**FTS-NCI**

**October 27, 2005**

**9:01 a.m. CDT**

Coordinator All participants are in a listen-only mode. Today's
conference is being recorded; if you have any objections, you may
disconnect at this time. Now, I'd like to turn the meeting over to Mr.
Doug Ulman. Thank you, sir, you may begin.

D. Ulman Thank you. Good afternoon, everyone. My name is Doug Ulman and
I'm the Chair of the NCI Director's Consumer Liaison Group. I want to
welcome you this afternoon, to the first in a series of conference calls
aimed at discussing the National Cancer Institute and allowing the
advocacy community to learn more about the NCI's activities and
initiatives.

Today, we're going to be discussing the 2015 challenge goal of
eliminating the suffering and death due to cancer by 2015, the future of
cancer research. For those of you who would like more information on
future calls, please go to
[www.la.cancer.gov](http://www.la.cancer.gov/) where you can find
information and register for those additional calls.

We are privileged today to have several speakers, Colonel Jim Williams,
Dr. Andrew C. von Eschenbach, and I will be closing before Q&A with some
additional comments about the role of the advocacy community in the
future of cancer research. At the current time, I'm going to turn it
over to my colleague and super cancer advocate, Colonel Jim Williams,
who is also a member of the DCLG, for comments that he is going to share
with the group. Jim.

Col. J. Williams Thank you, Doug. Good day, ladies, and gentlemen. I am
a 14-year prostate cancer survivor, and I extend a special welcome to
the cancer survivors and advocates on this call today. I hope my
comments will stimulate thought and encourage you to participate in this
and future calls in this NCI teleconference series.

How many times has someone come up to you and promoted some product they
claimed to cure cancer? How often do you hear tales about someone who
took something and was now "tumor free"? NCI recognizes that discoveries
in cancer research are limited by the failure to apply new findings in a
timely manner. However, there is a right way and a wrong way to
accomplish our objective to eliminate cancer. In my opinion,
evidence-based research is the only way to go.

My observations as a member of the NCI Director's Consumer Liaison group
has revealed to me that there is a priority shift from organ specific
research to other advanced technologies and techniques, to include teen
signs, personalized or individualized medicine, proteomics,
naotechnology, a new world science that takes to a world 80,000 smaller
than a ridge on your finger. Bio-infomatics improve imaging,
bio-repositories and others.

What will be the role of cancer patient advocates in the years ahead as
parties change from organ research to these new sciences? We in the
cancer patient advocate community find ourselves at a crossroads. Do we
continue to only pursue our disease-specific objectives? Do we
understand that true collaboration among all of us will be the key, as
NCI shifts away from site-specific research? Are we interested in only
our own organ-specific disease or do we understand that the answer
really lies within a much broader spectrum, for instance, molecular
science.

Molecular counterization is much more than the change in emphasis, it's
the basis on the knowledge of the process of cancer. The scientific
community is being challenged to share information, specimens, and
tissue that's noted in the creation of the National Biospecimen Network
and the National Tissue Bank. We in the advocacy community also have a
challenge to build uniform language and our strategic goals in test
planning, which demonstrates a unified effort in the war against cancer.

Unfortunately, many decision-makers currently view the cancer advocate
community as organ orientated, having a stovepipe mentality and very
fragmented, providing conquer techniques that are often used
successfully to keep us apart. The advocacy organizations would be more
effective if they truly work in harmony. I might be wrong, however, I
believe that true collaboration and partnership is the key to defeating
cancer. It reminds me of our efforts in the Department of Defense with
military joint task forces, where each service brings different strength
and a variety of resources to the table. However, duplication is
minimized and the focus is on the enemy objection, not on who should
receive the resources to complete the job.

I am pleased to note that in the restructuring of the clinical trial
enterprise ... advocate involvement begins in the design phase and that
the patient advocacy community is being asked to participate in all
segments of the research process. These are exciting times in cancer
research. However, we as advocates should one, begin to think out of the
box. Two, figure out how we can truly speak with one voice to the
decision makers and three, truly join forces with NCI to eliminate the
burden of cancer by 2015. Thank you, Doug.

D. Ulman Thank you, Jim, very much. I think your experience as an
advocate over the years is incredibly helpful, and I think your comments
really resonate in terms where we need to go as an advocacy community if
we want to reach the 2015 goal. At the current time, let me just remind
everybody on the call that we will be doing a Q&A at the end of the
prepared comments. At the current time, I'd like to turn it over to the
NCI Director, Dr. Andrew von Eschenbach.

