Stephen Barrett, M.D.
Questionable Cancer Therapies
- Has the method been objectively demonstrated in the peer-reviewed scientific literature to be effective?
- Has the method shown potential for benefit that clearly exceeds the potential for harm?
- Have objective studies been correctly conducted under appropriate peer review to answer these questions?
FDA Historian Wallace F. Janssen has noted that in every decade since 1940, a questionable cancer remedy has attracted a large following and become a national issue [2]. It was Koch Antitoxins in the 1940s, Hoxsey treatment in the 1950s, Krebiozen in the 1960s [3], laetrile in the 1970s, and immuno-augmentative therapy in the 1980s. Today’s questionable methods include corrosive agents, plant products, special diets and „dietary supplements,“ drugs, correction of „imbalances,“ biologic methods, devices, miscellaneous concoctions, psychological approaches, and worthless diagnostic tests. Many promoters combine methods to make themselves more marketable. A 1987 ACS investigation found that 452 (9%) of 5,047 cancer patients identified through a telephone survey had used questionable treatments. Of these, 49% had used „mind therapies“ (mental imagery, hypnosis, or psychic therapy) and 38% had used diets [4]. The dangers of using questionable treatments include delay in getting appropriate treatment, decreased quality of life, direct physical harm, interference with proven treatment, waste of valuable time, financial harm, and psychological damage [5].
Quackwatch has heard from many people who have been defrauded of large sums of money pursuing nonexistent cancer „cures.“ Most of these cases involved offshore clinics to whom money was wired in advance. The Federal Bureau of Investigation (FBI) has jurisdiction over cases involving wire fraud. Americans who believe they have been victims of wire fraud should report what happened to the FBI.
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Typical Misrepresentations
Proponents of questionable methods typically claim that marketplace demand and testimonials from satisfied customers are proof that their remedies work. However, proponents almost never keep score or reveal what percentage of their cases end in failure. Cancer cures attributed to questionable methods usually fall into one or more of five categories:
- The patient never had cancer.
- A cancer was cured or put into remission by proven therapy, but questionable therapy was also used and erroneously credited for the beneficial result
- The cancer is progressing but is erroneously represented as slowed or cured.
- The patient has died as a result of the cancer (or is lost to follow-up) but is represented as cured.
- The patient had a spontaneous remission (very rare) or slow-growing cancer that is publicized as a cure.
Promoters of questionable methods often misrepresent their methods as „alternatives.“ Genuine alternatives are comparable methods that have met the criteria for safety and effectiveness. Experimental alternatives are unproven but have a plausible rationale and are undergoing responsible investigation. Questionable „alternatives“ are unproven and lack a scientifically plausible rationale. When referring to the latter, we use quotation marks because they are not true alternatives. Some promoters of „alternative“ methods are physicians or other highly educated scientists who have strayed from scientific thought. The factors that motivate them can include delusional thinking, misinterpretation of personal experience, financial considerations, and pleasure derived from notoriety and/or patient adulation.
Misinformation about questionable cancer therapies is spread through books, articles, audiotapes, videotapes, talk shows, news reports, lectures, health expositions, „alternative“ practitioners, information and referral services, and word of mouth. Promoters typically explain their approach in commonsense terms and appear to offer patients an active role in their care: (a) cancer is a symptom, not a disease; (b) symptoms are caused by diet, stress, or environment; (c) proper fitness, nutrition, and mental attitude allow biologic and mental defense against cancer; and (d) conventional therapy weakens the body’s reserves, treats the symptoms rather than the disease [6]. Questionable therapies are portrayed as natural and nontoxic, while standard (responsible) therapies are portrayed as highly dangerous. The figure below comes from a misleading comic book designed to undermine public trust in conventional methods.
During the past few years, the news media have publicized „alternative“ methods in ways that are causing great public confusion. Most of these reports have contained no critical evaluation and have featured the views of proponents and their satisfied clients. Many have exaggerated the significance of the National Institutes of Health (NIH)’s Office of Alternative Medicine (OAM)—now called the Center for Research in Alternative and Complementary Medicine—whose creation was spearheaded by promoters of questionable cancer therapies who wanted more attention paid to their methods. Most of the its advisory panel members have been promoters of „alternative“ therapies. In 1994, the OAM’s first director resigned, charging that political interference had hampered his ability to carry out OAM’s mission in a scientific manner [7]. The OAM has funded several dozen studies related to „alternative“ methods, including a few related to cancer treatment. However, it remains to be seen whether such research will yield useful results. Even if it does, the benefit is unlikely to outweigh the publicity bonanza given to questionable methods. Some of today’s „alternative“ methods are described below in alphabetical order. Longer reports on many of the methods can be accessed by following the hyperlinks.
