Alternative Medicine Comes of Age

by Nicholas Gonzalez, M.D.

With permission from totalhealth Magazine, Volume 23, No. 1. For subscription information, call 1-888-316-6051.

The date of July 13, 2000 may very well go down in history as a turning point for the future of medicine and health care in the United States. On that typically hot, humid Washington D.C. day, President William Clinton appointed 13 members to the White House Commission on Complementary and Alternative Medicine. By that act President Clinton has formally and officially recognized at the highest levels of government the importance of non-traditional medicine in the lives of American citizens.

President Clinton created the Commission by direct executive order, with a two-year agenda to evaluate the changing presence and importance of complementary and alternative medicine (CAM) and to provide guidance and recommendations to governmental agencies for its orderly study and incorporation into mainstream medicine. The creation of the commission represents an extraordinary turning point in the history of alternative medicine in this country and is the result of unusual bipartisan support in Washington.

The roots of the commission really go back 10 years when a group of senators led by Tom Harkin, D-Iowa, first proposed the creation of an office at the National Institutes of Health to investigate and validate promising alternative therapies amidst much opposition from the government scientific bureaucracies. At the time, mainstream academic medicine, particularly at the federal level, perceived alternative medicine practices as at best "unscientific," and at worst, outright "quackery." But Senator Harkin was responding to his own successful use of alternative medicine for treatment of his resistant allergies as well as the growing demand by his constituents that the government begin evaluating alternative approaches fairly. Senator Harkin, as chair of the subcommittee that funds health research, convinced his colleagues to allocate $2 million to create the then Office of Alternative Medicine. In the context of a $20 billion federal medical research budget, two million might seem slight but it was a beginning. And indeed the original OAM was small, underfunded and under attack by many in mainstream medicine. From that humble start grew the now powerful National Center for Complementary and Alternative Medicine, an independent agency with an impressive $87 million budget and a directive to evaluate fairly and objectively the best of alternative medicine.

As the Office grew in stature, members of both Houses of Congress and members from both parties began to realize the growing importance of alternative medical practices. By 1997 it was estimated that over 40 million Americans used some form of alternative medicine and Americans made 629 million yearly visits to alternative practitioners, with a total expenditure of $27 billion, most not covered by insurance. Americans were taking alternative medicine seriously and Congress listened. Representative Dan Burton, a conservative Republican and chairman of the influential House Committee on Government Reform and Oversight, held a series of pivotal hearings that sought to bring alternative practitioners and government officials together. Senator Tom Harkin, a liberal Democrat, forcefully lobbied yearly to increase the funding and staff of the Office of Alternative Medicine until it achieved its current stature as an independent research center.

The various government agencies themselves began responding to the mushrooming popularity of alternative approaches by the American people. In October 1998 the National Cancer Institute established the Office of Cancer Complementary and Alternative Medicine within the NCI, headed by Jeffrey D. White, M.D., a career NCI research scientist and a strong advocate for fair investigation of promising alternative treatments.

Inevitably the growing interest in alternative practices would reach the presidential level. Senator Hillary Clinton particularly, with her great interest in health care issues in general, has long been an advocate of increased expenditure for CAM research. And President Clinton himself has argued for increased research support for non-traditional approaches.

Clearly, alternative medicine was an issue that crossed all boundaries, all socioeconomic and political divisions. Americans from all walks of life want alternative medicine and want it taken seriously.

All this reached an historic watershed when on March 8, 2000 President Clinton created the White House Commission on Complementary and Alternative Medicine Policy under the Federal Advisory Committee Act. This act allows the president to create commissions to advise on important public policy issues without the need to go through Congress and without the need to create new legislation. The commission was placed under the umbrella of the Department of Health and Human Services, which directly oversees all government research agencies such as the National Institutes of Health and the National Cancer Institute. But the commission from the outset was perceived as an independent working group that would answer directly to the president and provide advice on issues related to CAM practices. The commission is independent from the National Center for Complementary and Alternative Medicine, which is directly under the National Institutes of Health and serves primarily as a funding agency for CAM research. The commission will not provide funding but rather public policy suggestions.