Dr. von Eschenbach Good afternoon. Let me begin by thanking all of you
for taking time to join with us on this very important phone call, which
is in very much a beginning. A beginning of a conversation that I
certainly am looking forward to, between you -- those of you who are
committed and concerned about our effort against cancer -- and those of
us at the National Cancer Institute who are committed to working with
you towards an ultimate solution of the problem that we know is so
devastating to so many of our friends and our family.

It's a conversation that I come to as not only the Director of the
National Cancer Institute, but also a conversation that I come to as a
physician and as a cancer survivor. From that perspective, it's so
important that we have the opportunity to discuss and to share with you
the National Cancer Institute's agenda and its effort in order for us to
be able to make a difference in cancer.

It's important that we have this conversation because you have invested
in us. As taxpayers, you have invested your dollars and your resources
in the National Cancer Institute. Even more importantly, as an advocacy
community, you've invested in us your hopes. Your hopes that we will be
able to use the investment of the resources that have been given to us
in an effort to make a difference.

That investment began in earnest in 1971. That investment of resources
and the hope that the National Cancer Institute would be able to lead an
effort to conquer cancer began in 1971 when we as a nation, targeted
cancer. An effort to conquer cancer, a disease that we were aware then
was causing a great deal of suffering and death that we're all aware of.
It was a disease that we really knew very little about.

Our effort at the very outset was a commitment to cancer research. To be
able to begin to understand cancer as the disease by targeting and
focusing on cancer with regard to our research effort. I think over the
years, it's important to realize that although cancer research was our
focus, cancer research is not our end. Cancer research and the efforts
of the National Cancer Institute are only a means to an end. The end is
the importance of being able to affect the lives of those who are
threatened by and those who are dealing with, cancer.

Research as a means is a critically important means. Without research,
without our ability to understand cancer, we have very little chance of
being able to accomplish or achieve that end. But we will never loose
sight of the fact that it is the end that is most important. NCI has
endeavored to frame that in terms of a commitment to -- if you will -- a
dream with a timeline or goal. Our commitment is to be able to eliminate
not cancer at this point, but to eliminate the outcome of the disease
process of cancer. The outcome being the suffering and death that we see
all around us.

As we are on this conference call today, not only are one out of every
two men and one out of every three women at risk of being told in their
lifetime that they have cancer, but the fact of the matter is that as we
speak, one American every minute is suffering and dying as a result of
this disease. The NCI is committed to eliminating that suffering and
death due to cancer by capitalizing on the effort that we have made in
cancer research.

We have now begun to be able to understand cancer as a disease process.
To understand that disease process at its very fundamental, molecular
basis. We're beginning to understand the genes, the proteins, the
molecules, and the interactions between cells that are responsible for
this phenomenon we recognize as cancer. We're beginning to understand
the interaction between the tumor and the person with the tumor, such
that we can begin to understand what factors are determining and
predicting the outcome of this disease process.

We believe that this knowledge is leading us to a period of time in
which we have the opportunity to intervene in that process and preempt
the initiation and the progression of cancer in an effort to be able to
eliminate the outcome of cancer. The suffering and death we recognize
and see all around us.

Cancer research is also being accelerated and facilitated by the fact
that all around us we have an incredible explosion in advances that are
occurring in technology. Technologies that are enabling us to understand
genomics or the genetic basis for the development of cancer, our
susceptibility to cancer, the procession of cancer. We're beginning to
see technologies emerge in areas for example, that Colonel Williams
alluded to in protemics. Where by understanding proteins that are
produced by tumor cells, we're beginning to understand how we may be
able to detect those proteins and define a signature for cancer. That
even using one drop of blood or small amount of fluid, we can be able to
detect the presence of proteins that would indicate the development and
the presence of cancer very, very early on at a time where we can more
safely and more easily eliminate it.

We're seeing opportunities in imaging. Where now we are dependent upon
seeing a lump or the expression of a tumor once it is advanced, but be
able to visualize the biochemistry and the biology of the disease
process. Not only be able to see cancer at the molecular level rather
than at the macroscopic level, but we're able to actually also see the
impact of our treatments and our therapies in being able to alter or
change the biology or the biochemistry of the tumor.

We're seeing the fact that we now understand the mechanisms that are
responsible for a tumor's development and its progression. That
understanding is opening the doors. That discovery is opening the door
for the development of targeted interventions that are directed towards
those mechanisms. We are daily seeing as we monitor the progress that's
being made, the introduction of new drugs, new therapies, that are being
able to target and directly impact on the tumor process. Gleevec for the
treatment of leukemia was one of the early examples of a targeted
therapy. There are many others that are also becoming and are available.
Including for example, ... Herceptin for patients with breast cancer.

