Girouard and his company have also been warned by the FDA that their devices require professional supervision and cannot be legally marketed directly to consumers. The warning letter states that Girouard obtained marketing clearance only for use in medically indicated colon cleansing, such as before radiologic or sigmoidoscopic examinations. The suit alleges that the woman was unsupervised when she administered the "colonic," perforated her colon early in the procedure, required surgery the same day, and remained seriously ill for several months before she died from liver failure. The complaint also alleges that Years to Your Life Health Center falsely advertised colonic irrigations as "painless" procedures which provided health benefits including an improved immune system and increased energy, as well as relief from indigestion, diarrhea, constipation, weight loss, body odor, candida, acne, mucus colitis, gas, food cravings, fatigue, obesity, diverticulosis, bad breath, parasitic infections, and premenstrual syndrome. In 1997, the FDA warned Girouard about safety violations and warned Tiller Mind and Body, Inc. (another defendant) about illegal claims and manufacturing violations.

Colonic irrigation has no rational role in the prevention or treatment of any health problem. The Colon Therapeutics Web site actually states that "there are no proven medical benefits from colonics."

In December 2003, the Texas Attorney General announced that he had filed a total of six lawsuits against Eternal Health Inc., dba Years to Your Life and Cynthia Pitre; Jennifer Jackson, dba Body Cleanse Spa; Tiller Mind Body Inc., dba Mind Body Naturopathic Institute and Jerri Tiller; Colon Therapeutics Inc. and Jimmy John Girouard; International Association for Colon Hydrotherapy, Class 3 Study Group and Augustine R. Hoenninger III; Linda Gonzalez, dba El Paso Health Center. The suits charge that all of the defendants have engaged in the promotion, sale or unauthorized use of prescription devices for colonic hydrotherapy treatments without physician involvement. The state is seeking (a) temporary and permanent injunctions, (b) civil penalties of up to $25,000 per day per violation of the state's Health and Safety Code, (c) civil penalties of up to $20,000 per violation of the state's Deceptive Trade Practices Act, (d) investigative costs, and (e) attorneys' fees.

COLON THERAPEUTICS, INC.

The plaintiffs, the Estate of Laverne Burrell, by and through its Administrator, Duane Burrell, Duane Burrell, Individually, Diane Hampton, and Lindell Burrell, file this Seventh Amended Petition complaining of the following defendants: Cynthia Pitre, Eternal Health, Inc. d/b/a Years to Your Life Health Centers, Jimmy John Girouard, Colon Therapeutics, Inc.. Alice Coudrain, Tiller Mind and Body, Inc., the International Association for Colon Hydrotherapy, Candace L. Stowers, Colon Therapeutics Research Institute, Atlantis Plastics Company, and PFI Molding, Inc. For causes of action, the plaintiffs respectfully show the following.

Colon Therapeutics, Inc. has answered this lawsuit.

The International Association for Colon Hydrotherapy has answered this lawsuit.

Colon Therapeutics Research Institute has not yet answered this lawsuit.

Venue is proper in Jefferson County, Texas because Jimmy John Girouard resides in Jefferson County, Texas, and because his company, Colon Therapeutics, Inc., is located in Jefferson County, Texas.

On August 14, 2002, Laverne Burrell died from complications of a punctured colon. Ms. Burrell's colon was punctured on April 20, 2002 when she received a "colonic" at Years to Your Life Health Centers. Ms. Burrell was in immediate severe pain, and she died a slow and painful death over the next 116 days.

When Laverne Burrell arrived at Years to Your Life Health Centers, Candace L. Stowers, an employee, took Ms. Burrell into a room where she was shown a video about proper nutrition. The video had nothing to do with the colonic procedure that Ms. Burrell was about to receive. When the video was over, Candace L. Stowers took Ms. Burrell into a second room which contained an inclined colon irrigation table. Ms. Burrell was briefly told how to administer the procedure to herself, which included disrobing from the waist down, climbing up on the table, and sliding down on the table until a plastic tube located in the middle of the table was pushed into her rectum. Ms. Burrell was told to then press a button which would start the flow of water into her colon. Ms. Burrell was left to do this alone.

Ms. Burrell started the process as she had been instructed by Candace Stowers, but began suffering severe abdominal pain almost immediately. Unbeknownst to her, the plastic water nozzle from the irrigation table had punctured her colon, which began leaking and poisoning her internal organs. No one from Years to Your Life Health Centers offered Ms. Burrell assistance or called an ambulance.

