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*Ad Hoc members
The National Advisory Council for Complementary and Alternative Medicine (NACCAM) convened at 8:30 a.m. on January 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: presentations by Dr. Stephen Straus, director of the National Center for Complementary and Alternative Medicine (NCCAM), Dr. Sharon Hrynkow, deputy director of the Fogarty International Center, and Dr. Joana Rosario of NCCAM; presentation of two concepts and an update on two new initiatives; a public comment session; an opportunity for Council-initiated discussion; and a closed session at the end of the day. A vote was taken to approve the minutes of the previous Council meeting; approval was unanimous. Dr. Kinsel confirmed future meeting dates; the next meeting will be held on May 28, 2002.
Dr. Kinsel reviewed the general rules under which Council must operate. The general public may attend the open session; as required by law, there was an opportunity for public comment. The closed session 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).
Dr. Stephen Straus welcomed two ad hoc members, Drs. Berman and Timmerman. The Secretary of Health and Human Services (DHHS) has lifted the freeze on hires, including NIH advisory council memberships, but the new NCCAM council slate has not yet been approved. Therefore, NCCAM has been relying on ad hoc members. Dr. Straus thanked Drs. Rhoades and Lawrence for staying on past their previous appointments. He acknowledged that Dr. William Fair died recently; Dr. Fair had been involved with complementary and alternative medicine (CAM) for many years as both an articulate advocate and a patient and had served as a member of NCCAM's Cancer Advisory Panel on Complementary and Alternative Medicine.
Dr. Straus discussed the state of the Center, summarizing the prior year's activities and presenting a look to the year ahead. He began his presentation by identifying the four key areas in the NCCAM strategic plan: investing in research, training CAM investigators, expanding outreach, and facilitating integration. Investing in research includes several goals:
In FY 2001, NCCAM research accomplishments included presentation of eight approved concepts, announcement of 10 active initiatives, co-funding with the National Cancer Institute (NCI) of five new cancer centers, funding of eight SBIR grants, 24 R01s, and 56 R21s, and the establishment of NCCAM's intramural program at NIH.
In the cancer area, NCCAM has tripled its investments since 1999. This does not include general approaches that might also apply to cancer, but only those projects that are specific to cancer. Dr. Straus highlighted several examples. The Johns Hopkins Center has four cancer-related studies in progress. Another center, at the University of Colorado, is co-funded with the NCI and has three projects under way.
Much of the portfolio consists of R21s, which are developmental research grants. In addition, NCCAM has a growing number of large multi-center phase III trials. The first, on St. John's wort for major depression, is completed and has been submitted for publication. Four more are in progress, one has been awarded, another is to be awarded soon, and yet another has been announced. The trials in progress include shark cartilage for lung cancer, ginkgo biloba for the prevention of dementia, acupuncture for osteoarthritis pain, and glucosamine/chondroitin for osteoarthritis. Applications submitted in response to a Request for Applications (RFA) on chelation therapy would be reviewed by Council during the afternoon closed session.
The St. John's wort study is one of a number of studies that NCCAM supports; a large, multi-center, phase III trial will commence soon to study the substance in treatment of minor depression (as opposed to major depression). Cranberry for urinary tract infections will eventually be studied in a large multi-center trial. In the interim, NCCAM has released a request for proposals (RFP) to develop high-quality materials suitable for large trials.
The November 2000 placebo workshop recommendations are now moving forward. Two initiatives have been issued. These have the purpose of elucidating the nature and mechanisms underlying placebo effects, identifying and exploiting adjunct effects, studying the ethical context of clinical trials of placebo, and developing new methods for study design.
Since 1999, NCCAM has used virtually all NIH mechanisms to support training and education. The Center is funding pre- and post-doc fellowships (F and T grants) and junior faculty (K01, K02, K08, K23), midcareer (K24), and senior faculty (K05) projects. In research training, NCCAM had seven RFAs and program announcements. The Center funded a range of trainees in 2001.