Every day we're seeing advances, but it is not simply enough to discover
and develop new opportunities or new therapies. They must be delivered,
and they must be delivered to all who are at risk or of need. In the
actual delivery of these new interventions, we have the opportunity to
learn even more about the human reality, the human biology, of cancer.
Delivery is also becoming for us an extremely important opportunity for
discovery. It will require a delivery system that not only provides
access to and the opportunity for these interventions to be delivered,
but allows for patients to actively participant in the process. Where
their experience can be captured, the data can be recorded, assembled,
and analyzed.

In that very experience, we will be able to learn more and ultimately do
more about eliminating the outcome of cancer. The suffering and death
due to the disease, and in the process, reduce the burden and the
occurrences of cancer. Ultimately to be able to prevent more cancers
from ever developing, to be able to detect and eliminate cancers much
earlier in the course of the disease. To be able to control or modulate
other cancers in a way that patients live with and do not die as a
result of the disease.

We've made progress since 1971 in cancer research in terms of our
understanding of cancer. We've moved from an era where the only way that
I as a urologic oncologist could diagnose prostate cancer was based on
what I could feel with the tip of my index finger. We've moved from an
era where the only thing we knew about a tumor is what we could observe
by looking at the cells under a microscope. To now a time where we can
actually work inside the cell and look at the genetic and molecular
mechanisms that are driving that cell. Look at the genetic and molecular
make up of the person with that cancer, and that has opened the doors to
an entirely new reality, an entirely new set of opportunities.

It is the future that the NCI is committed to working together with you
to explore and to implement. We're looking forward to being able to do
this as a community in which all the parts and all the components are
crossed. Discovery, development, and delivery must come together. Work
and integrate together so that we can assure a nation and a world
threatened by cancer that no one need suffer and die as a result. I'm
going to turn it back over to Doug Ulman, and look forward to our
opportunity for questions and answers.

D. Ulman Great. Thank you, Dr. von Eschenbach. I'm going to take just a
few minutes to talk briefly about what I see as the role for advocates
in the community to propel us towards the future of cancer research and
the 2015 goal. It's evident by the comments of Dr. von Eschenbach that
the community is really crucial if we are to reach our collective
horizon and this 2015 challenge goal.

Again, this is first in a series of teleconference calls aimed at
providing another way for the community to interact with NCI. I feel
strongly that the institute values the voice of consumer advocates, and
we need as a community of advocates, to provide a constructive voice,
constructive ideas, and really create the dialog.

There are many ways to get involved from an advocate standpoint in the
National Cancer Institute's efforts and initiatives. The DCLG has
launched a Web site called Listens and Learns. There is the CARRA
program. There of course is the DCLG itself. We will be taking
nominations later this year for new members for that initiative. We are
also in the preliminary stages of planning a summit for 2006.

The goal of the DCLG is to serve as a conduit to the cancer advocacy
community, and we welcome your interaction and participation through all
of the means that I just mentioned. As a community, we must truly come
together to focus our energy on the new world of cancer research. The
world that Dr. von Eschenbach just explained. That is the crosscutting
issues that will ultimately get us closer to the 2015 goal.

These initiatives are the key to the future of cancer research, and we
must put aside our specific disease sites and channel our energy on the
larger issues that are plaguing the cancer research enterprise. If we
collaborate and work with the research community in a constructive
manner, we will catapult ourselves towards the 2015 goal. We will all
witness a day when no one suffers and dies from this illness. As the
Chair of the DCLG, I welcome your input. I encourage you to attend our
public meetings. I look forward to working with you to ensure that we
don't miss this opportunity to transform the cancer advocacy community
into a force that allows us to reach the 2015 goal.

Let me just briefly mention before we move to question and answer that
we encourage everyone to join us for the remained of the Understanding
NCI series to learn more about the crosscutting issues in cancer
research. Members of cancer advocacy organizations, survivors, family,
and friends are encouraged to participate in each call to learn more
about NCI's important cancer research programs and how advocates are
involved. Participants will always have the opportunity to ask questions
of the various panel members.

For more information you can to the Web site for the Office of Liaison
Activities, which is [www.la.cancer.gov](http://www.la.cancer.gov/).
Additionally, questions can be e-mailed in for a follow-up to the
following e-mail address: <liaison@od.nci.nih.gov>. I'll repeat those
again at the end of the call after the question and answer period.

At this time, we will open it up for questions for our panelists,
Colonel Jim Williams, Dr. Andrew von Eschenbach, and myself. I believe
the operator will provide instructions on how to ask a question.

Coordinator Our first question comes from Ann Fonza. You may ask your
question, and please state your affiliation.