Ms. Burrell's condition worsened, and she was hospitalized within two or three hours of receiving the colonic. That night, emergency surgery was required to resect Ms. Burrell's colon, wash out her abdominal cavity, and perform a colostomy. A few weeks later while still in the hospital, an intestinal obstruction developed which required a second surgery. During the second surgery, infection was found in Ms. Burrell's pelvis area. Ms.

Colon Therapeutics, Inc.;

Jimmy John Girouard, Colon Therapeutics, and Alice Coudrain manufactured and sold the colon irrigation table that was used to administer the colonic to Laverne Burrell. Jimmy John Girouard and Colon Therapeutics, Inc. are "sellers" and "manufacturers" of defective products, as defined by Section 82.001(3) & (4) of the Texas Civil Practice & Remedies Code. Alice Coudrain is a "seller" of defective products, as defined by Section 82.001(3) of the Texas Civil Practice & Remedies Code. These defendants' products were prescription medical devices which could only be possessed by, and used on the order of, a licensed physician. Despite these restrictions, Jimmy John Girouard, Colon Therapeutics, Inc., and Alice Coudrain sold these products to anyone, regardless of their medical training.

Atlantis Plastics Company manufactured the rigid plastic tubing that was a component part of the rectal nozzle that Jimmy John Girouard, Colon Therapeutics, and Alice Coudrain incorporated into their colon irrigation table. Therefore, Atlantis Plastics Company is a "seller" and a "manufacturer" of defective products, as defined by Section 82.001(3) & (4) of the Texas Civil Practice & Remedies Code. On information and belief, Laverne Burrell was administered a colonic using a rectal nozzle that had been manufactured by Atlantis Plastics Company.

As such, the nozzle tips were component parts of the rectal nozzles that Jimmy John Girouard, Colon Therapeutics, and Alice Coudrain incorporated into their colon irrigation table. Therefore, PFI Molding, Inc. is a "seller" and a "manufacturer" of defective products, as defined by Section 82.001(3) & (4) of the Texas Civil Practice & Remedies Code. On information and belief, Laverne Burrell was administered a colonic using a rectal nozzle that had a tip on it that had been manufactured by PFI Molding, Inc.

In addition, Jimmy John Girouard, Colon Therapeutics, Inc., Alice Coudrain, and Colon Therapeutics Research Institute trained Cynthia Pitre regarding the administration of colonics, even though they had no college degrees or medical training. Upon the conclusion of the defendants' multi-day training course in a trailer located behind Jimmy John Girouard's house, Cynthia Pitre had no medical credentials whatsoever, and she had no authority to possess, prescribe, or use the prescription medical devices that were designed, manufactured, and sold by Jimmy John Girouard, Colon Therapeutics, Inc., and Alice Coudrain. On behalf of the "Board of Examiners of Colon Therapeutics Research Institute," Jimmy John Girouard signed Cynthia Pitre training certificate as a "certified instructor," and Alice Coudrain signed the certificate as a "certified examiner." The defendants knew or should have known of these restrictions, yet their training course failed to inform Cynthia Pitre in this regard. This same training course also failed to inform Cynthia Pitre of the serious risks associated with colonics, even though these defendants knew or should have known of these risks.

Finally, the International Association for Colon Hydrotherapy (which is abbreviated as "I-ACT") is an organization of colon hydrotherapists located in San Antonio. It has no government affiliation or sponsorship whatsoever. On information and belief, I-ACT created the curriculum that was used by Jimmy John Girouard, Colon Therapeutics, Inc., Alice Coudrain, and Colon Therapeutics Research Institute to teach Cynthia Pitre and Candace L. Stowers about colonics.

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Around the turn of the twentieth century many physicians accepted the concept of autointoxication, but it was abandoned after scientific observations proved it wrong. In 1919 and 1922, it was clearly demonstrated that symptoms of headache, fatigue, and loss of appetite that accompanied fecal impaction were caused by mechanical distension of the colon rather than by production or absorption of toxins . Moreover, direct observation of the colon during surgical procedures or autopsies found no evidence that hardened feces accumulate on the intestinal walls.

Some chiropractors, naturopaths, and assorted food faddists claim that "death begins in the colon" and that "90 percent of all diseases are caused by improperly working bowels." The practices they recommend include fasting, periodic "cleansing" of the intestines, and colonic irrigation.

