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to Menu Page~improvements in the quality of life, very little documentation exists of either the methods or the results of Burton's therapy. After the hostile reaction by the cancer establishment in the 1970s, Burton retaliated by withdrawing from his former colleagues and ignoring the basic requirements of scientific documentation. A standoff resulted, which OTA was unable to resolve. It is possible that the Freeport clinic, now led by R.J. Clement, and the other existing clinic in Germany will be more willing to cooperate in concrete studies and that serious investigations of immunoaugmentative therapy can now be launched.
714-X
The ideas of French-born Gaston Naessens are a controversial area on the fringe of modern medicine. Naessens, a microbiologist whose formal education was interrupted by World War II before he could earn an advanced degree, has proposed a theory that cancer cells are deficient in nitrogen and can become normal cells if they receive it. Naessen's treatment to provide the nitrogen is a mixture of camphor and nitrogen called 714-X. The camphor is present reputedly to help deliver the nitrogen when 714-X is injected into the lymph system ~in the region of the abdomen. Naessens also uses the treatment for AIDS. To find out whether the 714-X treatment is working, Naessens uses a special microscope that he invented, called a somatoscope. The somatoscope has been described as an altered dark-field microscope. Naessens claims it can visualize living things at magnifications unattainable through the ordinary light microscope. He monitors improvement in his patients by the status of their "somatids," variable particles that he has described in his viewings with the somatosocope.
In the 1980s in Quebec, Naessens was prosecuted for health fraud and threatened with life imprisonment. He was acquitted, however, after many people testified not only to his character, but also to beneficial results from using 714-X. Some of the individuals claiming cures for cancer and AIDS are quoted in Galileo of the Microscope (Bird, 1989).
Many Americans, including former congressman Berkley Bedell (Bedell, 1993), have used 714-X as an unconventional treatment for cancer.4 It has penetrated a number of alternative clinics that concentrate on other treatments. Stories are circulating of dramatic improvements ~or, with AIDS, of conversion from HIV positive to HIV negative. However, Naessens has not published in peer-reviewed literature. Without impartial scientific evaluation, it is difficult to reach conclusions on his work.
Hoxsey Method
The Hoxsey treatments are among the oldest U.S. alternative therapies for cancer and have been some of the most controversial. Like Essiac (see next section), they use a mixture of powerful herbs. These mixtures were probably derived from early Native American Indian medicines, although that connection is not as well established as with Essiac. Some of the same herbs are included in the formulas for both methods.
In the early part of the century Harry Hoxsey, an uncredentialed layman, marketed several cancer treatments in his clinics across the South. He claimed his remedies had been passed down to him by his father and grandfather, and he kept the ingredients secret until 1950. Eventually U.S. authorities shut down Hoxsey's clinics, but the treatment is still available at ~the Bio-Medical Center in Tijuana, Mexico, which is headed by Mildred Nelson, Hoxsey's former nurse assistant. Hoxsey indicated that some of his herbal components were present to necrotize tumors and others, as purgatives, to carry away the waste.
Hoxsey's remedies basically consist of an external salve and an herbal potion. The external medicine is an escharotic--a kind of burning paste--composed of zinc chloride, antimony, trisulfide, and bloodroot; its purpose is to corrode cancers. The paste is used principally for skin cancer (usually basal cell carcinomas), and many ambitious claims have been made for it. However, few reports on its efficacy (or lack thereof) exist in peer-reviewed literature. Moh's micrographic surgery, an orthodox procedure that bears some relationship to the Hoxsey treatment, is cited (Swanson, 1983): Moh's method consists of the use of zinc chloride paste to "fix" the tumor in place; the tumor is then removed in a series of steps.
The internal medication, which is the primary concern here, is made up of various herbs added to a base of potassium iodide and cascara, which is a bark preparation. The principal herbs are pokeweed root, burdock root, barberry (Berberis), buckthorn bark, stillingia root, ~and prickly ash. As Patricia Spain Ward noted in a contract report to OTA for its Unorthodox Cancer Treatments project, many of these roots and barks are now known to have anticancer and immunostimulatory effects.5 The following items discuss several:
• Pokeweed. Pokeweed root (Phytolacca americana) has several effects on the immune system including stimulation of the production of two cytokines (see the glossary), interleukin 1 (IL-1) and tumor necrosis factor (TNF) (Bodger et al., 1979a, 1979b). Boosting the immune system is generally thought to help the body fight cancer.6 Although pokeweed root is poisonous, it apparently has been used without serious toxicity problems since the mid-18th century.