A. Fonza Thank you. I'm the President and founder of the Annie Appleseed
Project. Our particular area of interest and expertise has been
complementary alternative approaches. When NCI proposed reduction of
pain and suffering, we were really excited because we see this as a real
opportunity to look at the entire world of complementary approaches,
which definitely have been shown to help reduce pain and therefore
suffering.

We'd like to see more resources put into that. Not just in the
specialized of the Office of Complementary Approaches because that's a
huge mandate, but more integrated. Can you speak to that?

Dr. von Eschenbach Sure. I think one of the most important points to be
made, as you were nice enough to comment on is that the goal is about
both quantity of life as well as quality of life. Eliminating the
suffering as well as the death associated with cancer is an important
part of that. What we are increasingly becoming aware of is in looking
at quantity and quality of life, and looking at opportunities from the
perspective of understanding some of the fundamental molecular
mechanisms that are associated with the process that we think about as
cancer is that it really is a dynamic interaction between the tumor and
the person with the tumor.

One of the important I think, areas of focus that we've seen coming
historically from the area of complementary and alternative medicine has
been the opportunities for a more holistic approach. The understanding
of many of the factors associated with the person with the disease as
well as the disease itself. We're very interested in many of the
insights that have been able to be derived from components of what has
traditionally been thought of as complementary alternative medicine.
Including promoting programs that will look at those factors in terms of
the role that nutritional interventions can have. The kinds of issues
that are associated even with regard to interventions that are
associated with relaxation, meditation, etc.

It's important that we do this in a rigorous and scientific way that not
only determines and defines the impact that these interventions have on
eliminating or reducing suffering as well as improving and enhancing
survival and outcome. But that we also understand the mechanism, and
that we understand what the molecular correlates are of these
interventions, just as we must understand what the molecular correlates
are of a new targeted drug.

We're committed to the inclusion of this important area in our
portfolio. We're committed to the continuing scientific exploration of
the important contributions that it can make. We're going to continue to
do that in the context of our broader research portfolio.

Coordinator Thank you. Our next question comes from Rick Wassermann. You
may ask your question and please state your affiliation.

R. Wassermann Yes, my name is Rick Wassermann. I'm with the National
Patient Advocate Foundation. I was just wondering how we can as
advocates, specifically best implement resources to unit and pool their
resources? That's an open question for anyone to answer.

D. Ulman This is Doug, I can take a first stab at that. I think that
some of the things that we've been seeing coming out of different
reports and coming out of the National Cancer Institute are really
encouraging again, some of these crosscutting research initiatives. In
doing so, are also encouraging things like team science and research
angles of the future, which hopefully will allow people in the research
field to work together.

I also should mention things like the National Biospecimen Network as
well as CAB, which are two initiatives that hopefully will provide
platforms for researchers to share information, share data, and work
closely together to expedite the development of the research enterprise.
I don't know, Jim, if you want to comment on that? Or Dr. von
Eschenbach, if you want to comment on that?

Dr. von Echenbach Yes, this is Andy von Eschenbach. I think there are a
number of different dimensions to the question. Let me just focus on one
of them. I alluded to earlier the importance of emerging technologies
and how they were beginning to impact on this transition to a greater
understanding of cancer. Particularly as we understand patient
experiences. Last week for example, the results were released from the
digital mammography trial. Which in the early diagnosis of breast
cancer, the use of digital mammography as compare to film mammography
showed across the entire population, they were equivalent and were of
equal value. In fact, in a subset of patients -- those who were younger,
women who had dense breasts or were pre or perimenopausal, the digital
mammography was actually superior.

One of the advantages and interesting implications of this study, which
hasn't been really fully discussed, is not only is this a very important
step forward in our ability to accurate diagnose breast cancer earlier
and especially for this one group of patients in particular, but it puts
all that information on a digital basis. The patient's information, the
patient's data now is able to become a part of an electronic medical
record infrastructure. It could conceivably enable us to electronically
be able to assemble and assimilate all of the information that's coming
from opportunities to detect breast cancer using digital technology, and
create a database that we could extract knowledge from.

Patients willingness to participate, to contribute their data, their
information, their medical records, in an appropriate, protected,
confidential way. Patients as Doug alluded to, who would be willing in
their experience to make available their tissue and their fluids for
part of the advances that we need to make in our molecular understanding
of cancer. Allows the patient to not only be the recipient of the
benefits, but also one of the drivers of the progress that we could
ultimately make.

A greater awareness of the community that can come from patient
advocates to help others understand the importance of their
participation -- not just in clinical trials, but in clinical registry.
Not just being involved in research to test new drugs, but the
willingness to use their experience and the information that they have
in our ability to create databases is a very important contribution to
the future of cancer research.

