Government Reform and Oversight Committee
February 12, 1998
James S.Gordon, MD
My name is James S. Gordon, M.D. I'm a Clinical Professor
in the Departments of Psychiatry and Family Medicine at the
Georgetown University School of Medicine and Director of the
Center for Mind-Body Medicine. I was the first Chairman of
the Program Advisory Council of the National Institutes of
Health's Office of Alternative Medicine, and after my initial
two-year term, I was reappointed by NIH to an additional year
as Chairman. I've published well over 100 articles in the
scientific and popular press and written or edited ten books,
including most recently Manifesto for a New Medicine: Your
Guide to Healing Partnerships and the Wise Use of Alternative
Therapies. For more than twenty-five years, I've been
integrating a variety of complementary and alternative approaches
into my practice and teaching of medicine and psychiatry.
We are in the midst of a revolution in the practice of medicine
and a transformation in the kind of health care Americans
want and receive. We are in the processing of shifting the
center of gravity of our system from high-tech diagnosis and
treatment to self-care and mutual help; from a Western biomedicine
preoccupied exclusively with finding the ultimate cause of
and instituting aggressive treatment for discrete disease
states to a "world medicine" which is equally concerned with
balance and harmony within the individual and between the
individual and his or her natural and social world; from a
relentlessly secular system of treatment to a profoundly spiritual
approach to care. For tens of millions of Americans, it is
no longer a question of either modern science or ancient wisdom,
but of combining both in a new, richer, more effective and
more humane synthesis.
Thirty years ago, Americans and their physicians believed
that blood pressure and heart rate, the pain of cancer and
the level of responsiveness of the immune system were utterly
beyond the control of the individual. Acupuncture and Chinese
medicine were anthropological curiosities whose practices
were limited to the Asian community in the United States.
Physicians could lose their membership in state medical societies
for referring patients to chiropractors. And massage was a
subject for dirty jokes.
Today we know that ordinary human beings are capable of mobilizing
their minds--through biofeedback, relaxation, imagery and
hypnosis--to improve and alter virtually every physiological
function. Between twelve and fourteen thousand acupuncturists
practice openly in the United States, and some 3,000 are physicians.
Chiropractors have won anti-trust suits against the AMA, are
licensed in every state and serve approximately 10% of the
population. Massage therapy is a growing profession whose
practitioners are providing relief from stress, enhancing
the mood of depressed patients, and giving help to those with
cancer and post-operative pain.
In their 1990 national survey, Dr. David Eisenberg and his
colleagues found that some 34% of Americans were already using
these and other "alternative" therapies. The word "alternative"
designated practices other than those taught in medical school
or in post-graduate training. Seven years later, it is likely
that over 40% of Americans use these therapies and that the
vast majority use them as a "complement" to conventional therapies,
as part of a self-created program of health care. Physicians
in increasing numbers (close to 90% of family physicians in
one study) are looking for information about these approaches,
and studying and incorporating them into their practices.
More than one-half of all American medical schools presently
have electives which offer an overview of these alternative
and complementary therapies.
When attacks are launched against "alternative medicine,"
the attackers tend to turn their sights on practices they
believe to be inherently foolish. "Imagine actually giving
research money to studying massage therapy," they say. Or
,"Why bother with herbs when we already have drugs?" or, "Do
you really expect us," as one major figure in American medicine
recently said to me at Grand Rounds at one of our most respected
teaching hospitals, "to take prayer seriously?" Some laugh
at homeopathy--the use of infinitely small doses of substances
to relieve symptoms that larger doses of those substances
could produce. And many simply state that all of the therapies
for which there is good evidence (for example, biofeedback)
are already included within the medical canon, while there
is obviously no "good" evidence for the others.
The complaints about insufficient data are rarely grounded
in thorough study. There is, in fact, a sizable body of research
information on a variety of different alternative and complementary
therapies. I cite several hundred epidemiologic and randomized
controlled studies from peer-reviewed journals in Manifesto
for a New Medicine. "Alternative Medicine: Expanding Medical
Horizons," a report prepared by over 200 researchers and clinicians
for the Office of Alternative Medicine contains many hundreds
more citations. And, those who deny the possible utility of
therapies for which there is no clear mechanism or resist
funding studies of them, I think, are both obtuse and forgetful.
