NCI Director's Address, Annual Meeting of the American Society for Clinical Oncology, 2011

George: I'm now pleased
to introduce to you the Director
of the National Cancer
Institute; Dr. Harold Varmus.
Dr. Varmus has dedicated his
over 40 year career to the study
of cancer serving as professor,
journal editor,
committee member, reviewer,
director of the NIH,
president of Memorial
Sloan-Kettering Cancer Center,
and currently
as the 14th director
of the National
Cancer Institute.
Ladies and gentlemen,
please join me in a warm welcome
for Dr. Harold Varmus.
[ Applause ]
Dr. Varmus: George,
thank you very much.
My intention is
to have a fireside chat;
speak informally, no slides.
I know this is not entirely an
informal setting,
but we'll do our best.
I'm very pleased
to have a chance to be
at this ASCO meeting
for a variety of reasons:
to see our old friend
and co-author,
Bob Weinberg get honored;
my former colleague, Mark Kris,
my current colleague,
Lee Helman.
Also a great chance
to watch the transition
as the baton is passed
from George Sledge
to Michael Link, and to meet
and get to know Jane C. Wright;
a truly remarkable early pioneer
both in this organization
and the use of chemotherapy
and the advancement
of African Americans
in our science.
I especially want
to thank Alan Lichter
for giving me a chance to speak
about the state of the NCI
and about my first year
which will be coming
to a celebration point
on July 12th.
The most striking thing to some
about this first year has been
fiscal stringency.
The NCI and the NIH budgets
as I assume most
of you know have actually been
cut 1% below 2010 levels.
A cut; I'm used to doublings.
I've tried to tell everyone
who is in the constituency
of the NCI about this
in a very forthright letter
that was sent
to all grantees a few weeks ago
and I've also warned them
about deeper cuts.
Money is the lifeblood
of the NCI and the situation
we're facing
in appropriations is everyone's
problem and we need
everyone's help.
But my topic today is not
that because I'm not prepared
to worry just about the budget.
We have 2 other major truths
to think about.
First as I think everyone
in this audience understands,
we have unprecedented
opportunities
to accelerate progress
against cancer and as I reflect
on my 40 years
in cancer research
and observed what's happened
in 40 years since the passing
of the National Cancer Act,
one cannot help but marvel
at the pace of progress
over the last decade
and see every induction
that progress will only
accelerate in the near future.
And that progress will occur
across all fronts:
in discovery using new powerful
methods, largely in genomics,
but many other areas of science
as well; in the understanding
of mechanisms
of disease using mouse models,
computational methods,
systems biology, and many kinds
of so-called omics;
and most importantly
for patients in the area
of translation
and clinical research
with the development
of new therapeutics,
diagnostics,
prevention strategies,
biomarkers, imaging devices,
and so forth.
The NIH is also setting
up a new center, National Cancer
for Advancing Translational
Sciences, that will help us
in these efforts
to translate discovery
into practical benefits
at the same time that we keep
up the pressure
to make the discoveries
that are sorely needed.
The second major thing we must
keep in mind is
that we do have a $5 billion
budget and that's a lot of jack.
We don't want to forget that.
It's enough
to support many grants,
contracts, centers,
training programs,
and many other things.
We at the NCI are pledged
to spend it as wisely
as possible with increased level
of scrutiny of what we do,
heightened oversight helped
by many in this scientific
and clinical community,
and helped by great staff.
I'm not going to bore you
with a complete list
of the changes we've made
in personnel at the NCI,
but I do want
to highlight a couple
of very important things
for those of you
who are interacting frequently
with the NCI.
As you all probably know,
Douglas Lowy has been one
of my deputies
since the day I the oath
and recently Jim Doroshow known
very well to many
of you has become a second
deputy for clinical
and translational research.
In addition,
we are currently recruiting the
new head of the division
of cancer prevention
and we have a new
and distinguished executive
officer, John Gurtowski.