Coordinator Thank you. Our next question comes from Loren Pace. You may
ask your question and please state your affiliation.

L. Pace Loren Pace, Breast Cancer Help Incorporation and founder of the
Breast Cancer Mapping Project. This is a very exciting time for cancer
patients to give them some hope and it's wonderful what the NCI is
doing. However, my question is will you be using the geographic
information system to find out where the concentration of breast cancer
is? To hopefully help those people and to do some bio-monitoring to find
out -- of course you would need tissue banks and blood banks -- to find
out where there's a concentration of certain kinds of cancer? Is it from
some sort of chemical or the environment? Will there be studies being
done on that and will the geographic information system be used? In my
opinion, what we need is a national database with very important
information about cancer.

Dr. von Eschenbach This is, like the other questions, an extremely
important one and one that we are looking forward to in the future as an
exciting opportunity. It begins with the point that you've made about
how essential it is that we understand gene/environmental interaction.
The problem of cancer is not only one of our inherent susceptibility,
but it's also a fact in terms of what our exposures are and what various
insults may be that precipitate and drive the genetic damage that gives
rise to the cancer problem.

There are a number of opportunities that we've been engaged with. You
alluded to one; we've had collaborative interactions with NIEHS in terms
of being able to create an understanding of environmental carcinogens
and gene/environmental interactions. We have a plan, which is another
way of being able to look at the occurrences or the incidences of cancer
in geographic areas across the United States with their particular types
of cancers. Then also expanding that into the kind of programs that
could be appropriately implemented in those geographic areas to deal
with that particular cancer burden.

Then the ability to create mechanisms to survey and to provide
surveillance for the emergence of cancers, where we then have the
opportunity to correlate that with environmental and geographic factors
that might be causation factions is an important one. The Long Island
breast cancer study issues that are occurring now, and Marin Country are
just a couple of the examples of the important opportunities that we
have in that regard.

L. Pace Thank you.

Coordinator Thank you. Our next question comes from Sue Sumpter. You may
ask your question and please state your affiliation.

S. Sumpter Hi, I'm Sue Sumpter. I'm a member of the DCLG and work for
the leukemia and ... I want to thank you so much for doing this
education series. I think it's a wonderful way to inform the cancer
community and I want to say thank you first of all. My question refers
to childhood cancer research and the poor number of clinical trials that
there are for cancer research for children, especially the age group 15
to 25. I wondered if there was going to be any emphasis placed on that
in the future?

D. Olman Thank you, Sue. This is Doug, and I'll take a first stab at
that. Interestingly enough, the National Cancer Institute has just
launched the initial phases of a progress review group to study the
issue of young adult oncology, which is what you reference in your
question. For those who are unaware, this is an understudied and often
neglected population. Generously I guess between 15 and 35 years of age.
If you look at the relative five year survival data for this age group,
the increases if any, over the last 20 years, have been minimal.

Realizing that and working closely with a number of organizations in the
advocacy community -- the NCI agreed to partner with the advocacy
community to launch a progress review group. Which will take about 12
months, and hopefully then will lay out a series of recommendations
based on the PRG that the community will really have to come together to
implement. The implementation will not be left solely to the NCI, but
rather the community at large.

I think from your standpoint and the standpoint of your question, it is
clear that that is a topic of interest. It is a way that we can further
reach towards the 2015 goal. We need to do a lot in terms of
understanding not only the biological factors, but also the quality of
life and survivorship issues that impact people in that young adult age
range.

S. Sumpter Thank you.

Coordinator Thank you. Our next question comes from Polly Liss. You may
ask your question and please state your affiliation.

P. Liss Hi, I'm Polly Liss with the ... national capital area of the
National Breast Cancer Organization. I have two rather quick questions.
One is will the 1-800-4CANCER service be able to provide to the consumer
where to find the latest discoveries in relation to cancer? There are so
many different outlets to look for this information the average person
doesn't know where to look for it. If you happen to hit on the right
page in the newspaper, you could have gotten the information that you
mentioned a little while ago about the digital mammography. It would be
nice if there was one place we go to tell us where to go.

The other question I had when you mentioned knowing that you can look
inside the cell and you want to relate that with the genetic make up of
the person. I was wondering also, does the personality of the person
beyond the genetic make up contribute in any way to what happens with
the cancer cell?

