Finally, Science Weighs In
Dr. Stephen E. Straus has never tried acupuncture. He has never gone to a chiropractor, nor has he ever swallowed a Chinese herb. Millions of Americans have used complementary medical approaches, but Straus is not one of them.
Some might find this unusual, since it is Straus who leads the federal government’s research effort aimed at finding out what works and what doesn’t in this controversial medical field. Straus describes his abstinence as more the result of his robust physical condition than a product of his inherent scientific skepticism. “I have no symptoms,” he says. “I’m healthy.”
And he points out that his personal skepticism is an essential part of doing science. “Otherwise,” he says, “there wouldn’t be any point to studying things.” This has been the core of his approach to his job as director of the National Center for Complementary and Alternative Medicine (NCCAM), part of the National Institutes of Health. Many observers believe his perspective finally may bring credibility to the field and to a federal research effort that, by all accounts, got off to a rocky start when it began 10 years ago.
Alternative medicine--or “complementary” medicine--has been the subject of debate for many years. Although nontraditional therapies such as acupuncture and herbs have been embraced by consumers, many mainstream doctors continue to scorn them. To be sure, it is possible that many alternative therapies actually work, even if scientists don’t know exactly why. It is also possible that many do not work. And there is growing concern that some therapies may even be dangerous, especially nutritional supplements and herbs that remain largely unregulated for safety and effectiveness by the federal government.
But as these therapies gain acceptance with the public, more physicians, hospitals and medical schools have begun to embrace them in recent years. Acupuncture, chiropractic, biofeedback and herbal remedies, for example, are routinely used. Some health insurers cover them, though most don’t.
By all measures, alternative medicine stands on the cusp of respectability--as the mainstream medical world waits for the science to come in.
That’s where Straus’ center will play a crucial role. Its mandate is to oversee rigorous studies that will prove or disprove the worth of many of these alternative approaches. So far, the center has produced few significant findings, as only in the past few years has it embarked on the type of large-scale research studies that are likely to make headlines; most of those studies are not yet completed. Their outcome could have a profound influence on future medical practice and health care policies in this country.
“If it is clearly demonstrated that these [alternative] approaches work, then they will be rapidly incorporated into many medical practices,” said Dr. William Roper, dean of the University of North Carolina School of Public Health and a former director of the federal Centers for Disease Control and Prevention. “It has the potential to change medicine in dramatic ways.”
Dr. David Kessler, dean of Yale University’s medical school, echoes that sentiment. “At some point, all therapies move along the spectrum from experimental to the mainstream,” said Kessler, a former commissioner of the U.S. Food and Drug Administration. “If the data are there, it makes no difference what the origins of the therapies are, or their active ingredients--they will be accepted and move into the mainstream.”
The center was created by Congress in 1992 at the urging of Sen. Tom Harkin (D-Iowa), a devotee of alternative treatments. The goal was to draw attention to the field and study alternative medical approaches. But the relatively small office had a tiny budget and no real authority to fund credible research on its own.
Instead, it became a controversial symbol of the friction between alternative-medicine advocates and those seeking to debunk the field. Straus’ two predecessors had a difficult time reconciling these tensions and struggled with the office’s inability to promote or support legitimate research without the blessing of other institutes.
At Harkin’s urging, and in the face of opposition from Dr. Harold Varmus, then director of the NIH, Congress elevated the office to a center in the fall of 1998. The Clinton administration chose Straus, a stranger to the world of alternative medicine, as the first director.
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Director Has History in Traditional Science
Straus, 55, is the quintessential NIH insider whose background is deeply grounded in traditional science. He has degrees from the Massachusetts Institute of Technology and Columbia University College of Physicians and Surgeons. As a researcher, he has spent roughly 23 years at NIH, studying AIDS, Lyme disease and chronic fatigue syndrome, among other illnesses. Straus was widely criticized by chronic fatigue syndrome advocates for suggesting, at one point, that the condition had a psychological component. He was chief of the laboratory of clinical investigation at the National Institute of Allergy and Infectious Diseases before taking his current assignment.
His selection was such a surprise that people in the field of alternative and complementary therapies weren’t even sure how to react. “There was a watch-and-wait from the academic university world, wondering: Would he be allowed to do good science?” said Dr. Brian Berman, a professor at the University of Maryland School of Medicine in Baltimore and director of the school’s program on complementary medicine. “At the same time, he was very concerned that we would perceive him as the enemy. He has tried to be very clear with us that NIH is about doing excellent science.”
Some proponents of alternative medicine were nervous about what Straus might do. But in more than two years since assuming leadership of the center, Straus eased many of their initial concerns. He has launched credible studies of popular alternative remedies, involved other institutes in the research process and seems committed to learning more about the field, observers say.
“We feel like he’s done a lot to professionalize the center and get good people there to run the research,” said a Harkin spokesman who asked that his name not be used. “Research on complementary and alternative medicine faces an even higher hurdle in terms of scrutiny by the medical field, and that makes it all the more important to have the work be unquestioned science. He has made that a big focal point for the center.”
Berman agrees, saying Straus rose to the challenge of a difficult job. “I was amazed with how quickly he grasped the issues,” he said. “And he really is trying to bring this into the mainstream.”
In this country, medical practice depends heavily on scientific results. Without them, treatments are slow to move into routine practice and won’t be covered by health insurance. This is true for nontraditional remedies as much as for anything else, despite the fact that an oft-cited survey taken five years ago estimated that at least 42% of Americans use some form of alternative treatments.