Now I don't want to spend a lot
of time talking
about how we're trying
to manage these budgetary
shortfalls, but suffice to say
for those of you
who haven't seen the letter
that we are taking slight cuts
across the board and deeper cuts
in selected places trying
to protect first the number
of new grants
so that especially the new
generation of scientists have a
fair chance
at receiving an award;
we're trying
to protect the most important
features of our discovery
science, especially genomics
carried out through The Cancer
Genome Atlas;
and we're protecting the efforts
to reorganize
and reenergize the Cooperative
Group system of clinical trials,
a pledge that Jim
and I have made
to the scientific community.
Let me take that statement
to expand a bit
on what's happening
with the Cooperative Group
system which I know is
of interest to many of you.
Everyone here probably knows
that the ION [assumed spelling]
issued a report
that my predecessor had asked
for, the report being issued
early last year
to give us some guidance in how
to reorganize
and improve the clinical trial
system, Pegasystem,
which had served us well,
but has been in existence
for a very long time
and make it function
in a way that's more appropriate
to the science we're trying
to do.
Even before I arrived,
Jim Doroshow
and his colleagues had begun
to streamline the process
and speed up the approval
of trials.
Since then,
we have achieved a consensus
on realignment of the groups
so they'll now be 5 groups
instead of 9; 1 pediatric group
and 4 adult groups.
I met with the Cancer Center
directors in February
of this year to talk
about these changes,
learned that there was some
disgruntlement in the ranks.
We brought the Cancer Center
directors together
with the group leaders in May
and reached a set of agreements
that for example, we all adhere
to the principle
that there will be more science
embedded in the design of trials
to get more knowledge
out of trials,
whether those trials succeed
or fail.
It will expand opportunities
to use information that we get
from current methods of care
and from clinical trials using
genomic methods and I would cite
as one example a project that's
already underway through the use
of my discretionary funds
to attempt to identify genetic
markers that product the success
of current therapies
in treatment of adults with AML.
We're all agreed
that there should be more
experiments in trial design;
adaptive trials,
multi-drug trials,
and we're working closely
with the FDA largely
through the new NIH FDA council
to make these things a reality.
We are pledged
to enhance stipends,
to enhance enrollments,
particularly
at community hospital sites
to ensure that physicians are
still eager
to bring their patients
into trials
without undue fiscal burdens.
We are interested
in improving oversight of trials
and the design of trials
with oversight committees
that of multidisciplinary
representation
to plan disease
specify activities.
And we're committed
to better coordination
with community hospitals
and practices to ensure
that clinical trials are carried
out not just
at the Cancer Centers endorsed
by the NCI,
but throughout the
oncology community.
In addition, other aspects
of the clinical trial systems,
such as tumor banks,
are being further consolidated.
We believe we already have a
system that is more efficient,
deadlines are more frequently
honored, and fewer trials are
being terminated for delays.
I want to talk to you about 3
or 4 other ways
in which I'm trying
to make changes
within our limited resource pool
and to improve both the research
that we do and the incorporation
of the new evidence
and the new findings into care.
First in the area
of cancer genomics;
it's increasingly apparent
that genetic based oncology has
arrived and it's important
for us to coordinate all the
activities that the NCI's
currently carrying
out in the domain
of cancer genomics.
To that end,
I've set up a center
for cancer genomics
which will coordinate work being
carried out in many places
in the intramural research
program through the Cancer
Genome Atlas, the largest
and some ways the most prominent
of our programs,
the so-called target program
that does genomics
on pediatric cancers,
and a number
of other genomics projects being
carried out through a variety
of other grants.
We're using this
as an opportunity to evaluate
and advertise technical advances
and help our investigators
choose the best technical
approaches to their
particular investigations.
We are also thinking more
broadly of how to bring genomics
into medical practice.
Not just at the leading Cancer
Centers, but throughout the
oncology community.