In terms of expanding outreach and integration activities, NCCAM staff members have given over 100 lectures; written articles, book chapters, etc.; co-funded conferences; and developed dozens of fact sheets on CAM. NCCAM's Web site also won an award from Yahoo! as the best alternative health Web site in 2001 and 2002.
The Center has also been active in the area of facilitating integration. NCCAM has funded eight studies looking at integration, awarded five grants to integrate CAM into medical/nursing school curriculum, and co-funded and co-hosted a number of conferences. The Center also established an Integrative Medicine Task Force in the NIH Clinical Center.
Organizational developments for 2001-2002 include the creation of the Office of Science Policy and Operations, headed by Dr. Kinsel. NCCAM recruited Ms. Chris Thomsen to head the Office of Communications and Public Liaison. Mr. Steve Casady will direct the Budget Office. Dr. Blackman has almost finished recruiting staff for the intramural program. There are additional efforts to streamline and improve. NCCAM created an independent Office of Scientific Review, and is close to recruitment of a Director of Clinical and Regulatory Affairs. The Center recently appointed Dr. Richard Nahin to be Senior Advisor for Scientific Coordination and Outreach. In this capacity, he will work with other NIH institutes and centers to leverage intellectual and financial resources. NCCAM has initiated a search for a Deputy Director who will also head the Division of Extramural Research and Training.
Dr. Straus reviewed the Center's appropriations history. The budget for NIH has increased from $8.9 billion in FY 1992, to $23.4 billion in FY 2002. NCCAM's predecessor, the Office of Alternative Medicine (OAM), had an FY 1992 budget of $2 million; in FY 2002, NCCAM's budget is $104.6 million. The money has been allocated largely to clinical research (62%), the centers, and basic science; to the extent possible, the Center has tried to reflect NIH areas of emphasis, and leveraged investments through collaborations with other NIH Institutes and Centers. NCCAM has entered into co-funding arrangements with 24 other centers and institutes. For all of NIH, CAM research has grown from $116 million in FY 1999, to nearly a quarter of a billion dollars, $222 million, in FY 2002. There has been steady growth in CAM research funding by all other institutes. NCCAM stimulates and augments their interests, rather than replacing them.
Research project grants at NCCAM now account for about 43 percent of the budget, with centers at an additional 20 percent. Investigator training and curriculum and career awards have grown, contracts are steady, and intramural research is growing but is considerably smaller than that of other NIH ICs. In the area of research funding, the number of applications has gone up markedly, as the percentage of successful applications has taken a corresponding downward turn. The number of new awards seems to be leveling off after a spike in 2001. The score distribution of applications in 2001 was heaviest from 201 to 300; applications are getting better, so funding decisions are becoming more difficult.
NCCAM has a new opportunity to fund the repayment of outstanding debt for young trainees in CAM. This program promotes the recruitment and retention of people who might otherwise not be able to go into the field. Previously, these repayment programs have been targeted to specific areas in the intramural program. There are no new dollars for this important program, but NCCAM intends to participate. The Council will consider the first such applications in May and provide a secondary review on applications. Dr. Straus would like to give the award to one or two trainees this year. The program forgives up to $50,000 per year for one or two years.
The NIH budget for FY 2003 will likely increase, but there will be differences from prior years. Biodefense against terrorism research will be emphasized, as will cancer. NCCAM will make efforts to participate in NIH approaches to biodefense.
In the question and answer session following his presentation, Dr. Straus said that the public has a right to know how their dollars are spent. NIH has legal requirements to report performance under the Government Performance and Results Act of 1993, and provisions have been beefed up on how this is done. However, it is not yet clear how NCCAM's existence has affected the public. The Center's Web site and the information clearinghouse are reliable resources for the public to find information, and plans are under way to make the content more accessible. The Center has also provided tools for experts in their own communities to improve dialogue and promote integration.
