Alternative medicine: much promise, little data

While the medical community?s attitude toward alternative medicine is changing slowly, many patients who usenontraditional treatments enthusiastically endorse them.

By Rhea K. Farberman, Monitor executive editor, and Sandra Haber, PhD, private practice, New York

Barbara Conklin, a psychiatric social worker from Largo, Fla., was diagnosed with ovarian cancer in October, 1995. Surgeons removed two tumors and told her she had stage II cancer.

She?d had a long-running interest in alternative medicine and did more research at the time of her diagnosis. Rejecting the chemotherapy her physicians recommended, Conklin chose to undergo Gerson Therapy, at the Hospital Meridien in De Playas de Tijuana, Mexico.

Gerson Therapy, developed in the 1940s, is a dietary therapy developed by Max Gerson, MD. It requires patients to drink 13 glasses of fresh, raw juices and eat three vegetarian meals a day. The diet is fat- and sodium-restricted and high in vitamins, minerals and micro-nutrients. Gerson?s patients also undergo coffee enemas three times a day to stimulate the enzyme systems and enhance the exertion of bile and toxins through the liver.

Conklin?s experience with alternative medicine was positive. Her cancer score on a test to measure the amount of tumor- produced substance in the blood called CA 125 was 398 before her surgery, 85 after the surgery and 31 after three weeks of the Gerson Therapy. Two-and-a-half years after her initial diagnosis she is back at work full time, looks healthy and says she feels great. But the lack of hard data on the Gerson treatment makes it impossible to determine whether her experience is typical or unique.

Conklin is not alone in her choice of nonconventional medical treatment. Alternative medicine, including some mind/body interventions that psychologists consider solidly mainstream, such as biofeedback, psychoneuro-immunology and medical-crisis counseling, are the fastest growing part of the nation?s health expenditure.

Americans spend an estimated $14 billion a year on so-called alternative treatments. Most of these expenditures are out of the patient?s pocket, but insurance coverage for some is becoming more common.

Physician David Eisenberg of Harvard Medical School, who has studied alternative medicine and its consumer-acceptance, estimates that Americans made 425 million visits to alternative medical providers in 1990, exceeding the 338 million visits made to all U.S. primary-care physicians during the same period.

Eisenberg has also found that 70 percent of alternative medicine consumers did not inform their primary physician of their alternative therapy.

A call for more research

'Alternative isn?t necessarily good or bad; it?s another idea from what?s currently used,' says Nicholas Gonzalez, MD, who specializes in a nutritionally based approach to cancer treatment from his New York City office. 'At one time antibiotics were an alternative idea,' he says. 'There?s good orthodox science, and there?s bad orthodox science. There?s good unorthodox science and bad unorthodox science. Ultimately the data will tell.'

Gonzalez is one of the few alternative practitioners who has done research on his approach. Trained as a research immunologist, he has been treating cancer patients since 1987 with a three-pronged program of diet, supplements and detoxification. Gonzalez believes that people develop certain cancers because they eat the wrong diet for their metabolic type.

Patients under Gonzalez? care follow a diet that is pure vegetation, all meat or, for most, somewhere in between depending on their metabolic type; they take an average of 130 to 160 capsules a day of vitamins, minerals and trace elements including pancreatic enzymes; and they undergo coffee enemas to help the liver clean out tumor wastes from the body.

In 1993, the National Cancer Institute asked Gonzalez to do a pilot study on pancreatic cancer with 10 patients, all in an advanced stage of the disease. Of those 10 patients, five have now lived two years beyond their initial diagnosis. That?s significantly longer than the survival rates of pancreatic patients who receive chemotherapy: Typically, they only lived 5.5 months beyond their initial diagnosis.

Results of this pilot study are being submitted for publication to the Journal of the American Medical Association. Gonzalez is now conducting a large?scale controlled clinical trial of the effectiveness of his diet regimen, with underwriting from the Nestle Company. This randomized study will include 90 patients, all with advanced pancreatic cancer. Results are expected in 18 months.