Aspirin was happily used by conventional physicians long before
we had any notion of why it worked.
We know, to cite just a few examples, that meditation, relaxation
therapies, imagery and hypnosis can contribute in a major
way to decreasing stress, relieving pain and insomnia, as
well as altering blood pressure, enhancing immune functioning,
and helping to reduce the frequency and intensity of epileptic
seizures. There are hundreds of carefully controlled studies
in peer-reviewed journals, mostly from Europe and Asia, on
the utility of herbal preparations, for example, astragalus
and echinacea for enhancing immunity and St. John's wort for
alleviating depression. Massage appears to make a major difference
in the growth, development and well being of premature babies.
And homeopathy--improbable as it may seem--does in a careful
meta-analysis seem to have very real effects on a variety
of conditions. In some cases, the evidence is far more impressive
than that brought forward to justify a host of surgical procedures
and other expensive, side-effect laden, commonly used, high-tech
interventions such as electronic fetal monitoring of normal
births or the insertion of tubes in the ears of babies with
chronic infections.
There are, of course, a number of alternative and complementary
therapies that have not been adequately studied. This is precisely
why Congress established the Office of Alternative Medicine
at the National Institutes of Health. These include therapies
that hundreds of thousands or, indeed, millions of Americans
are looking to for answers to their health problems, therapies
about which patients would hope to query their doctors, just
as they might about the latest antibiotic or the newest surgical
technique. Half a million people have used intravenous EDTA
chelation to treat heart and peripheral vascular disease.
Many of these people claim that chelation has been a life-saver.
Most conventional physicians regard the success as an illusion,
if not a hoax. People with HIV look to herbal therapies to
enhance immune functioning. And cancer patients--as many as
70-80% of them in some studies--scour the bookstores and search
the Internet for help with tumors that are poorly treated
by conventional physicians or for side effects of even successful
treatment.
The Office of Alternative Medicine (OAM) was created to make
information about what is and is not known about alternative
and complementary therapies available to patients, clinicians
and researchers. It was mandated by Congress to "investigate
and validate" promising new therapies. Funded at $2 million,
in 1992, it was a small but bold initiative. It was seen as
a "beacon of hope" by many who were desperate for reliable
answers about the efficacy of unconventional therapies, as
well as by those who practiced or studied these therapies.
For the first time, the government would pull together information
scattered in thousands of journals across all the continents
and sort through it, culling what was valuable and discarding
what was not, and making the results as widely available as
possible. For the first time, there would be a body within
the world's premier research organization, the National Institutes
of Health, committed to a fair study of these therapies and
rapid dissemination of the results of these studies.
In the six years of its existence, the OAM has funded forty
small studies on specific alternative therapies and has established
ten academic centers, some of them at the nation's most respected
medical institutions, devoted specifically to studying these
therapies. It has brought together unconventional practitioners
and conventional researchers so that they might work together
to develop methodologies appropriate to the therapies and
the therapeutic systems under study and rigorous enough to
satisfy the most exacting scientist. It has published Alternative
Medicine: Expanding Medical Horizons and begun to make
available the results from the studies it has funded. It has
begun to build bridges with other NIH Institutes and the researchers
in them and with other federal agencies, including the Food
and Drug Administration and the Center for Disease Control.
It has provided technical assistance to dozen of investigators
who are committed to the scientific study of their treatments.
The OAM has developed a Consensus Conference on the use of
relaxation therapies and acupuncture. It has helped open the
way to the approval and use of herbal therapies and has just
recently funded a major prospective study on the treatment
of depression which will compare in head-to-head clinical
trials St. John's wort with one of the Prozac-like, selective
serotonin re-uptake inhibitors in the treatment of depression.
