UCLA's Office of the Vice Chancellor for Research and Center for East West Medicine
recently hosted a symposium on the future of complementary, alternative and integrative
medical research featuring nationally recognized speakers. The symposium took place
on the UCLA campus in late January and was targeted to the Geffen School of Medicine's
Institutional Review Board (IRB). Its purpose was to address the finding by the National
Center for Complementary and Alternative Medicine (NCCAM) that IRB's may be unfamiliar
and/or uncomfortable with unconventional medical modalities thus apt to disapprove
studies of those modalities (1). The hope was to better this state of affairs by familiarizing
the audience with some of the major controversies surrounding CAIM research and its
regulation.
As it turned out, NCCAM, itself came in for censure. Dr Daniel Cherkin, Associate
Director for Research and Senior Investigator at Group Health in Seattle functioned
as moderator and began the program with a catalog of ills from which the US health
care system suffers, a description of the role CAIM has played in responding to those
ills, a review of NCCAM's mission and several questions regarding how that mission
has been and should be carried out. A standing-room-only crowd then heard Dr Donald
Marcus, Professor of Medicine at Baylor University and well-known CAIM critic and
Dr John Longhurst, Director of the Susan Samueli Center for Integrative Medicine and
Professor of Medicine at the University of California at Irvine deliver their appraisals
of NCCAM. They decried the ‘too-low’ ratio of basic to clinical research, what they
view as the inordinate influence on the Advisory Council and review panels of CAIM
practitioners, many of whom lack research training and the investigation of ‘scientifically
implausible’ therapies for which there is inadequate preliminary data and which, in
some cases may be dangerous. NCCAM's EDTA chelation trial was mentioned as being especially
ill-advised. While largely critical, both speakers’ remarks included some praise.
Dr Marcus made reference to neuroscientific studies, work on the placebo effect and
negative trials of herbs as useful NCCAM achievements. Dr Longhurst spoke of NCCAM's
unique role in investigating modalities ignored by the rest of NIH. Although he favors
continued research on some CAIM treatments, Dr Marcus opined that other NIH Centers
are equipped to take on such projects. He repeated his call for an outside review
of NCCAM, citing his belief that political rather than scientific considerations drive
its agenda. He regards the situation as untenable, particularly in an era of major
cutbacks in research funding. While not calling for an independent review, Dr Longhurst
spoke strongly in favor of reform, a narrowing of the research agenda as well as an
increase in funding.
While Professors Longhurst and Marcus gave an overview of the field of CAIM research,
Dr Ary Goldberger, Director of the Margret & H. A. Rey Institute for Nonlinear Dynamics
in Medicine at Boston's Beth Israel Deaconess Medical Center and Professor of Medicine
at Harvard Medical School discussed his work on complex systems as one example of
where such research may be headed. In Dr Goldberger's view, conventionally designed
studies frequently err in focusing on only one molecular mechanism, ignoring communication
among pathways and sometimes leading to unforeseen adverse outcomes. Dr Goldberger
suggested that conservatism in science extends to the underlying approach to physiological
systems, often wrongly privileging homeostasis (‘constancy as the wisdom of the body’)
over complex adaptability, multi-scale dynamics and emergent properties. In as much
as they are non-linear, non-stationary, non-additive and show time irreversibility,
however, complex systems may be inaccessible to conventional analytic techniques,
according to the speaker. Dr Goldberger left the impression that he believes both
investigators and NIH Centers in general ought to be more open to novel but rigorous
research designs and methodology.
On the subject of the criticisms leveled at NCCAM, the speaker advocated ‘ruthless
neutrality’ in all scientific investigation but suggested that in its imperfection,
NCCAM in no way distinguishes itself from other NIH Centers. He criticized the NIH
system, generally, for a tendency to reward ‘specific-aimsmanship’ in grant writing
over originality. He advocated the same non-linearity of thought for the NIH that
his work has shown to be associated with good bodily health and adaptability to stress.
In noting that taxpayers ‘own’ NIH data, Dr Goldberger suggested that NCCAM take a
leadership role in advocacy for open access data and open source software, fostering
scientific collaboration by allowing validation of studies already completed.
NCCAM and CAIM leaders and investigators have countered several of the arguments made
by speakers Longhurst and Marcus in the past (2–10) and UCLA panelists echoed some
of those responses, adding queries of their own. Professor-in-Residence Mark Cohen
expressed the view that current research tools may be inadequate for measuring the
effects of some CAIM treatments. In addition, he noted that taxpayers already support
faith-based initiatives and questioned whether conventional science has a ‘special
entitlement’ to public funds, given that orientation. On the issue of the research
agenda at NCCAM, he made mention of the fact that in creating the R21 grant, NIH acknowledged
that existing funding mechanisms didn't sufficiently encourage creativity. With regard
to political considerations, he pointed out that these have played a role in the creation
of other NIH Centers, including the National Institute of Biomedical Imaging and BioEngineering
(NIBIB). Noted UCLA cancer researcher Dr Patricia Ganz seconded Cohen's concern about
conservatism at NIH, recounting difficulties convincing colleagues and reviewers of
the need to study links between the mind and body. She decried many investigators’
unwillingness to ‘think outside the heart’, a reference to her observation that most
rarely emerge from their disciplinary ‘silos’. Dr Marcus agreed on the importance
of supporting some mind-body research, but indicated he felt that funders have turned
a corner and are now more open to such work. Drs Ganz and Longhurst both spoke in
favor of the training of more persons capable of doing rigorous science across disciplines.
Distinguished Professor Edwin Cooper (Editor in Chief, Evidence Based Complementary
and Alternative Medicine) echoed others’ reluctance to single out NCCAM for castigation.
He, too, raised questions about what passes for good research methodology, asking
whether studying ancient, whole systems of medicine using Western, reductionistic
techniques doesn't strip them of essential features. Associate Professor of Pediatrics,
Jennie Tsao agreed on the importance of investigating traditional medicine as practiced
remarking that for most users—users in India and China, for example—such therapies
are not considered ‘alternative’. Dr Ganz added that some non-western practices are
associated with greater longevity and may merit study as potential models for biomedicine
as it faces an epidemic of chronic disease. On the subject of NCCAM's achievements,
Dr Tsao, suggested taking the long view. She noted that psychological treatments such
as cognitive-behavioral therapy (CBT) now have an established evidence base, thanks
largely to sponsorship by the National Institute of Mental Health (NIMH). However,
it took many years to separate empirically validated approaches from those with little
or no value. Thus, to summarily dismiss a whole group of therapies as unsupported
would be premature, in her view. Dr Alison Moore, an authority on geriatric alcoholism
questioned speakers on funding alternatives outside of NIH and opportunities for training
in CAIM research. Participants acknowledged the difficulty of finding research dollars
and Dr Longhurst named several non-governmental sources he had used, suggesting that
young investigators look to such funding as a bridge to support by NIH. After summarizing
points made by the speakers and panelists, Dr Cherkin concluded that there is a need
to broaden our view of what constitutes good science and that systems-level investigations
and a focus on patients’ concerns as they view them are important means of achieving
that end.
‘Science of CAIM’ was unusual in that it brought together experts representing widely
divergent opinions on how complementary, alternative and integrative modalities should
be studied for a face-to-face discussion. While consensus was not reached on most
issues, the symposium did succeed in offering those in the business of evaluating
CAIM proposals exposure to some of the most pressing questions regarding its study
and regulation, thereby addressing concerns expressed in NCCAM's Strategic Plan. A
pod cast of the symposium is available at http://www.cewm.med.ucla.edu/podcasts/index.html