National Center for Complementary and Alternative Medicine (NCCAM)

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NCCAM, NCI, and Cancer Therapy

Statement by Stephen E. Straus, M.D. Director, National Center for Complementary and Alternative Medicine before the House Committee on Government Reform

June 7, 2000

Mr. Chairman and Members of the Committee:

I appreciate the opportunity to appear before you today to address the application of research on complementary and alternative medicine (CAM) to cancer therapy, and the ways that the National Center for Complementary and Alternative Medicine (NCCAM) collaborates with the National Cancer Institute (NCI) to advance our common desire to improve public health.

My presence here today, and NCCAM's very existence, reflects the growing public interest in CAM. By some estimates 42 percent of Americans spent $27 billion on CAM therapies in 1997. In recognition of this growing consumer trend, Congress in 1998 elevated the NIH Office of Alternative Medicine (OAM), expanded its mandate, created the NCCAM, and afforded it administrative authority to design and manage its own research portfolio. The Congress has continued to reflect the growing interest in CAM by further increasing funding for the Center in FY 2000 to $68.4 million. The President's FY 2001 budget requests $72.4 million for NCCAM. We are indeed appreciative of this support.

NCCAM's Broader Mission

As CAM use by the American people has steadily increased, many have asked whether reports of success with these treatments are scientifically valid. A number of practices, once considered unorthodox, have proven safe and effective and been assimilated seamlessly into current medical practice. Practices such as meditation and support groups are now widely accepted as important allies in our fight against disease and disability.

In the absence of definitive evidence of effectiveness, however, some practices may impart untoward consequences. It is critical that untested but widely used CAM treatments be rigorously evaluated for safety and efficacy. Promising new approaches worthy of more intensive study must be identified. In addition, I am energized by this opportunity to help provide the American public the guidance it seeks.

NCCAM's strategy for taking on this challenge is somewhat different from that used by other NIH Institutes and Centers (ICs). While the research of other ICs is usually driven by basic scientific discoveries, NCCAM has chosen to focus most heavily on designing and carrying out definitive clinical trials of widely utilized modalities that, from evidence-based reviews, appear to be the most promising. We are mindful of the responsibility to do so in a manner consistent with established ethical standards and Federal guidelines—so as to ensure patient safety and public confidence to the maximum possible extent.

Compelling and rigorous data and not just anecdotes must be provided to the public, and we must educate conventional medical practitioners about the panoply of effective CAM practices, so they can be integrated into medical practice, including cancer care.

NCCAM has developed a draft Strategic Plan—now available for public review and comment on our Web site at nccam.nih.gov/about/plans/—to ensure that our continued growth, development, and research directions are consistent with the challenges set before us. Five strategic areas have been identified: investing in research; training CAM investigators; expanding outreach; facilitating integration; and practicing responsible stewardship.

Concurrently, along with all other NIH ICs, we are developing a multifaceted effort to eliminate health disparities. Our health disparities plan will focus upon

  • identifying the extent and nature of CAM use among special populations;
  • studying therapeutic interventions to reduce disparities;
  • increasing participation of minority and underserved populations in NCCAM-supported clinical trials; and
  • enhancing the ability of minority institutions to support CAM research.

The NCCAM is pleased to have recruited Dr. Morgan Jackson, most recently the director of the Minority Health Program at the Agency for Health Care Research and Quality, to finalize and help implement the plan.

It is to these ends, and in light of the breadth of CAM, that we have established close liaisons with all other NIH components and Federal health agencies. Among these, our relationship with the NCI is paramount: my staff and I work closely and on an ongoing basis with the NCI. Early in my tenure as NCCAM Director, and a number of times since, I have met with Dr. Richard Klausner, NCI Director, to discuss prospective collaborations and matters of common interest. I also communicate frequently with Dr. Robert Wittes, who will testify here today. Moreover, our extramural program director and I meet monthly with Dr. Jeffrey White, who directs the NCI Office of Cancer Complementary and Alternative Medicine (OCCAM) and who is accompanying Dr. Wittes today.

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St. John's Wort—An Example of NCCAM's Opportunities and Challenges

Already, NCCAM has developed a diverse research portfolio in partnership with the other NIH Institutes and Centers. Among these are some of the largest, and certainly the most definitive Phase III clinical trials ever undertaken for a range of CAM therapies. Allow me to highlight one of these studies.