The OAM has moved too slowly for some, particularly with
regard to life-threatening illness for which there is no conventional
medical answer, and has not always been responsible to the
needs of its constituents. For others, its progress has been
too rapid. Still, in spite of its still minuscule budget (its
first director, Joseph Jacobs, M.D., called it "homeopathic")
and opposition within and outside of it, the OAM provides
an opportunity for authoritative data collection, evaluation
and dissemination; a focus for scientific exploration of the
efficacy of alternative and complementary therapies; a forum
for debate about research priorities and methodologies; and
the possibility of the systematic study of the usefulness
of these therapies and of the ways they may enlarge and enrich
medicine in America.
In order for the OAM to move ahead more effectively, significant
increases in its funding and changes in its structure are
necessary. I'll address these later. They hold great promise
for the authoritative evaluation of complementary and alternative
therapies and for the creation of a means by which people
can most quickly obtain the most promising new treatments.
Now, however, I want to turn my attention to another matter:
the Access to Medical Treatment Bill
Scientific evaluation takes a considerable amount of time.
Randomized, controlled studies that satisfy the criterion
of the FDA require a great deal of money as well as time.
The Access Bill makes it possible for people to safely obtain
treatments that have not been approved by the FDA while the
engines of scientific progress move slowly ahead. The bill,
which has been introduced in both the House and Senate, permits
any individual to be treated by a licensed health care practitioner
with any method of treatment that that person requests; whether
or not it has been approved by the Food and Drug Administration.
The bill, whose co-sponsors range from conservative Republicans
like Orrin Hatch (Utah) to liberal Democrats like Tom Daschle
(S.D.), would not only expand health care options, it would
also bring alternative therapies safely within the embrace
of our health care system.
At present, fears of punitive action have some clinicians
and researchers reluctant to share information - positive
or negative - on the alternative therapies they use. Some
practitioners have been arrested for practices that the FDA
deems illegal. Others, including a number who treat cancer
or HIV, have moved their clinics to Mexico, the Bahamas and
Latin America. Some of these people appear unethical as well
as unscientific but others are offering treatments that seem
to hold genuine promise. The net result of forcing them off-shore
is that patients who cannot get the care they want in the
United States must go where it is unregulated, and physicians
and other health practitioners in this country are unable
to practice or study the medicine they believe will help.
The threat of overzealous regulation has made impossible
exactly the kind of scientific investigation that the FDA
and other regulatory agencies say they want. By requiring
that practitioners who wish to offer alternative therapies
be licensed, the legislation will help keep these practices
within the compass of state regulatory boards. It will require
that all practitioners report both positive and negative effects
to the Department of Health and Human Services. And by insisting
that practitioners who use these treatments not derive any
financial benefit from them (other than fee-for-service) the
bill removes the legitimate concern that unscrupulous practitioners
can make huge profits from the drugs or devices they use.
The Access to Medical Treatment Act will make it possible
for all of us to explore, with some reassurance of safety,
all of the complementary and alternative therapies that are
available. It will, as well, provide some feedback about therapies
that have been, at least in individual cases, helpful or damaging.
But it will not do the job of providing us with the rigorous
scientific data that we need to fully evaluate these therapies.
That job rests, as it should, with the Department of Health
and Human Services and most particularly with the NIH and
the Office of Alternative Medicine.
The Office of Alternative Medicine, as first established,
was an office within the Office of the Director of NIH. A
year ago, it was transferred to the Office of Disease Prevention.
Congress increased its budget from $2 to $12 million and most
recently to $20 million. This increase is, however, a pale
reflection of the interest in the office. The OAM receives
some 1200 calls a month, as many or more than institutes with
50 or 100 times its budget, from people desperate for information
(up to 80% of them have cancer).
With its current budget, the OAM cannot afford to establish
the database that Congress mandated and evaluate the existing
literature on alternative and complementary therapies. It
can not adequately fund academic centers for the investigation
of promising therapies for particular physical and mental
disorders. And it certainly can't investigate and validate
promising and/or controversial therapies. An adequate study
on St. John's wort for depression - a single herb for a discrete
condition - to be funded by the Office but through and under
the auspices of the National Institute of Mental Health, will
cost $1.5 million a year for three years, or approximately
one-twelfth of the OAM's entire budget. An appropriate clinical
trial of chelation therapy, the kind that is needed to help
Americans determine whether or not this procedure actually
works and, if so, for what conditions, would cost significantly
more. The size of the Office's staff is also completely inadequate
to investigate the hundreds of therapies that tens of millions
of Americans are using. A budget of $100-150 million with
staff large enough to manage it would enable the Office to
begin to address the scientific and human questions that are
continually being addressed to it.
