Confessions of a Quackbuster

This blog deals with healthcare consumer protection, and is therefore about quackery, healthfraud, chiropractic, and other forms of so-Called "Alternative" Medicine (sCAM).

Sunday, July 17, 2005

Probing Edges Of Medicine -- And Reality

Probing Edges Of Medicine -- And Reality
Homeopathy Against Bioterrorism? For a Local Research Institute, Few Areas of Study Are Too Far Out

By Sandra G. Boodman
Washington Post Staff Writer
Tuesday, July 12, 2005; Page HE01

Ask Wayne B. Jonas why the scientific foundation he directs is funding research into the effects of prayer, the use of homeopathy to fight bioterrorism and whether magnetic devices can heal orthopedic injuries, and he offers a straightforward answer: Science is the way to determine whether they work.

"We're trying to stimulate good-quality research," said Jonas, a former chief of the Office of Alternative Medicine at the National Institutes of Health (NIH) who directs the nonprofit Samueli Institute for Information Biology (SIIB) in Alexandria. "There is a good case for looking at these things scientifically, because we don't know a lot about them."

But, the 51-year-old board-certified family physician and retired Army doctor adds, "it's difficult to walk the scientific fence" -- dodging criticism from "the hard-core skeptics" who dismiss alternative medicine as quackery and the "hard-core advocates" who accept it uncritically.

Jonas has headed the institute -- named for its principal benefactor, California philanthropist Susan Samueli -- since its inception in 2001. What began as a two-person foundation has grown into a research organization with four offices and a staff of 15. It has an annual budget of about $4 million provided by the Samueli family, and an additional $5 million in contracts from the Department of Defense (DOD) to study alternative treatments. Currently the institute is funding about 50 projects, awarding grants ranging from $20,000 to $250,000 to researchers in the United States, Europe and Asia. Some grants have been awarded to institute staff members.

Among the DOD-related projects, which are a collaboration with the Uniformed Services University of the Health Sciences, the military medical school in Bethesda where Jonas is a clinical professor, are several to determine whether the use of extremely diluted poisons, including cyanide and botulinum toxin, might protect soliders from higher doses to which they could be exposed in biological warfare.

"The work in this area is in its earliest stages but has some promising characteristics," said Iris R. Bell, director of research for the integrative medicine program at the University of Arizona College of Medicine. "The Samueli staff are open-minded scientists, they are not taking anything as dogma. They are asking the bigger questions, such as what are the assumptions of science? I would expect the work they do and the work they fund is going to be controversial."

Critics of the institute say that while they support rigorous research into alternative medical treatments, Samueli is not doing it.

"There is nothing of scientific value they're doing that I'm aware of," said Wallace Sampson, editor of the Scientific Review of Alternative Medicine and clinical professor emeritus of medicine at Stanford. "They're all ideologues trying to prove something that doesn't exist."

Homeopathy, prayer and other forms of "energy medicine" belong to a category the NIH's National Center for Complementary and Alternative Medicine, the name for the office Jonas once directed, calls "among the most controversial of CAM practices."

Homeopathy, a treatment invented in the late 1700s, is predicated on the belief that "like cures like" and that illnesses can be treated by stimulating a healing response through the ingestion of highly diluted substances such as herbs, heavy metals or poison ivy, which would cause harm at larger doses. In most cases no single molecule of the substance remains.

Homeopathy has not been conclusively proven to be effective for any clinical condition, according to NCCAM, and its "key concepts do not follow the laws of science."

Sampson and other critics of Samueli's work also question its use of terminology not found in science, such as "information biology," which Jonas defines as "the interaction of information with biological systems"; and "salutogenesis," which he says is the process of healing and the opposite of pathogenesis, the process of disease.

"We have to keep an open mind, but not an open mind to nonsense," said Bruce Flamm, a clinical professor of obstetrics and gynecology at the University of California, Irvine.

"The Samuelis are very generous people," said obstetrician-gynecologist Flamm, "but this institute is a sadly misguided waste of money that could be spent on legitimate research."

Last year, after Flamm repeatedly raised questions about a widely promulgated study conducted by researchers affiliated with Columbia University that prayer could help infertile women conceive, the study was withdrawn. (Samueli had no affiliation with the study.) One of the authors is currently serving time in federal prison on unrelated criminal fraud charges.

Some skeptics say the Samueli-sponsored research is fundamentally unscientific and that much of it lacks the necessary safeguards to prevent spurious results. One paper presented at a Samueli-sponsored conference last year on optimal healing environments -- a concept Jonas said he is helping to synthesize -- was entitled "The Spa as a Model of an Optimal Healing Environment." Written by an executive of the posh Canyon Ranch Spa in Tucson, it was published in the Journal of Alternative and Complementary Medicine. Using Canyon Ranch as a case study, the author concluded that "creating an optimal healing environment at any price point" requires "a dedicated, caring staff."

"What they're doing isn't science, it's faith healing," said Robert L. Park, a professor of physics at the University of Maryland and the author of a 2002 book entitled "Voodoo Science," which includes a lengthy discussion of homeopathy.

Adrienne Fugh-Berman, an associate professor in the complemetary medicine program at Georgetown University, said she regarded the studies listed on the SIIB Web site as "pretty self-indulgent."