• Burdock root. Burdock root (Arctium lappa) contains what Japanese scientists have called the "burdock factor" (Morita et al., 1984), which is reputed to act as a desmutagen, that is, a substance that reduces mutations. Burdock also has been shown to inhibit HIV, according to the World Health Organization (1989). In Japanese and macrobiotic diets young burdock roots are eaten as a vegetable called "gobo."~ • Buckthorn. Buckthorn contains emodin, which has shown antileukemia activity in the laboratory (Kupchan and Karim, 1976).
It is noteworthy that, despite intense opposition, the Hoxsey formula has persisted as a cancer treatment for almost 100 years (Chowka, 1985). Among numerous anecdotal accounts of its effectiveness, some are hard to dismiss out of hand; it therefore warrants investigation. Despite decades of controversy, no clinical trials have ever been performed by either supporters or detractors of the Hoxsey therapies.7 But since the Hoxsey formula contains the poisonous substance pokeweed, testing the formula is also a public health concern.
Essiac
Like Hoxsey therapy, Essiac is an herbal treatment. Reported to be of Native American (Ojibwa) origin, it was first brought to public attention in 1922 by an Ontario nurse named Renée Caisse (Essiac is Caisse spelled backward). Caisse was impressed by the case of a ~local woman who claimed to have been cured of breast cancer by a local Native American healer. Caisse set up a clinic in Bainbridge and treated thousands of patients before being shut down by the Canadian medical authorities in 1942. One problem was that Caisse never made the formula public during her lifetime (1888-1978).
In 1982 a Canadian government report concluded, "No clinical evidence exists to support the claims that Essiac is an effective treatment for cancer." Nevertheless, the relevant government agency, Health and Welfare Canada (equivalent to FDA in the United States), agreed to make this medication legally available to advanced cancer patients under Canada's Emergency Drug Regulations. It is currently produced as a trademarked product in Canada. This and other versions of Essiac are also widely available through the "cancer underground" in the United States.
There are several different Essiac products, each of which claims to be the one and only authentic Caisse formula. According to author Gary L. Glum, a Los Angeles chiropractor, authentic Essiac contains four ingredients: (1) sheep sorrel (Rumex acetosella); (2) burdock ~(Arctium lappa); (3) slippery elm inner bark (Ulmus fulva); and (4) Turkey rhubarb (Rheum palmatum) (Glum, 1988).
• Sheep sorrel. The main ingredient, sheep sorrel--not to be confused with the more readily available vegetable garden sorrel, also known as "sour grass"--contains vitamins, minerals, carotenoids, and chlorophyll, all of which supposedly have anticancer effects either directly or through immunological or antimutagenic activity (Moss, 1992). Sorrel was the basis of a celebrated cancer "cure" in Virginia in the 1740s, and as jiwisi it was a noted remedy of the Algonquin Ojibwa (Snow, 1993). In folk tradition it is reputed to have many other medicinal qualities as well.
Sorrel also contains generous amounts of oxalic acid as well as emodin, which has been shown to have "significant antileukemia activity" (see discussion of buckthorn in the "Hoxsey Method" section).
• Burdock. (See also the "Hoxsey Method" section.) That the two long standing ~remedies of Hoxsey and Caisse have burdock in common is suggestive, although both formulas were long held in secret, and it is unlikely that Hoxsey and Caisse communicated or even knew of each other's existence. Burdock has been shown to be bioactive in a number of experiments (Dombradi and Foldeak, 1966; Foldeak and Dombradi, 1964; Morita et al., 1984; World Health Organization, 1989).
• Slippery elm inner bark. Slippery elm inner bark was tested by NCI without producing any sign of anticancer activity. Slippery elm lozenges, powdered bark, and slippery elm extracts are often available in health food stores and catalogs, with a wide range of curative and restorative claims listed for them.