This is one
of the topics we've been taking
up with the Center for Medicare
and Medicaid Services
and with the FDA.
We're also attempting to ensure
that genomics efforts are not
simply confined
to stored samples
that are unconnected
to clinical histories,
but instead applied to samples
that are collected during
routine care
or during clinical trials
to help may find better markers
to identify who is going
to respond and who will not,
to conventional therapy as well
as new therapies,
to identify new targets
for therapy,
and to link what we discover
to trial design
and the development
of good practices
in comparative
effectiveness research.
Barbara Wold,
a distinguished geneticist
from Cal Tech will be running
the center for the first year
after which she'll be returning
to Cal Tech and by then we hope
to have a permanent director
in place.
The second area
where we are trying
to extend our reach
in a quite dramatic way is
in global health
and we're establishing a Center
for Global Health at the NCI
that is intended to first
of all look
at the current portfolio
of investments we're making
abroad, to try to assess
that portfolio
and rebuild a research program
that is in a sense
opportunistic; taking advantage
of affordable approaches
to reducing the burden of cancer
as a diseases
in developing countries
especially as those
countries age.
These approaches will include
attention to the use
and development of new vaccines,
including human papillomavirus
vaccine, hepatitis B,
interest in developing vaccines
against EBD and Kaposi's virus,
and thinking
about other important infectious
agents linked to cancer,
including helicobacter
and parasites.
This effort is being assisted
by our close collaboration
with the National Institute
of Allergy and
Infectious Disease.
We're also interested
in understanding what therapies
are feasible (surgical,
theological, medical)
and paying attention case
by case to health systems
in developing countries.
We're also giving due attention
to the training
of investigators working closely
with partners including this
society, AACR,
American Cancer Society,
with universities
and Cancer Centers
such as the Fred Hutchinson
Cancer Center,
and the Dana-Farber Cancer
Center, and taking advantage
of existing global health
efforts at the World
Health Organization.
Ted Trimble who many of you know
from his work in the Division
of Cancer Therapeutics
and Diagnostics is temporarily
heading this center as it gets
up and running.
A third initiative is less
structured and more intellectual
if you will
and that's called the
Provocative
Questions initiative.
I've been disturbed
by the possibility
that in these times
of fiscal restraint,
there is a tendency to do things
that are obvious.
Some of these things may be
extremely important
like making investments
in the Cancer Gnome Atlas
or making investments
and attempts
to identify new targets
for therapy
or understanding the mechanism
of metastasis,
but there are a lot
of clinical problems
that we know are extremely
interesting
and have traditionally seemed
difficult to study.
For example,
why do certain chemo therapeutic
drugs that are often bashed
in private conversations
nevertheless cure some cancers;
leukemia, testicular cancers,
and so forth?
We don't really know the answer
of why that match works so well.
What is the relationship
between obesity and cancer?
We know from epidemiological
studies that as much as 20%
of cancer mortality
in this country could be
eliminated if there were
no obesity.
What is the connection?
Is it reversible
as bariatric surgery results
might suggest?
Are there approaches
to management of obese patients
that might include something
other than weight reduction
to lower their propensity
to cancer?
What is it about the context
of certain cancers that results
in different effects
by different genes
on the cancer phenotype
or on the resistance
or susceptibility
of those cancers
to certain drugs?
We have evidence
from the prevention literature
that anti-inflammatory agents,
most obviously aspirin,
can protect not only
against colorectal cancer,
but also against esophageal,
gastric, and probably
lung cancer.
What is the mechanism
by which these drugs work?
Is it possible
to use anti-inflammatory agents
without the risk
of hemorrhagic complications
to significantly reduce
cancer mortality?
There is a substantial list
of these questions that's been
developed largely
through the conduct of workshops
on the NIH campus,
workshops that have included
distinguished investigators
from all fields
of cancer research; behavior,
clinical research,
translational research,
basic research, physics,
and many other areas.