In response to another question, Dr. Straus observed that the proportion of funds dedicated to multi-year commitments differs from that of most other institutes. The more-established institutes have had very stable funding, which allows them the ability to predict what they can do, even with the recent budget increases. NCCAM has more short-term studies, resulting in greater turnover, while receiving less dramatic budget increases. Therefore, NCCAM must make adjustments to the number of studies funded. In terms of prevention and wellness studies, which have longer time lines, these tend to be expensive. NCCAM has managed to leverage this so far. As the NCCAM portfolio matures, the average cost of awards is increasing. Moving from phase II to phase III trials will also raise costs. Clinical research costs more than laboratory research, and CAM research is concerned with clinical use.
In further discussion, Dr. Straus noted that the frontier medicine applications had been set aside on recommendation from the Council at the May 2001 meeting. There will be further review in April. Council will discuss the applications in May. In terms of sharing costs, he reminded the Council that there is much collaboration. NCCAM staff have access to proposals from other institutes, and vice versa. In his new position, Dr. Nahin will focus on negotiating and promoting joint research. NCCAM's large trials are increasingly co-funded by other ICs. On another issue, Dr. Straus said that accountability is important. NCCAM is just starting to do cogent evaluation. The Center tracks publications that acknowledge NCCAM funding of projects, and Ms. Jennifer Sutton was recently hired to do program evaluation. She will conduct an assessment of the NCCAM centers program, followed by an assessment of the training program. There will also be benchmarks developed. Dr. Straus plans to bring this information to the Council.
Dr. Straus introduced Dr. Sharon Hrynkow, deputy director of NIH's Fogarty International Center. The Fogarty Center was established at NIH in 1968 to support and promote international research and training. To qualify for NIH funding, foreign scientists must demonstrate expertise and access to equipment, resources, and populations not available in the United States. The number of direct foreign research awards has increased since 1999. Since 1996, foreign components to domestic grants have increased, showing more collaboration with foreign partners. At the same time, foreign investigators are competing for NIH awards more successfully. Canada and the United Kingdom have had the most success, but some developing-countries are doing well, including China, India, Uganda, Brazil, Mexico, and others. Five years ago, few developing countries were on the funding list.
The benefits of funding international research include adding to the scientific knowledge base, developing low-cost interventions, and building capacity for future collaborations and partnerships. Developing country scientists are receiving more emphasis, because they have much of the burden of disease and other health challenges. Their work is predominantly through partnerships. One goal at Fogarty is to build research capacity in the developing world, so that their scientists can become equal partners with U.S. colleagues, and to support cross-cutting research not conducted by other NIH components on global health issues. The portfolio is large and growing. There are now 25 programs devoted to global health challenges.
The AIDS International Training and Research Program (AITRP) supports research capacity building while advancing specific international research projects. It will bring foreign scientists to the point where they can successfully compete for awards at NIH and can affect policy in their own countries. A U.S. academic institution will collaborate on a research project that also has a training component, with all the practical work done in the other country. The program has had enormous impact. In Uganda, for example, one-third of the leadership positions in the Ministry of Health were trained in this program. The successful nevirapine study was conducted in Uganda by Fogarty trainees with support from the National Institute of Allergy and Infectious Diseases (NIAID), and has global applications.
The AITRP illustrates Fogarty's core values: long-term commitment, responsive to local needs, mentoring, networking, flexibility, leveraging, individual and institutional partnerships, and mutual reinforcement of investments in training and research. Fogarty partners extensively across NIH and has developed other programs based on the AIDS program model. One of these, the International Cooperative Biodiversity Group (ICBG) program shares many features of the AIDS program. The biodiversity program goals are to discover natural products for pharmacological and agricultural development, while considering the needs of country; promoting scientific and economic development; providing training, along with technological and infrastructure enhancement that will enable sustainable use; and promoting conservation of biological diversity. These are large awards, about $500,000 per year for five years. There are also very elaborate agreements in place about royalties from resulting drugs, to ensure that local communities receive the appropriate benefits.
