FOLK CURES ON TRIAL Alternative Care Gains a Foothold

Subject: NIH & Alternative Care NY Times  January 31, 2000



BALTIMORE -- In the year he has suffered from osteoarthritis, Harold Katcoff has followed his doctors' advice, to no avail: aspirin, steroids, the latest anti-inflammatory drugs. The pills, he says, offer little relief from the stabbing pain in the back of his knees. So Mr. Katcoff, an 80-year-old retired pharmacist, is trying Chinese medicine instead. Or at least, he thinks he is. Every Tuesday and Thursday since late November, Mr. Katcoff has come here, to Kernan Hospital, to see an acupuncturist who pokes him with 20 needles, 9 in each leg and 2 in the belly, and then hooks the probes to a mild electrical current. The patient is convinced that the therapy works. "It's  fantastic," Mr. Katcoff says. But in the same breath, he admits that he cannot be certain if the effect is real, or imagined. That is because Mr. Katcoff may be receiving sham acupuncture -- needle sticks in places where, according to the theories of traditional Chinese medicine, they should not do any good. He is a volunteer in a $2.5 million federally financed study, run by a rheumatology professor and a family-practice doctor at the University of Maryland. The study represents a new wave in academic medicine: the application of rigorous, Western scientific methods -- including the gold standard of medical research, the placebo, or fake therapy, as a control -- to test alternative therapies, from ginkgo biloba to shark cartilage to a mystical Chinese healing art known as qi gong. Just five years ago, many academics would not have gone near such studies, for fear they would become a laughingstock. And while alternative therapies remain hugely controversial in the staid world of science-- "quackupuncture," is how one vocal critic, Dr. Victor Herbert of the Mount Sinai School of Medicine, summed up the University of Maryland's work -- large, multimillion-dollar clinical trials are getting under way this year at some of the nation's most prestigious university hospitals. "The scientific games have begun," declared Dr. David Eisenberg, director of the Center for Alternative Medicine Research and Education at Beth Israel Deaconness Medical Center in Boston. Or, as Dr. Barrie Cassileth, chief of integrative medicine at Memorial Sloan-Kettering Cancer Center in Manhattan, said: "The research is just coming into its maturity. It's bar mitzvah time."

The boom is being driven by the National Institutes of Health, which, under pressure from Congress, has sharply increased its budget for studies of alternative medicine. Eight years ago, much to the chagrin of the institutes leadership, Congress required the institutes to establish an Office of Alternative Medicine, a tiny operation with a budget to match, just $2 million. "It was," said Dr. Daniel Moerman, a medical anthropologist at the University of Michigan, "like setting up an office of deviltry within the Catholic Church."

But after a rocky beginning, the office is gaining acceptance at the institutes and is setting the tone for scientists around the country. Last year, Congress upgraded the office, making it the National Center for Complementary and Alternative Medicine, which means it now has grant-making authority. Its yearly budget has grown to $68 million. In October, a new director came on board, Dr. Stephen E. Straus, a virologist and longtime N.I.H. insider whom Dr. Harold Varmus, the former director of the institutes and once one of the program's biggest detractors, describes as "a really distinguished scientist."

At the same time, hospitals and medical schools are bowing to economic reality: Alternative medicine is big business. According to the Nutrition Business Journal, an industry trade publication, Americans spent $27.2 billion in 1998 on providers of alternative health care, including those in chiropractic, traditional Chinese medicine, homeopathy, naturopathy and massage therapy. Sales of herbs are also growing, to $4.4 billion last year, from nearly $2.5 billion in 1995, the journal said.

And a survey of more than 2,000 adults, conducted by Dr. Eisenberg and published in November 1998 in The Journal of the American Medical Association, estimated that 46 percent of the American population had visited a practitioner of alternative health care in 1997, up from 36 percent in 1990. Patients like Mr. Katcoff, who had never before tried alternative therapies, are increasingly doing so. "Consumers are saying, I want some type of care and I will pay for it out of pocket if I need to," said Dr. Brian Berman, the principal investigator in the Maryland acupuncture study.

