Office Of Alternative Medicine Gets Unexpected Boost

A proposal to elevate the National Institutes of Health's Office of Alternative Medicine (OAM) into an institute fell short during the appropriations process, but a 60 percent increase in funding represents a victory of sorts for the office. The $8-million boost proposed by a conference committee would raise OAM's current $12-million budget to $20 million for FY1998. The conference committee's decision was a surprise considering earlier requests. The House and the Clinton administration both so

Nov 10, 1997
Paul Smaglik

A proposal to elevate the National Institutes of Health's Office of Alternative Medicine (OAM) into an institute fell short during the appropriations process, but a 60 percent increase in funding represents a victory of sorts for the office. The $8-million boost proposed by a conference committee would raise OAM's current $12-million budget to $20 million for FY1998.

The conference committee's decision was a surprise considering earlier requests. The House and the Clinton administration both sought cuts in the office's funding, down to $7.5 million for 1998; the Senate requested a slight funding increase, to $13 million. If OAM had been elevated to an NIH institute, it could have received a $200-million annual budget.

The OAM's status sparked a debate during an October 9 Senate hearing over who should have granting authority for studies of unconventional therapies-skeptical scientists or alternative medicine proponents. Critics say that therapies investigated by OAM should undergo the same scientific rigors as conventional therapies, but supporters contend that mainstream scientists don't always cooperate. Both sides agree that such practice warrants a closer look, since according to some estimates, more than a third of Americans use some form of alternative medicine.

Sen. Tom Harkin (D-Iowa) formed OAM in 1992 by adding a $2 million item into a Health and Human Services appropriations bill. The office's budget-and profile-has grown every year and, as it has grown, has attracted increasing controversy. OAM studies cover a broad range of practices, from the benefits of meditation to outcomes of "touch therapy," in which practitioners don't actually touch the patient but purport to manipulate invisible energy fields inches away from patients' bodies that only they can detect.

GRANTING AUTHORITY: James Gordon of Georgetown's Center for Mind-Body Medicine wants more granting autonomy for OAM.
The conflict between OAM's supporters and those who question its science was highlighted during the October 9 Senate Subcommittee on Public Health and Safety hearing. James S. Gordon, director of Georgetown University School of Medicine's Center for Mind-Body Medicine, who served as the first chairman of OAM's advisory board, testified that the office has been unable to fully investigate alternative treatments because it has been institutionally shackled. As an office, OAM needs approval from other institutes to begin studies. Some, like the National Institute of Mental Health (NIMH), have been cooperative. NIMH and OAM are launching a study to investigate St. John's wort, an herb that some say has the same antidepressive qualities as Prozac and other serotonin-enhancing drugs. "If, however, the National Heart, Lung, and Blood Institute, based on its evaluation, decides it is not important to study chelation therapy, or the National Cancer Institute disagrees about the value of investigating a new, apparently promising but controversial, unconventional cancer treatment, careful scientific investigations of these widely used approaches simply cannot proceed," Gordon noted.

Harkin contends that the anti-OAM sentiment within NIH starts at the top, with Harold E. Varmus, NIH director. Varmus asked for lower levels of funding for the office in two consecutive years, even though NIH's funding level has increased each year. "What kind of signal does that send about how important this is?" asked Harkin, who credits unconventional therapies for curing his allergies and easing a relative's pain.

Varmus has said that he does not think the field needs a separate institute. Two different cultures-conventional and alternative-now provide health care to the public, he told Stanford Medical School graduates this summer during a commencement speech. "Ours has the scientific record of accomplishment, but the other is acquiring enormous public support-even getting the credit for many preventative, behavioral, and low-tech methods that mainstream medical science introduced and validated."

STATUS QUO: Robert Rich, dean for research at Baylor College of Medicine, thinks OAM should remain an office, not an institute.
While not disputing that alternative medicine warrants investigation, Robert R. Rich, dean for research at Baylor College of Medicine, who represented the Association of American Medical Colleges (AAMC) at the hearing, disagrees that OAM should have its own review and granting authority. Such a system could result in the promotion of untested therapies, rather than a skeptical analysis of their effectiveness. Rich contends that the same scientific rigor should be applied to alternative medicine as is used to judge conventional medicine-a skeptical board of reviewers promoting sound research design with falsifiable hypotheses. "As scientists, we need to be disciplining ourselves to base our research on hypotheses, not belief systems." He favors investigating alternative treatments by disease category, in arrangements similar to the NIMH-OAR investigation of St. John's wort, so the people with the most expertise in a disease perform the review and granting process, rather than the proponents of a particular therapy.

