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The Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM)
convened at 8:30 a.m. on December 13, 1999 at the Pooks Hill Marriott Hotel in Bethesda, Maryland. Richard Nahin, M.P.H., Ph.D., Executive Secretary, called the meeting to order.
On this page
- Call to Order
- Introduction of Panel Members
- Review of Confidentiality and Conflict of Interest
- Approval of Minutes
- Future Meeting Dates
- Introductory Remarks - Dr. Michael Hawkins, Chairperson, CAPCAM
- Dr. Stephen Straus, Director, NCCAM
- Introductory Remarks and BCS Update - Dr. Jeffrey White, Director, Office of Complementary and Alternative Medicine, NCI
- Mind-Body Medicine and Cancer
- Initial Efforts to Develop National Clinical Trials on CAM within the Radiation Therapy Oncology Group (RTOG)
- CAPCAM Options
- Public Comment
CAPCAM Members Present*
- Michael Hawkins, M.D., Chair
- Ian D. Coulter, Ph.D.
- Susan S. Ellenberg, Ph.D.
- William R. Fair, M.D.
- James S. Gordon, M.D.
- David J. Hufford, Ph.D.
- Frances A. Jacobs, R.N.
- Ralph W. Moss, Ph.D.
- Douglas L. Weed, M.D., Ph.D.
- Jeffrey D. White, M.D.
- Lauren V. Wood, M.D.
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CAPCAM AD HOC Members Present
- Mitchell R. Hammer, Ph.D.
- Ms. Susan Holloran
- Konrad Kail, N.D.
- Gilbert Ramirez, Ph.D.
- Leanna Standish, N.D., Ph.D., L.Ac.
- James E. Williams Jr., M.A.
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CAPCAM Members Absent
NIH Staff Members
- Dr. Sheryl Brining, NCCAM
- Dr. John Chah, NCCAM
- Ms. Odessa Colvin, NCCAM
- Ms. Marguerite Evans, M.S., R.D., NCCAM
- Ms. Carol Fitzpatrick, NCCAM
- Ms. Anita Greene, M.S., NCCAM
- Mr. Lawrence Haller, NCCAM
- Dr. Eugene Hayunga, NCCAM
- Mr. Doug Hussey, NCCAM
- Mr. Steve LeBlanc, NCCAM
- Dr. Richard Nahin, NCCAM
- Mr. Charles Sabatos, NCCAM
- Dr. Stephen Straus, Director, NCCAM
- Ms. Shirley Villone, NCCAM
- Dr. Neal West, NCCAM
- Ms. Suzanne White, NHLBI
- Mr. Patrick Williams, NIH OD
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Others Present
- Dr. Pratip Banerji, Calcutta, India
- Dr. Prasanta Banerji, Calcutta, India
- Dr. Lawrence Berk
- Mr. Angelo P. John, New York
- Dr. M.A. Richardson, University of Texas
- Dr. David Spiegel, Stanford University
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I. Call to Order
The meeting was called to order at 8:30 a.m. by Dr. Richard Nahin, Executive
Secretary, CAPCAM.
Dr. Nahin reviewed the purposes of CAPCAM, which are to review data on
unconventional medical alternatives and recommend next research steps
to Dr.
Stephen Straus, Director of NCCAM.
There are three possible determinations the panel can make on a research
presentation:
- There are data of sufficient quality and quantity to warrant further
research.
- There are not enough data to warrant more research.
- The treatment is interesting but more data are needed.
If further research is warranted, the CAPCAM's role is to determine:
- The scientific significance of the proposed concept, i.e., will the
treatment alleviate cancer symptoms or alleviate treatment side effects?
- Can the treatment be evaluated in a scientific manner?
- Does it fall within the purview of NIH or NCCAM?
CAPCAM does not make funding decisions but can suggest research projects
to
NCCAM. Its major role is to identify CAM interventions that should be
studied
further.