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Antineoplastons
Stanislaw R. Burzynski, M.D., has given the name „antineoplastons“ to substances he claims can „normalize“ cancer cells that are constantly being produced within the body. He has published many papers stating that antineoplastons extracted from urine or synthesized in his laboratory have proven effective against cancer in laboratory experiments. He also claims to have helped many people with cancer get well. A 1992 analysis concluded that none of Burzynski’s „antineoplastons“ has been proven to normalize tumor cells [8].
In 1988, Burzynski got a tremendous boost when talk-show hostess Sally Jesse Raphael featured four „miracles,“ patients of Burzynski, who she said were cancer-free. The patients stated that Burzynski had cured them when conventional methods had failed. In 1992, „Inside Edition“ reported that two of the four patients had died and a third was having a recurrence of her cancer. (The fourth patient had bladder cancer, which has a good prognosis.) The widow of one of Raphael’s guests stated that her husband and five others from the same city had sought treatment after learning about Burzynski from a television broadcast—and that all had died of their disease. In 1995, a federal grand jury indicted Burzynski for mail fraud and marketing an unapproved drug. The indictment charged that he had billed insurance companies using procedure codes for chemotherapy, even though his treatment was not chemotherapy. He was tried in 1997 but not convicted.
In 1998, the Texas Attorney General secured a consent agreement stating that Burzynski: (a) cannot distribute unapproved drugs in Texas; (b) can distribute „antineoplastons“ only to patients enrolled in FDA approved clinical trials, unless the FDA approves his drugs for sale; (c) cannot advertise „antineoplastons“ for the treatment of cancer; and (d) on his website and in promotional material and ads must place a disclaimer that the safety and effectiveness of „antineoplastons“ have not been established. The agreement also called for Burzynski to pay $50,000 to reimburse the Attorney General’s office and the Texas Health Department for the cost of their investigation [9]. The Cancer Letter subsequently noted that although Burzynski has set up many „clinical trials,“ they do not conform to usual standards [10].
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CanCell
CanCell—originally called Entelev and recently renamed Cantron and Protocel—is a liquid claimed to cure cancer by „lowering the voltage of the cell structure by about 20%,“ causing cancer cells to „digest“ and be replaced with normal cells. Accompanying directions have warned that bottles of CanCell should not be allowed to touch each other or be placed near any electrical appliance or outlet. CanCell has also been promoted for the treatment of AIDS, amyotrophic lateral sclerosis, multiple sclerosis, Alzheimer’s disease, „extreme cases of emphysema and diabetes,“ and several other diseases. In 1989, the FDA reported that CanCell contained inositol, nitric acid, sodium sulfite, potassium hydroxide, sulfuric acid, and catechol. Subsequently, its promoters claimed to be modifying the formulation to make it more effective [11]. They have also claimed that CanCell can’t be analyzed because it varies with atmospheric vibrations and keeps changing its energy [12]. Laboratory tests conducted between 1978 and 1991 by the NCI found no evidence that CanCell was effective against cancer. The FDA has obtained an injunction forbidding its distribution to patients.
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Cell Specific Cancer Therapy (also called Zoetron Therapy)
According to information on the promoter’s web site during 1997, Cell Specific Cancer Therapy (CSCT) was applied with a device that was four inches thick, shaped like a donut, and exposed the patient to a magnetic field that was much weaker than that of magnetic resonance imaging. It was offered a clinic in the Dominican Republic that later was moved to Mexisco. The advertised fee was $20,000, payable in advance, but the fee was sometimes reduced or waived for people unable to pay. CSCT was claimed not to cure cancer but to „destroy active cancerous cells in a body and to do so without causing any damage to healthy cells.“ Its stated objective was to destroy enough cancerous cells that the body’s immune system is „once again able to take over and do its normal job.“ The device was claimed to „detect cancerous cells with a sensitivity much greater than that of either conventional magnetic resonance imaging (MRI) or CAT scans“ and to destroy cancer cells without harming adjacent normal cells.“ The promoter claimed that cancerous cells have an „atypical metabolic mechanism that made them „susceptible to polarizing electromagnetic fields.“ There is no scientific evidence that magnetic energy can selectively destroy cancer cells. Coordinated action by agencies in the United States, Canada, and Mexico resulted in closure of the clinic in 2003. Similar treatment was offered at the Davidson Cancer Clinic in Mexico, whose proprietor was imprisoned for fraud.
