Opening Statement
Good morning. I am pleased to be here today to talk with you about the
National Cancer Institute (NCI) and the evaluation of complementary and
alternative medicine in cancer. I am pleased because we recognize that this
is an important and challenging issue, and we have been taking steps to
significantly alter our approaches to complementary and alternative
medicine.
I am also pleased to be able to say unequivocally that this Nation is
experiencing real progress against cancer. This is evident in our cancer
incidence and death rates, which are declining. Between 1990 and 1995,
these rates dropped for all cancers combined and for most of the top 10
cancer sites, reversing an almost 20-year trend of increasing cancer cases
and deaths in the United States.
After increasing 1.2 percent per year from 1973 to 1990, the incidence rate
for all cancers combined declined an average of nearly 1 percent per year
between 1990 and 1995. The rates declined for most age groups, for both men
and women, and for most racial and ethnic groups. The exceptions were black
males, when the rates continued to increase, and Asian and Pacific Islander
females, when the rates were level. The overall death rate declined an
average of 0.5 percent a year from 1990 to 1995, with the declines greater
for men than for women. The only racial and ethnic group not included in
the downturn was Asian and Pacific Islander females.
We realize that these declines, while encouraging, must be accelerated and
extended so that all of our population benefits.
Recent Advances in Understanding Cancer
As we understand the nature of cancer, we understand that it is a unique
set of diseases, and that the answers to cancer are related to the most
fundamental mysteries of life itself. We know that cancer is not one
disease, but at least 100 different diseases that share certain features.
Because of this it is unlikely that one magic bullet will solve the
problem.
The most remarkable progress in the past 25 years has been in our knowledge
of cancer biology. We are dramatically extending our understanding of what
is required to turn a normal cell into a cancer cell. Cancer arises when a
single cell changes so that it divides continuously, released from the
controls that constrain the replication of normal cells. This
transformation results from changes in the function and activity of genes.
Of the approximately 100,000 genes found in the human genome, the altered
activities of only a relatively small number of genes are responsible for
transforming a normal, well-behaved cell into a cancer cell. Identifying
these cancer genes defines the central scientific hunt in cancer biology,
and opens an unprecedented window into the nature of cancer. Up until now,
our detection tools have lacked the sensitivity and the specificity that we
must demand if early detection is to be useful and successful. Our
interventions, despite their success, have, by and large, been the result
of guesswork. But now, we are at a point where we can transform our
approach to cancer.
We also are learning to understand the causes of cancer. Research on cancer
risk � the probability that the disease will occur in a given population �
is identifying populations with a significant probability of developing
cancer. Because cancer is a multistage process, analysis of risk factors
leads to the development of prevention and control strategies, as well as
early detection methods, and in some cases more precise treatments.
Epidemiologic research has identified many factors that increase cancer
risk. Most of these are related to environment and lifestyle, while others
are part of a person�s genetic makeup. With the exception of a few genetic
conditions, however, it is still not possible to predict with any degree of
certainty that a person having one or more of these factors will develop
cancer. This uncertainty is related to the very nature of cancer and the
need for many specific alterations to accumulate in a single cell for that
normal cell to be transformed into a cancer cell.
NCI Support of Complementary Treatments for Cancer - Links to CAM cancer
research
Let me emphasize at the start that the basic tenet of the NIH is to employ
rigorous methodologies to reach conclusions based on evidence and not on
belief. It is through such methodologies that the intersection between
"so-called" traditional medicine and "so-called" complementary and
alternative medicine will be sought. Standards of evidence cannot be
compromised and I am pleased that, on this crucial point, I and many
colleagues in the complementary and alternative medicine community agree.
By employing rigorous methodologies to studies in complementary and
alternative medicine, NCI has awarded and continues to support many high
quality CAM-related research projects, including projects examining the
effects of dietary interventions in cancer treatment, projects examining
the therapeutic value of vitamins and minerals in cancer treatment and
prevention, studies in stress and pain management to enhance the quality of
life for cancer patients, and studies examining the effect of natural
inhibitors of carcinogenesis.
Before I describe what the NCI is doing to alter both our approach to the
evaluation of complementary and alternative therapies and our relationship
with the complementary and alternative medicine communities, let me make a
few underlying points. First, why is there so much complementary and
alternative medicine in cancer? Let me propose two reasons:
First, is the near universal and quite ancient desire both to explain
observations about health and disease and to contribute by turning those
observations, beliefs and theories into interventions. Whether capturing
folk traditions or individual contributions, these activities offer an
often confusing but potentially rich storehouse of information.
Second, is the frustration that all of us have with the inadequacy of so
many of our current therapies, especially for certain cancers and
especially for far advanced cancer.
Those of us dedicated to eradicating cancer have two reasons to be open to
the evaluation of non-traditional therapies. However, under no
circumstances can that replace the need to subject them to vigorous tests
of efficacy that must be based on rules of evidence and not on anecdotes,
beliefs or testimonials, no matter how compelling they may seem.
First, we will not be successful in alleviating cancer unless we are open
to new ideas and new approaches. We have learned that anecdotes and folk
traditions have often guided us to real and effective therapies.
Second, many people take complementary and alternative medicines and they
reasonably ask who is providing evidence as to whether they help, do
nothing or are harmful. The question is, how do we best go about both
choosing which complementary and alternative medicines to evaluate through
rigorous clinical trials and designing those trials so that they yield
timely and credible answers.