Extracts of St. John's wort, a flowering plant, have become quite popular as a treatment for depression. In fact, by some accounts, St. John's wort is the number-one-selling nutritional supplement. Because of this intense interest, NCCAM, the National Institute of Mental Health (NIMH), and the NIH Office of Dietary Supplements (ODS) are collaborating on a study of the safety and effectiveness of St. John's wort in treating depression.

A recent report in The British Medical Journal showed that St. John's wort is more effective than placebo in treatment of depression, and perhaps as effective as an older generation anti-depressant drug, imipramine. NCCAM's larger and longer-term study compares St. John's wort with placebo and with Zoloft, currently one of the most commonly used anti-depressants.

The potential benefit of St. John's wort, however, comes with previously understudied, and therefore unappreciated risks. An NIH study published February 12th in Lancet found that St. John's wort, when taken together with the important HIV protease-inhibiting drug indinavir, increased the rate at which indinavir was eliminated from the bloodstream, to the extent that blood levels fell below the desired level for effective AIDS treatment. More recent studies have suggested that St. John's wort has a similar effect on some types of birth control medication and on cyclosporin A, a drug used to prevent the rejection of transplanted organs. Other studies have shown that the use of St. John's wort may also increase an individual's sensitivity to exposure to the sun. These findings illustrate vividly both the promise and challenges presented by CAM therapies. Only through rigorous research on these CAM modalities will we be able to determine not only to what extent each is safe or effective, but under what circumstances an effective CAM modality may be contraindicated.

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CAM and Cancer

The prospective application of CAM modalities to treat cancer is a major interest of the American public, as reflected in the over 2,000 inquiries that the NCCAM Clearinghouse receives each month. The committee's consideration of the subject today is especially timely, for the NCCAM is pleased to sponsor—along with the NCI, the University of Texas-Houston, and Dr. James Gordon's Center for Mind-Body Medicine—the Comprehensive Cancer Care 2000 conference beginning this week in Arlington, VA. I appreciate and concur with the goals articulated by conference organizers: to bring together “those who are conducting the most innovative research on CAM therapies for cancer…with the most distinguished mainstream oncologists to evaluate promising therapies and how they can be successfully integrated into comprehensive cancer care.”

Simply put, CAM-Cancer research, and rigorous, scientific evaluation of CAM therapies for cancer, are among our highest priorities. With this in mind, we recently recruited Dr. Mary Ann Richardson to our extramural program staff. Dr. Richardson comes from the University of Texas—Houston School of Public Health and will direct our research portfolio and stimulate new initiatives in the area of oncology. She brings expertise and experience as director and principal investigator of our first exploratory research center focused solely on cancer and co-sponsored by NCI. In her new role in the NCCAM, Dr. Richardson is meeting today with NCI staff and the National Brain Cancer Foundation. I am confident that she will build upon her developmental and field work and extensive network of conventional and CAM practitioners to move the field forward on a national and international level.

In Fiscal Year 2000, the NCCAM plans to spend over $4 million in support of cancer research studies. This represents a three-fold increase in a single year. We expect to augment our support for cancer studies again in 2001. Against that backdrop, I would like next to acquaint the committee with our activities involving the integration of CAM and cancer in particular. The portfolio, directed at CAM therapies appropriate to the treatment of cancer as well as its complications, encompasses both the study of cancer interventions and palliative care.

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Specialty and Botanical Centers

Specialty Research Centers form an historical foundation for conducting CAM research through the NIH, and provide the setting for ongoing collaborative research. In this regard, our Centers assemble critical masses of basic and clinical scientists to conduct clinical studies into CAM approaches for a variety of health conditions. They also encourage CAM practitioners and researchers to conduct relevant joint research projects. Each focuses on one of several areas, including pediatrics, addiction, cardiovascular disease (CVD), minority aging and CVD, aging, neurological disorders, craniofacial health, arthritis, and chiropractic medicine. Average funding for our new Centers exceeds $1 million annually for 5 years. In addition, NCCAM supports three Botanical Research Centers in collaboration with the ODS, the National Institute on Environmental Health Sciences (NIEHS), the National Institute on General Medical Sciences (NIGMS), and the Office of Research on Women's Health (ORWH).

Currently, NCI and ODS have joined NCCAM in a solicitation for a new Center to focus on cancer-related research issues. This Center will focus on basic and clinical studies; Phase I and II clinical trials of botanicals; drug-botanical interactions; unconventional nutritional approaches and dietary supplements that either augment conventional cancer therapies or diminish side effects; and studies of the potential effect of mind-body modalities (e.g., relaxation, imagery, meditation, psychosocial support groups, and the like). I am pleased to report the receipt of a substantial number of applications that will be reviewed this summer, and from which we expect to make as many as two awards.