• Rhubarb. Rhubarb has been used in Chinese medicine since at least 220 B.C. It is believed to exert a beneficial effect on the liver and gastrointestinal tract. Rhubarb extract showed anticancer activity in the sarcoma 37 test system (Belkin and Fitzgerald, 1952). It contains rhein, an anthraquinone, which has been shown to have antitumor effects (Office of Technology Assessment, 1990).~Essiac is widely used throughout North America, although, unlike ushe of Hoxsey's formula, use of Essiac is not associated with any particular clinic (Snow, 1993).
Coley's Toxins
Like many of the other pharmacological and biological treatments, Coley's toxins have attracted considerable medical and political controversy. More than 100 years ago, a New York bone surgeon at Memorial Hospital, William B. Coley, was investigating new approaches to curing cancer after his surgery failed to save a 19-year-old cancer patient. Coley chose to buttress a patient's immune system by giving him a bacterial infection that would cause a high fever and potently mobilize the patient's immune system to fight the cancer cells. Today, Coley is widely recognized as the first pioneer of immunotherapy--an approach that was virtually unknown in the 1890s.
The preparations that Coley developed were a mixture of killed cultures of bacteria from Streptococcus pyogenes and Serratia marcescens. Although not all patients responded to ~Coley's toxins, his treatment is reported to have shown dramatic curative effects on various cancers for many patients (Coley, 1894). These results were documented by Coley's daughter, Helen Coley Nauts, in a series of articles and monographs (Nauts, 1976, 1982, 1989.) Helen Nauts also founded the Cancer Research Institute in New York in 1953; this institute devotes itself to "the immunological approaches to the diagnosis, treatment, and prevention of cancer."
Nauts's monographs outline remarkable cures from the use of Coley's methods. Lloyd Old, an immunologist at Memorial Sloan-Kettering Cancer Research Center and a colleague, wrote, "Those who have scrutinized Dr. Coley's records have little doubt that the bacterial products that came to be known as Coley's toxins were in some instances highly effective" (Old and Boyse, 1973).
Over the years, Coley's work led to other discoveries. For instance, in the course of work on Coley's toxins in the 1940s, M.J. Shear of NCI discovered lipopolysaccharide (LPS), a component of bacterial cell walls. By injecting LPS into mice previously treated with bacillus ~Calmette-Guérin, Old discovered TNF (Old, 1987, 1988; Oettgen, 1980).
The original Coley formulas are no longer being used, even experimentally, in the United States. Until the 1980s, they were being tested at Temple University, Pennsylvania (Havas et al., 1958; Havas et al., 1990). In his 1990 paper, Havas pointed out that using purified LPS to evoke immune reactions is problematic because of its toxicity and proposed returning to a cruder mixture, a mixed bacterial vaccine similar to Coley's toxins. The research reported in that paper showed the mixed bacterial vaccine to have anticancer and immunostimulatory properties at nontoxic levels in animals with tumors. The authors concluded that the vaccine "compares favorably with other biological response modifiers."
Outside the United States, Coley's toxins are being used in Beijing Children's Hospital, the People's Republic of China, and Germany (Kölmel et al., 1991).
MTH-68
~The MTH-68 vaccine is a form of immunotherapy that employs a little-known biological product against viral diseases and various kinds of cancer. Developed by Lászlo K. Csatáry, a Hungarian-American physician who currently resides in Ft. Lauderdale, FL, MTH-68 therapy is based on the idea that certain nonpathogenic viruses can be used to interfere with the growth of cancer in humans and the activity of harmful viruses.
MTH-68 is a modified attenuated strain of the Newcastle disease virus of chickens (paramyxovirus). In poultry, it causes an acute, fever-causing, generally fatal disease. In humans, however, the worst it does is trigger an acute but transient conjunctivitis (pinkeye), but this side effect is rare (Moss, 1992).
While Csatáry was searching for a virus that would be harmless to humans but would attack cancer viruses, it came to his attention that a chicken farmer in Hungary with advanced metastatic gastric carcinoma had undergone a complete regression of his cancer after his flock experienced an epidemic of Newcastle disease. Csatáry published his early observation in the British medical journal Lancet (Csatáry, 1971). In 1982, 1984, and 1985 ~he published study results and a general article on interference between pathogenic and nonpathogenic viruses (Csatáry et al., 1982, 1984, 1985).
