the last few decades have really been related to the area of
prevention. If you look at the progress we're now making in terms of
tobacco control is great news as tobacco - associated cancers are
prevalent and very deadly . As we reduce the usage of tobacco in the
community, we will see a decline in those kinds of cancers . I think the
dissemination of vaccines to prevent cancer with the Hepatitis B
vaccine and HPV , human papillomavirus vaccines, those will prevent
cancers and are useful . We know obesity is related to cancer.

Those areas of prevention, avoiding mutagens like sunlight and
tobacco , and staying thin , and getting your vaccines are things I think
most of us can agree on is ve ry effective, very useful prevention
measures . Then the topic gets harder as you alluded . Who should we
screen for cancer and what ? We think that screening for cervical
cancer, Pap smears , is highly effective and has led to a widespread
decline in that can cer in the United States and other countries. We
think that a colonoscopy is highly effective for preventing colon
cancer . It's an area where I think we'd like to see increased usage of
colon cancer screening . Mammography and PSA testing are both
more comp licated conversations . In general , we refer patients to their
doctors to discuss whether or not the appropriate person based on
their age and risk , because those tests, they are effective at finding
cancer, but they're also, sometimes we'll find indolent c ancers that
will not hurt the patient , and so can lead to over - diagnosis and
overtreatment. How to use those tests appropriately in the
community is where I think we need additional research.

What hope I have is just like precision oncology has helped us in the
area of therapy , I think a better understanding of an ind ividual's
precise cancer risk will make prevention somewhat easier. A test like
PSA testing, which may be more valuable in patients because of their
family history, their age , and their geneti c risk, one could have a sort
of personalized approach to prevention that might make that kind of
a general screening more useful where we maximize the chances of
catching a cancer early and treating it effectively , and minimize the
chances of finding unim portant cancer that lead s to over - diagnosis
and over - screening.

I think that personalized oncology is not just for therapy . It is also an
important part of prevention and making sure we treat every patient
appropriately based on their sort of lifetime ris k of cancer. One thing
that we're going to need and do more of, I think for this sort of
personalized prevention, is more understanding of the genetics of
individuals that predispose them to certain kinds of cancer or make
them at less risk for cancer.

Th at is now just starting to happen. We're just starting to get in that
topic of should we sequence individuals to sort of determine they

Dr. Norman Sharpless

have certain cancers . That ' s a topic where we don't know the answer
yet. We're still trying to do research in this area . In specific
populations , [inaudible 00:13:08] assessment is very, very useful .
Whether or not everybody should be getting that kind of testing, we
don't think that's the case yet. Although one can imagine a time in the
future where that may be something w e do as we personalize
rescreening based on genetic risk .

Mark Masselli : We ' re speaking today with Dr. Norman Sharpless , Director of the
National Cancer Institute at the National Institute s of Health , the
leading cancer research funder in the world.

Now, I'm not sure , Dr. Sharpless , that the public knows how large the
research enterprise is . 3, 500 researchers working at the National
Cancer Institute , and I believe over 37,000 members of the American
Association for Cancer Research . Beyond our borders , ther e's a global
community that's engaged in research . I'm wondering if you could tell
us a few things. How's the funding look ? Also , what's the
collaboration across borders look like for information that I think our
listeners would be excited to know about?

D r. Sharpless: Let's start with the funding. I think biomedical research in general and
cancer research in particular have been well supported the last few
years. We've seen increases to our budget . For the NCI , for example,
our total budget now is on the o rder of $6 billion a year. A few years
ago , it was $5 billion a year . We've had a nearly $1 billion increase to
our budget. That represents a broad bipartisan support for cancer
research in United States. I had the opportunity to speak to lots of
people in Congress and just about everybody thinks we need to be
doing cancer research , and thinks this is a good use of federal funds.

Mark Masselli : That ' s good to he ar.

Margaret Flinter: Lucky you.

Dr. Sharpless: Yeah. The support for cancer has been pretty robu st. You alluded to
the ability to collaborate internationally and this is really important .
As I mentioned, some of these entities that we ' re really interested in ,
some of these kinds of cancer , are just sort of too rare to study in any
one hospital , or an y one state , or even any one country. If we really
want to make progress against the disease , like glioblastoma or
pancreatic cancer, we really can benefit from international
collaboration.

