Journal of the National Cancer Institute, Vol. 92, No. 24, December 20, 2000
White House Commission Examines Research on Complementary Cancer
By Matthew Fritts
"Within 5 to 10 years, complementary therapies will be a part of the
care in every major hospital and clinic across the country," predicted
James Gordon, M.D., clinical professor of psychiatry at the Georgetown
University School of Medicine in Washington, D.C. Gordon is chair of
the White House Commission on Complementary and Alternative Medicine
The 19-member commission is charged with developing legislative,
administrative, and public policy recommendations to maximize the
benefits of complementary and alternative medicine for Americans. "If
we are going to hold complementary and alternative therapies to an
appropriate standard of accountability, we need to invest in research
so health care professionals and consumers can make informed judgments
about the appropriate use of these services," President Clinton stated
upon appointing the chair and first 10 commissioners.
At a recent commission meeting to review the latest research in
complementary and alternative medicine, Jeffrey D. White, M.D.,
director of the National Cancer Institute's Office of Cancer
Complementary and Alternative Medicine, highlighted two
NCI-coordinated phase III clinical trials. Both trials are funded by
the National Institutes of Health's National Center for Complementary
and Alternative Medicine.
One trial at New York's Columbia University is comparing the
Kelley/Gonzalez protocol, a nutritional program with oral pancreatic
enzymes and a detoxification regimen, with conventional chemotherapy
for advanced pancreatic cancer (see News, Oct. 4, p. 1558).
The other is a multicenter trial coordinated by the University of
Texas M. D. Anderson Cancer Center in Houston. This trial is examining
the efficacy of shark cartilage versus placebo, both in combination
with platinum-based chemotherapy and radiation therapy. A total of 756
stage III lung cancer patients are being randomly assigned to receive
either shark cartilage extract or placebo. Patients also receive
infusions of cisplatin plus vinorelbine over a 12-week period or
carboplatin plus paclitaxel over a 3-week period, plus radiation
therapy beginning at week 8 and continuing for 6 weeks. Patients will
be evaluated every 8 weeks for 2 years.
A third study sponsored by NCI at Memorial Sloan-Kettering Cancer
Center, New York, is investigating whether dietary changes can slow or
halt increases in prostate-specific antigen levels in prostate cancer
patients who have undergone prostatectomy or radiation therapy.
Patients are randomly assigned to a diet low in fat and high in soy,
fruits, vegetables, green tea, vitamin E, and fiber, or to a standard
healthy diet. PSA levels will be tested at baseline, 1 and 3 months
into the study, and then quarterly thereafter.
Dietary modification is also the theme of the Prostate Cancer
Lifestyle Trial, directed by Dean Ornish, M.D., clinical professor of
medicine at the University of California at San Francisco, president
and director of the nonprofit Preventive Medicine Research Institute
in Sausalito, Calif., and a member of the commission. Ornish began his
prostate cancer trial 31/2 years ago at PMRI in conjunction with UCSF
and Memorial Sloan-Kettering Cancer Center.
At the meeting, Ornish reported that 85 of 120 patients with
biopsy-proven prostate cancer who have elected to undergo "watchful
waiting" have been randomly assigned to an experimental group that is
asked to make comprehensive lifestyle changes or to a control group
that is not. These changes include a very low-fat vegetarian diet,
moderate exercise, stress management training, and group support
Participants undergo quarterly PSA testing and MRI and MR spectroscopy
scans of the prostate to determine tumor size and activity.
"While it would be premature and unwise to draw any definitive
conclusions from a study that is still in progress, our preliminary
data are encouraging," Ornish said. "Whatever we find, the data will
be important, because many people in the general public are making
changes in diet and lifestyle without conclusive scientific evidence
to support these changes."
Researchers from the federal, private, and not-for-profit sectors
addressed illnesses from heart disease to arthritis and therapies from
herbal medicine to chiropractic manipulation. The commission also
discussed research priority setting, regulatory challenges, and
outcomes research and heard public comments on how public policy
changes might be used to help disseminate research findings to medical
practitioners and the general public.
"At this early stage, it is difficult to see how the diverse
presentations and discussions with the commission will be crystallized
into specific policy recommendations," commented White. "There are
some difficult issues in advancing CAM research, some of which we're
only beginning to uncover. Their solutions are likely to require
The commission has planned a series of town hall and public meetings
to address these issues. It will prepare an interim report next summer
and a final report to the president in March 2002.
Gordon is optimistic about the work of the commission and the future
of CAM in the United States. "Our definition of medicine will be far
larger than it is today," said Gordon, who is the president of the
Center for Mind-Body Medicine, Washington, D.C. "The questions are not
'if' or even 'when' this will happen. The questions that must be
answered, and the ones the commission will address, are how we can
find out which of these therapies are truly effective; how clinicians
can be trained in using them and the public educated about them; and
how therapies that do prove effective will be safely integrated into a
truly comprehensive and humane care for all Americans."
More information about the commission is available at its Web site:
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