Various substances present in natural products, including botanicals, have been shown to inhibit cancer in animals. However, little information is available on what may account for their apparent anticarcinogenic effects. Even less is known about interactions among these substances and other dietary components. Research is also needed to provide better understanding of the potential impact of natural products on the treatment of precancerous conditions or early-stage cancerous lesions. Research that examines the potential use of such products for the treatment of conditions which may accompany or follow cancer (pain and loss of appetite, for instance) or side effects of conventional therapies (e.g. nausea, vomiting, and neuropathy) are obvious undertakings for new CAM Cancer Centers.

These Centers are only a part of our expanding research portfolio, which includes a rapidly increasing number of investigator-initiated grants, some of which I will briefly describe.

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Studies of Cancer among Specific Populations

The NCCAM is already supporting studies of CAM therapies for cancers which predominantly affect women. According to the CDC, 175,000 women will be diagnosed with breast cancer this year; some 40 percent will die of the disease. A University of Texas study, conducted in collaboration with the National Institute on Nursing Research (NINR), introduces strategies of self-transcendence among support group members to improve well-being and immune function and to increase understanding of the relationship between survival rates and support group participation. Also, the NCCAM-funded Center for Alternative Medicine and Women's Health at Columbia University is supporting trials that evaluate the use of Traditional Chinese Medicine to treat uterine fibroids and breast cancer. At the same time, the Columbia University group is conducting evidence-based reviews of the literature regarding CAM approaches to the prevention and treatment of breast cancer.

Our cancer research portfolio also includes

  • Studies of shark cartilage that are funded jointly by NCCAM and NCI. These include an ongoing Phase III clinical trial involving as many as 500 lung cancer patients in both the United States and Canada. A second trial will examine safety and efficacy of shark cartilage in patients with a variety of advanced cancers.
  • Investigations of cancer prevention and treatment strategies. Clinical trials at the University of Texas Center for Alternative Medicine Research are examining herbal, nutritional, mind-body, and biopharmacologic treatments for lymphoma, lung, and esophageal cancer.
  • Basic research studying the effects of magnetic fields on cancer cell growth.

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Controversial CAM Cancer Regimens

Many CAM approaches are controversial, particularly those used as strict alternatives to conventional regimens for treating life-threatening diseases such as cancer. Nonetheless, NCCAM will pursue rigorous investigations of any such therapy for which there is adequate preliminary data and a compelling public health need. Our commitment is illustrated by our support of a study of the therapy advocated by Dr. Nicholas Gonzalez, in which cancer patients are treated with dietary supplements including pancreatic enzymes, magnesium citrate, papaya plus, vitamins, minerals, trace elements, and animal glandular products, as well as with coffee enemas. There are very preliminary data suggesting the therapy might be effective in prolonging life-expectancy for those individuals suffering from cancer of the pancreas. Given that conventional regimens for pancreatic cancer only moderately prolong life, from a public health standpoint there is sufficient argument to evaluate the Gonzalez protocol in a rigorous scientific fashion. For this reason, the NCCAM and NCI are funding a substantive pilot trial in 90 patients with pancreatic cancer according to Dr. Gonzalez's protocol, at the Columbia-Presbyterian Cancer Center in New York City.

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Steps to Expedite Our Research

I am also pleased to report that our National Advisory Council on Complementary and Alternative Medicine (NACCAM) recently approved our proposal to provide supplementary funds to existing NCI Cancer Centers to initiate new CAM research studies. NCI staff are currently considering our offer. This program will encourage communication and collaboration between CAM practitioners and outstanding conventional cancer researchers. Emphasis will be placed, where possible, on the study of minority and under-served populations. Preliminary data from this research will serve as the basis for subsequent, more definitive clinical trials. To be sure, some of the CAM interventions now used to treat cancer will not be validated in those trials, and just as likely some will emerge as important, adjunctive and alternative therapies.

The NCCAM and NCI are also embarking jointly upon a creative, new research grant mechanism—Quick-Trials for Novel Cancer Therapies—designed to simplify the grant application process and provide a rapid turnaround from application to funding. Its features include accelerated peer review, with the goal of issuing new awards within 5 months of application receipt. Initially announced for a pilot program in prostate cancer, the Quick Trial mechanism provides rapid access to support for pilot, Phase I, and Phase II cancer clinical trials testing new agents, as well as patient monitoring and laboratory studies to ensure timely development of new treatments.