II. Introduction of Panel Members
CAPCAM members were introduced by name, title and area of expertise.
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III. Review of Confidentiality and Conflict
of Interest
Dr. Nahin reminded CAPCAM members that conflicts of interest may occur
if:
1) the member has a designated role in the research; 2) the member has
a self-
interest in the research results; or 3) there is an appearance of conflict
stemming from participation of a family member. If any of these conditions
exist, the member must withdraw from the discussion to prevent the proceedings
from appearing biased. Dr. Nahin stated that no confidential material
was
being discussed at this meeting. He reminded members, however, that private
discussions of CAPCAM topics should be conducted only between a committee
member and a member of the NIH staff, not with researchers or people outside
the committee membership. Dr. Nahin was asked to clarify whether members
can
express personal views to others on subjects discussed in open meeting.
He
said when speaking to others, members should make clear their views are
their
own and that they are not representing the positions of CAPCAM.
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IV. Approval of Minutes
The minutes of the July 8 and 9, 1999 meeting were approved and signed
with
the following notations: Dr. Kail was listed as an M.D., instead of an
N.D.
V. Future Meeting Dates
Dr. Nahin reported the next meeting will be June 12, 2000. At that time,
three best case series will likely be presented. (NOTE: Since the December
13
meeting was held, the date of the next CAPCAM meeting was changed from
June 12
to September 18, 2000)
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VI. Introductory Remarks - Dr. Michael
Hawkins, Chairperson, CAPCAM
Dr. Hawkins welcomed the committee and introduced Dr. Straus.
VII. Dr. Stephen Straus, Director, NCCAM
Dr. Straus noted that an increasing portion of the population is turning
to
complementary and alternative medicine (CAM). There are few areas that
have
benefited from biological and clinical advances more than oncology. New
modalities can cure some cases of cancer or extend the lives of patients
with
cancer. But these lifesaving methods can be hard on patients. The public
is,
therefore, using CAM to maintain alleviate some symptoms during invasive
therapies. Others, for whom there are no effective lifesaving treatments
in
conventional medicine, are looking for alternatives. Dr. Straus said that
anecdotes about alternative treatments are encouraging, but doctors need
to
know which are safe and effective.
Certain modalities are well-established. For example, acupuncture has
been
effective in dealing with chemotherapy-induced nausea. There are many
other
examples. NCCAM is charged with studying the therapeutic and palliative
approaches that appear most promising. The Best Case Series (BCS) program
allows novel approaches to be identified and provide resources to test
them.
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VIII. Introductory Remarks and BCS Update
- Dr. Jeffrey White, Director, Office of Complementary and Alternative
Medicine, NCI
Dr. White discussed the NCI BCS program, which began in 1991. His office
is
currently soliciting submissions on complementary and alternative cancer
treatments for presentation to CAPCAM. Since January 1999, he has had
11
contacts for more information on how to participate in the program, nine
from practitioners in the United States and two from foreign countries.
There have been two BCS solicitations from the U.S. and two submissions.
Of
the two submissions, one applicant has sent data but has been asked to
furnish more information to complete the patient files. In the second
case,
the applicant is obtaining the necessary information and plans to submit
in
time for review by CAPCAM at its next meeting. Dr. White's office is
publicizing the BCS program through journal interviews and advertisements,
presentations at conferences and direct mailings to practitioners (50
letters
were to be mailed the day of the meeting). He urged CAPCAM members to
help
spread the word through personal contacts.
A discussion ensued about the low response to the BCS and what barriers
might
exist that prevent practitioners from applying for the BCS program. One
concern
was that practitioners may not want their treatments discussed until they
submit their completed data. Dr. Hufford questioned whether CAPCAM should
divulge information about a BCS that is submitted but not yet reviewed
nor
decided upon. Should a practitioner sign a release about what specifics
can be
divulged about a project? Dr. Hawkins, CAPCAM Chair, suggested Dr. White
propose a policy to address this.
