By David S. Rosenthal, MD
2009-07-01
Dr. Rosenthal is Medical Director, Leonard P. Zakim Center for
Integrative Therapies at Dana-Farber Cancer Institute, Henry K. Oliver
Professor of Hygiene, Harvard University, and Professor of Medicine,
Harvard Medical School.
Dr. Rosenthal consults for Genzyme and receives research funding from NIH/NCCAM.
What happened to the time when a physician, hematologist or
otherwise, was a researcher, clinician, teacher, and healer? As medical
practice has become more complex, have we become too focused on
treating disease and not the whole person? Have we incorporated both
qualitative research, such as quality-of-life and survivorship
findings, and quantitative research, such as tumor models, into
standard care? To achieve the goal of best managing patients’ symptoms,
it seems important to address both quantitative and qualitative
measures.
Recently, it has been reported that there are some who would like to
“defund” the National Institutes of Health’s (NIH) National Center for
Complementary and Alternative Medicine (NCCAM)1 and also,
perhaps, close the Office of Cancer Complementary and Alternative
Medicine (OCCAM) within the National Cancer Institute. Currently, these
two entities fund about $244 million of NIH’s total $300 million
allotment for integrative therapies or CAM research. Given that the
total NIH budget is more than $29 billion, this allocation represents
just over 1 percent of the budget. These critics also would like to
prohibit the 0.3 percent of the NIH stimulus funds from going to NCCAM,
on the basis that this money is being taken away from “scientific
approaches.” Their criticism stems from the observation that the
results of a small number of studies funded to date have been
inconclusive, while other studies have produced negative results,
leading to a premature pronouncement that there is a better use for
those funds elsewhere.
Terminology, such as the often cited use of “alternative medicine”
versus “complementary” or “integrative” medicine, is one of the
challenges for leaders in the field of complementary/integrative
therapy research. Many of these leaders have worked in conventional
medical disciplines and have contributed to that body of research
before embarking on research in the emerging field of integrative
medicine.
In the United States, hematology and oncology patients frequently
use CAM therapies, not as “alternatives” to conventional therapy, but
instead, in combination with conventional care to assist with
controlling symptoms, to improve quality of life, to increase tolerance
of the symptoms of disease and/or the side effects of the therapy, and
to rehabilitate after curative therapies.2 Most Americans
visit CAM practitioners more frequently than they visit physicians, and
they often do not share their CAM practices with their primary
physicians.3 The use of biologicals and herbs is widespread
in the hematology/oncology community, and the importance of studying
potential drug interactions (either positive or negative) of these
therapies with conventional chemotherapy cannot be overemphasized.
Given the extensive use patients make of these modalities and the
modest scientific study into their utilities, the call to abandon
further scientific inquiry is puzzling.
The Society of Integrative Oncology (SIO) was founded in 2003 as a
“forum for presentation, discussion, and peer review of evidence-based
research and treatment modalities in the discipline known as
integrative medicine.” This international association has established
recommendations regarding the use of CAM. The first two recommendations
are most important. First, all patients with cancer should be asked
specifically about their use of CAM, and, second, all patients with
cancer should receive guidance about the advantages and limitations of
complementary therapies in an open evidence-based and patient-centered
manner by a qualified professional. The Institute of Medicine (IOM) and
the Bravewell Collaborative hosted a “Summit on Integrative Medicine
and the Health of the Public” in February 2009. Dr. Ralph Snyderman,
chair of the Summit Planning Committee and chancellor emeritus of Duke
University, described that the purpose of the summit was to “explore
how science and a patient-centered, prospective integrated approach to
care can make a positive difference.”
Integrative medicine emphasizes the patient–physician therapeutic
relationship. It neither rejects conventional medicine nor accepts
alternative therapies. The principles of integrative
hematology/oncology optimally combine the best of all available
therapies, the combination of evidence-based complementary therapies,
and the best evidence-based conventional therapies for each patient,
while strengthening the patient–physician relationship.
It is a weakness of CAM research to date that it has been more
focused on survey information and small trials. It has been debated
whether the same criteria used for drug clinical trials should be
applied to acupuncture, massage, music therapy, etc. and how best to
address controlling for the placebo effect. It stands to reason that
the same general scientific principles should apply to research
endeavors in either a conventional biomedical or complementary medicine
realm (e.g., standardization of product in pre-clinical studies and
adherence to randomization, masking, adequate reporting, etc.) for
clinical studies. Reproducibility is important to studies across the
full spectrum. Problems with adequate funding, resources, recruitment,
and retention of study subjects are common to many research studies;
however, the effects are magnified when opportunities for scientific
inquiry are scarcer, as in CAM research. There is a need for novel
research designs and approaches in both biomedical and CAM research.
Some methodological issues still need to be solved, such as for
acupuncture, which is a procedure, not a drug delivery equivalent. CAM
studies have also been criticized for their infrequent demonstration of
efficacy; however, a recent article regarding investigational drugs in
phase III clinical trials in oncology indicated that only 5 percent
reached the market.4
At the upcoming 2009 ASH Annual Meeting in December, Drs. Volker
Diehl and Kara Kelly, two outstanding clinicians and investigators in
adult and pediatric hematology/oncology, respectively, will discuss the
role and importance of integrating complementary medicine into
hematology care. Dr. Diehl, whose research on Hodgkin lymphoma is well
known, will discuss the importance of dealing with life after
treatment, and Dr. Kelly, known for her work on childhood leukemia,
will discuss nutrition and the role of antioxidants. It is imperative
that we continue to increase research funding in all sectors of
hematology and medical oncology: the conventional basic, molecular, and
clinical as well as the integrative therapies. We need to find novel
research protocols that take advantage of all evidence-based therapies
to treat disease and improve patients’ quality of life.
Brown, David. “Critics Object to ‘Pseudoscience’ Center.” The Washington Post. 17 Mar. 2009: HE01.
Richardson MA, Sanders T, Palmer JL et al. Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology. J Clin Oncol. 2000;18:2505-14.
Eisenberg DM, Kessler RC, Van Rompay MI et al. Perceptions
about complementary therapies relative to conventional therapies among
adults who use both: results from a national survey. Ann Intern Med. 2001;135:344-51.
Adjei AA, Christian M, Ivy P. Novel designs and end points for phase II clinical trials. Clin Cancer Res. 2009;15:1866-72.
back to top