The ICBG has had numerous accomplishments. They have been a model in biodiversity studies and benefits-sharing situations. Lessons learned are numerous, and include the need for long-term partnerships to achieve progress in this area. At the beginning of the discussion session, Dr. Timmerman commended the Fogarty Center for its efforts to promote research. The Center supports not only basic research for drug discovery but also training and career development. As a PI supported by Fogarty for nine years, Dr. Timmerman has seen numerous young scientists in her program receive training. The Center allows multi-disciplinary work in the training program, producing good cross-fertilization. Students are sent all over world to do biomedical research. In answer to a question about intellectual rights in drug discovery, Dr. Hrynkow explained that benefit-sharing is key; the pertinent questions are how to accomplish this, and who speaks for the community. Each country looks at the issue differently, based on local culture, traditions, and needs. In addition, informed consent varies from country to country. One Council member noted that companies from other countries sometimes find it hard to win NIH awards. Dr. Hrynkow noted that Fogarty staff want to talk to investigators so they can provide links to the appropriate resources. Dr. Straus added that much of CAM reflects respect of traditions. NCCAM is not involved in traditional drug testing, but instead is concerned with testing the natural products people are using in their own environments elsewhere, without breaking substances down to single components. Ethnobotanicals are a growing area of interest in the ICBG program. Dr. Timmerman added that the Chilean government is interested in quality control of phytomedicines. Another element in the growing interest in phytomedicines is that it is an important primary care resource in the developing world, and is one of the best linkages between conservation and development.
Dr. Joana Rosario presented NCCAM's 5-year strategic plan for international health research, Expanding Global Horizons of Health Care. This is a dynamic document that NCCAM will adjust when necessary. Americans are increasingly receptive to CAM practices that originate elsewhere and are standard practice there. The challenge is to study CAM in the native environment with native practitioners. Some U.S. minorities use the original or adapt native practices.
NCCAM will explore CAM practices in the context of rigorous science, educating and training CAM researchers and disseminating authoritative information to the public and professionals. The vision of the International Health Research Office is to advance research to yield insights and tools derived from CAM to benefit the health and well-being of the public, while enabling the public to reject ineffective or unsafe practices. The Office has a number of goals and objectives.
The first goal is to foster international research. Related objectives include encouraging the development of international sites of CAM research excellence through U.S.-foreign partnerships, sponsorship of CAM-related research with other agencies in areas of the world that possess unique CAM resources, promotion of studies of whole systems of CAM in their countries of origin, and facilitation of productive partnerships through programs focused on bioethical concerns and intellectual property rights.
The next goal, to promote international research training, will be met through facilitating the acquisition of research skills by foreign investigators through formal training; sponsorship of workshops at international sites, with emphasis on training in research methodology and grant-writing; work with new and existing NIH research training award programs and supplements tailored to international researchers; support of NIH-wide efforts to improve the quality of international ethics training and the training of individuals to assume leadership in this area; and partnership with the World Health Organization (WHO) to support extramural CAM research for international scientists in the United States.
The third goal is to expand outreach and dissemination of international research information. This can be achieved through presence at international meetings; development and distribution of culturally sensitive information; creation of a user-friendly international health homepage on the NCCAM Web site; and collaboration with other NIH components, the WHO, and other relevant organizations involved in communication and outreach in the international area.
The final goal, to facilitate integration using global methods, involves encouraging integration of CAM teaching into domestic medical schools through international faculty exchanges; promotion of international meetings and workshops involving both CAM and conventional practitioners; and identification of barriers to the integration of safe and effective CAM practices.
Dr. Straus explained that a subgroup of the Council looked at earlier iterations of the plan; he asked the entire Council to study it and provide further input. NCCAM will post the plan on its Web site for public comment. Dr. Rosario has been assembling an operational plan for each of the four key areas. A number of Council members expressed support for the plan. It was noted that there are many studies of traditional Asian healing approaches funded by NCCAM, but approaches developed in Latin America, Africa, and the Indian subcontinent do not receive appropriate attention; it would be good to see some of their systems on the NCCAM agenda.
Ms. Linda Engel, NCCAM, provided a summary of two initiatives on which NCCAM is collaborating with other NIH institutes.