However, more than money is needed. The current position
of the OAM as an Office restricts its capacity to do the research
it is mandated to perform. All of its grants have to be funded
in collaboration with and through the administrative mechanism
of other Institutes. This means, quite simply, that other
Institutes with other priorities and other means of calibrating
scientific importance and public accountability may frustrate
the research agenda set by sectors of the scientific community
and the representatives of public organizations who advise
the OAM. When the National Institute of Mental Health agrees
that a study comparing St. John's wort, which has been used
regularly by over 20 million Germans, is a worthy subject
of study, the granting mechanism proceeds apace. If, however,
the National Heart, Lung and Blood Institute, based on its
evaluation, decides it is not important to study chelation
therapy, or the National Cancer Institute disagrees about
the value of investigating a new, widely-used and apparently
promising but controversial, unconventional cancer treatment,
careful, scientific investigations of these widely-used approaches
simply cannot proceed. The OAM needs to become the National
Center for Complementary and Alternative Medicine, an independent
NIH body with its own granting capacity and an advisory council
with the authority to approve these grants.
The OAM is also limited in a second, and equally important,
way. It is not able to create its own standing review committees,
committees which would include members with expertise in complementary
and alternative approaches as well as in scientific methodology.
At present, there are approximately 26 standing review committees
at NIH, with 125 people. At last count, none of the members
of these review committees had degrees or licensure in any
of the commonly used complementary or alternative therapies.
There were, for example, no chiropractors, acupuncturists
nor, so far as we were able tell some months ago, did any
committee member with M.D.'s and Ph.D.'s have adequate expertise
on complementary and alternative therapies. Transforming the
OAM into a Center would enable it to appoint distinguished
researchers and clinicians with significant expertise in these
areas to its review panels. It would put the scientific study
of complementary and alternative practices on equal footing
with the scientific investigation of conventional medical
and surgical therapies.
We also need a well-funded, independent Center to explore
the utility of comprehensive approaches to the diseases which
kill and disable large numbers of Americans, approaches which
include a variety of alternative and complementary, as well
as conventional, medical treatments. We need to see if shifting
the emphasis from high-tech treatment controlled by physicians
to teaching self-care and helping people to help one another
can alter health status as it does mood, self-esteem and sense
of control. We need to move beyond our single minded focus
on modern biomedicine to explore the richness and relevance
of the world's many healing traditions. We need to determine
if some plants in the world's pharmacopeia may have greater
benefits and fewer side-effects than manufactured pharmaceuticals.
We need to be open-minded enough to see if the "vital energy"--the
Chinese call it "chi," the Indians "prana"--which is regarded
as an integral part of every healing system in the world can
be measured scientifically and used therapeutically.
We need a Center committed to finding out not only whether
these therapies work and if so, how, but how they can be implemented
in real life, in hospitals and clinics across the country,
for the poor who cannot pay out of pocket as well as for the
wealthy who can. And we need to see if these approaches are
indeed capable, as a number of them have already been shown
to, to save us significant amounts of money.
We need a Center where we can create models for the health
care of the future and for the education of those who will
practice it on themselves and others. This Center could help
create a larger, more humane, more intellectually and humanly
responsible professional education that will enrich and humanize
the lives and practices of medical and nursing students and
their future patients.
Finally, a Center with wide-ranging authority is necessary
because complementary and alternative therapies are not simply
specific approaches to specific disease states. When used
appropriately, they embody a new way of approaching health
and illness with implications not only for research and treatment
but for every aspect of health care and education: for the
financing of health care; for the education of future health
professionals; and, indeed, for our conceptualization of health
and illness.
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