Dr. Kail raised another concern: the difficulty of gathering all the
documentation required for the BCS because the effort is time consuming
and
expensive. Practitioners may lack the infrastructure to get the work done.
Sometimes other specialists who hold certain patient records, such as
pathology reports, won't cooperate. Dr. Gordon suggested an effort be
made to
identify what is preventing practitioners from submitting BCS so CAPCAM
can
consider ways to assist in the process.
Dr. White said the low response may also be due to a lack of awareness
of the
program, which has only been advertised in the last few months. Ms. Holloran
suggested that Dr. White's office also look at what help might be given
to
those practitioners who have submitted but not completed their applications.
Dr. Straus said another reason for low response could be practitioners'
unwillingness to share what they do with the federal government. He added
that
he isn't sure that lack of infrastructure is a limiting factor, but that
he
will be recruiting a clinical epidemiologist/statistician who could help
provide expertise.
It was suggested that in the future, NCCAM could consider letting practitioners
apply for money to put a BCS application together. Dr. Nahin commented
that
NCCAM's developmental grant program (R21) might be an appropriate vehicle
for
such applications.
Dr. White reported on the status of two previously reviewed prospective
single-
arm clinical trials that were reviewed by CAPCAM at the July 1999 meeting.
Additional documentation has been requested from both applicants and has
not
yet been received. However, both applicants anticipate completion before
the
next CAPCAM meeting.
One applicant is the Banerji Homeopathic Research Foundation in India.
It has
submitted 12 cases for evaluation by CAPCAM. Four of these cases appeared
to
document tumor regression after administration of a homeopathic cancer
treatment. Dr. White is developing a Prospective Outcomes Monitoring and
Evaluation System (POMES) to help practitioners pursue research. In addition,
he is trying to identify a clinical research organization to track 30-50
lung
cancer patients in Dr. Banerji's clinic. Dr. White hopes to find an
organization with previous NIH experience, but he has been unable to locate
one acceptable to the clinic. The Indian practitioners have recommended
a
hospital in Calcutta with which they are comfortable. Dr. White is still
exploring whether the hospital is suitable.
The other applicant is Dr. Alexander Sun who has developed a therapeutic
"soup" - Sun Soup -- made with Chinese herbs. He is applying
for a Small
Technology Transfer Research grant from NIH.
Dr. White also reported on the Physician Data Query (PDQ) CAM summaries
available through the NCI cancer information toll free number (1-800-4CANCER)
and Web site (http://cancernet.nci.nih.gov).
The newest summary is on laetrile. Dr. White presented a list of other
topics planned for summaries in the future.
Dr. Moss said he had seen the laetrile summary and felt it was seriously
flawed because it was one-sided. He fears such summaries could widen the
gulf
between the conventional and alternative medicine communities. He suggested
NCI
submit such reports in the future for prior review by CAPCAM.
Dr. White said the PDQ process is independent of NCI. He discussed the
issue of
prior CAPCAM review with the producers of the PDQ. Dr. White suggested
a CAPCAM
subcommittee review the laetrile summary before the next CAPCAM meeting.
Hearing no opposition, the Chair, Dr. Hawkins, agreed to assign the review
to a
subcommittee. He said the group members should be furnished with both
the PDQ
summary and the literature referenced in it. After the material is circulated,
members can discuss those areas where they have differences of opinion.
Linda McClure, who manages the PDQ office, said she hopes to produce
new
summaries every month. Topics selected are based in part on the volume
of
inquiries received by the Cancer Information Service. Then her office
looks at
whether any data exist. Dr. Gordon said he'd like to recommend additional
topics such as antioxidants and melatonin.
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IX. Mind-Body Medicine and Cancer
Dr. Spiegel explained that a number of underlying processes affect patients'
emotional and medical outcomes. Mind-body techniques can affect those
outcomes.