Researchers in Hungary--under the direction of Sandor Eckhardt, the 1990-94 president of the International Union Against Cancer and the director of the Institute of Oncology--completed a multicenter, Phase II, double-blind, placebo-controlled clinical trial with terminal cancer patients (Csatáry et al., 1990; Moss, 1992). According to the statistical analysis in internal reports on the Phase II study, "the number of cases with stabilization or regression was significantly higher in the MTH-68/N group; favorable response in subjective parameters, such as pain relief, occurred in a significantly higher percentage in the MTH-68/N group; and performance status improved in the MTH-68/N group and significantly deteriorated in the placebo group."
Patients in Phase II received MTH-68/N by nasal drops or by inhalation (MTH-68/N is a live virus vaccine derived from the attenuated strain). The researchers say that the treatment has proved to be nontoxic and devoid of side effects. Currently, the Hungarian research ~team is still waiting for financial arrangements for Phase III trials.
A recently published report provides more details concerning the Phase II study (Csatáry et al., 1993). The study subjects had advanced cancers with multiple and widely distributed metastases. The duration of the protocol was 6 months, but those patients who had reacted favorably to treatment were continued on therapy. Further evaluation about survival was done after 1 and 2 years.
There were 59 patients in the study--33 in the MTH-68/N group and 26 in the placebo group. Their tumor types included lung, pancreas, kidney, sigmoid colon, and stomach cancer. In the MTH-68/N group, 2 patients experienced complete remissions, 5 experienced partial remission, 1 had moderate remission, and 10 had stabilization, for a total of 18 positive responses. Median survival time was significantly extended beyond that of the placebo group, which had only 2 stabilizations.
In addition, 26 subjects in the MTH-68/N group versus only 7 in the placebo group had ~either unchanged or increased weight. In the MTH-68/N group, 15 subjects had a sense of better well-being, 13 reported increased appetite, and 11 reported decreased pain; no one in the placebo group reported these effects (Csatáry et al., 1993).
Csatáry is currently negotiating with an American biotechnology company to speed development in the United States, and he has expressed willingness to have OAM conduct clinical trials of his product. He does not treat patients in the United States. Csatáry's explanation of how MTH-68 works is based on his belief that many human cancers are of viral origin.
Three possible mechanisms of antitumor action by the nonpathogenic avian viruses include direct cytolysis (cell killing), tumor-specific immune enhancement, and cytokine (see the glossary) stimulation. Thus, the avian viruses may modify tumor cells and enhance tumor-specific immunity (Schirrmacher et al., 1986). Or they may selectively kill cancer cells. Or they may stimulate a wide variety of cytokines (Csatáry, 1986, 1989), such as TNF (Lorence et al., 1988), interferons (Wheelock, 1966), and interleukins (Van Damme et ~al., 1989).
Neural Therapy
Neural therapy is a healing technique for attempting to deal with chronic pain and other longstanding illnesses and conditions. It involves injecting local anesthetics into autonomic ganglia (nerve cell bodies), peripheral nerves, scars, glands, acupuncture points, trigger points (points that produce a sharp pain when pressed), and other tissues and anatomical sites. Though unfamiliar to most American practitioners--and therefore part of alternative medicine--neural therapy is apparently quite widely used in Europe, especially for the treatment of chronic pain. According to its advocates, such as the American Academy of Neural Therapy, this "gentle healing technique" can instantly and lastingly resolve chronic problems when correctly applied (Klinghardt, 1991).
The history of neural therapy began with the discovery of local anesthetics in the late 19th century. In 1883, the Russian physiologist Ivan Petrov (1849-1936) laid the basis for the ~entire field when he hypothesized that the nervous system exercises a coordinating influence over all organic functions. Before he developed psychoanalysis, Sigmund Freud (1856-1939) discovered the anesthetic effect of cocaine on mucous membranes. In 1890, abdominal surgery was first performed using a 0.2-percent solution of cocaine. In 1903, a French surgeon first employed cocaine as an epidural anesthetic.