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Clark’s „Cure for All Cancers“
Hulda Clark, Ph.D., N.D., an unlicensed naturopath claimed that (a) all cancers and many other diseases are caused by „parasites, toxins, and pollutants“; (b) cancers can be detected with a blood test for ortho-phospho-tyrosine and a device that identifies diseased organs and toxic substances; (c) cancers can be cured by killing the parasites and ridding the body of environmental chemicals; (d) black walnut hulls, wormwood, and common cloves can rid the body of over 100 types of parasites; and (e) the amino acids ornithine and arginine improve this recipe. Her book Cure for All Cancers, contains 103 case histories of her supposed cancer cures. However, judging from her descriptions (a) most did not have cancer, and (b) of those that did, most had received standard medical treatment or their tumors were in early stages. In 2009, Clark died of complications of multiple myeloma, a form of lymphoma in which plasma cells become overabundant in the bone marrow. Information posted by supporters suggests that life was shortened because she treated herself rather than seeking timely and appropriate medical care.
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Devices
Many types of devices are used with unfounded claims that they are effective against cancer. These include devices that pass low-voltage electrical current through tumors or the body, „electroacupuncture“ devices purported to measure the electrical resistance of „acupuncture points,“ electrical devices claimed to „charge“ blood samples taken from patients and later reinjected, negative ion generators claimed to have an effect against tumors, radionics devices claimed to diagnose and cure cancer by analyzing and emitting radio waves at the correct frequencies, magnets claimed capable of curing cancers by „improving circulation“ or by intracellular effects, and projectors of colored light claimed to exert healing effects [13].
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Essiac
Essiac is an herbal remedy that was prescribed and promoted for about 50 years by Rene M. Caisse, a Canadian nurse who died in 1978. Shortly before her death, she turned over the formula and manufacturing rights to the Resperin Corporation, a Canadian company that has provided it to patients under a special agreement with Canadian health officials. Several reports state that the formula contains burdock, Indian rhubarb, sorrel, and slippery elm, but there may be additional ingredients. Essiac tea claimed to be Caisse’s original formulation is also marketed in the United States. Several animal tests using samples of Essiac have shown no antitumor activity. Nor did a review of data on 86 patients performed by the Canadian federal health department during the early 1980s [14].
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Fresh cell therapy, also called live cell therapy or cellular therapy, involves injections of fresh embryonic animal cells taken from the organ or tissue that corresponds to the unhealthy organ or tissue in the patient. Proponents claim that the recipient’s body automatically transports the injected cells to the target organ where they repair and rejuvenate the ailing cells. The American Cancer Society states that fresh cell therapy has no proven benefit and has caused serious side effects (infections and immunologic reactions to the injected protein) and death [15]. In 1984, The FDA issued an Import Alert asking the U.S. Customs and Postal Services to block the importation of all „cell therapy“ powders and extracts intended for injection.
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Gerson Method
Proponents of the Gerson diet claim that cancer can be cured only if toxins are eliminated from the body. They recommend „detoxification“ with frequent coffee enemas and a low-sodium diet that includes more than a gallon a day of juices made from fruits, vegetables, and raw calf’s liver. This method was developed by Max Gerson, a German-born physician who emigrated to the United States in 1936 and practiced in New York City until his death in 1959. Gerson therapy is still available at Hospital Meridien in Tijuana, Mexico and, since February 1997, at the Gerson Healing Center in Sedona, Arizona.
Gerson therapy is still actively promoted by his daughter, Charlotte Gerson, through lectures, talk show appearances, and publications of the Gerson Institute in Bonita, California. Gerson protocols have included liver extract injections, ozone enemas, „live cell therapy,“ thyroid tablets, royal jelly capsules, linseed oil, castor oil enemas, clay packs, laetrile, and vaccines made from influenza virus and killed Staphylococcus aureus bacteria.