Some of the techniques in which NCCAM is interested include: hypnosis,
acupuncture, massage, psychotherapy, support groups, guided imagery, yoga,
and
relaxation techniques. There have been some exciting findings, such as
a study
indicating that psoriasis patients who meditate do better than those who
do
not. Research dollars to study the effectiveness of alternative therapies
is
growing but still far below the amount allocated to conventional medicine
treatments. Many patients spend more out-of-pocket on alternative medicine
because such treatments aren't covered by their health insurance; some
patients
spend more on alternatives than on primary care. This demonstrates that
patients are motivated to find solutions, but there is concern that they
might
be steered away from helpful, proven therapies. We need to know what they
are
spending money on and what works.
Pain relief is the main reason people seek CAM treatments; as a rule,
they do
not seek CAM treatments for the initial diagnosis but instead seek help
for
chronic problems that regular medicine does not manage well. Cancer patients
not
only suffer physical problems but also psychological and financial. The
rate of
major depression is 3 to 4 percent of the general population, but is found
in
one out of nine medical inpatients. Among the terminally ill, more than
20
percent suffer from depression, and 60 percent of those seeking assisted
suicide
are depressed. Yet depression is often ignored. At different stages of
cancer
care, patients' psychological problems are different. The initial diagnosis
leads to an existential crisis and life change. Acute treatment disrupts
their
lives on various levels: family, social, and vocational, among others.
At the
end of acute treatment, patients may feel vulnerable because they are
no longer
in contact with their medical team. A relapse often means a truncated
future, a
loss of important life roles, and difficult treatment decisions. Failure
to
address these adjustment problems is costly to the patient and society.
Dr. Spiegel said that studies show patients' coping styles affect their
medical
outcomes. Mortality is higher for those who are socially isolated. In
addition,
men do better when they are married, women when they have women friends.
This
may indicate a need to build an alternative support network in some cases.
These support groups have been highly successful; often, participants
want to
continue meeting after the group has served its function. Feelings of
helplessness and hopelessness shorten survival time. More research is
needed on
interventions to provide emotional and social supports.
Dr. Spiegel has conducted randomized studies of support groups. At Stanford,
his support groups are designed to build bonds to prevent feelings of
isolation
and help patients express emotions, deal with death, communicate with
their
doctors, and control their pain through methods such as self-hypnosis.
Patients make downward comparisons with those who are worse off, which
is not
demoralizing; it helps them to see someone worse off. Physicians can help
by
communicating with plain language, having the family present for important
discussions, and having the patient write down questions. It also helps
to aid
the patient in identifying choice points, and encouraging patient participation
in selection of treatment alternatives and the exploration of treatment
that
complements traditional care. Doctors should make direct eye contact,
acknowledge distress, express concern, and avoid interruptions. The medical
profession needs to factor in care as well as cure.
Dr. Spiegel reported on a study of metastatic breast cancer patients
treated at
Stanford. They were found to suffer many symptoms of post-traumatic stress,
which were reduced in group therapy. The study found that not only did
patients
assigned to group therapy report a higher quality of life (such as less
pain)
than did those who weren't in a group, they also lived, on average, 18
months
longer than non-group therapy patients. This was true even of anxious
and
depressed patients in the therapy group. There also are data indicating
that
women in intervention groups have increased contact with others beyond
the
group, while those not participating in groups decrease their contacts.
The
preliminary conclusion is that the group leads patients to make better
use of
outside contacts. Dr. Spiegel noted that more studies are needed to determine
whether mind-body medicine not only helps people cope but also improves
their
survival. There have been five other randomized studies that looked at
the
effects of psycho-social intervention on survival. Three showed no effect
but
two found a positive effect from psycho-social interventions. The three
showing no effect on survival also failed to find psycho-social benefits,
leading him to question the effectiveness of the group therapy the patients
in
the study received. He also noted that one of those major studies included
only patients whose cancer was already far advanced.