The executive order outlines the specific function of the commission, and its impressive agenda:

"Sec. 2. Function. The Commission shall provide a report, through the Secretary (of Health and Human Services) to the President on legislative and administrative recommendations for assuring that public policy maximizes the benefits to Americans of complementary and alternative medicine. The recommendations shall address the following:

"a) the education and training of health care practitioners in complementary and alternative medicine;

"b) coordinated research to increase knowledge about complementary and alternative medicine practices and products;

"c) the provision to health care professionals of reliable and useful information about complementary and alternative medicine that can be made readily accessible and understandable to the general public; and

"d) guidance for appropriate access to and delivery of complementary and alternative medicine."

Importantly the order directs that the "heads of executive departments and agencies" work with the commission, and provide assistance as needed. Thus, the commission has access to the multitude of scientific agencies, government scientists and scientific resources in Washington.

Initially President Clinton suggested the commission consist of "not more than 15 members appointed by the president from knowledgeable representatives in health care practice and complementary and alternative medicine." This was subsequently amended to allow for 20 members, including a chair. The president did indeed select the commission members, who represent a variety of backgrounds and interests. The current 19 members include George M. Bernier, Jr., M.D., an oncologist and vice president for education at the University of Texas Medical Branch, Galveston; David Bresler, Ph.D., an acupuncturist; Thomas Chappell, Co-Founder of Tom's of Maine Inc.; Effie Yew Chow, a Ph.D. practitioner of Traditional Chinese Medicine and President of East West Academy of Healing Arts in San Francisco; Charlotte Kerr, an acupuncturist in Maryland; Linnea Signe Larson, associate director of the Center for Integrative Medicine in Oak Park, Illinois; Tieraona Low Dog, M.D., medical director for the Tree House Center of Integrative Medicine in Albuquerque, New Mexico; Dean Ornish, M.D., president, Preventive Medicine Research Institute in Sausalito, California; George DeVries, III, CEO, American Specialty Health Plans in San Diego; William Fair, M.D., formerly chairman, Department of Urology, Memorial Hospital, New York; Joseph Fins, M.D., director of medical ethics, Weill Medical College of Cornell University; Veronica Gutierrez, D.C., a chiropractor from Arlington, Washington State; Wayne B. Jonas, M.D., formerly director of the Office of Alternative Medicine of the NIH and currently in the Department of Family Medicine at the Uniformed Services University of the Health Sciences, Bethesda, Maryland; Conchita M. Paz, M.D. in family practice in Las Cruces, New Mexico; Buford L. Rolin, Poarch Band of Creek Indians in Atmore, Alabama; Julia Scott, president, National Black Women's Health Project, Washington, D.C.; Xiaoming Tian, M.D., Wildwood Acupuncture Center, Bethesda, Maryland; and Donald W. Warren, D.D.S., of Clinton, Arkansas.

President Clinton chose as chairman James S. Gordon, M.D., director of the Center for Mind-Body Medicine in Washington D.C., and previously chair of the Program Advisory Council at the Office of Alternative Medicine.

After several months of planning the commission officially got off the ground at the July 13th, 2000 ceremony, when the first 13 members of the commission took an oath of office. Donna Shalala, the Secretary of Health and Human Services, presided over the meeting. In addition to the Commission members, it included appearances and speeches by Senators Tom Harkin and Barbara Mikulski, who were instrumental, along with the president, in creating the commission. President Clinton's own statement clearly defined the purposes of the commission: "This commission, created by an executive order on March 8, 2000, is charged with developing a set of legislative and administrative recommendations to maximize the benefits of complementary and alternative medicine for the general public�

"If we are going to hold complementary and alternative therapies to an appropriate scientific standard of accountability, we need to invest in research so health care professionals and consumers can make informed judgements about the appropriate use of these services. In that vein, we have worked with Senator Harkin and a bipartisan coalition of members of Congress to establish the NIH Center for Complementary and Alternative Medicine to invest resources in scientific analysis to make such information available.

"But we need to do more. We need to be able to use information about alternative therapies to set the national agenda for the education and training of health care practitioners in this field and provide recommendations for advisable coverage policies for alternative therapies�"

Secretary Shalala, in her remarks, called for a national policy for alternative medicine and clearly revealed a new attitude among government scientific agencies. She said, "As the utilization of CAM interventions continues to increase, the need becomes more essential for administrative policies and legislative initiatives to address the integration of CAM services into the medical care system, provide for adequate reimbursement for CAM services, appropriate licensing, training and education of all providers of CAM interventions, and methods to provide readily accessible and easy to read information describing the benefits and shortcomings of these interventions to health care providers and the general public.