People “need and deserve answers,” said Straus. “Studies take a long time, but we have established the right base.” While most NIH research is aimed at discovering new science, “here we’re grappling with things people are using today, and have been for thousands of years, and looking at them through the lens of contemporary science,” he said.
Unlike its precursor, the center has a hefty budget of nearly $105 million and autonomy, including the power to initiate research on its own, although most of the major studies are being conducted in collaboration with other institutes.
When the Office of Alternative Medicine was created 10 years ago, it was a “coordinating” office located within the NIH director’s office. Coordinating offices are established by Congress and do not have the capability to issue grant announcements or fund research grants. Their role is to coordinate research in a particular area. Institutes and centers, however, actually can issue research grants.
Center funding for the current fiscal year is $104.6 million, plus more than $100 million from other institutes for collaborative studies--a total of roughly $220 million.
Among other things, the center is sponsoring a range of research into the effects of supplements, botanicals and other products already in popular use, among them ginkgo biloba, saw palmetto, and glucosamine and chondroitin.
Some of the NIH center-funded research includes:
* The first U.S. multi-center study to investigate glucosamine and chondroitin, two dietary supplements widely marketed as natural remedies for osteoarthritis. In September 1999, the center, in collaboration with the National Institute of Arthritis and Musculoskeletal and Skin Diseases, awarded a research grant to the University of Utah to test the efficacy of the combination for knee pain associated with osteoarthritis.
* A collaboration with the National Institute on Aging on a six-year trial of an extract of ginkgo biloba to see if it can help prevent age-related dementia. Researchers from the University of Pittsburgh School of Medicine are coordinating the study, which will enroll 3,000 individuals in four clinical centers.
* A research project involving 15 cancer centers to study the impact of complementary therapies on the disease. The most recent grants included $8 million to Johns Hopkins University in Baltimore and the University of Pennsylvania in Philadelphia.
* A broad study to examine the so-called placebo effect, in which patients experience health benefits if they think they are taking a drug, even when it turns out to be a medically worthless dummy pill. This study is still in the design phase.
Straus sees endless possibilities and says he is particularly interested in research about the so-called mind-body connection. He cites a Stanford University hypnosis study, in which body changes actually could be measured. Study participants underwent hypnosis and were hooked up to a PET scanner, which measures blood flow in the brain. The researchers then asked participants to view pictures in black and white and color. When the subjects viewed the black and white pictures, they were told that it was really in color, and researchers actually saw increased blood flow to the specific portions of the brain that process color. Blood flow decreased when the people were shown color pictures but told they were looking at black and white images.
“What was important was what people perceived,” Straus said. “These kinds of studies help inform us of the tools we can bring to bear in the practice of medicine.”
Most of the center’s research results are years away; however, the findings from a study on St. John’s wort for depression, which began three years ago, are scheduled for publication in a scientific journal within a few months.
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Center Has Encountered Some Bumps in the Road
But the path to scrupulously designed clinical trials has not been entirely smooth. Like the rest of NIH, the center must grapple with input from Congress, whose members often believe they should have a say about how money is spent by government-funded agencies. Harkin, for example, was not entirely pleased with the design of the St. John’s wort study, believing that it did not take into account that most consumers use the herb to treat mild to moderate depression, not more severe forms, says his aide. “This [study] won’t give the vast majority of the people using it information on what they are using it for,” he said.
Also, the center is sponsoring a five-year, $1.4-million study of a regimen promoted by New York physician Nicholas Gonzalez using pancreatic enzymes, coffee enemas and dietary supplements to treat pancreatic cancer. The treatment piqued the interest of Rep. Dan Burton (R-Ind.), who four years ago urged the National Cancer Institute to study it.
Straus insists that the study is valid. “The center studies [alternative] therapies that Americans are using and those where preliminary results suggest that a particular therapy may work,” he said. “In the case of the Gonzalez nutritional regimen, this was not politically thrust on the NIH by Congress.”
The center decided to study the Gonzalez regimen in a small but prospective study because the preliminary data suggested that it prolonged life in patients who would otherwise die of pancreatic cancer, he said. The disease kills nearly 30,000 Americans each year.
Straus, not specifically addressing the Gonzalez study, feels that some avenues are worth exploring scientifically if consumers are using them, “even if ultimately they are shown not to work.”
The University of Maryland’s Berman agrees. “I know there are people who say the center is funding frivolous studies, and that it’s all political, but I haven’t seen that,” said Berman, a researcher whose arthritis work is being funded by the center. “This field is about alternative and complementary therapy. So some people might say none of it should be evaluated.”
Straus points out that Congress also has asked the center to pursue studies many regard as scientifically sound. For example, lawmakers asked the NIH center to study the value of cranberry in preventing urinary tract infections. Cranberry is a preventive remedy most women have known about and used for years by drinking its juice. Many women, including some female physicians, swear by it.
“But there’s no proof,” Straus said. “Congress asked us to do it, and we’d already decided months earlier to do it.”
Straus acknowledges that when he took this job he knew little about the field in which he now plays a key role. “What I knew about complementary and alternative medicine was what I’d read,” he said, “and what my patients told me about.”
Now, he says, he finds his new world of research exciting. “Science is about measurement.
“It’s not enough for someone to testify he or she feels better. We need to measure it and understand it. That’s what it is all about.”