The first is an RFA on alternative therapies for benign prostate hyperplasia. The RFA is co-sponsored with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Office of Dietary Supplements (ODS). The purpose of the RFA is to establish a research consortium to conduct a randomized controlled clinical trial of Serenoa repens (saw palmetto) and Pygeum africanum in men with benign prostatic hyperplasia (BPH). The objective is to determine if saw palmetto and Pygeum africanum prevent the clinical progression of BPH. The total commitment in Fiscal Year (FY) 2002 is approximately $2 million in total costs; NCCAM's contribution will be $500,000. The RFA will use the cooperative clinical research (U01) agreement award mechanism. Dr. Neal West, NCCAM, is the Program Officer.
Ms. Marguerite Evans, NCCAM, is the lead on an RFA dealing with SAM-e (S-Adenosyl-Methionine) and liver disease. Co-sponsors are the National Institute on Alcohol Abuse and Alcoholism (NIAAA), NIDDK, and ODS. The purpose of this RFA is to invite applications for grants proposing innovative basic and preclinical research to understand how SAMe may be effective in the treatment of liver disease caused by alcohol and other factors such as hepatitis C virus (HCV). The co-sponsors have committed a total of $1.5 million in FY 2002 to fund about 6 to 10 new and/or competitive continuation grants. NCCAM committed $500,000 for FY 2002. This RFA will use the R01, R21, and R03 mechanisms. NCCAM does not support R03s but would convert such an application to an R21.
Dr. Nahin presented a concept on the topic of CAM Approaches to Diseases of Bioterrorism. The purpose of the initiative is to aid the nation's efforts against bioterrorism. NCCAM will support innovative research to test CAM approaches to treat and/or prevent diseases associated with biological warfare activities, to ameliorate the effects of conventional treatments, and to provide supportive care in the aftermath of attacks. Historically, there has been a low incidence in the United States of diseases associated with bioterrorism. Three scenarios exist at present: 1) no intervention is currently available; 2) limited quantities of interventions are available (i.e., smallpox vaccine); or 3) the available interventions carry a public perception of side effects and/or low compliance, as has been seen with the anthrax vaccine and the long-term antibiotics given to those who might have been exposed. Therefore, many people turn to alternative interventions that have little supporting data or possibly toxic effects. Some CAM interventions, such as immune enhancers, could be useful now. These might reduce doses and side effects of conventional medications, or treat associated problems, such as the pox lesions from smallpox. CAM interventions may be able to reset homeostasis by reducing stress, anxiety, and/or depression. Finally, some treatments may ameliorate the side effects of treatments.
Therefore, this program will support basic and early phase clinical research on CAM approaches for treating and/or preventing infectious diseases that might be employed by terrorists, as well as those that might ameliorate the psychological and physical effects of bioterrorism. Examples of approaches that could fall within NCCAM's purview include:
The funding mechanism will be R21s for up to two years, and R01s for up to four years. NCCAM is pursing partnership with the National Institute of Allergy and Infectious Diseases (NIAID), the lead NIH Institute on biodefense. Dr. Straus noted that the funding would come from the money allocated to NIH for biodefense in FY 2003.
Council approved the concept.
Dr. Morgan Jackson presented a concept on CAM Therapy in the Treatment of HIV/AIDS. The initiative will support research to identify potential roles for the use of CAM in the treatment of HIV/AIDS and its complications, or to ameliorate medication side effects. NCCAM intends to fund research projects including in vitro, animal model, and phase I/II studies investigating the range of CAM modalities with the potential to contribute to the treatment of HIV/AIDS. Surveys indicate that HIV-infected persons use CAM at rates higher than the general population. CAM modalities might have various roles in treating patients with HIV/AIDS: enhancing energy and productivity, improving quality of life and well-being, or treating pain and other symptoms. Reports in the literature also suggest the possibility of additional roles in treating HIV infection: as antiretrovirals, as immunomodulators, and to lessen side effects of pharmaceutical medications.