Dr. von Eschenbach Let me take that in two parts. First of all, the
1-800-4CANCER is our cancer information service, and that is a very
important portal for being able to direct patients, families, as well as
healthcare professionals to all of the various assets that we have to
specifically address questions, concerns or issues that they may raise.
One very important more recent opportunity along those lines is number
one, the ability to disseminate the information I alluded to earlier
about the digital mammography trial and how people understand that.

Also, it was very important as cancer patients after Hurricane Katrina
in those areas, were seeking or looking for advice and direction. This
was an opportunity for us utilize the cancer information service in that
1-800 number. Particularly working with the American Society of Clinical
Oncology to help patients and to help support even displaced
oncologists. It's a comprehensive, very broad way of connecting patients
with a particular need to the resources or the specific portal that they
need to go to or have access to in order to be able to address that
particular need.

It's also important to realize that
[www.cancer.gov](http://www.cancer.gov/) is another portal and another
way of accessing information and being able to determine resources that
are available and required. Of course, we have an important partnership
with the American Cancer Society, and they have a call line service
that's available 24 hours a day, seven days a week. They can provide
important information or an important link and collaborator to help
patients. They're also an important resource.

We've attempted independently, as many of you know, to create a
publication that we issue every week called *Cancer Bulletin*. That's an
opportunity to simply make everyone in the community aware of some of
the things that are occurring at the NCI, some of the latest advances
that have occurred. Areas that we are considering to be high priority
programs that we're implementing, or even just simply insights for
example, in the director's update, to what we're thinking. What some of
the important issues are that we believe need to be addressed.

We're trying in an open and transparent way, to provide as many portals
as possible to the community to help them understand what the NCI agenda
and programs are, what the resources are that are available to them and
how we can guide them through the system and the problems. Anyone want
to add to that question?

In regard to your second question regarding personality, I do not know
the answer to that. I think that is a legitimate area of important
investigation. We are continuously becoming more and more aware of -- as
I alluded to earlier -- the need for a holistic approach to the cancer
problem and to the person who is threatened or affected by cancer. What
role emotion, what role mood, play in the entire process, what those
correlates are that may perhaps have some expression in the endocrine or
hormonal ... or the immunologic or immune responses, are areas of
legitimate important investigation.

What are we are viewing going forward in the future is the opportunity
to really not only be aware that these things seem to and appear to be
an important component as we observe the problem of cancer. To more
importantly be able to delve into them in a way that we'll understand
the mechanisms and the processes in terms of how they affect the
ultimate outcome of cancer, and then what we can do about that in terms
of being able to get a more positive outcome as it relates to the cancer
problem itself. These are areas yet to be explored, but areas of
important opportunity.

P. Liss Thank you.

Coordinator Thank you. Our next question comes from Judy Allen. You may
ask your question and please state your affiliation.

J. Allen Hello, my name is Judy Allen, and I am a member of the UCSF ...
Advocacy Core. I'm also the advocate member of the Breast Tissue Use
Committee. I'm also a breast cancer survivor of ten years, and I just
called the hospital where my surgery was done to see where my tumor was.
I kind of suspected that after ten years their policy is to discard
tumors. I told them please hold on to my tumor and I'd pick it up. I've
sent an e-mail to our Breast Tissue Use Committee asking them to
consider a program where we might be able to work with either the Cancer
Registry or some program to see if we can't recover tissue that is
expected to be discarded from hospitals that don't have a tissue bank.
How we might go about getting retroactive consent from patients
regarding their tissue?

At the same time, which I think is really important, is do an
informational -- maybe a national -- informational program or campaign
that basically educates people about tissue donation in the same sort of
way -- with a difference obviously -- of organ donation. Organ donation
obviously is a method ... but tissue donations so that people understand
what a valuable resource it is in discovering and curing and coming up
with treatments for disease. Not only that, that if you do donate your
tissue, that every effort would be made to maintain confidentiality as
well as to let them know that they're not going to loose an extra scoop
of tissue during their surgery in order to participate in tissue
donation.

That's a very strong interest of mine. I think it's one that is not
addressed as broadly as it should be because of the fact that so many
resource organizations whether it's industrial or academic, are
requesting tissues for this important research that's going on.
Particularly with the new targeted research efforts. That the resources
are limited, and I think that we have the opportunity to go and collect
these tissue specimens from other hospitals. I'm wondering if there's
any way that perhaps the NCI could get involved in this effort?

Dr. von Eschenbach Thank you for that question, and I'm going to follow
it up with both an answer and a request, so I'll forewarn you. First of
all, let me begin with the answer. This is going to be an exceedingly
important area for us to address, and we have already begun the process
in a number of important ways.