The Total Health Connection and Canadian Natural Health and Healing Center Web sites provide more details of proponents' claims. The latter states that "there is only one cause of disease—toxemia" and offers "the most comprehensive in-depth colon therapy on the continent." The course costs $985 for 5 days of in-clinic training or $295 by correspondence.

Although laxative ads warn against "irregularity," constipation should be defined not by the frequency of movements but by the hardness of the stool. Ordinary constipation usually can be remedied by increasing the fiber content of the diet, drinking adequate amounts of water, and engaging in regular exercise. If the bowel is basically normal, dietary fiber increases the bulk of the stool, softens it, and speeds transit time. Defecating soon after the urge is felt also can be helpful because if urges are ignored, the rectum may eventually stop signaling when defecation is needed. Stimulant laxatives (such as cascara or castor oil) can damage the nerve cells in the colon wall, decreasing the force of contractions and increasing the tendency toward constipation.

The FDA classifies colonic irrigation systems as Class III devices that cannot be legally marketed except for medically indicated colon cleansing (such as before a radiologic endoscopic examination).

No system has been approved for "routine" colon cleansing to promote the general well being of a patient. Since 1997, the agency has issued at least seven warning letters related to colon therapy:

In 1997, Colon Therapeutics, of Groves, Texas, and its owner Jimmy John Girouard were warned about safety and quality control violations of the Jimmy John colon hydrotherapy unit and related devices .

In 1997, Colon Hygiene Services, of Austin, Texas and its owner Rocky Bruno was notified that their colonic irrigation system could not be legally marketed without FDA approval .

In 2001, Clearwater Colon Hydrotherapy, of Ocala, Florida, and its vice president Stuart K. Baker were warned about quality control violations and lack of FDA approval for marketing their colonic irrigators .

In 2003. the International Colon Hydrotherapy Association, of San Antonio, Texas and its executive director Augustine R.

In 2003, Girourd and Colon Therapeutics were notified that his devices require professional supervision and cannot be legally marketed directly to consumers. The letter noted that he had obtained marketing clearance only for use in medically indicated colon cleansing, such as before radiologic or sigmoidoscopic examinations .

Girouard, Colon Therapeutics, Tiller Mind & Body, operators of the Years to Your Life Health Centers, companies that manufactured several components of Girouard's colonic irrigation systems, and organizations that trained operators of the devices are being sued in connection with the death of a 72-year-old woman who perforated her large intestine while administering colonic irrigation. The suit alleges that the woman was unsupervised when she administered the "colonic," perforated her colon early in the procedure, required surgery the same day, and remained seriously ill for several months before she died from liver failure. The complaint also alleges that Years to Your Life Health Center falsely advertised colonic irrigations as "painless" procedures which provided health benefits including an improved immune system and increased energy, as well as relief from indigestion, diarrhea, constipation, weight loss, body odor, candida, acne, mucus colitis, gas, food cravings, fatigue, obesity, diverticulosis, bad breath, parasitic infections, and premenstrual syndrome . In response to the woman's death and reports of serious injuries to four other patients, the Texas Attorney General filed lawsuits against:

Girouard and Colon Therapeutics

International Association for Colon Hydrotherapy, Class 3 Study Group and Augustine R. Hoenninger III

How Clean Should Your Colon Be?

Baca JR. Warning letter to Colon Therapeutics, April 27, 1997.

Baca JR. Warning letter to Colon Hygiene Services, June 20, 1997.

Singleton E. Warning letter to Clearwater Colon Hydrotherapy, Sept 13, 2001.

Marcarelli MM. Warning letter to International Colon Hydrotherapy Association, March 21, 2003.

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The cases include a variety of cancers: seven lymphome (various types); six pancreatic; five prostate; four breast; four melanoma; three Hodgkins disease; three leukemia; two each of colon, lung, ovary, rectosigmoid, and testicular; and one each of bile duct, brain, cervix, metastatic liver (primary unknown), myeloma, kidney, stomach, and uterine. Each case history consists of a narrative by Gonzalez and copies of some supporting medical records.