Sen. Bill Frist (R-Tenn.), the subcommittee chairman who also is a surgeon and researcher, agrees. At the hearing, he hypothetically stated that a review board of 12 acupuncture practitioners would be more likely to give a green light to acupuncture studies than a board of physicians-even if the study had a flawed design. "There's a fear that the peer review there won't be as rigorous as at other institutes," he noted.

OAM's first director, Joseph J. Jacobs, tells The Scientist that he also opposes elevating the office to an institute because such a move would only add to administrative costs and further politicize the office. Jacobs, now the medical director for Vermont's state department of corrections and its Medicaid program, resigned after two years at OAM because of pressure from congressional staffers who wanted him to fund what he thought was poorly designed research. For example, he opposed funding the Bastyr School of Naturopathic Medicine in Seattle. The site, which has since been funded through a $1 million OAM grant, has been one of the most criticized because it merely asks HIV-positive subjects what forms of alternative therapies they use without questioning if or how they work and without accounting for conventional therapies the subjects also use.

Jacobs believes alternative medicine should be subject to the same kinds of clinical trials as conventional medicine. "It adds credibility to the research," he maintains. Proponents of isolating alternative medicine actually are doing the field a disservice because skeptical mainstream scientists will continue to say that many studies in alternative medicine lack sound methodology, he says. Proponents like Harkin also defend questionable studies on an emotional rather than a logical basis. "He's very inflammatory in his remarks," Jacobs adds.

HIGHER STANDARDS: Carnegie Institution's Maxine Singer contends that OAM research is held to lower standards than other NIH research.
At the hearing, Harkin denounced letters from scientists to Frist, Sen. Arlen Specter (R-Pa.), Rep. John Porter (R.- Ill.), and other legislators who are involved in the NIH appropriations process. The letters ask for the elimination of OAM on the grounds that its research design does not pass muster. "Quite frankly, I don't think they're qualified" because they lack the background in alternative medicine, Harkin asserts. Writers include Nobel laureate Paul Berg, a biochemist at the Stanford University Medical Center; Maxine F. Singer, president of the Carnegie Institution of Washington, D.C.; and D. Allan Bromley of Yale University, president of the American Physical Society and former science adviser to President George Bush.

CLINICAL TRIALS: Stanford biochemist Paul Berg says alternative medicine should undergo clinical trials, not simple, observational ones.
Berg wrote that he doesn't object to investigating supplemental forms of medicine. "However, advertising and promoting their medical value without the rigorous clinical trials required by the FDA [Food and Drug Administration] for other drugs and treatments is a great disservice, particularly as it keeps people from seeking the best modern care."

Singer wrote that other NIH institutes could investigate alternative treatments "by the rigorous standards of modern, main-line biomedical research." Bromley noted that OAM studies have not been held to the same standards as other research funded by NIH. "When the Office of Alternative Medicine was created in 1992, I think most of us assumed that its mandate would be to critically evaluate practices that lie outside mainstream medicine," he wrote. "Unfortunately the OAM has emerged as an undiscriminating advocate of unconventional medicine. It has bestowed the considerable prestige of the NIH on a variety of highly dubious practices, some of which clearly violate basic laws of physics and more clearly resemble witchcraft than medicine."

VOCAL OPPONENT: OAM should be eliminated because of poor research designs, states Maryland's Robert Park.
Many alternative medicine treatments don't lend themselves well to conventional research protocol, Robert L. Park, a physicist at the University of Maryland and vehement OAM opponent, tells The Scientist. For example, he says, it's difficult to set up a double-blind study to test the efficacy of acupuncture. "People are either being punctured or not." That makes it impossible to tell if any self-reporting of improvement by the patient is due to the needles or to the placebo effect. Much of OAM's research uses these observational studies rather than clinical, randomized trials, he says.

ALTERNATIVE PRACTITIONER: OAM's director Wayne Jonas practices homeopathy, which many of the office's detractors say runs contrary to science.
Some other research the office has sponsored violates the laws of physics-especially touch therapy. No study has examined whether the energy field that its practitioners say surrounds people exists-just whether or not people say they feel better after undergoing the therapy. Homeopathy (of which OAM's director, Wayne B. Jonas, is a practitioner) also flies in the face of science, Park contends. Homeopaths say trace amounts of symptom-causing materials can cure diseases. Physicists say these materials are too minute to have any effect-positive or negative. Jonas declined comment for this article through OAM's public relations office.

Had OAM studies been following stringent research protocols with falsifiable hypotheses, they quickly would have shown that such practices simply don't work, Park says. "They've been exempted from real scientific research."