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*Ad Hoc members
The National Advisory Council for Complementary and Alternative Medicine (NACCAM) convened at 8:30 a.m. on May 28, 2002, at the NIH Neuroscience Conference Center in Rockville, Maryland. Dr. Jane Kinsel, Executive Secretary, called the meeting to order and reviewed the agenda. A vote was taken to approve the minutes of the previous meeting; approval was unanimous. Dr. Kinsel added that, prior to the closed session in the afternoon, the meeting would be open to the public.
Dr. Stephen E. Straus, Director of NCCAM, welcomed and introduced the new Council members: Drs. Zang-Hee Cho, Kristina M. Collins, Murray Goldstein, Michael Irwin, and Benjamin Chi-Koo Yang. Dr. Barbara Timmerman, who was absent, would also be joining the Council. For the present Council meeting, the new members retained ad hoc status, until the final paperwork has been processed. Departing Council members included Dr. Michael Cantwell, Dr. Richard Grimm, Ms. Diana Manley, Dr. Karen Olness, and Dr. Herbert Pardes. Drs. Grimm, Cantwell, and Pardes had agreed to serve until the next slate of candidates is approved. In addition, several ad hoc members attended this meeting to provide subject matter expertise: Drs. Jonathan Davidson, Chung Hsu, Kuo-Hsiung Lee, Paul Lietman, and Michael Sporn (via speakerphone).
In February, President Bush released his Fiscal Year 2003 budget, which included $27.3 billion for NIH, and $113.8 million for NCCAM. This funding represents an increase of 8.4 percent over 2002 for NCCAM. Dr. Straus testified before House and Senate committees in March (nccam.nih.gov/about/congressional). On April 9, he also testified at a special House Labor, DHHS appropriations subcommittee hearing on research collaboration, at which he discussed how science has become a multi-disciplinary enterprise. In additional news from Capitol Hill, in early May, the U.S. Senate unanimously confirmed Dr. Elias Zerhouni as NIH Director. Dr. Straus briefed Dr. Zerhouni on his first day in the position and was impressed by his warmth and the speed with which he has begun to master the myriad NIH issues.
On May 4, Dr. Straus participated in two public health forums in Wisconsin, sponsored by Congressman David Obey (D-WI) and Congressman Ralph Regula (R-OH), entitled "Bench to Bedside and Beyond--How Research Is Changing the Public's Health." He provided health care professionals and members of the public with information about NIH and research advances, activities, and resources.
In March, NCCAM held its third annual town meeting in Portland, Oregon, in conjunction with two NCCAM-supported research centers: The Oregon Health Sciences University and Kaiser Permanente's Center for Health Research. With over 700 attendees, the meeting was broadcast on Portland cable television and covered by the local press. Also in March, the White House Commission on Complementary and Alternative Medicine Policy issued its final report. The Secretary of Health and Human Services (DHHS) is studying the Commission's recommendations (www.whccamp.hhs.gov/finalreport.html). The Commission advocated continued funding for basic and clinical CAM research.
NCCAM has begun an assessment of the research centers program, in the context of the overall research and research-training portfolio. Plans are underway to convene a panel of experts on June 18 to review the role of centers in NCCAM's research portfolio and to discuss future directions. The panel will recommend a range of options for NCCAM, which Dr. Straus plans to bring to the next Council meeting.
The Institute of Medicine is planning to conduct a study exploring the scientific and policy implications of CAM. The study will provide an overview of CAM use by the public, identify major scientific and policy issues, and develop a framework to guide decision-making on these issues. NCCAM, a major sponsor of the study, is being joined by 18 other NIH Institutes, Centers, Offices, and sister agencies who have committed approximately half a million dollars to the study. Once the details are finalized, the study will take about 21 months.
As the Council liaison to the Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM), Dr. Konrad Kail reported on the February 25 CAPCAM meeting that focused on two topics. First was an update on the Best Case Series (BCS) contract with the RAND Corp. RAND has completed chart reviews at two CAM cancer practices and is currently accumulating supporting pathology and radiology data. Once complete cases are identified, they will be presented to the Office of Cancer Complementary and Alternative Medicine (OCCAM) at the National Cancer Institute (NCI) for review and, if acceptable, to CAPCAM for review and discussion. Discussion at the CAPCAM meeting led to a recommendation that NIH should direct and/or solicit prospective research activities on CAM and cancer, since the retrospective approach to evaluating cases often elicits cases that lack sufficient information and adequate documentation. Dr. Jeff White, Director of OCCAM, stated that the BCS is a complex process, and he believes that CAPCAM needs to be aggressive in pursuing BCS.
