Unconventional Treatments Bump Into Scientific Hurdles
Researchers call it “good science.”
It works this way: A scientist gets an idea about a drug or therapy and asks the National Institutes of Health for money to study it. Once there is “good science” to support the therapy, consumers start to use it.
But with alternative medicines, the process is working in reverse: Millions of Americans are embracing alternative treatments--even without “good science”--and researchers are trying to catch up.
The focal point for the federal part of the catch-up effort is the NIH’s Office of Alternative Medicine, established by Congress in 1992 to draw attention to alternative approaches and sponsor research.
But the office has been a lightning rod for controversy almost since its inception. It has become a reluctant symbol of the friction between those who seek respect for alternative approaches and those who would like to debunk them.
Inherently, the office must serve two masters. It is a part of the NIH, which traditionally has held a somewhat conservative view of unconventional medical approaches. At the same time, it must respond to the growing community of alternative practitioners who argue that their techniques are validated by thousands of years of successful use.
A Study in Contrasts
Practitioners of alternative medicine would like more money to conduct research to convince skeptics that their approaches work. But to do so, they need to work in the only “language” that traditional researchers understand--carefully designed studies, the so-called “good science,” that often take years to conduct.
“In Europe and Asia they believe that if something seems to be effective--and it’s not doing harm--let’s use it,” said Dr. James Gordon, director of the Center for Mind/Body Medicine, a holistic medical practice in the Washington, D.C. area and a former NIH researcher. “But here, the sense is we have to have the studies before” mainstream physicians and others will endorse it.
“In many cases there may be evidence that something works, but it’s often hard to communicate this evidence in standard practice,” said Dr. Wayne Jonas, director of the NIH’s alternative medicine office. “Even when there is good evidence, sometimes that isn’t even enough. What is the science?”
Alternative practitioners are eager to see the research done, but many feel the money has been slow in coming and that the NIH has been unenthusiastic about providing it. Also, they believe that good science already exists--from other countries--and that U.S. researchers have resisted accepting it.
Not so, insists Dr. William Harlan, the NIH’s associate director for disease prevention, who is Jonas’ boss and who oversees the Office of Alternative Medicine. He said the NIH “is really quite interested,” in alternative medicine. But, he said, it is important for health care practices in this country--particularly the use of new medicines--to be founded on “evidence developed through good scientific work, with the gold standard being randomized clinical trials.”
Such studies have strict requirements for participation, and usually involve a “control” group receiving a different therapy for comparison purposes. Treatments are randomized by computer, and sometimes--particularly in the case of drugs--neither the researcher nor the subject knows who is receiving what.
This philosophy especially annoys Sen. Tom Harkin (D-Iowa), who was the driving force behind the creation of the NIH office, and who has described the benefits of certain alternative therapies, such as acupuncture, on members of his own family who faced serious illness.
Harkin complains privately that top NIH officials were unenthusiastic about research into alternative medicine. He has also sought more money for the office, now funded at about $20 million for fiscal 1998, a fraction of NIH’s total of $13 billion. That $20 million, of which $14.5 million is earmarked for research, says a spokesman in his office, is “laughable, when you compare it to the usage of these therapies by the public.”
Currently, major research initiated by the office must be sponsored by another institute at the NIH, rather than by the alternative medicines office itself. For example, a study of the herb St. John’s wort in treating depression is being carried out by the National Institute of Mental Health, in cooperation with the Office of Alternative Medicine.
Tight Controls
Critics don’t like this approach much, saying it sends a message that the NIH really doesn’t trust the office to run such a study on its own. It also puts the control in the other institute.
In addition, it puts too narrow a focus on the approach being studied, critics say. Institutes typically are grouped around a specific disease or category of conditions, but alternative approaches represent “a whole new way of looking at medicine,” Gordon says. “They go beyond the boundaries of specific diseases and look at the body as a whole.
“They keep a very tight rein on that office,” Gordon added. “They want things to be done the way NIH has always done them, which is why they insist that the studies be done through the institutes.”
But Jonas defends this approach.
“NIH is trying to identify areas where research will have an impact on the public health,” he said. “This is not an issue of trying to prove or disprove a therapy--we want to improve the public health. We also have concerns about safety--in all research, we must be concerned about both efficacy and safety.
“I think at NIH, we’re all on board about doing the research,” he said. “But by working through the institutes, we can better help identify where this contribution to public health can occur. The institutes have the ability to manage and carry out the research.”
In addition to designing and launching several major studies, the office also has sponsored conferences on alternative approaches. Last year, for example, experts spent three days examining the value of acupuncture for pain relief and other uses.
The office also funds 10 disease-oriented centers outside of the NIH, looking at alternative approaches to treating conditions associated with cancer, women’s health, HIV, pain, aging, allergies, addiction, neurological disorders and other conditions. The funding for each center is $1 million, spread over three years.
“I think the science is very important, but there has to be popular and political pressure to get it done,” said Gordon. “That’s why research has gone ahead, for example, with HIV and women’s health. The mass of people [in the public] will demand it.”
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