Critics object to 'pseudoscience' center

The impending national discussion about broadening access to health care, improving medical practice and saving money is giving a group of scientists an opening to make a once-unthinkable proposal: Shut down the National Center for Complementary and Alternative Medicine at the National Institutes of Health. The notion that the world's best-known medical research agency sponsors studies of homeopathy, acupuncture, therapeutic touch and herbal medicine has always rankled many scientists. That the idea for its creation 17 years ago came from a U.S. senator newly converted to alternative medicine's promise didn't help. Although NCCAM has a comparatively minuscule budget and although it is a "center" rather than an "institute," making it officially second-class in the NIH pantheon, the principle is what mattered. But as NIH's budget has flattened in recent years, better use for NCCAM's money has also become an issue. "With a new administration and President Obama's stated goal of moving science to the forefront, now is the time for scientists to start speaking up about issues that concern us," Steven Salzberg, a genome researcher and computational biologist at the University of Maryland, said last week. "One of our concerns is that NIH is funding pseudoscience." Salzberg suggested that NCCAM be defunded on an electronic bulletin board that the Obama transition team set up to solicit ideas after November's election. The proposal generated 218 comments, most of them in favor, before the bulletin board closed on Jan. 19. NCCAM has grown steadily since its founding in 1992, largely at the insistence of Sen. Tom Harkin (D-Iowa), as the Office of Alternative Medicine (OAM) with a budget of $2 million. In 1998, NIH director and Nobel laureate Harold Varmus pushed to have all alternative medicine research done through NIH's roughly two dozen institutes, with OAM coordinating, and in some cases paying for, the studies. Harkin parried with legislation that turned OAM into a higher-status "center" (although not a full-fledged "institute"), and boosted its budget from $20 million to $50 million. NCCAM's budget this year is about $122 million. Research in alternative medicine is done elsewhere at NIH, notably in the National Cancer Institute, whose Office of Cancer Complementary and Alternative Medicine also has a budget of $122 million. The entire NIH alternative medicine portfolio is about $300 million a year, out of a total budget of about $29 billion. (NIH will get an additional $10.4 billion in economic stimulus money over the next two years, of which $31 million is expected to go to NCCAM.) Critics of alternative medicine say the vast majority of studies of homeopathy, acupuncture, therapeutic touch and other treatments based on unconventional understandings of physiology and disease have shown little or no effect. Further, they argue that the field's more-plausible interventions -- such as diet, relaxation, yoga and botanical remedies -- can be studied just as well in other parts of NIH, where they would need to compete head-to-head with conventional research projects. The critics say that alternative medicine (also known as "complementary" and "integrative" medicine, and disparagingly labeled "woo" by opponents) doesn't need or deserve its own home at NIH. "What has happened is that the very fact NIH is supporting a study is used to market alternative medicine," said Steven Novella, a neurologist at Yale School of Medicine and editor of the Web site Science-Based Medicine (http://www.sciencebasedmedicine.org), where much of the anti-NCCAM discussion is taking place. "It is used to lend an appearance of legitimacy to treatments that are not legitimate." Beyond the Blogosphere So far, most of the debate has occurred in the blogosphere. But as health-care reform moves toward center stage, so may this fight. At a Senate committee hearing on integrative medicine held Feb. 26, Harkin said: "I want to lay down a . . . marker: If we fail to seize this unique opportunity to adopt a pragmatic, integrative approach to health care, then that, too, would constitute a serious failure." At the hearing, Harkin introduced Berkley W. Bedell, a six-term Democratic congressman from Iowa who retired in 1987 after contracting Lyme disease. Bedell credits alternative therapies for his recovery from that infection and later from prostate cancer. He helped convince the Iowa senator of alternative medicine's promise. Nevertheless, Harkin said he was somewhat disappointed in NCCAM's work. "One of the purposes when we drafted that legislation in 1992 . . . was to investigate and validate alternative approaches. Quite frankly, I must say it's fallen short," he told the committee. "I think quite frankly that in this center, and previously in the office before it, most of its focus has been on disproving things, rather than seeking out and proving things." Critics say this shows Harkin's lack of understanding of scientific inquiry, which tests hypotheses (with negative results as informative as positive ones) but doesn't intentionally attempt to "validate approaches." NCCAM's current director, Josephine P. Briggs, agrees that hypothesis-testing is the proper function of the center. "We are not advocates for these modalities," she said last week. "We are trying to bring rigor to their study and make sure the science is objective." Even so, Harkin was on to something: Most of NCCAM's results have been negative or inconclusive, not positive and encouraging. For example, a randomized controlled trial of the botanical echinacea published in 2003 found it was ineffective in treating upper respiratory infections (although it did cause more rashes). In a study from last year, neither the Japanese "palm healing" therapy known as reiki, nor sham reiki, reduced the symptoms of fibromyalgia, a chronic pain syndrome. A study in December comparing real and sham acupuncture in 162 cancer patients who'd undergone surgery found no difference in their levels of pain. At the same time, it's difficult to determine the clinical implications of some of the positive studies. For example, reiki -- but not sham treatment -- blunted the rise in heart rate, but not the rise in blood pressure, in rats put under stress by loud noise. Therapeutic touch, a different modality, increased the growth of normal bone cells in culture dishes, but decreased the growth of bone cancer cells. Many NCCAM-funded studies examine not the effectiveness of alternative medicine but its use, and how it affects the interaction of practitioners and patients. The idea that the center is spending lots of money running large clinical trials of such practices as homeopathy and ayurvedic medicine "is a misperception," the director said. She noted that most such proposals lack methodological rigor and aren't approved. A physician and kidney specialist who never used alternative medicine in her practice, Briggs said "mind-body management for pain control and stress reduction" is a large topic of the research at the moment, with mindfulness, meditation, yoga and tai chi all under study. "Some of the way these approaches work is through 'positive expectancy,' which is part of a placebo effect," she said. Indeed, many of NCCAM's critics view complementary medicine as nothing more than the placebo effect dressed up in a dozen different costumes. Carlo Calabrese, a researcher at the National College of Natural Medicine in Portland, Ore., one of the country's five naturopathic medical schools, isn't one of them. But even if one were to concede that view, he thinks the field is still worth studying. Although the overall effect of therapies such as homeopathy and acupuncture may be small, individual response can be large. The route to the placebo effect -- if that's what it mostly is -- also varies in method and efficiency. "What can be done to generate a better placebo? Why isn't that an interesting and valid area of investigation?" said Calabrese, who was on NCCAM's advisory council from 2004 to 2007. "Here we have a totally harmless intervention that seems to get a better result in some people than others. Why wouldn't you want to study that?"