The second topic was a retrospective evaluation program on macrobiotics presented by the Kushi Foundation. Dr. White added that the case series was intriguing and warranted follow-up. CAPCAM recommended that a prospective study was the next research step and interested investigators should apply for funding through traditional NIH peer-reviewed channels.
Dr. Straus noted that a large number of claims are made for positive clinical outcomes with CAM cancer therapies. However, practitioners need to document the cancer diagnosis and response to the therapy in question. The Council commended Dr. White for his efforts to collect valid case reports.
Dr. Straus next gave an update on the situation with PC SPES, the herbal mixture that is sold as a dietary supplement and marketed for "prostate health." In February 2002, the U.S. Food and Drug Administration (FDA) issued a warning that consumers should stop taking PC SPES because it contains undeclared prescription drug ingredients that could cause serious health effects if not taken under medical supervision. Shortly thereafter, BotanicLab, the California-based manufacturer of the product, voluntarily recalled PC SPES nationwide and subsequently officially closed June 1, 2002.
NCCAM has funded four research studies of PC SPES to evaluate effectiveness and mechanisms of action. Because the product that was used by the public is no longer available, the issues of whether and how to study the product are relevant. There is no guarantee that a newly formulated version would be identical to the product previously used by the public or tested in NCCAM-funded research. Dr. Straus asked Council to advise NCCAM in resolving this complex issue.
Col. Williams stated that many prostate cancer patients were disturbed by the announcement that the product was no longer available since few options exist and PC SPES seemed to be helping many of the men. He suggested that the research be continued because he believes that something in the product was effective.
In response to a suggestion that NCCAM meet with the FDA to discuss the possibility of a compassionate response scenario, Dr. Straus stated that he was unsure if the FDA would allow compassionate use of an adulterated product.
There was further discussion about the possibility of obtaining the herbs and reconstituting PC SPES. It was unclear whether the company that made PC SPES would share the ratio and extraction information.
Dr. Kaptchuk noted that product contamination is likely to occur for other herbal products because quality control in Asia is variable. However, other companies could reformulate an uncontaminated version of the PC SPES herbal mixture. Therefore, he suggested that research continue in this area.
There was discussion that other companies are marketing "PC SPES"-like products, using a similar formula and clean herbs; however, these knock-off products will require further characterization and pre-clinical study to justify clinical study. The issue of contamination of herbs from China is troubling but may lead to greater review of herbal products by the FDA.
In another line of discussion, Council addressed the need for safety criteria as well as education of clinical trial participants about the limitations of knowledge in this area. Although public use is one criteria used by NCCAM to justify an evaluation, public use does not imply safety or efficacy. Therefore, it was recommended that any intervention supported by NCCAM must have as much supporting documentation on safety and efficacy as possible to justify NCCAM support.
Issues of liability and reproducibility were also raised. It was suggested that NCCAM insist on ingredient standards to ensure both the conduct of rigorous research and the safety of study participants. Dr. Straus assured the Council that NCCAM would study these issues carefully, inform Council of a plan within 2 weeks, and present a recommendation at the August Council meeting.
Ms. Chris Thomsen, Director of NCCAM's Office of Communications and Public Liaison (OCPL), reported on key communications activities. OCPL's mission is to provide information, offer education, and conduct communication activities for NCCAM. OCPL's vision is to support the work of NCCAM by establishing NCCAM as the recognized leader in CAM research and information, by educating the public and practitioners, and by promoting informed consumerism. The 2002 plan involves development of the communications program, audit of materials for content, enhancement of public response programs, and incorporation of new technology through an improved Web site.
The recent focus has been on the Web site. Information in the digital age replaces many other modes of communication. There are more than 2.5 million health-related Web sites and consumers account for 86 percent of the visitors, but less than half of all doctors use the Internet for health information. A study by the Pew Internet and American Life Project found that 73 million Americans are using the Internet for health information, at a rate of 6 million per day. Seventy-two percent of the women on the Internet are seeking health information, as are 51 percent of men. Of those in the United States seeking health information from the Internet, 71 percent are between 50 and 64. These figures mirror the demographics of those who contact the health-related call centers that NIH sponsors. When they find information, 68 percent of these people use it for health decision, but only 37 percent take it to their doctors. Forty-eight percent are seeking CAM information, and two-thirds of this group have existing chronic health conditions.