The biochemical approach

Biochemist and physician Stanislaw Burzynski, MD, is another leader in the effort to validate the effectiveness of alternative treatments for cancer. In his large clinic and pharmaceutical lab in Houston, Burzynski is running 72 clinical trials of his thesis that problems with a person?s biochemical system cause up to 80 percent of all cancers.

When a cancer occurs, Burzynski believes, a cell?s oncogenes are turned up and the tumor suppressor genes are turned down. He uses antineoplasms to reverse that occurrence. His antineoplasms therapy has shown good effectiveness with certain types of brain cancers in 24 clinical trials. It also shows promise in treating kidney and esophageal cancer, but more research is needed with these cancers.

Burzynski?s work is probably the best example of the changing climate of alternative medicine. Since 1983, Burzynski has had charges brought against him by the Food and Drug Administration stemming from his use of patient treatments that are not recognized by the FDA for medical use. Last year, Burzynski was cleared of those charges and now conducts clinical research under FDA supervision, although only the most gravely ill cancer patients are allowed by the FDA to receive his treatment.

'We see the patients that are sentenced to death,' says Burzynski. 'It?s always more difficult to treat the patient who has gone through chemotherapy and radiation because we are dealing with very sick people, but the FDA limits us to the toughest cases.'

Burzynski, who has spent nearly 30 years studying his treatment theories, feels that he?s been ahead of the science curve regarding cancer treatment.

'The main problem,' he says, 'is to live long enough for the other guys to understand what you are talking about.'

Schools of thought

There may in fact today be two schools of alternative therapies. One group has begun to become a part of the medical mainstream?just as psychotherapy has become part of an integrated approach to physical illness. Those belonging to this group include chiropractic and mind-body medicine. The other group still remains far outside the boundaries of conventional medicine and includes a host of therapies from shark cartilage to bio-magnetics. The problem with the catch-all phrase is that not all alternative therapies are equal.

'Alternative medicine is a catch-all phrase for everything that is not accepted by mainstream medicine,' says Ralph Moss, a science researcher and writer and author of the Moss Reports about Cancer. 'But therapies are not accepted for a variety of reasons. Some are not accepted because they don?t work, but some others may not be accepted because they don?t fit into the framework of conventional medicine.'

Protecting the consumer has to be an important part of the decision-making process, but ill patients often care less about the scientific data than finding someone who believes that they can be cured. Herein may lie the most important role for psychologists: helping patients evaluate the research and select appropriate treatment choices.

'Curing cancer is a great practice builder, but you can kill people if you don?t know what you?re doing,' adds Gonzalez.

Patient hopes

Tijuana, Mexico, is regarded as the alternative medicine capital of the world, housing nearly 70 alternative medicine clinics. Most of the patients here are Americans with cancer.

There is a stark difference between the upbeat mood of these patients, looking healthy and confident of being healed, and the near-death aura surrounding so many patients undergoing chemotherapy and radiation at traditional cancer treatment centers in the United States.

That contrast, in fact, sways many into deciding to find cancer treatments south of the border. People like Chuck Stroup.

A robust-looking man in his mid 60s, Stroup was attached to a portable intravenous and eating his lunch accompanied by approximately 20 pills when he described his belief in the treatment he was receiving at the Hospital Santa Monica in Rosarito Beach, Mexico.

The hospital markets itself as 'the right alternative for those who have been told ?you have an incurable disease.?'

'This is a great place,' Stroup says. 'What?s different is they give you everything that may work for you. In the states, they might just try one thing. But here they try lots of things. It?s like when you go rabbit hunting. Would you rather have a pistol or a large-gauge shotgun? We want to take as many shots at the cancer as we can.'

Stroup was diagnosed with a large cancer mass in his right lung four months ago. He chose not to pursue the conventional treatment recommended by physicians in California, and at the time he was interviewed, he had been in the hospital in Rosarito Beach for two weeks of an intensive three-week stay, which will cost him $15,900. Stroup?s treatment consisted of a special diet minus all natural or refined sugar, large doses of vitamins and pulse-modulated microwave hyperthermia treatments designed to kill or damage cancer cells.