One obvious problem with cocaine, however, was its potential to be addictive. In 1904, Alfred Einhorn discovered procaine (novocaine), still widely used in medicine. In 1906, G. Spiess observed that wounds and inflammations subsided with fewer complications if they were first injected with novocaine. In 1925, a French surgeon, René Leriche, used this compound for treating chronic intractable arm pain. He called novocaine "the surgeon's bloodless knife." In the same year, two German physicians described another local effect, claiming that an intravenous injection of novocaine could abolish migraine headaches (Dorman and Raven, 1991; Dosch, 1984).
A key development came in 1940, when Ferdinand Huneke discovered an instant healing ~reaction--what is now called the "lightning reaction" or the "Huneke phenomenon." First, Huneke injected novocaine into the shoulder joint of a woman with a severely painful, frozen right shoulder, but without any beneficial local effect. Instead, unexpectedly, the woman developed severe itching in a seemingly unrelated and relatively distant scar on her lower left leg. On a hunch, Huneke then injected novocaine into the itching scar, and within seconds the woman obtained full and painless range of motion in her right shoulder. The woman's scar dated from an operation on an infected tibia (shin bone). Although the leg operation was a "success," the woman soon afterward developed the frozen shoulder on the opposite side of her body. The initial scar had become, in neural therapy terminology, an interference field (Huneke, F., 1950; Huneke, W., 1952).
By combining the use of local anesthetics with the treatment of such (inferred) interference fields, Huneke and colleagues created an entirely new healing system they called neural therapy (Dosch, 1985). Neural therapy is said to be widely used for pain control in Europe, Russia, and Latin America and by 35 percent of all Western German physicians.
~At first sight, it seems improbable that a scar on the left leg could cause a pain in the right shoulder or be resolved by an injection of local anesthetic into a scar at a site so distant from the shoulder. Dietrich Klinghardt offers several possible explanations for this phenomenon (Klinghardt, 1991), including one that he calls the "nervous system theory." Klinghardt's teacher, A. Fleckenstein, demonstrated that normal body cells and cells in scar tissue have a different electric potential across the cell membrane. In cells that have lost normal potential, the ion flux across the membrane stops (Fleckenstein, 1950). This means that toxic substances and abnormal minerals build up inside the cell. In turn, the cell becomes unable to heal itself and resume normal functioning. Treatment with local anesthetic may help restore ion flux for 1 to 2 hours, which could be enough time for the cell to partially repair itself and resume normal activity.
Another theory is that scar tissue can become, in effect, a "battery" of about 1.5 volts in the body. This scar "battery" sends forth abnormal electrical signals that disturb the autonomic nerve fibers (which lack the protective myelin coating possessed by most other nerve cells in the body). This electrical abnormality can disturb the overall autonomic nervous system, ~leading to systemic, and often severe, bodily dysfunction.
Also proposed is what Klinghardt calls the "fascial continuity theory." According to this theory, the fascia, or sheaths of connective tissues, are all interconnected. If scar tissue is present anywhere in this system, fascial movement can become impaired. Klinghardt claims that back pain, for instance, can sometimes be completely resolved by injecting a local anesthetic (novocaine or lidocaine without epinephrine) into a scar, such as that from an appendectomy or gallbladder operation.
In addition to its antipain functions, neural therapy has been used to treat allergies, chronic bowel problems, kidney disease, prostate and female urogenital problems, infertility, and tinnitus (Brand, 1983), as well as other problems (Pischinger, 1991). Klinghardt contends that although many diseases and conditions can be successfully treated by a variety of healing techniques, some conditions can be treated successfully only with neural therapy.
If it is an effective method, why is neural therapy not more widely accepted in the United ~States? One explanation may be that it does not lend itself to a double-blind study. According to Klinghardt, "each patient with low back pain needs to be treated in a different way." In addition, neural therapy also requires a meticulous injection technique and detailed history taking, both of which are time-consuming.
Apitherapy
Apitherapy is the medicinal use of various products of Apis mellifera--the common honeybee--including raw honey, pollen, royal jelly, wax, propolis (bee glue), and venom. Various studies attribute antifungal, antibacterial, anti-inflammatory, antiproliferative, and cancer-drug-potentiating properties to honey (Science News, 1993). In China, for example, raw honey is applied to burns as an antiseptic and a painkiller. Recently, propolis (the bee product that cements a hive together) has been identified as containing substances called caffeic esters that inhibit the development of precancerous changes in the colon of rats given a known carcinogen (Rao et al., 1993). Preparations from pieces of honeycomb containing pollen are reported to be successful for treating allergies, and bee pollen is touted as an ~excellent food. This section focuses on bee venom to treat chronic inflammatory illness because of the popularity of this treatment and the availability of related research material.