These data present challenges. Not all Web sites have the same quality of data. Users want Web information of personal relevance that is tailored and interactive. They seek multiple sources, usually investigating up to five sites to seek confirmation of what they have found. For example, Yahoo brings up 120,000 sites on St. John's wort, and Google has 306,000 sites on kava kava. Many of these search engines charge Web sites to pull up their sites first. In addition, there are hidden tags that allow commercial sites to come up before government sites do. This created a need to educate consumers on evaluating Web sites.
OCPL wants to make NCCAM's site a trusted, accurate, and credible source of information by meeting users where they want to get information and increasing access to as many users as possible while protecting their privacy. The previous Web site won awards. In an effort to continuously improve the site, OCPL added content and improved the architecture. Before the redesign, 76 percent of those tested found information on the Web site. By organizing according to topic, reworking long pages, improving the search engine, and using clear language, NCCAM now has an 86 percent success rate. The site has new sections on training, information, and clinical trials, along with added accessibility features.
The main topics are now on the home page to find at a glance. A health information page is a portal for government information on CAM. Treatment information is searchable by condition or by therapy. The research page discusses plans, current projects, past projects, opportunities available, and how to apply for a grant. The clinical trials page has a section educating consumers on what these are, a searchable section on what NCCAM funds by treatment or condition, and links to other NIH studies. There is also an option to search an alphabetized list of clinical trials. Ms. Thomsen thanked those who worked on the redesign.
Dr. Jonathan Davidson, professor of psychiatry and director of the Anxiety and Traumatic Stress Program at Duke University Medical Center, presented the results of a clinical trial of St. John's wort (hypericum). The purpose of the trial was to study the efficacy and safety of a standardized extract of St. John's wort in treating patients with major depression. The trial, jointly funded by NCCAM, the National Institute of Mental Health (NIMH), and the Office of Dietary Supplements (ODS), was launched in response to the growing use of St. John's wort in the United States and a need for more definitive data on its use for depression.
Dr. Davidson served as the principal investigator for the study, which involved 12 sites with experienced investigators across the United States. Training took place at Columbia University; reports were submitted to and reviewed by the Data Safety and Monitoring Board (DSMB) three times each year. The study compared St. John's wort, a placebo, and sertraline (Zoloft) in a randomized, double-blind, 8-week trial that had an 18-week continuation option. The dose of sertraline used in the trial was comparable to that used in clinical practice.
Inclusion criteria for entry into the trial were a diagnosis of a major depressive disorder, minimum age of 18, and a Hamilton Depression (HAM-D) score of moderate depression. Excluded were patients who were proven non-responders to treatment, suicide risks, pregnant women, significant laboratory abnormalities, substance abuse, and serious medical illnesses. Two primary outcomes were measured: improvement in the HAM-D score and complete response to treatment. The results showed no statistically significant difference among the three arms of the study.
Dr. Kail questioned the quality and standardization of the St. John's wort product used. Dr. Davidson said that a single batch of St. John's wort was used in the study and was standardized to contain between 0.12 and 0.28 percent hypericin, which is thought to be one of the primary active ingredients. This level is comparable to what is sold on the market.
In response to a query about the use of St. John's wort to treat other forms of depression, Dr. Straus commented that NCCAM is co-funding with NIMH and ODS a study of the safety and efficacy of St. John's wort for the treament of minor depression.
Several Council members noted that, while it is good to have an office of international health research in NCCAM, collaborations with other countries should be pursued carefully. It was argued that the commitment and interest of the recipient organization or institution is a critical issue. Dr. Rosario stated that grant applications require proof that investigators are backed by their institutions.
Dr. Straus said that the OIHR vision is modest. He also commented that the WHO report, to which NCCAM contributed, supports the need for highly standardized products.
Dr. Morgan Jackson, Director, Office of Special Populations, NCCAM, presented NCCAM's strategic plan to address racial and ethnic health disparities. The DHHS Initiative to Eliminate Racial and Ethnic Disparities in Health identified six areas: infant mortality, cancer, cardiovascular disease, diabetes, HIV/AIDS, and immunizations. The NCCAM Strategic Plan to Address Racial and Ethnic Health Disparities (REHD) addresses these areas of concern (nccam.nih.gov/about/plans/healthdisparities).