Those questions can be seen
on the Provocative Questions
website which can be accessed
through the traditional
cancer.gov homepage
and you will see many questions
contributed by workshop members
and by individuals providing
questions online.
And there's also a list
of questions
that have been endorsed
by the leadership of this effort
which includes myself,
Doug Lowy, Ed Harlow who's
working with me
as a special assistant,
and Tyler Jacks, the director
of the Koch Center at MIT.
We are currently preparing a
request for proposals
that is now being viewed
by the Board
of Scientific Advisors
and we hope in the near future
to be advertising our interest
in receiving applications
from those who believe they have
novel and promising ways
to address some
of these questions.
I'll just mention briefly one
last initiative I think is quite
important and that is an
initiative that involves working
much more closely
with our sister agencies
in the Department of Health
and Human Services.
And in particular,
we've had many fruitful
conversations with Don Berwick
and his high level associates
at the center for Medicaid
and Medicare Services.
We've been discussing
as I've already mentioned how we
instantiate genomic
testing...genetic testing
into clinical care
and especially in the use
of antineoplastic drugs
that are targeted,
but also thinking
about how the results
of the National Lung Screening
Trial, the use
of low-dose helical CT scanning,
can be brought
into clinical practice
with proper oversight
to prevent undue radiation
exposure, proper use
of the findings,
and appropriate reimbursement.
In addition, we are working both
with the FDA and CDC as well
as CMS to be able to look
down the pike a little bit.
Things are happening very
rapidly with oncology,
but we are seeing the shape
of things to come
and it's important
that we work closely
with our colleagues throughout
the health related portion
of HHS to ensure
that we are prepared
for the changes
that the research done by all
of you and all the investigators
supported by the NCI can be put
into practice as quickly
as possible.
Let me just say a final word
or two about where we stand
in relation
to the National Cancer Act.
Attention is being given
at this meeting
to that 40th anniversary,
an anniversary that I resonate
with because it's only a few
months more
that I have been involved myself
in cancer research.
I think we've all come
to appreciate
that the simplistic metaphor is
not a credible one.
Cancer is not one disease,
one simple enemy;
we're not going
to simply win or lose.
Cancer is a collection
of complex conditions becoming
in a sense more heterogeneous
the more we learn
about individual tumors.
There are of course important
commonalities having to do
with the nature
of the DNA damage
that gives rise to cancers,
the way in which cancers grow,
many of the so-called hallmarks
of cancer.
But because cancer is inherently
complex, arising
in different organs,
in different cells
in different organs,
by different genetic mechanisms,
we could anticipate and have
in fact seen different levels
of progress
in different settings.
Sometimes dramatic progress
as we've seen with the use
of imatinib chronic myeloid
leukemia, quite dramatic
as seen this year
with new immunological
and oncological approaches
to metastatic melanoma;
sometimes incremental,
but nevertheless important.
And of course
in some disease we've seen very
little progress at all.
But we also know
that there are extraordinary new
opportunities in prevention;
witnessed the human
papillomavirus vaccine
in screening, witnessed the use
of low-dose helical CT scanning
and its documentation as a tool,
able to reduce lung cancer
specific mortality by 20%,
new advances in treatment,
witnessed the multiplicity
of targeted therapies not just
imatinib, but many others
that may not work quite as well
yet but when we understand drug
resistance, perhaps they will,
and new diagnostics means
of classification
and I'm gratified to see
that ASCO is already endorsing
the use of EGF receptor mutation
testing in all patients
with lung cancer.
But now we have the challenge
of instantiating
and implementing that
and making it a reality
throughout the country
and indeed throughout the world.
We all know,
to return to my initial theme,
that we could move faster
if we had more resources,
but we at the NCI
and I hope everyone here is
pledged to make use,
the best possible use
of the people and dollars
that we have.
Thank you very much
for helping me with that effort.
[ Applause ]