NCCAM currently funds studies on a range of CAM interventions for HIV-infection, including projects investigating botanical-drug combinations, studies researching immunomodulatory effects (dehydroepiandrosterone--DHEA; alpha lipoic acid), grants to evaluate CAM treatments for side effects (acupuncture and moxibustion for chronic diarrhea; garlic for hyperlipidemia), as well as projects on spirituality, stress management, and distance healing. Additional studies are needed to identify the range of CAM therapies that may provide benefit in treating HIV. While ineffective CAM therapies cannot be advocated in place of demonstrably effective pharmaceutical therapy, there are circumstances where the use of CAM therapies merits consideration. For example, recent changes in recommendations have resulted in later initiation of highly active antiretroviral therapy (HAART). Studies may investigate ethically the use of CAM to reduce viral load earlier in the course of infection and potentially delay progression of HIV infection prior to the time conventional treatment is recommended. Also, data indicate that the proportion of resistant virus is increasing. Although more new medications are being developed and introduced, individuals with resistant virus may be candidates for complementary, non-pharmaceutical treatment. With the increased life expectancy afforded by HAART, individuals are on antiretroviral medications for longer periods of time, increasing the risk of side effects. While the discovery of potent and effective CAM antiretroviral treatments may not be highly likely, some agents might be sufficiently active for use by individuals who cannot tolerate or do not accept conventional drugs. Moreover, they may be adequate to enhance antiviral responses when combined with conventional therapy, thereby decreasing required doses of pharmaceuticals, potentially lessening medication side effects and improving patient compliance. Finally, the identification of useful CAM antiretrovirals might serve to promote their further development and chemical refinement by other organizations.
The objectives of this initiative are: 1) to identify potential roles for CAM therapies in treating HIV/AIDS and its complications, or to ameliorate medication side effects; 2) to establish possible synergistic combinations of CAM and conventional treatments for HIV; and 3) to understand mechanisms of action of CAM therapies that have the potential for contributing to the treatment of HIV/AIDS. The funding mechanisms would include R21s for two years and R01s for up to five years. NCCAM is pursing collaboration with NIAID.
Dr. Straus observed that in a strategic context, the HIV portfolio is only 3 percent of NCCAM funding, but it should be higher since HIV patients use a lot of CAM. Council approved the concept.
A public comment period was held, as required by law. There were no participants.
Time was set aside for discussion of topics that Council members wished to introduce. Dr. Kail raised the issue of oxygen therapies beyond hyperbaric treatments. These are becoming popular, especially for the treatment of viral diseases and chronic conditions. Some involve intravenous procedures and therefore might merit investigation. The people with the greatest expertise have trained in Germany, and while a few are now based in the United States, the focus is still in Germany. Most of the work has been with clinical applications of the therapies. Practitioners have equipment to measure ozone in a specific dose. There have been some strokes as a side effect of peroxide drips, so there are safety issues to consider.
Col. Williams introduced two areas of concern in the lay community. First, people are looking at early diagnostics and challenging whether they do any good. Physicians are detecting diseases but not treating them successfully, so the argument is that the screening is a problem. Also, NCCAM does long-term clinical trials, which take a long time. He wondered if the clinical trial series is in fact the best way to get to the end of the problem. They are expensive, and most fail after a lot of money is spent on them. There is a great deal of difficulty going from the bench to the clinic. He wondered if CAM might have a solution, since CAM practitioners are people who might be able to look outside the box on this. In response, Dr. Straus observed that many diagnostic techniques in the CAM field have not been carefully scrutinized, and therefore no one knows if they are reliable techniques. Dr. Grimm addressed the clinical trials question, saying that most major advances in medicine are due to clinical trials; before that, medical practice relied more on decisions, which were often wrong. Trials are expensive, but they establish a foundation for basic researchers to go in new directions as needed.
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 3:00 p.m. A total of 115 applications were assigned to NCCAM. Of these, 78 were reviewed by NCCAM, and 37 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 81 applications requesting $68,434,035 in total costs.
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