The NCCAM has also announced our intent to establish the Frontier Medicine Program. This initiative will promote collaborations between conventional and CAM institutions, practitioners, and researchers to study promising and widely used CAM practices—including cancer therapies—that appear to produce benefits but for which there is no plausible explanation or existing scientific support.

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CAPCAM

The federally-chartered Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM) frames NCCAM's cancer-related activities broadly—and our collaborations with the NCI in particular. Its membership includes CAM practitioners and health care professionals from conventional medicine. CAPCAM represents a unique approach to enabling identification of promising CAM cancer treatments for which scant scientific data are currently available. It is intended to help move into the research stream those practices worthy of scientific study.

CAPCAM advises the NCCAM Director on the assessment of present and future cancer clinical trials and medical interventions, potential research opportunities, and means of communicating research results to key constituencies. The panel affords CAM practitioners world wide the opportunity to submit retrospective analyses of data of patients treated with a specific modality in order to assess possible therapeutic benefit. This is formally known as the Best Case Series (BCS). The Panel will recommend selected BCS cancer treatments to the NCCAM for further study as appropriate.

The NCI developed the BCS Program in 1991 because most alternative treatments had not been formally evaluated in prospective studies. The CAPCAM process and its predecessor, the Cancer Advisory Panel (CAP), were an outgrowth of the Practice Outcomes Monitoring and Evaluation System (POMES), developed jointly by the former NIH Office of Alternative Medicine (OAM) and NCI. I have already met with the CAPCAM twice, and will next meet in September. Already its members have recommended additional study of a specific dietary supplement as a treatment for non-small cell lung cancer, and further exploration of homeopathic cancer treatments, provided by the PB Homeopathic Research Foundation, Calcutta, India. Moreover, the CAPCAM recently advertised widely in journals and targeted materials its desire to receive best case submissions. We anticipate two additional best case reviews for the next meeting of CAPCAM in September 2000.

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NCCAM's Palliative Care Research

Whether palliative care involves conventional or complementary approaches, its purpose is to add scientifically verified evidence to our base of knowledge about appropriate and compassionate health care. Many of our current studies truly represent palliative care research as they focus on increasing patient comfort, diminishing pain, and rendering disease symptoms less intense or severe. Although some studies do not expressly focus upon cancer patients, research results may be beneficial to them, or others who may be near the end of life.

Our palliative care projects include an examination of the benefits of hatha yoga on cognitive and behavioral changes associated with aging and neurological disorders; evaluation of the effects of acupuncture on persistent pain and inflammation; the aforementioned study of St. John's wort and its effects on major depression; and the effect of acupuncture and moxibustion (heat applied at the acupuncture point).

Palliative care for cancer patients will also be an obvious interest of our evolving NIH Intramural Research Program. The Director of our program will interact closely with the newly appointed director for palliative and pain care of the NIH Clinical Center, Dr. Ann Berger, who arrives this summer from the Fox Chase Cancer Center in Philadelphia.

I also want to briefly mention NCCAM's interest and support of the study of certain mind-body research modalities. Although CAM and mind-body medicine only partially overlap, NCCAM is pursuing investigations involving still undocumented CAM techniques; modalities for which there is little evidence in the conventional medical research community; and unorthodox uses for otherwise conventionally accepted mind-body techniques. In this context, the NCCAM looks forward to evaluating the effectiveness of selected mind-body approaches in cancer treatment. We currently support one such project—a study examining whether self-transcendence strategies affect immune function, well-being, and survival rates among breast cancer patients.

I note parenthetically that one key aspect of mind-body research involves studies of the “placebo effect.” In November, NCCAM, in collaboration with NIDDK, NCI, and other ICs, will convene a major trans-NIH conference on this subject. Goals of the conference include providing a scholarly assessment of the state of the field; identifying areas for which there is scant research, but considerable opportunity; and recommending a formal research agenda to move the field forward, in particular projects to be pursued by interested ICs through individual or joint initiatives with NCCAM. Elucidating the nature of the placebo effect will help us better harness the healing power of the mind.

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Integrative Medicine Research Training, and Communications

Medicine is an ever-evolving discipline. It integrates or rejects approaches based on scientific evidence. The results of rigorous research in CAM, including studies of its efficacy in treating cancer and the disease's many complications, will enhance the successful integration of safe and effective modalities into mainstream medical practice. We have initiated a series of specific activities to facilitate this. In particular, NCCAM recently solicited applications to incorporate CAM information, including that which relates to cancer care, into model curricula of medical and allied health schools and continuing medical education programs through Education Project grant awards.