In one case history, a woman in her early 40s was diagnosed with a seven-centimeter "infiltrating adenocarcinoma of the colon, intermediate differentiation with full thickness involvement of bowel wall but no evidence of regional lymph node metastasis." It was removed surgically. She did well, except for chronic fatigue, until about a year and a half later, at which time she had a car accident and then developed severe abdominal pain with significant weight loss. Outpatient studies "revealed a large, restricting tumor in the remnant of her descending colon." The narrative reports that the patient said her doctor told her that the cancer "had metastasized widely." She refused recommended surgery. Shortly, she began the Kelley program, at a time when she appeared to be "critically ill." Within a week, her bowel obstruction cleared and she improved gradually. "Eleven months after beginning her protocol, she reports passing a large globular mass of tissue which she and Dr. Kelley assume was the remnants of her tumor." Seventeen years after diagnosis, she is alive and in "excellent health and apparently cured of her cancer."

A macrobiotic approach to treating cancer would first classify each patient's illness (see footnote 7) as predominantly yin or yang, or sometimes as a combination of both, based in part on the location of the primary tumor in the body and the location of the tumor in the particular organ. In general, tumors in peripheral or upper parts of the body or in hollow, expanded organs are considered yin; examples include lymphoma, leukemia, Hodgkins disease, and tumors of the mouth (except tongue), esophagus, upper stomach, breast, skin, and outer regions of the brain. Tumors in lower or deeper parts of the body or in the more compact organs are considered yang, e.g., cancers of the colon, rectum, prostate, ovaries, bone, pancreas, and inner regions of the brain. Cancers thought to result from a combination of yin and yang forces include melanoma and cancers of the lung, bladder, kidney, lower stomach, uterus, spleen, liver, and tongue (509).

In his book, The Cancer Prevention Diet, Kushi claims that macrobiotic diets have "helped relieve" patients with a variety of tumor types, but notes that the "best responders" have been cancers of the breast, cervix, colon, pancreas, liver, bone, and skin (509). He believes that cancers of the lung, ovaries, and testes have responded poorly to the macrobiotic approach (509). Clinical data in support of these claims are not provided.

Several of the current unconventional cancer treatments, e.g., the Gerson treatment and the Kelley regimen, include a recommendation that patients take coffee enemas several times a day. Proponents believe that coffee enemas stimulate the secretion of bile and the action of the liver, helping to "detoxify" the body of waste products and poisons accumulated in the gastrointestinal tract (337,472). "Colonic irrigation" and "high colonics" are terms referring to a related procedure that involves flushing a larger portion of the colon with water. Colonic irrigation is used in the context of physical cleansing and general detoxification in many unconventional settings (450,959), but is usually distinct from the use of enemas in cancer treatment.

A few studies examining the theory of self-poisoning through the accumulation of toxins and waste products in the body were published in the 1920s (21,259) as a result of a belief common at the turn of the century that impacted feces in the colon produced pathogenic toxins. The specific causative toxins have apparently never been identified or measured and possible physiologic effects of the "detoxifying" enemas have not been studied systematically.

Colon cleansers are marketed as powders to which water is added before use. The ingredients vary from one product to another, but the basic ingredients include fiber (e.g. psyllium, flaxseed, bentonite) and laxatives such as cascara and magnesium oxide. Other ingredients include vitamins, minerals, amino acids, herbs, and probiotics, all of which are variously claimed to promote detoxification, boost the immune system, promote weight loss and restore helpful bacteria. Magnesium oxide is claimed to release nascent oxygen. The laxative ingredients may be included in the powder or as a separate herbal tea. Users are generally instructed to drink 6-10 glasses of water daily. The recommended duration of use varies from a few days to several months. Some people have reported expelling large amounts of what they claim to be feces that have accumulated on the intestinal wall. However, experts believe these are simply "casts" formed by the fiber contained in the "cleansing" products. In the absence of constipation, concern about regularity should be met with reassurance. If hard stools are a problem and no underlying pathology is suspected, increasing dietary fiber or using a stool softener should help. “Cleansing” products offer no additional benefit, and some can cause unnecessary bloating, cramps and diarrhea.