"The task of the commission is to provide recommendations to me that can be transmitted to the president for appropriate administrative and legislative initiatives to improve the health care and wellness of all segments of the United States population.

"By signing the Executive Order this year, the President lifted the issues related to Complementary and Alternative Medicine to the highest levels of government. As the head of the Department responsible for these activities, I intend to keep them there. The needs of all citizens must be a core mission of every Federal department and agency. I don't consider this simply an administrative obligation. This is a moral obligation to the public - and good government being responsive to the needs of its citizenry.

Senator Harkin gave a particularly impassioned speech outlining his own involvement in the creation of the Office of Alternative Medicine, his fight to increase its funding and his battle to have alternative medical practices considered seriously in Washington. He said, "Today is a great moment in history�" emphasizing the importance of the Commission, and its independence from agency politics: "And let me be clear," Senator Harkin stated, "this commission does not answer to NIH or anyone else. This is a White House commission formed to answer to the American people."

The Commission, funded in excess of $1 million, was given two years to investigate the status of CAM treatments in the country, and write a position paper for the president with legislative and administrative suggestions. The change of administrations, and of political parties, should make very little difference. Support for alternative medicine research strongly crosses party lines and both of President Bush's parents have used alternative medical practices.

Members of the commission, under Dr. Gordon's direction, got to work at once. They conceived a program of town meetings around the country, to give American citizens from all walks of life the opportunity to directly address the commission and express their wishes and needs regarding alternative medicine and health care. The commission held the first town meeting on September 8, 2000, in San Francisco. The meeting, attended by several hundred people, was a great success, generating much discussion and much enthusiasm. The second meeting, held in Seattle in late October, was equally successful and the next regional town meeting will be held January 23, 2001 in New York City.

In addition to these regional town meetings, the commission planned intensive, formal hearings in Washington D.C., at which officials from the various government agencies as well as alternative practitioners would be invited to discuss their perspectives, hopes for, and opinions about CAM. The first of these was a two-day event held October 5-6, 2000 at the Hubert H. Humphrey Building amidst the federal complex in D.C. The purpose of this particular hearing was succinctly outlined in the announcement of the event:

1. What can be done to expand the current research environment so that practices and interventions that lie outside conventional science are adequately and appropriately addressed?

2. What types of incentives are needed to stimulate the research of CAM practices and interventions by the public and private sectors?

3. How can we more effectively integrate the CAM and conventional research communities to stimulate and coordinate research?

This was truly a star studded hearing, bringing together influential representatives from major federal research agencies. Individual sessions were arranged by topics with each topic presented by one or more speakers. On Day One, at Session I, Dr. Leon Rosenberg, chair of the Institute of Medicine Committee on the NIH Priority-Setting Process, discussed changing attitudes toward CAM at high levels of the NIH. A particularly impressive session titled "Federal (NIH) Support for CAM Research," brought together Dr. Jeff White of the NCI, Dr. Claude Lenfant, director of the National Heart, Lung and Blood Institute, Dr. Marvin Cassman, director of the National Institute of General Medical Sciences, Dr. Steven Hausman, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases and Dr. Paul Coates, Office of the Director/Office of Dietary Supplements, the recently created agency given the task of formulating policy regarding nutritional and herbal supplements. All these influential speakers discussed their intention to support CAM research enthusiastically and scientifically, to help sort out what works from what does not. Dr. Stephen E. Straus, director of the National Center on Complementary and Alternative Medicine, gave a long and insightful presentation on his office's varied research projects. His talk was one of the highlights of the day.

The complex regulatory and legal issues surrounding CAM practices and CAM approaches were discussed extensively during several presentations on both days. At the session "Facilitating CAM Research and Regulatory Challenges," five officials from the Food and Drug Administration talked of FDA's changing approach to nutritional, herbal and alternative medicine. What became clear is that there is indeed a new attitude toward alternative medicine at the FDA and a willingness to support CAM research.