Hospital Santa Monica director Kurt W. Donsbach claims that the hospital achieves a better than 50 percent recovery rate with its cancer patients after five years, including its advanced cancer patients. But no actual patient survival data were available from Donsbach.

The hospital incorporates 17 different treatment protocols into each patient?s three-week stay and then provides follow-up care via specific dietary instructions and telephone consultation. Among the treatments are massive doses of anticancer hormones such as melatonin, large doses of vitamins and enzymes, ozone therapy, interferon therapy and laetrile.

But to an observer, what seems most palpable within the hospital, and among its staff and patients, is the assumption of recovery. The belief that they have the tools to control cancer. 'Cancer is a terrible diagnosis for people to have to hear,' says Donsbach, who is trained as a chiropractor. 'When you hear it, you lose all common sense, and you almost turn to jelly. But there?s no reason for that. We know so much about cancer,' he explains, 'so many things that can interrupt the cancer cycle today that in some respects cancer might be easier to treat than other degenerative diseases.'

Donsbach?s almost casual optimism about his ability to cure cancer is only one of the controversies swirling about him. Twice he has been found to be claiming academic credentials he does not have, and last November he was found guilty of smuggling illegal medications into the United States and of tax evasion. In an interview with the San Diego Union-Tribune, Assistant U.S. Attorney Patrick O?Toole, who prosecuted Donsbach?s case, said that he saw two different portrayals of the accused. 'I got a lot of calls that this guy is a quack, and I got calls that he is a great guy. It doesn?t make any difference if he is a quack or not. You can?t introduce unapproved drugs into interstate commerce.'

Disagreement about value

Recently mainstream medicine has begun to recognize its need to learn more about complementary therapies, but there is still much disagreement about their value.

Approximately 37 U.S. medical schools are beginning to devote a small amount of students? overall medical training to complementary or mind-body medicine?typically one or two courses over the medical school curriculum.

The editors of the Journal of the American Medical Association have announced that publishing research on alternative therapies will be one of its priorities this year. And the attitude of the National Cancer Institute toward alternative treatments seems to be changing.

Another sign of changing times: The budget of the NIH Office of Alternative Medicine grew from $2 million to $20 million last year.

A dimension however, that continues to work against alternative therapies is the regulatory process and the economics of drug research. Moss suggests that when a substance is not patentable, such as many natural substances used in alternative treatments, the economics work against further testing of that substance.

Patent ability wields more influence on which drugs and substances reach the marketplace than does their potential efficacy, according to Moss.

'One feeds the other; the existence of the patent system feeds the regulatory mechanism, and the high regulatory barrier makes the patent system necessary,' he said.

The baseline issue is often an economic one. The cost of bringing a new drug to market is huge. If you cannot patent the substance, as in the case of an herbal tea mixture, the economic motivation to collect the data necessary to bring the product to market just isn?t there.

According to the Office of Alternative Medicine, it can take up to 10 years and millions of dollars to obtain FDA approval of a new drug.

Editor?s note: Ralph Moss will speak at APA?s 1998 Annual Convention. His address 'Alternative and complementary treatments for cancer: telling fact from fiction,' is scheduled for 3 p.m. Sunday, Aug. 16.

Further reading

On the web

? The Moss Reports about Cancer, Robert W. Moss, PhD, http://www.ralphmoss.com

? Office of Alternative Medicine web sites:

altmed.od.nih.gov/oam/clearinghouse and altmed.od.nih.gov/oam/what-is-cam?

? National Cancer Institute web site: www.nci.nih.gov

Other resources

? 'Alternative Medicine: Expanding Medical Horizons. A Report to the National Institutes of Health on Alternative Medical Systems and Practices in the United States.' Washington, D.C.: U.S. Government Printing Office. 1992.

? Fink, John M. 'Third Opinion.' Avery Publishing Group. Garden City Park, N.Y., 1997.