The research goal is to advance the understanding of the development and progression of diseases and disabilities that contribute to minority health and other health disparities. In this context, NCCAM will work to determine the safety and efficacy of CAM treatments. NCCAM has a number of initiatives that are planned or in progress to support research and research training. Another area of focus is community outreach: NCCAM's Office of Communications and Public Liaison will work with community organizations to disseminate research findings and CAM information.
Dr. Goldstein suggested that NIH tends to support programs that deal with "the easy problems"; a greater challenge goes beyond prevention of disease to maintaining the health of populations. Dr. Straus said that NCCAM would welcome Council suggestions on a model for studying this.
Ms. Leila Seldanha, Vice President, Nutritional Sciences, Consumer Healthcare Products Association (CHPA), raised the issue of greater industry participation in NCCAM programs. CHPA supports NCCAM's emphasis on clinical research and believes that the American people need information based on scientific evidence in order to make informed health care choices. CHPA members can bring unique expertise to the study of CAM products. With 200 members in health care manufacturing, distribution, supply, research, and advertising, CHPA represents extensive experience in designing and implementing trials to support the efficacy and safety of products. Yet industry is not as active a participant in the research process as CHPA believes it could or should be. Industry members can bring pragmatic expertise, serve on external review panels, comment on study design, and facilitate identification and sourcing of clinical supplies. NCCAM supports important research in the field of CAM, which would be enhanced by industry involvement. Ms. Saldanha also mentioned that programs exist to assess the safety of supplements. The Institute of Medicine is completing a project to develop a framework for assessing the safety of dietary supplements, and the Office of Dietary Supplements (ODS) has funding for reference materials. Dr. Straus thanked Ms. Saldanha and added that NCCAM is open to working with industry, including considering nominations for review panels and Council.
Dr. Kail raised the issue of standardizing botanical products to ensure that certain levels of active constituents are present. Dr. Straus said that this is an important issue for Initial Rreview Group and Council members to keep in mind. Dr. Lee asked if NCCAM has a mechanism to establish a national center for quality control. Such a center could then produce certified, standardized products for clinical trials. NCCAM requires evidence of high quality research materials, which has delayed the start of some studies. NCCAM supports projects to develop standardized products for selected botanicals, for example for cranberry, milk thistle, and valerian. The standardization effort is costly and requires the participation and commitment of industry sponsors.
On the issue of training, Dr. Goldstein said that one of best places for training is in a research center and suggested that a training element be included in the centers as an integrated program. Dr. Straus explained that the existing centers do include training. The centers' review panel will discuss the scope of responsibilities for the centers program as it moves forward. Dr. Leitman suggested that NCCAM emphasize the training of individuals to conduct rigorous clinical research in CAM. Dr. Meeker added that training efforts should focus on CAM institutions. While the average CAM practitioner will not be a productive researcher, good research can be and is conducted at CAM institutions. Dr. Straus noted that Council would hear about an initiative on CAM research education at a future Council meeting.
Dr. Goldstein said that many aspects of research should be conducted in community-based rather than academic settings. He suggested that NCCAM address the issue of how to provide clinicians with the fundamental body of knowledge necessary to facilitate participation in the research environment. Dr. Straus replied that this is a difficult question. NIH has attempted to address the issue by supporting a number of community-based cooperative trial groups; NCCAM is cosponsoring, with the National Cancer Institute, a shark cartilage study through one of these.
Dr. Straus concluded the discussion by commenting that Council helps NCCAM set priorities and maintain a balance among all the competing priorities within the resources allocated.
The remainder of the meeting was closed to the public in accordance with the provisions set forth in Section 552b(c)(4) and 552b(c)(6), Title 5, U.S.C. and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
The closed session began at 2:20 p.m. A total of 210 applications were assigned to NCCAM. Of these, 163 were reviewed by NCCAM, and 47 were reviewed by the Center for Scientific Review. Applications that were noncompetitive, unscored, or were not recommended for further consideration by the initial review groups were not considered by Council. Council reviewed and concurred with 163 applications requesting $36,035,281 in total costs.
There being no further business, the meeting was adjourned at 5:30 p.m.
We hereby certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.
Jane F. Kinsel, Ph.D.
Executive Secretary
National Advisory Council for Complementary and Alternative Medicine
Stephen E. Straus, M.D.
Chair
National Advisory Council for Complementary
and Alternative Medicine
Resize text: SML This page last modified December 01, 2008.
Department of Health and Human Services
National Institutes of Health (NIH)
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