That forms of apitherapy have been used since ancient times is not remarkable, because bees formed an important part of many early economies. Ancient writers as diverse as Hesiod (ca. 800 B.C.), Aristophanes (ca. 450-ca. 388 B.C.), Varro (166-27 B.C.), and Columella (1st century A.D.) all wrote on the cultivation of the hive, and Charlemagne (742-814 A.D.) is said to have had himself treated with beestings. The Koran (XVI: 71) refers to bee products in the following terms: "There proceeded from their bellies a liquor wherein is a medicine for men" (Kim, 1986). For apiculture and the scientific understanding of bees, real progress began about 100 years ago when physician Phillip Terc of Austria advocated the deliberate use of beestings in his 1888 work, Report about a Peculiar Connection Between the Beestings and Rheumatism.
Today's proponents of apitherapy cite the benefits of bee venom for alleviating chronic pain and for treating many ailments including various rheumatic diseases involving inflammation ~and degeneration of connective tissue (e.g., several types of arthritis), neurological disease (e.g., multiple sclerosis, low back pain, migraine), and dermatological conditions (e.g., eczema, psoriasis, herpesvirus infections).
In one sample description of the use of bee venom therapy, a physician reported anecdotally that among 128 patients with a wide spectrum of illnesses, all but 11 appeared to improve (Klinghardt, 1990). (Of the 11 who did not improve, 1 was worse and 10 were unchanged.) This report is typical of anecdotal apitherapy reports that begin with stories of beekeepers recounting various health improvements after receiving accidental multiple stings from their bees. Klinghardt's patients had diagnoses of gout, rheumatoid arthritis, fibromyalgia, spinal strain or sprain, spinal disc injuries, postlaminectomy pain, bunion, postherpetic neuralgia, incomplete healing of a fractured bone, intractable pain from large burn wounds, osteoarthritis, ankylosing spondylitis, vertigo, and multiple sclerosis. Earlier, Steigerwaldt and colleagues (1966) reported improvement among 84 percent of 50 cases of arthritis in a controlled study.
~In contrast, interest in bees has been sporadic in conventional medicine, focusing mainly on three areas unrelated to the therapeutic uses proposed above. These areas are (1) the danger of hypersensitivity reactions, including anaphylactic shock, from the sting of insects of the genus Apis; (2) the use of bee venom itself as immunotherapy for allergic reaction to such stings, especially to prevent life-threatening anaphylactic reactions in adults; and (3) the danger of infants contracting botulism from ingesting raw honey--possibly one death every 2 to 5 years (Wyngaarden and Smith, 1988).
The modern movement promoting apitherapy is spearheaded by veteran beekeeper Charles Mraz of Vermont and physician Bradford Weeks of Washington State, assisted by other members of the American Apitherapy Society. They cite studies identifying various biological properties for semipurified fractions of bee venom and for more purified products to help explain the curative properties attributed to this venom. Table 1, adapted from Klinghardt (1990), summarizes these properties, which include pronounced anti-inflammatory, analgesic, and immunostimulatory properties.
~The American Apitherapy Society contends that hypersensitivity reactions to bee venom therapy are very rare, occuring mostly from stings by related species but not by the honeybee. The procedures the society recommends include always testing a new patient first with a small amount of venom to look for possible allergic reactions and never using bee venom without an emergency beesting kit (containing epinephrine) available.
In practice, proponents say that the best results are obtained when there is a "good reaction"--considerable swelling and inflammation--at the site of sting. Mraz believes that the optimal means of delivering venom is through a hypodermic needle administered by a licensed physician. However, since most medical practitioners do not recognize the benefits of bee venom, practicing apitherapists almost always use "the original hypodermic needle developed by Mother Nature and the honeybee some 30 million years ago: the bee stinger." Procedures for obtaining and purifying venom have been developed, but of course this product in liquid or dried form costs more than using live bees.
The usual treatment involves stinging the patient at a specific site relative to the illness and
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