Fugh-Berman, a physician who has published two dozen studies of alternative treatments, called the belief that homeopathy could be used to fight bioterrorism "embarrassing" and said she regarded optimal healing environments as "spa therapy for rich people."

"What bothers me about some of the research is that I suspect its objective is to create a veneer of science over certain strongly held beliefs," she said.

Jonas disputes these criticisms and says the institute follows standard NIH grant review practices. He said the goal is to fund credible pilot studies to determine what works -- or doesn't -- and that he has no other agenda. Negative results of studies are published on the SIIB Web site, he noted.

While the nonprofit foundation tries to subsidize research that is rigorous, Jonas continued, it is not always possible to conduct randomized, double-blind, placebo-controlled studies of alternative therapies.

"A high percentage meet those requirements," he said, but "some things can't be blinded."

Richard H. Grimm, an epidemiologist who is director of the Berman Center for Outcomes at the University of Minnesota, agreed, noting that much of conventional medicine is predicated on treatments that haven't been put to such a test.

"It's relatively easy to do a randomized, placebo-controlled trial of something that fits into a capsule," Grimm said, but not for a non-drug treatment.

Andew J. Vickers, an assistant attending research methodologist at Memorial Sloan-Kettering Cancer Center in New York, said the Samueli Institute should be judged on the quality of science it supports. Vickers said he forsees three possible outcomes for the research on homeopathy and prayer. The first is that they work, the second is that "none of this works and it's a waste of time" and the third is that "they find other things along the way that would be scientifically useful. Science is full of examples of that."

It was Susan Samueli's longstanding interest in alternative medicine that led to the creation of the institute in 2001, Jonas said. Around the same time, she and her husband Henry endowed the Susan Samueli Center for Integrative Medicine in the medical school at the University of California, Irvine.

The family's fortune comes from Henry Samueli's interest in Broadcom, a company he co-founded in the early 1990s while on leave from teaching at UCLA, where he earned a doctorate in electrical engineering. Broadcom pioneered the manufacture of chips used in DSL and cable modems just before the demand for these chips skyrocketed. Over a period of a few years, that invention catapulted the Samuelis from middle-class comfort to the ranks of the Forbes 400, a listing of America's richest families.

The son of Polish Holocaust survivors who as a youth worked in his family's liquor store, Henry Samueli has made record gifts to the engineering schools at UC Irvine and UCLA, both of which now bear his name. Several months ago the couple bought the Mighty Ducks professional hockey team.

Susan Samueli, whose undergraduate degree in math is from Berkeley, has a PhD from the American Holistic College of Nutrition and a diploma from a British homeopathic institute. The holistic college is an unaccredited correspondence school located in Birmingham, Ala.

Jonas's interest in homeopathy dates back to college. In a 1996 book entitled "Healing With Homeopathy," he wrote that as a medical student he suggested trying homeopathy on several patients who were faring poorly with conventional treatments and was upbraided by supervisors.

Later, while stationed as an Army doctor in Germany, where homeopathy is popular, Jonas said his interest in the subject grew, in part because he couldn't understand how it might work.

Jonas said he thinks the answer might lie in a substance released by an ingredient in glass or could be due to the placebo effect. He said he doubts the view, widely held by other homeopaths, that the water somehow retains the "memory" of the diluted substance, which results in healing.

"There are possible ways to explain this on a rational basis," he said.

Two months after the Sept. 11 terrorist attacks, Jonas, a former official at the Walter Reed Army Institute of Research, urged Congress to consider the use of homeopathy to fight bioterrorism. In testimony before a commitee chaired by Indiana's Republican Rep. Dan Burton, one of the most enthusiastic supporters of alternative medicine in Congress, Jonas said that "homeopathic medical literature reveals numerous reports of apparently successful treatment of epidemic diseases . . . including smallpox" from the last century.

A month later NCCAM chief Stephen E. Straus, a virologist, warned the House commitee against using alternative remedies for biological weapons.

In 2003 Jonas was lead author of an analysis of homeopathy studies published in the Annals of Internal Medicine. The authors, all specialists in alternative medicine, concluded that homeopathy may be effective for some conditions and "deserves an open-minded opportunity to demonstrate its value" but should not supplant proven therapies.

To Colorado physician Steven Bratman, the author of a dozen books on alternative medicine and an expert in research in the field, using homeopathy to combat bioterrorism is "completely insane -- not as insane as UFOs, but pretty close."

"For homeopathy to work, there would have to be a whole new law of science," said Bratman, a former alternative medicine practitioner who said he abandoned acupuncture and other treatments about a decade ago after he grew increasingly uneasy about their lack of scientific underpinnings.

"The fact that DOD is spending money on this research is unfortunate," he said.

Increasingly, Jonas said, the Samueli Institute is focusing on projects that explore and define optimal healing environments, a concept that grows out of his long-standing interest in preventive medicine.

"We have a biomedical system that is attempting to apply the acute care model to chronic illness," he said. "We need a new way of thinking. . . . That's the salutogenic model."

This interest in healing is reflected in the institute's expensively decorated suite of offices overlooking the King Street Metro station in Old Town Alexandria.

Situated outside Jonas's office is a large section of an aspen tree, trucked in from land the Samueli family owns in Telluride, Colo. Native Americans, Jonas said, believed the aspen tree was endowed with curative properties. It seemed a fitting symbol.