The NCI is a big supporter of that. We have ways of supporting
in ternational endeavors in cancer research . Then we also collaborate
with other international funders of research in a variety of ways
because we really believe that if progress against cancer is a benefit
for all of humankind, cancer does not end at any cer tain border , and

Dr. Norman Sharpless

we want to make progress as expeditiously as possible . We think that
international collaboration and sharing of data is a key part of that .

In terms of the best practices of how you get good cancer care out in
the community , so that it's used routinely , t his turns out to be a more
frustrating endeavor than I would've imagined . When I was a cancer
center director , I had a more limited knowledge of how cancer care
was done in a specific health system . Now as NCI director , I appreciate
that w hile cancer care in the United States is in general quite good, it
can be uneven . A real challenge for the NCI is to make sure, and this is
a research question, by the way, is when there is an effective therapy,
why doesn't it get used appropriately in the community at all times?
Why does n't it disseminate quickly enough?

Understanding how we use best practices of cancer care is identified
and implement them through our practice is a n interesting research
question where the NCI is still funding . We have 70 NCI designated
cancer centers that are supported by the NCI. For the most part , they
all provide excellent care and are places where the science is great,
where the cancer care is great . The problem is , or a problem is , that a
lot of patients don't live n ear a cancer center . They don't want to
drive five hours back and forth each time they have to get to see their
doctor . We really need to take the care that is quite strong in many of
the cancer centers and figure out how to get it out into the
community , so that everybody gets great care.
st
Margaret Flinter: Well, over these years , we've had the Cancer Moonshot and the 21
Century Cures Act , and then the project that we're probably the most
familiar with, the All of Us Precision Medicine Initiative that Dr. Khan's
l aunched . In participating in that, what I've been really struck by is
what a remarkable job they've done of engaging the public in this,
speaking around the country, both at professional meetings , but also
pushing this out to consumers to enroll p eople . It seems that their
ability to engage people in thinking about this as a n issue of concern
to everybody is kind of fundamental to their success.

I'm curious at the NCI , what is the NCI doing in that realm of engaging
the American community in think ing about your research and
support ing your research?

Dr. Sharpless: Right . First off, the NCI is one of the NIH ' s . I'm on the same campus as
Dr. Collins , for example . Because of that , we are a supporter and a
user of an effort like all of us. We certainly expect that massive study
to lead to a real wisdom and knowledge related to cancer , particularly
the sorts of diet and exercise , and their relation to genetic risk, w hich
are very hard to study by other means. All of us may be a very useful
trial for the NCI . We have great hope for what that'll be able to teach
us .

Dr. Norman Sharpless

The community that cares about cancer is very large and vibrant.
Everybody's either been personally touched with cancer , h as a
relative . There are people that have a lot of interest in what the NCI
does . We vigorously embrace the advocacy community. I spend a lot
of my time trying to meet with advocates and patients to make sure
the NCI really keeps our eye on the ball, so to speak. The
communication , I agree with you , is critical to the success of the
endeavor, particularly in a very heterogeneous complex thing like
cancer , where there are so many parts to it . We know we need to be
making sure we address the issues of 100 % of patients. It's why we
spend a lot of time and effort on it. One of the reasons why I come on
radio shows like this --

Mark Masselli : We appreciate it .

Dr. Sharpless: -- is to talk about the NCI and make sure everybody understands our
goals .

Mark Masselli : We ' ve been speaking today with Dr. Norman Sharpless , Director of
the N ational Cancer Institute at the National Institute of Health ,
leader of the National Cancer Program , the world's leading cancer
research fund er . You can learn more about their work by going to
cancer.gov or you can fol low them on Twitter @ the NCI , or you can
follow them directly @NCIDirector.

Dr. Sharpless , t hank you for your dedication and to your colleagues as
well to advancing this critical area of science , and for joining us on
Conversations on Health Care today.

Dr . Sharpless: Thank you for having me here , r eal pleasure today.

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Mark Masselli: At Conversations on Health Care , we want our audience to be truly in
the know when it comes to the facts about health care reform and
pol icy. Lori Robertson is an award - winning journalist and managing
editor of FactCheck.org , a nonpartisan , nonprofit consumer advocate
for voters that aim to reduce the level of deception in U.S. politics.

Lori, what have you got for us this week?