But applying Western methods to Eastern traditions may be easier said than done, as Dr. Berman well knows. For one thing, how do you do placebo acupuncture? Dr. Berman and a Chinese colleague, Dr. Lixing Lao, ran several experiments just to figure out a technique that, they say, can reliably fool patients. And medical concepts do not easily translate. The diagnosis "osteoarthritis of the knee" does not exist in traditional Chinese medicine. The closest translation, Dr. Lao said, was "the knee area is energy blocked."

Cultural clashes aside, the work proceeds. At Duke University, 330 patients are being enrolled in a study of St. John's wort, an herb that is thought to relieve mild depression. One-third of the participants will receive the herb, one-third will receive a placebo and one-third will receive Zoloft, a commonly prescribed drug. In  Houston, the M. D. Anderson Cancer Center has just begun testing shark cartilage as a treatment for lung cancer; the study, sponsored by the National Cancer Institute and approved by the Food and Drug Administration, will involve as many as 700 patients who will receive either shark cartilage or a dummy pill in addition to conventional treatment.

And at the University of Michigan, Dr. Steven F. Bolling, a heart transplant surgeon who describes himself as "the high priest of techno-medicine," is surprised to find himself examining whether practitioners of the Chinese art of qi gong can help his cardiac surgery patients recover faster. One-third of the patients in the clinical trial will be visited by a qi gong master, who performs slow-motion exercises that are said to release a healing energy. One-third will be visited by an impostor and one-third will not have visits.

"If it's proven, it works and it helps my patients," Dr. Bolling said, "so be it." The trend is affecting the training of young doctors as well. Two-thirds of the nation's medical schools now have courses on alternative medicine, many of them to teach doctors how to handle questions from patients. Harvard Medical School is about to begin a fellowship program to train internists in how to conduct research on alternative therapies.

"We need a small army of clinician researchers who will do this work now," said Dr. Eisenberg, the co-director, "and for the next generation."

 The Politics Push by Senator Defeats Opposition

The story of how alternative medicine has worked its way into the mainstream of research begins not with scientists, but politicians.

In the late 1980's, Senator Tom Harkin, Democrat of Iowa, became chairman of the subcommittee that holds the purse strings to N.I.H. At about that time, Mr.  Harkin said, a  friend, Representative Berkley Bedell of Iowa, became ill with Lyme disease and prostate cancer, and resigned from Congress. "A couple of years after that, Berkley came to see me and he looked like a new man," Mr. Harkin said. "He told me about a strange cure he had taken, an alternative approach. I was  just amazed." Mr. Harkin has since become an aficionado of alternative medicine himself: He takes bee pollen for his allergies, a practice that critics find silly. But Mr. Harkin may have had the last laugh. In 1991, he inserted a provision into the N.I.H. appropriations bill requiring the institutes to create an Office of Alternative Medicine, with a $2 million budget.

"They fought it and fought it and fought it," he said in an interview. "You'd think I was single-handedly destroying N.I.H. by spending $2 million on alternative therapies." The amount was indeed a drop in the bucket for the institutes, an agency that now has a $15 billion annual budget. The tiny office on alternative care was set up in a  remote outpost, nowhere near the institutes' main campus in Bethesda, Md. Its mission was complicated. Alternative medicine is such a vast conglomeration of practices, ranging from the use of vitamins and herbs, to meditation, massage, movement therapy and acupuncture, that even its practitioners cannot agree on what  to call it. (The terms "complementary," "integrative" and "alternative" are used interchangeably.)

The office began by offering small grants of $30,000 each. Soon, it was drawing fierce criticism for spending taxpayers' money on projects of dubious scientific merit. "The quality was incredibly low," said Dr. Varmus, who is now executive director of Memorial Sloan-Kettering. "The investigators who were applying didn't really know much about science."