First of all, working through C-Change, which is formerly the National
Dialog on Cancer. The NCI has spearheaded an effort to create a
blueprint for a national bio repository system. It's extremely important
that we address this from the perspective of quality control and
standards. The blueprint is a community-based collaborative effort that
has brought all the components and parts and pieces to address the
issue. How we can put a system in place that captures the resources that
you were alluding to, but did it in a way that absolutely assured the
quality that is critically important?

There are many issues with regard to these bio-repositories and the
utilization of specimens. You've alluded to some of them having to do
with the privacy issues and HIPAA regulations, informed consent, and
many of the legal and ethical components. They are being addressed. The
policies and the procedures that are necessary in order to do that
appropriately and maintain confidentiality and privacy, etc., are all
being addressed.

Also equally important is the realization that although tissue has been
obtained and preserved, they were obtained and preserved not with the
expectation that they would be used or needed for elegant genetic or
molecular analysis years in the future. But would really be available
for subsequent historologic examination or review under a microscope.
Those involve two very, very dramatically different sets of conditions
for how those tissues are preserved, how they're handled, and whether in
fact they would be able to be effectively utilized. We have lots of
tissue, but it's in various states, if you will, with regard to how it
could be ultimately utilized for some of these molecular studies.

We've brought into the NCI, significant leadership in the form Dr.
Carolyn Koffton to head up an effort to begin to move towards how we can
look at all the bio repositories that are currently in place? How we
could look at various specimens that have been maintained and kept for
other purposes, and whether they could then be subsequently utilized for
some of these elegant kinds of studies. We need help.

My request comes in the form of asking you and other advocates who want
to help participate in being able to create this networking. If you
would e-mail us at <liaison@od.nci.nih.gov>, your interest, your name,
and your contact information. As we move forward in this important
initiative and as we need to continue to network more broadly and more
widely into the community. We need the participation and the support of
interested and informed advocates such as you to help us to be able to
create this kind of network, but do it in a way that is on an
appropriate foundation of quality control and quality assurance. So that
the materials are utilized appropriately and the information that is
gleaned is valid and reliable and can be utilized in an effective way.

It's a work in progress, but we can't let these precious resources
unnecessarily go to waste, and we're going to need your help both
retrospectively as well as need your help prospectively as we go forward
from here in terms of putting in place standards and networks. Not to
create a central repository where we'll have all the material captured
and put in one place, but to have all of these distributed repositories
adhering to a set of standards and quality control measures. So that
your material will ultimately one day -- when it's needed -- be in a
condition and a state that we can then make sure that it would be able
to be utilized appropriately and effectively.

J. Allen Well, I thank you. I think the advocate component of this issue
is extremely important because I think that there are trust issues with
patients who don't have as global of an understanding of research and
patient confidentiality issues and consent issues as we would all like
to have. I certainly will e-mail you and I'd really like to see a
program in place to use these resources and have the patients understand
how important their contributions are and what impact they would have on
them personally, if any.

Dr. von Eschenbach I agree. This is an important role for the Director's
Consumer Liaison Group as it serves as a conduit between the NCI and our
programs and the broad advocacy community. I can assure you that there
are people like Colonel Williams -- who's on the call and he may want to
speak to this -- who are both passionate as well as effective in being
able to be certain that patient's interests and perspectives are being
not just represented, but taken into account and are a part of the
planning and the implementation process. Colonel Williams, I don't know
if you want to speak to that role from the DCLG perspective or not, but
I know you've been pretty vocal and adamant about the role of the
patient and the advocate in this whole process.

Col. J. Williams Yes, thank you, Dr. von Eschenbach. I would like to
speak to that. I'm glad that question was brought up because it reminds
me, what is the role of the patient advocate in the community? The
tissue issue is one of those areas. I know I'm preaching to the choir
here. However, I think we all appreciate that advocacy is very hard
work. Many times there is little return on our investment of time and
resources. Many times it's one on one with you on a patient or family
member on one hand. Many times it's a health administrator or a
politician on the other hand.

We have national programs that are very important, but the true patient
advocate can have most influence in his community. Many decisions in
medicine in this country are not based on the research that we're
reaching for or those researched findings, they're based on advocacy. In
those areas where advocacy has worked very, very hard, they've seen a
lot of support for their specific calls. Where there hasn't been that
advocacy, your party hasn't been there.

I encourage all of you who have listened on this call, when you're
trying to figure out what role you can play. You can play a very
important role as a catalyst within your community. Not only talking to
patients as was mentioned before about the bio infomatics which is
coming onboard, and their fear of the privacy issue, and how we need to
overcome that barrier so the information is readily available when it's
needed. The problem when we talk about clinical trials and being a
guinea pig. Not only is that phenomena in the minority community, but
also those who get their service in an academic medical setting. Many
times they're reluctant to participate and have more than "one person"
look at them.