In 1947, the NCI reviewed ten cases selected by Dr. Gerson and found his report unconvincing. That same year, a committee appointed by the New York County Medical Society reviewed records of 86 patients, examined ten patients, and found no evidence that the Gerson method had value in treating cancer. An NCI analysis of Dr. Gerson’s book A Cancer Therapy: Results of Fifty Cases concluded in 1959 that most of the cases failed to meet the criteria (such as histologic verification of cancer) for proper evaluation of a cancer case [16]. A recent review of the Gerson treatment rationale concluded: (a) the „poisons“ Gerson claimed to be present in processed foods have never been identified, (b) frequent coffee enemas have never been shown to mobilize and remove poisons from the liver and intestines of cancer patients, (c) there is no evidence that any such poisons are related to the onset of cancer, (d) there is no evidence that a „healing“ inflammatory reaction exists that can seek out and kill cancer cells [17].
Between 1980 and 1986 at least 13 patients treated with Gerson therapy were admitted to San Diego area hospitals with Campylobacter fetus sepsis attributable to the liver injections [18]. None of the patients was cancer-free, and one died of his malignancy within a week. Five were comatose due to low serum sodium levels, presumably as a result of the „no sodium“ Gerson dietary regimen. As a result, Gerson personnel modified their techniques for handling raw liver products and biologicals. However, the Gerson approach still has considerable potential for harm. Deaths also have been attributed to the coffee enemas administered at the Tijuana clinic.
Charlotte Gerson claims that treatment at the clinic has produced high cure rates for many cancers. In 1986, however, investigators learned that patients were not monitored after they left the facility [19]. Although clinic personnel later said they would follow their patients systematically, there is no published evidence that they have done so. A naturopath who visited the Gerson Clinic in 1983 was able to track 21 patients over a 5-year period (or until death) through annual letters or phone calls. At the 5-year mark, only one was still alive (but not cancer-free); the rest had succumbed to their cancer [20].
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The principal proponent of the Greek Cancer Cure was microbiologist Dr. Hariton-Tzannis Alivizatos, of Athens, Greece, who died in 1991. He claimed to have a blood test that could determine the type, location, and severity of any cancer. He also asserted that his „serum“ enabled the patient’s immune system to destroy cancer cells, and helped the body rejuvenate parts destroyed by cancer. Knowledgeable observers believe that the principal ingredient of the so-called Greek Cancer Cure was niacin. The American Cancer Society and the NCI asked Alivizatos several times for detailed information on his methods, but he never replied [21].
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Naturopath Harry Hoxsey promoted an herbal treatment consisting of an externally used paste or powder and a tonic taken orally. The external preparations contained corrosive agents such as arsenic sulfide. The internal medicine, said to be adjusted on a case-by-case basis, contained potassium iodide and such things as red clover, licorice, burdock root, Stillingia root, Berberis root, pokeroot, cascara, prickly ash bark, and buckthorn bark. Hoxsey said that the formulas were developed in 1840 by his great grandfather and passed to him by his father while the latter was dying of cancer.
Hoxsey’s treatment was offered at clinics in the United States from 1924 until repeated clashes with the FDA led him to close his main clinic in Dallas in the late 1950s. In 1963, Hoxsey’s former chief nurse Mildred Nelson began offering it at a clinic in Tijuana, Mexico [22]. Hoxsey himself contracted prostate cancer in 1967 and underwent surgery after treating himself unsuccessfully with his tonic. Most of the herbs in the tonic have been tested for antitumor activity in cancer, with negligible results for a few and no results for the others. Some of these herbs, most notably pokeroot, have toxic side effects. The NCI evaluated case reports submitted by Hoxsey and concluded that no assessment was possible because the records did not contain adequate information [23]. Hoxsey died in 1974. Nelson died in January 1999.