Let me emphasize that an evidence-based approach to evaluating therapies
must be imposed on every step that leads us to initiate a trial. There are
thousands of potential therapeutics and that number multiplies with the
nearly endless combinations that could be tested. The result is that only a
tiny fraction of what is possible to test could possibly be brought to
clinical trial. At every step of the way, the weight of evidence supporting
an intervention and the rationale behind it must be evaluable and evaluated
to prioritize which approaches to move forward with. The challenge before
us is to assure that complementary and alternative approaches have real
access to the same processes of evidence and review that all interventions
must live up to.
NCI/OAM Collaborative Efforts to Evaluate CAM Cancer Research
The NCI is moving very quickly in important directions to develop CAM
information and expand research opportunities for CAM investigators. These
activities are broad in scope and include strengthening our relationship
with the Office of Alternative Medicine (OAM), the careful evaluation of
CAM therapies, and the development of accurate CAM information for the
public.
- While it is true that the relationship between the CAM
communities and the NCI has been distant at best, I
feel we have finally and securely moved beyond this
period. There exists a real commitment by the NCI to
learn as well as to inform and to listen as well as to
speak. We are in final stages of appointing an
individual to be the Coordinator for CAM therapies at
NCI, a position that has never before formally existed.
This individual will be a member of the cancer research
community whose primary interest and responsibility
will be to develop relationships with the CAM community
and to function as a liaison with the NCI research
community on behalf of the CAM community to encourage
collaboration and joint research initiatives.
- We are also collaborating with OAM to implement the
recommendations of the Practice Outcomes Monitoring and
Evaluation System (POMES) report including the
establishment of a Cancer Advisory Panel (CAP-CAM). A
slate of potential members has been jointly developed
by NCI and OAM to be presented to the OAM advisory
board for their review in September. The CAP-CAM will
be expected to meet 2 or 3 times a year and draw its 13
members from a broad range of experts from the
conventional and CAM cancer research community. This
group will review and evaluate summaries of evidence
for CAM cancer claims submitted by practitioners, make
recommendations to the OAM and the NCI on whether and
how these evaluations should be followed up, and, be
available to observe and provide advice about studies
supported by the OAM and NCI, and about communication
of the results of those studies. We are enthusiastic
that this group can work collaboratively in a new
partnership between the conventional and CAM cancer
research community. There already are two submissions
from the homeopathy community for review and
consideration once the panel is constituted. Rather
than have NCI conduct "best case series" review
independent of the CAM community, the CAP-CAM will
facilitate the joint review of data using this model.
We are also moving ahead with a number of research efforts that involve the
evaluation of CAM therapy.
- Due to public interest in the potential anti-cancer
activity of shark cartilage and its continued use
despite the lack of definitive clinical evidence of
efficacy, the NCI is collaborating with OAM to sponsor
clinical trials in this area. The NCI issued a public
request soliciting proposals to conduct randomized
phase III clinical trials evaluating the clinical
activity and efficacy of a shark cartilage product.
Five proposals have been received and are in the
process of being reviewed.
- The NCI is working with OAM to begin an evaluation of
Dr. Gonzalez�s therapy at Columbia Presbyterian Medical
Center, one of the NCI-designated Cancer Centers. Both
NCI and OAM will be providing support for the trial and
NCI is working with the Columbia clinical investigators
to have the Investigative New Drug (IND) filed as
quickly as possible. It is expected that funds will be
in place and the IND approved by the end of September.
- Another interesting area of potential research activity
is the evaluation of green tea as a cancer prevention
strategy. NCI staff in the Division of Cancer
Prevention have met this week to review the evidence
that exists, make an assessment of the weight of this
evidence, and then propose recommendations about the
appropriateness of moving forward with future
evaluations.
Of considerable importance to all of us is the public availability of
accurate, up-to-date information about CAM therapies. NCI has taken steps
to assure that this information receives the same consideration as
conventional approaches in our evaluation and dissemination efforts.
- Detailed CAM summaries are being prepared for cancer
therapies identified by our Cancer Information Service
and the OAM Clearinghouse as being of public interest.
The development of these summaries will follow the same
model as those for conventional therapies and include
specific trial results and references to the published
literature. They will be reviewed by the appropriate
Physicians Data Query (PDQ) Editorial Board depending
on whether the intervention is for the treatment or
prevention of cancer or used as a supportive care
intervention. In addition, these summaries will be sent
to experts in the CAM community for review and comment
before they are made available on the NCI web site.
- Reviews are in progress for shark cartilage and
hydrazine sulfate; summaries for laetrile, Essaic, and
antineoplastins will be drafted in the near future.
- Several months ago, as a result of our own concerns and
the constructive input from the CAM community, we
removed from the NCI web site all previous CAM
information and are creating new information that
treats CAM dispassionately and fairly. We are in the
process of completely rewriting all the NCI fact sheets
that deal with CAM , with hydrazine sulfate and
antineoplastons being the first therapies newly
available on the web site.
- We shall establish a lecture in CAM at the NCI as part
of the medical grand rounds series in our Division of
Clinical Sciences and open to all members of the NIH
community interested in CAM approaches.
- We are discussing with Dr. Barnett Kramer, the Editor
of the Journal of the National Cancer Institute, the
possibility of instituting a regular feature on CAM and
cancer. This would, in my view, be a very useful thing
to do; the ultimate decision on how this ought to be
implemented will rest with Dr. Kramer and his Editorial
Board.
As Director of NCI, I have a strong commitment to improving relations and
eliminating as best as possible the tension between the two research
communities. Both communities share a common and admirable goal - to cure
cancer. It is vital that we work together to that end.
I will be happy to answer any questions.