Remember we're still talking about the practice of medicine. I think the
advocate plays a very, very important role and we're working very hard
to be part of that medical team and more than just a recruiter or just
as a spokesperson. As a patient we bring a lot of skills to the table.
We're not brain dead just because we've been prostrate with prostate
cancer. We have a dual role as I see it. We must work with our community
members in trying to them bring them up to the level of awareness that
we have come to because of our involvement in advocacy. We also have a
job in trying to convince the health administrators and the health
professionals that we truly can plan an important role beginning in the
development of trials and other protocols through the conclusion of
finding a cure for cancer.

D. Ulman Great, thanks, Jim. I think we have time for one more question.

Coordinator Thank you. Our final question comes from Susanne Provo. You
may ask your question and please state your affiliation.

S. Provo Hi, I'm with Young Survival Coalition and I actually have kind
of a two-part thing. The first is that I think it is very important that
we have patients involved in the process of research. One thing I know
right now is sitting in Congress is a bill to have some federal funding
to allow patient navigators in various hospital programs. I know that
that's for people with chronic diseases, of which cancer is considered
one. I don't know how soon that will be implemented. I know it's
supposed to be voted on in Congress very soon.

The other thing is that I am a young survivor and I am in research
studies. I'm hoping that what they find with the research study that I'm
in will help other people and I applaud the efforts that they're finally
looking at young patients because so many of us are loosing the battle.
I'd like to know how the national government looks at how quickly the
paradigm is going to shift as far as using complementary treatments?

I know a lot of patients, because I work with them, that are doing
complementary things. They're looking at the alternative publications;
they're doing a lot of research themselves. There are a lot of patients
that are using the treatments because they feel they're getting good
results. I know that the research basis, they would like it to be more
scientific. You need to maybe speed up the pace because they're being
used because people think that it's giving them a better quality of
life. Could someone speak to those issues?

Dr. von Eschenbach Yes, this is Andy von Eschenbach. I'm going to be
very quick. I really appreciate all the questions. I know there are
many, many more and we're going to continue to take those
electronically. Complementary approaches are extremely important that we
factor those in to the traditional standard methods of intervention.

One thing that will help us a great deal in this regard is as we move
toward an electronic medical record and the ability to have things more
patient-centric and patients able to record and transmit and communicate
information directly to us in the medical record. We would then not only
know what treatments are being employed for example in the report of a
clinical trial, but know all the other things that patients are doing
and taking, whether it's vitamins or a particular nutritional
supplement. That will give us the opportunity to really understand the
implications.

We've seen more recently a clinical trial in which there was expected to
be a very positive outcome from a particular intervention and it did not
occur. It was hard to understand why that was the case. It was only when
the investigators were able to go back and delve into the patients'
history that they found out that the difference had to do with whether
patients were or were not taking vitamin B-12. It's very important that
we recognize the role that complementary medicine is playing. The fact
that patients are engaging and accessing these interventions. We must be
able to know about that and factor it in to this important equation.

With regard to patient navigators, we have reached out to HRSA, which is
the agency that's been charged with the implementation of the patient
navigator program. We have the benefit of having Dr. Harold Freeman, who
is a special advisor to me, and has been the champion of the patient
navigator program. As HRSA formulates its implementation strategy, now
that the President has signed the Patient Navigator Act, we will be
working with them to be certain that cancer is liaison into that.
Hopefully we'll play a very important leadership role in the rollout of
the patient navigator program through HRSA and the Department of Health
& Human Services.

I'll very quickly give it back to Doug, and end by thank you all for
your participation from my perspective.

D. Ulman Let me just close by thanking our speakers, Colonel Jim
Williams, and Dr. Andrew von Eschenbach. While we do know there are many
of you on the call with questions yet to be answered, I would encourage
you to use the e-mail address that we've given,
<liaison@od.nci.nih.gov>. Additionally encourage people to visit the
[www.la.cancer.gov](http://www.la.cancer.gov/) Web site to learn more
about this continuing teleconference series, Understanding NCI. The next
call will take place on Wednesday, October 19^th^ at 2:30 Eastern
Standard time, and the title of that call is Why Statistics Matter For
Advocates, Follow Up from the April 2005, CR Advocacy Conference.

Thank you again for everyone participating. We look forward to speaking
with you, and again, we look forward to this only serving as the
beginning of a long dialog, so that we can help reach the 2015 challenge
goal. Thanks, and good afternoon.

Coordinator Thank you. This concludes today's conference call. Thank you
for your participation. You may disconnect at this time.