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In the mid-1970s, hydrazine sulfate was proposed for treating the progressive weight loss and debilitation characteristic of advanced cancer. Based on animal data and preliminary human studies, it has also been claimed to cause tumor regression and subjective improvement in patients. However, three recent trials sponsored by the National Cancer Institute demonstrated no benefit attributable to hydrazine sulfate [24-26]. The trials involved 243 patients with newly diagnosed non-small cell lung cancer, 266 patients with advanced non-small cell lung cancer, and 127 patients with advanced colorectal cancer. The largest of the three found that nerve damage occurred more often and that quality of life was significantly worse in the hydrazine sulfate group. After these studies were published, proponents claimed that they were flawed because patients were permitted to ingest tranquilizers, barbiturates, or alcohol, which allegedly would nullify the effect of hydrazine sulfate. The National Cancer Institute rejected these concerns, and an investigation by United States General Accounting Office found no difference in survival times between the patients who had taken these drugs and those who had not [27]. In December 2000, the Annals of Internal Medicine published a case report of a 55-year-old man with cancer of the sinus near his left cheekbone. Instead of undergoing recommended medical treatment, he obtained hydrazine sulfate through a Web site and, for four months, followed the regimen published on the kathykeeton.com Web site. Two weeks later, he was hospitalized with signs of kidney and liver failure. Despite intensive hospital care, he died within a week [28,29].
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„Hyperoxygenation“ therapy—also called „bio-oxidative therapy“ and „oxidative therapy“—is based on the erroneous concept that cancer is caused by oxygen deficiency and can be cured by exposing cancer cells to more oxygen than they can tolerate. The most touted agents are hydrogen peroxide, germanium sesquioxide, and ozone. Although these compounds have been the subject of legitimate research, there is little or no evidence that they are effective for the treatment of any serious disease, and each has demonstrated potential for harm [30]. Germanium products have caused irreversible kidney damage and death [31]. The FDA has banned their importation and seized products from several U.S. manufacturers.
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Immuno-augmentative therapy (IAT) was developed by Lawrence Burton, Ph.D., a zoologist who claimed he could stimulate the immune system’s natural ability to detect and destroy cancer cells. He claimed to accomplish this by injecting protein extracts isolated with processes he had patented. However: (a) the immune system does not detect and destroy cancer cells as Burton postulated, and (b) the substances he claimed to use cannot be produced by the procedures described in his patent applications and have not been demonstrated to exist in the human body [32].
NCI scientists who analyzed IAT treatment materials given to several patients concluded that the materials were dilute solutions of ordinary blood proteins, primarily albumin. None were electrophoretically pure, and none contained Burton’s postulated components. Burton did not publish detailed clinical reports, divulge to the scientific community the details of his methods, publish meaningful statistics, conduct a controlled trial, or provide independent investigators with specimens of his treatment materials for analysis. During the mid-1980s, several of his patients developed serious infections following IAT [33].
In 1980, CBS-TV’s „60 Minutes“ gave Burton a tremendous publicity boost when a prominent physician stated that one of his patients appeared to have recovered miraculously with Burton’s treatment. Although the patient died of his cancer twelve days after the program was shown, „60 Minutes“ refused to inform viewers of this fact. In 1986, the Congressional Office of Technology Assessment assembled a group of technical experts and representatives of Burton to design a clinical trial to evaluate IAT. However, communication between Burton and U.S. government authorities broke down after he insisted that a „pre-test“ be conducted at his clinic [34]. Burton died in 1993, but the clinic is still operating.
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Iscador
Iscador is an extract of mistletoe first proposed for the treatment of cancer in 1920 by Rudolph Steiner (1861-1925), who espoused many occult beliefs. Steiner founded the Society for Cancer Research to promote mistletoe extracts and occult-based practices he called anthroposophical medicine. A 1962 report by the society claimed that the time of picking the plants was important because they react to the influences of the sun, moon, and planets. Various mistletoe juice preparations have been studied with the hope of finding an effective anticancer agent. However, in 1984, the expert working group of the Swiss Society for Oncology concluded that there was no evidence that Iscador was effective against human cancers [35]. To date, more than 30 clinical studies have investigated imistletoe as a cancer treatment. The National Cancer Institute has concluded: „Reports of improved survival and/or quality of life have been common, but nearly all of the studies had major weaknesses that raise doubts about the reliability of the findings.“ [36]
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To be continued …
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Original source for the text: http://www.quackwatch.org
www.prirodanadar.rs www.prirodanadar.com www.natureasthegift.com
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