Lori Robertson: Representative Elect Alexa ndria Ocasio - Cortez tweeted that $21
trillion worth of Pentagon acco unting errors could finance two - thirds
of Medicare for All . It can't. The misguided tweet is based on a tally by
university researchers , who found $21 trillion worth of untraceable
transac tions in the Department of Defense between 1998 and 2015.
It's a legitimate problem the Pentagon says it's trying to fix .
Transactions , which can be counted multiple times as they pass
through accounts , are not the same as spending.

Dr. Norman Sharpless

In fact, the U.S. actu ally spent a total of a little over $9 trillion on
defense in those years. Even if the U.S. had eliminated the entire
defense budget for those years, that wouldn't cover two - thirds of
Medicare for All .

Ocasio - Cortez , an incoming Democratic representative , supports the
expanded and improved Medicare for All Act , a house bill that would
expand Medicare into a universal health care program . An Urban
Institute analysis of a similar plan proposed by Senator Bernie Sanders
in 2016 put the cost to the federal gov ernment at about $32 trillion
over 10 years.

As for the $ 21 trillion in Pentagon accounting errors , as Ocasio - Cortez
put it , t hat's a reference to research by Mark Skidmore , an economics
professor at Michigan State University , and Catherine Austin Fitts . The
two looked into trillions of dollars worth of unsupported journal
voucher adjustment identified by the Office of the Comptroller at the
Department of Defense.

In testimony before the House Armed Services Committee in January ,
David Norquist , the Penta gon's comptroller , acknowledged this was a
problem, but he said characterizing it as lost money is inaccurate. This
isn't missing or wasted money that could simply be reallocated to
other government functions like health care. These are transactions.
Every time the money is moved, it gets counted. The $ 21 trillion figure
is double and triple counting the same funds .

That's my fact check for this week . I'm Lori Robertson, managing
editor of Fact C heck .org.

Margaret Flinter: FactCheck.org is committed to fact ual accuracy from the country's
major political players and is a project of the Annenberg Public Policy
Center at the University of Pennsylvania. If you have a fact that you'd
like checked, email us at chcradio.com . We 'll have FactCheck.org ' s
Lori Robertson check it out for you here on Conversations on Health
Care.

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Mark Masselli : Each week , Conversations highlights a bright idea about how to make
wellness a part of our communities and everyday lives. Asthma is one
of the leading causes of trips to the emergency room for children .
There are often a correlation between high density, low income
neighborhoods , and more trips to the hospital for treatment and
intervention.

When officials at Boston Children's Hospit al noticed a spike in asthma
outbreaks in certain neighborhood clusters, they decided to do
something about it. They launched the Community Asthma Initiative .
They realize that if you could treat the environments in the patient's

Dr. Norman Sharpless

home, that might reduce th e need to treat the patient in the
emergency room.

Dr. Elizabeth Woods: The home visiting efforts work with children and families that have
been identified through their hospitalizations and emergency room
visits as an identification of having poorly contr olled asthma and also
it's a teachable moment.

Mark Masselli : Dr. Elizabeth Woods heads the program and says, the first step is to
identify the frequent flyers, those kids who make repeated trips to
the emergency room. Then they match with the community he alth
worker who visits their home several times and assesses the home for
asthma triggers .

Dr. Elizabeth Woods: They work on three areas, understanding asthma itself, understanding
the medications and the need for control led medications, and then
working o n the environmental issues .

Mark Masselli : Families are given everything from HEPA filter vacuum cleaners to air
purifiers . The homes are monitored for the presence of pest or
rodents. The result says Dr . Wood s has been pretty dramatic.

Dr. Elizabeth Woods : What's remarkable is that there was a 56 % reduction in patients with
any emergency department visits and 80 % reduction in patients with
any hospitalization.

Mark Masselli : The program has been so successful . It's being deployed in other
hospital communit ies around the country. The Community Asthma
Initiative , a simple re - shifting of resources , aimed at removing the
cause of disease outbreaks in the community , leading to healthier
patient populations , n ow that's a bright idea.

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Mark Masselli: You've been listening to Conversations on Health Care. I'm Mark
Masselli.

Margaret Flinter: I ' m Margaret Flinter.

Mark Masselli: Peace and h ealth.

Margaret Flinter : Conversations on Health Care is recorded at WESU at Wesleyan
University , streaming live at chcradio.com , iTunes, or wherever you
listen to podcasts. If you have comments, please email us at
[email protected] , or find us on Facebook , or Twitter. We love
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Health Center.

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