Dr. Spiegel noted limitations of the randomized trial method but acknowledged
the need to conduct this type of research if it is to be accepted by
mainstream medicine. One problem is the difficulty in recruiting patients
for control groups because most want to be in the intervention group.
He also
noted the difficulty of getting men to participate in group therapy. However,
once men enter groups, they do very well. Their tendency is to create
informal
groups rather than participate in organized support groups.
Dr. Spiegel then reported on his research showing support can act as
a stress
buffer. He explained that the brain regulates the body's systems so they
adjust
to stress. But repeated stress causes the brain to lose it's ability to
regulate
stress response. His study measured cortisol steroid levels in women with
metastatic breast cancer. By looking at salivary cortisol levels, researchers
found that patients with cortisol fluctuations had shorter survival times.
Patients who feel their support is good and have more cohesive family
environments have lower cortisol levels. Suppression of emotions can cause
higher levels of the hormone. Other research, in which patients' bodies
are
exposed to a series of antigens injected under the skin, shows people
with
higher cortisol levels have reduced autoimmune function. More study is
needed
to explore which physiological systems affect adjustment and progression
of
disease.
In summary, Dr. Spiegel said randomized trials involving larger numbers
of
patients and at multiple sites will be needed to convince mainstream medicine
of the effectiveness of group therapy and other psycho-social interventions.
Dr. Hawkins asked how the quality of therapy groups can be controlled.
Dr.
Spiegel said he has a training program for group leaders and he evaluates
videos of the groups. To gauge results, he administers a standard
questionnaire that is widely used to measure moods. Dr. Hufford said the
quality of psychological support must be considered if doctors decide
group
therapy should be part of the standard of care. Dr. Spiegel said he is
examining the elements of Stanford's model that seem most effective, noting
that his is only one model. Other models might be more effective in other
situations. He warned that bad groups are those that promise too much
and
delivery too little. Dr. Spiegel is particularly concerned with those
groups
where patients are told they can "cure" their cancer by visualizing
white
cells eating up cancer cells. Patients can feel guilty or think they failed
when they are unable to stem the progress of their disease. His model
focuses
not on cures but on living better. He suggested future medical studies
should
examine how patients respond to a treatment psychologically as well as
medically.
Dr. Spiegel said it will be one to two years before his latest research
on
cortisol levels is completed. Meanwhile, his new book, "Group Therapy
for
Cancer Patients," has just been published by Basic Books. He believes
more
surgeons would send patients to groups if insurers would cover the cost.
Dr.
Kail said NIH and NCI need to give a stamp of approval to group therapy
before insurance companies will consider covering the costs. It was
suggested that a consensus conference, like the one that endorsed
acupuncture for treating nausea, is needed.
The committee adjourned for lunch at 1 p.m. and reconvened at approximately
2
p.m.
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X. Initial Efforts to Develop National
Clinical Trials on CAM within the Radiation Therapy Oncology Group (RTOG)
Dr. Berk reported on NCI-funded CAM clinical trials to be conducted through
RTOG academic centers and community programs. Dr. Berk noted the difficulty
of
defining CAM therapies when selecting which trials to fund. His group
is
looking at therapies that are considered nonstandard practices or fall
within
NCCAM definitions. Any therapy chosen must fit with what RTOG already
is doing
(i.e., already accessible patient population), must use well-defined agents,
and must have a reasonable probability of success and acceptance. The
therapy
must also fit into a randomized, placebo-control trial model.
One proposal is to study melatonin as a treatment for brain metastasises
to see
if the deterioration of patients' mental status can be slowed. Another
proposed study would look at a treatment for cancer-induced cachexia,
in which
patients lose muscle due to an inability to eat. The condition affects
a
majority of advanced cancer patients, and present interventions are inadequate.
Juven, a metabolite of an amino acid that prevents the breakdown of muscle
mass,
aids in regeneration, and has shown excellent preliminary results in AIDS
patients, would be tested. The study would examine quality of life and
muscle
mass/weight gain. A third study would look at whether ginseng can relieve
cancer-induced fatigue, especially common in lung, breast, or brain cancer.