In 1994, Congress took a step that would have a major effect on patients' access to alternative therapies. It passed a law that permits manufacturers to make claims about health benefits for herbal medicines whose safety and effectiveness had not been proved by the usual standards applied to prescription drugs. Now, said Dr. Cassileth, of Memorial Sloan-Kettering, "everybody can play doctor and buy anything they want over the counter and treat themselves." Good research became even more necessary, she said.

But the battles at N.I.H. continued. The alternative medicine office ran through a string of directors. The man who took the job in 1995, Dr. Wayne B. Jonas, drew criticism because he practiced homeopathy, a 200-year-old system of medicine in which illnesses are often treated with diluted solutions of plant extracts. Most  mainstream scientists, including Dr. Varmus, take a dim view of homeopathy. As a result, said Dr. Jonas, who left the institutes at the end of 1998, he had a difficult time getting approval of proposals to finance research.

But as Congress continued to appropriate more money for the office and public interest grew, Dr. Varmus said, "I came to feel that there was a real public health concern that N.I.H. had a responsibility to address."

By 1996, the alternative medicine office had moved onto the main institutes' campus, and Dr. Varmus had formed an advisory group of government scientists to set priorities. The alternative medicine literature contains thousands of studies, but the majority are scientifically flawed. Dr. Varmus wants scientists to test the most promising and most widely used therapies.

But the critics remain. Dr. Herbert, the Mount Sinai professor, calls the center on alternative medicine "a worthless waste of money" that was "set up to promote fraud."

Dr. Marcia Angell, the editor of The New England Journal of Medicine, said the center had so far failed to publish any significant articles in scientific journals. "The proof is in the pudding," Dr. Angell said. "Just show me the papers." That may take some time.

It will be three to four years, Dr. Straus predicts, before the current crop of clinical trials is complete. Still, in a recent interview, Dr. Straus came armed with two loose-leaf notebooks full of articles that had grown from N.I.H.-financed research, some published in the respected Journal of the American Medical Association. He acknowledged that the center "still has to prove itself." But, he said, "I predict it will."

The Research Holding Future of New Therapy

For the American health care system, the implications of the new research will be vast, medically and economically. Health maintenance organizations are just beginning to cover some alternative therapies; Oxford Health Plans, for instance, offers coverage for acupuncture. If therapies being tested prove effective, patients will undoubtedly begin demanding coverage.

The new research could be a boon to manufacturers of herbs. Several manufacturers of dietary supplements  are beginning studies of products such as ginkgo and St. John's wort that could lead to their approval by the Food and Drug Administration, in the same way the agency approves prescription drugs, said Michael McGuffin, president of the American Herbal Products Association, a trade group.

The University of Pittsburgh, meanwhile, is joining Chinese scientists to develop herbal medicines as drugs. In addition, Dr. Steven DeKosky, who directs the university's Alzheimer's Disease Research Center, has also received a $3 million N.I.H. grant to see if the ginkgo herb can prevent dementia. Two thousand elderly patients will be enrolled.  If it works, he said, the next step will be to isolate the active ingredients and figure out how they work.

Some researchers, including Dr. Eisenberg of Harvard, say alternative therapies will not be truly accepted as mainstream until scientists can prove not just that they work, but how. But already, medical practice is opening up, said Dr. Marc C. Hochberg, the rheumatology professor at the University of Maryland who is an investigator in the acupuncture study. This year, acupuncture was mentioned for the first time in the American College of Rheumatology's guidelines for medical management of osteoarthritis of the knee. "Our work has opened people's eyes," he said. "This used to be in the same ball park as copper bracelets. I think we have taken acupuncture for osteoarthritis out of that realm."

Still, Dr. Hochberg said, an important question remains: does the acupuncture really work, or is it just the placebo effect? Dr. Hochberg hopes to have an answer by 2002. As for Mr. Katcoff, he is sold. He said he had been reading up on Chinese medicine, and had learned that even people who did not believe in it could benefit.  "I think I'm getting the real goods," he said recently. "I've been going twice a week, and this is my fifth week, and I can honestly say that the pains in the back of my legs are gone."