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New Studies May Boost Credibility of ProductsBy: Lisa M. Krieger Many hope to cement place for botanicals in treating patients There is something new and exciting in the growing field of alternative medicine: credibility. Prestigious doctors at 15 major medical centers are launching large studies to determine, once and for all, the safety and efficacy of controversial botanicals and supplements such as ginkgo, glucosamine, Saint-John's-wort and saw palmetto. Bankrolled by the federal government, these studies may put to rest centuries-old claims that such agents can boost memory, alleviate depression, soothe symptoms of arthritis and treat a multitude of other ailments. Or, if the agents prove effective, these studies could accelerate the adoption of such products in mainstream medical practices. ``Our future depends on a rich pipeline of original, high quality research,'' said Dr. Stephen E. Straus, first director of the new National Center for Complementary and Alternative Medicine at the National Institutes of Health in Bethesda, Md. ``We need to fill this pipeline with better information than is in it today,'' said Straus, speaking in San Francisco last Thursday at the International Scientific Conference for Complementary, Alternative and Integrative Medical Therapies, which was co-sponsored by the University of California-San Francisco and Harvard University. ``This is not a hobby. This is not a garage-based business. This is serious stuff with major research implications,'' Straus told the crowd of 400 medical practitioners from 17 nations. Historically, the field of alternative medicine has relied on anecdotal evidence and aggressive advertising to promote its products. There have been few reliable ways to tell if many products meet high standards of quality and consistency. Nor have there been any uniform guidelines for how to use them. A reason for more research There is growing interest in complementary and alternative medicine -- and some preliminary evidence that alternative medicines may play a role in improved public health. Approximately 42 percent of U.S. health care consumers spent $27 billion on ``complementary and alternative medicine'' therapies in 1997, the most recent year for which data is available. Alternative medicine enjoys particular popularity among baby boomers. A number of practices, once considered unorthodox, have proved to be safe and effective and have been seamlessly assimilated into traditional medical practices. For instance, diet and exercise now are commonly used to prevent and control disease. Acupuncture is routinely applied to manage the chronic pain and nausea associated with chemotherapy. And some of our most important drugs -- digitalis for heart disease, vincristine for AIDS-related cancers and other malignancies, and taxol for cancer of the ovaries, breast and certain types of lung cancer -- are of botanical origin. To get a grip on this growing field, Congress created the National Center for Complementary and Alternative Medicine in February 1999. It is now one of 25 institutes that comprise the National Institutes of Health, the world's leading institution devoted to biomedical and behavioral research. Leading the center To run the center, the NIH tapped the formidable Dr. Straus, who previously served as chief of the Laboratory of Clinical Investigation in NIH's National Institute of Allergy and Infectious Diseases. A physician educated at the Massachusetts Institute of Technology and Columbia University, Straus brought to the job 23 years of experience in clinical research and scientific leadership. Complementary and alternative medicine practices have the potential to prevent and treat chronic disease, to improve understanding of how healing works and to be integrated into the routine practice of medicine, Straus said. But they first have to prove themselves worthy, he said. The field of alternative medicine has been ``advocacy-driven,'' he said, with minimal interest from credible academic institutions. For practitioners, there were few opportunities for funding and even fewer promotional career opportunities. None of the materials was standardized, a necessary step to assure doctors and patients of uniformity and consistency. ``There is a lack of scientific tradition in the field -- that is now changing,'' he said. ``Until recently, there were few competent investigators. ``We need biomarkers -- that is, objective measures of outcome -- rather than subjective evaluations. It is not sufficient to ask: `Do you feel better?' ``We need to understand how products act in the body. They may be natural but have unnatural consequences or interactions with other drugs. And we need to standardize products, so that everyone around the country knows what they're taking, and that they're taking the same thing.'' Finding answers The center now has abundant opportunities to answer these big questions. During the past three years, its budget has climbed from $49 million, in 1999, to $69 million in 2000 and $89 million in 2001. The number of research applications has increased also, jumping from 23 to 117 and then 212 in the past three years. Thus far, more than 400 applicants have arrived requesting funding for the year 2002 -- and many more are expected. ``This first meeting is very encouraging,'' Straus told the crowd. ``But there is a wide range of quality here. It needs to get better. And we need to entice more experienced researchers into the field. For many scientists, this remains a young and risky enterprise. ``We need to look to our colleagues in the field of conventional medicine,'' he said. ``We'll accept only the highest quality research. We'll apply the same study design and outcome measures as conventional medicine. We will not compromise. ``There is only one scientific method,'' he said. He also urged those in the alternative medicine industry to create and support their own scientific studies. Unlike conventional medicine, where pharmaceutical giants such as Pfizer or Merck underwrite large studies of their products, the hundreds of companies that produce alternative medicines have done little to study what they sell. ``There are truly interesting scientific studies to be done,'' he said. ``But this is the province of experts in the field, not amateurs.''
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