This is the most speculative study because there are no basic or clinical
studies or strong scientific indication that ginseng works. Proposals
will be
presented in January to the CCOP (community clinical oncology program).
Dr. Berk explained that all the proposals involve trials of dietary supplements
because they are easier to study and are more readily accepted by RTOG,
a
mainstream group, than other types of complementary treatments. Dr. Nahin
asked
how easy it would be for CAPCAM to fit a study into RTOG's system. Dr.
Berk
responded that a proposal carrying CAPCAM's approval would be more likely
to
get through the RTOG review process. Dr. Straus said that using established
trial groups such as RTOG could offer a good chance for success because
they
are a ready-made vehicle for testing. The downside, however, is that a
proposal
would have to fit the established group's rules (such as RTOG's preference
for
testing only dietary supplements).
Dr. Kail pointed out the difficulty in having CAM study protocols designed
by
RTOG, which has no CAM practitioners. It would help if there were a national
clinical trials group for CAM studies that could coordinate trials conducted
by national groups such as RTOG. Dr. Gordon said CAPCAM needs to address
methodologies and encourage more complex studies rather than a single
method.
He proposed looking at Chinese data on herbs, for example. Dr. Wood stressed
that any research methodology should consider whether the trial can be
standardized. Dr. Kail pointed to the difficulty of randomized trials
because
patients often won't participate if they think they'll be put into a control
group rather than the CAM treatment. CAM researchers may have to resort
to
matched cohort studies that compare patients treated with alternative
therapies
and those who didn't pursue alternative treatments.
Dr. Hammer noted that when the RTOG had choice points, they seemed to
go with
the more conservative approach. Dr. Berk explained that he came to the
meeting
hoping for ideas on how to stretch the field in the future; later, he
took
advice from the panel on dosages for the ginseng.
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XI. CAPCAM Options
Dr. Nahin presented a flow chart showing a decision tree outlining CAPCAM's
options in deciding whether to pursue a study of a CAM therapy. This decision
tree covers 80 percent of the mechanisms available. The squares symbolize
CAPCAM, and triangles are endpoints. Circled letters L and M illustrate
processes. There are three basic types of recommendation: recommended,
not
recommended, and requires additional information.
Projects come to this decision tree via investigators or practitioners.
Part
of the mission of CAPCAM is to identify these practitioners and encourage
their participation in the CAPCAM process.
Discussion returned to the issue of methodology. Dr. Nahin brought up
the
possibility of a methodology subcommittee or subgroup that could e-mail
each
other and also have face-to-face meetings outside of the regular CAPCAM
meetings. Members decided that at the next meeting, CAPCAM should discuss
methodology. Dr. Gordon proposed appointing a subcommittee to draft general
guidelines for clinical methodology and circulate them before the June
meeting. The motion was approved, and Dr. Hawkins appointed Drs. Hufford,
Gordon, Kail, Hammer, Moss, and Coulter to the subcommittee.
Dr. Hammer asked about the difference between regular members and voting
members
of CAPCAM. Dr. Nahin explained that CAPCAM's charter stipulated that it
have a
certain number of members representative of certain groups, but that the
staff
added some ad hoc members because it wanted additional expertise. Some
ad hoc
members could become permanent members when there are openings. He stressed
that
ad hoc status does not diminish the value of each member's contribution
to CAPCAM.
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XII. Public Comment
Mr. Angelo P. John presented a description of his work of many years
involving
controlled amino acid therapy as a dietary approach to complement chemotherapy
in
treating inoperable tumors. A paper detailing the work was made available.
The meeting adjourned at 5:15 p.m.
Certification: We hereby certify that, to the best of our knowledge,
the foregoing
minutes are accurate and complete.
* Members absent themselves from the meeting when CAPCAM discusses projects
from
their own institutions or when a conflict of interest might occur
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