Also, the NCCAM must educate eager students about CAM so that they may knowledgeably guide their future patients toward safe and effective CAM applications. In addition, we must work to overcome the reluctance of conventional physicians to consider validated CAM therapies and to assimilate proven ones into their practice. With this in mind, we established a Clinical Research Curriculum Award (CRCA) to attract talented individuals to CAM research and to provide them with the critical skills that are needed. NCCAM also plans to solicit applications for applied research on identifying barriers to the use of CAM modalities by conventional physicians, including oncologists; strategies to incorporate validated CAM interventions into standard medical practice; and evaluating the effects of this incorporation.

Integrative medicine (of which the field known as “integrative oncology” is a subset) is also a key aspect of NCCAM's planned Intramural Research Program and a component of NCCAM's Specialized Research Centers. Research training is conducted by these Centers, in part to advance our goals in integrative medicine, but also to assist us in building a cadre of skilled CAM investigators. Some of NCCAM's Centers spend as much as 10 percent of their budget on training.

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Public Outreach and Collaboration with NCI

Specific statutory authority enables NCCAM to reach out directly to the public and practitioners to provide them with critical and valid information regarding the safety and effectiveness of CAM therapies, including cancer. This information dissemination involves extensive and ongoing interaction with NCI.

A focal point for information about NCCAM programs and research findings is the NCCAM Information Clearinghouse, which develops and disseminates information that reflects the state of the science of various CAM modalities. To this end, NCCAM and NCI have undertaken a collaboration to develop—within the coming year—as many as 10 fact sheets that discuss CAM use as therapy for specific cancers.

Assembled by NCCAM from the National Library of Medicine's (NLM) MEDLINE database, the CAM Citation Index (CCI) affords the public access to approximately 175,000 bibliographic citations from the NLM Medline. The CCI is searchable by CAM system, disease, or method. For most types of cancer, the CCI contains many references to alternative medicine research published in the medical literature. {C}

In February 1999, NCCAM joined the federally supported Combined Health Information Database (CHID), which includes a variety of health information materials, including nearly 1,000 CAM citations not available elsewhere. The CAM subfile of CHID contains extensive information on therapies for cancer.

The NCCAM Information Clearinghouse receives more than 250 cancer-related inquiries from the public per month. The Clearinghouse identifies the NCI as the Federal Government's lead agency for cancer research and training, and routinely directs consumers and practitioners to the following NCI resources:

  • Information specific to CAM, including CAM clinical trials and studies, found in CancerNet on the NCI Web site at www.cancer.gov/cancertopics/treatment/cam
  • The information sheet “Complementary and Alternative Medicine: Treatment Options”
  • The NCI Web site: www.nci.nih.gov
  • The Cancer Information Service at 1-800-422-6237
  • NCI Public Inquiries Office
  • NCI Office of Cancer Complementary and Alternative Medicine (OCCAM)

The NCCAM Web site has already been linked to the new Cancer CAM Web site just launched by the OCCAM. It provides the NCI and NCCAM with an interface with the general public, and the health practitioner and research communities regarding CAM cancer issues. Among other things, the new NCI site states that it is “designed specifically for people with cancer and the people who care about them.” I applaud this valuable contribution by the NCI to enhancing public knowledge of CAM and cancer care.

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Conclusion

In closing, I would like to share with the Committee my vision of where I expect complementary and alternative medicine to be in the years to come. NCCAM's leadership will stimulate both the conventional and CAM communities to conduct compelling and open-minded scientific research. Several therapeutic and preventative modalities currently deemed elements of CAM will prove effective. Based on rigorous evidence, these interventions will be integrated into conventional medical education and practice, and the term “complementary and alternative medicine” will be superseded by the concept of “integrative medicine.” The field of integrative medicine will be seen as providing novel insights and tools for human health, and not as a source of tension that insinuates itself between and among practitioners of the healing arts and their patients. Modalities found to be unsafe or ineffective will be rejected readily by a well-informed public.

My vision is an optimistic one. However, I am confident that the NCCAM, building on a foundation of superb science and consumer service, and collaborating with such outstanding partners as the National Cancer Institute, will be a world leader—not only in complementary and alternative medicine as a whole, but in addressing the painful and tragic disease of cancer that touches the lives of every American family.

I will be pleased to answer any questions that you may have.

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