A particularly significant panel included a presentation by Dr. James Winn, rector of the Federation of State Medical Boards. Traditionally the state medical boards have been notoriously antagonistic toward most, if not all, forms of nutritional, herbal and alternative medicine, using loss of license as a very direct way to control CAM practices. But Dr. Winn spoke of his hope that controversial alternative practices, such as chelation -- which have led to many battles between alternative proponents and state boards -- be given a fair chance to prove themselves. He stated that he would not want any useful alternative therapy to be unfairly oppressed. If this proves true, this certainly represents a turning point in the attitudes of state medical boards.

I spoke myself, at the end of Day One, as part of a panel chosen to discuss "Outcomes Research: Interface Between CAM Research and Regulatory Agencies." I presented, along with Dr. White of the National Cancer Institute, Dr. Ann McCombs and Dr. Devi Nambudripad, who both use an acupuncture-based system for allergy treatment. Dr. Gordon had specifically asked me to highlight -within the framework of the allotted 10 minutes - a brief history of my own approach to the treatment of cancer with pancreatic enzymes, the roots of which go back 100 years. I was also asked to discuss the subtle and direct harassment I have endured in my attempts to have my work properly tested and my success in gaining research support.

After our panel presentation, the commissioners questioned us for over an hour, so interested were they in the political and legal problems faced by alternative practitioners who work outside the academic mainstream. For me it was an extraordinary experience to relate to a receptive audience the struggles I've faced to have my work tested and hopefully accepted by academic medicine. It was evident that commission members not only take their directive very seriously but that they are going to work hard to insure that future researchers, who may begin outside the mainstream, will have an easier time getting their work evaluated.

Some time after the October session I had the opportunity to sit down with Dr. Gordon, and discuss his plans and hopes for the Commission. He has impressive credentials: a graduate of Harvard College and Harvard Medical School, he completed a residency in psychiatry before moving to the National Institutes of Health as a research psychiatrist. There, over a 10-year period, he developed the first national program for runaway and homeless youth. He directed the Special Study on Alternative Services for President Carter's Commission on Mental Health. He is a clinical professor in psychiatry at the Georgetown University School of Medicine, served as first chair of the Program Advisory Council of the National Institutes of Health's Office of Alternative Medicine and currently is director of the Center for Mind-Body Medicine. He is the author of numerous books including Manifesto for a New Medicine, which greatly affected Senator Hillary Clinton's attitude toward alternative medicine, and his newest, Comprehensive Cancer Care.

Dr. Gordon was quite enthusiastic when he discussed the importance of the commission; he believes that the commission will have nothing less than a revolutionary effect on the future of medicine. He said, "I believe that the report we are going to provide the president in two years has the potential to be, for medicine in the 21st century, as important as the Flexner report was to medicine in the 20th century. The Flexner report was the result of a committee created at the beginning of the 20th century to develop policies and standards for medical education. The report of the Flexner commission had a profound effect in establishing standards for scientific medical education that helped bring American medicine into modern times. I believe our commission can have an equally significant effect in this century. I don't perceive our goal as limited to discussing research approaches to CAM practices; I see it far more expansive. I believe this commission has an opportunity to look at medicine and health care from a different perspective that can lead to a new model of medicine and even a new model of human biology.

"I believe we need to change our fundamental orientation from a too narrow focus on end stage disease management to keeping people healthy, whole and well. We need to change the distribution of resources from overwhelming emphasis on acute care at the end of the line to teaching people how to stay well. We need to begin with health care education in the schools, as early as possible.

"Alternative and complementary medicine has much to teach us and the rewards can be great on many levels. For example, recently Tiffany Field, Ph.D. completed a study on the use of massage with premature infants. Volunteers gave the infants in the neonatal ward 30 minutes of gentle massage daily. The end results from this simple alternative intervention were remarkable; babies treated with daily massage left the hospital significantly earlier, they needed less medical and high tech intervention, they were healthier, and in terms of the bottom line, the hospital saved an average of $10,000 per baby in medical costs.

"Similarly, patients who have been taught simple relaxation techniques prior to surgery have a much better outcome, with fewer complications and overall more rapid recovery. These are simple interventions that can help make surgery less difficult.

"We need a model of medicine that doesn't just look at the disease or just treat the immediate problem. We need a model of medicine that looks at the total person, his/her body, mind and spirit, nutrition, structure and psychology. And I am convinced, after 30 years of learning about, practicing and advocating such medicine, that this commission can be the vehicle to help transport medicine in that new, and I believe, better direction."

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