Colonic irrigation (also called colon hydrotherapy) is intended to flush the entire length of the colon. It is done both at home and in commercial offices. The fluid may be plain water or contain enzymes, coffee, probiotics, ozone, and/or herbs. Various web sites indicate that the amounts used range from a few gallons up to as much as 30 gallons, a few pints at a time. The fluid is delivered through a tube or speculum inserted into the rectum. Most devices depend on gravity to deliver the water and peristalsis to expel the fluid and debris. Home kits (colonic boards) enable the user to flush gradually from a 5-gallon tank. Closed-system colonic machines have one tube for delivering the fluid and another for its removal. Open-system devices use a smaller tube connected to a water tank and a built-in basin to receive the waste. Sessions generally last between 25 and 50 minutes and may include abdominal massage. Some systems have disposable specula and tubing. Reusable components are sterilized after each patient. Colon irrigation has a few legitimate medical uses, such as preparation for surgery or radiological endoscopy and for treating fecal incontinence, but its use for “detoxification” is irrational .

Colon cleansing and “detoxification.” The Medical Letter on Drugs and Therapeutics (in press).

Several epidemiologic studies show that the garlic may be effective in reducing human cancer risk (Dorant et al., 1993). A relatively large case-control investigation conducted in China showed a strong inverse relationship between stomach cancer risk and in-creasing allium intake (You et al., 1988). More recently, in a study of more than 40,000 postmenopausal women, garlic consumption was associated with nearly a 50% reduction in colon cancer risk (Steinmetz et al., 1994). Not all epidemiological studies, however, have shown garlic to be protective against carcinogenesis. A 1991 review of 12 case-control studies (Steinmetz and Potter, 1991b), found that eight showed a negative association, one showed no association, and three studies showed a positive association. A more recent review of 20 epidemiological studies (Ernst, 1997) suggests that allium vegetables, including onions, may confer a protective effect on cancers of the gastrointestinal tract.

Dairy Products. There is no doubt that dairy products are functional foods. They are one of the best sources of calci-um, an essential nutrient which can prevent osteoporosis and possibly colon cancer. In view of the former, the National Academy of Sciences recently increased recommendations for this nutrient for most age groups. In addition to calcium, however, recent research has focused specifically on other components in dairy products, particularly fermented dairy products known as probiotics. Probiotics are defined as "live microbial feed supplements which beneficially affect the host animal by improving its intestinal microbial balance" (Fuller, 1994).

More evidence supports the role of probiotics in cancer risk reduction, particularly colon cancer (Mital and Garg, 1995). This observation may be due to the fact that lactic acid cultures can alter the activity of fecal enzymes (e.g., b-glucuronidase, azoreductase, nitroreductase) that are thought to play a role in the development of colon cancer. Relatively less attention has been focused on the consumption of fermented milk products and breast cancer risk, al-though an inverse relationship has been observed in some studies (Talamini et al., 1984; van't Veer et al., 1989).

In addition to probiotics, there is growing interest in fermentable carbohydrates that feed the good microflora of the gut. These prebiotics, defined by Gibson and Roberfroid (1995) as "nondigestible food ingredients that beneficially affect the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon and thus improves host health," may include starches, dietary fibers, other non-absorbable sugars, sugar alcohols, and oligosaccharides (Gibson et al., 1996). Of these, oligosaccharides have received the most attention, and numerous health benefits have been attributed to them (Tomomatsu, 1994). Oligosaccharides consist of short chain polysaccharides composed of three and 10 simple sugars linked together. They are found naturally in many fruits and vegetables (including banana, garlic, onions, milk, honey, artichokes). The prebiotic concept has been further extended to encompass the concept of synbiotics, a mixture of pro- and prebiotics (Gibson and Roberfroid, 1995). Many synbiotic products are currently on the market in Europe.

Rao, C.V., Wang, C.X., Simi, B., Lubet, R., Kellogg, G., Steele, V., and Reddy, B.S. 1997. Enhancement of experimental colon cancer by genistein.

Steinmetz, K.A., Kushi, H., Bostick, R.M., Folsom, AR, and Potter, J.D. 1994. Vegetables, fruit, and colon cancer in the Iowa Women's Health Study. Am. J. Epidemiol. 139: 1-15.

The IRC proposed a clinical trial in patients with peritoneal mesothelioma who did not have advanced disease. According to the proposal, patients would have to be diagnosed in the United States and "given a definitive prognosis by the evaluating oncologist(s)."9 Patients would be treated at IRC under Burton's direction. After treatment, "Patients would be re-examined at a period after their prognosis date thought to have statistical significance and possibly again near the end of the study period." Serious problems with this proposal, discussed below, relate to the patient population and the basic study design. Peritoneal mesothelioma is an exceedingly rare cancer; about 200 cases per year are diagnosed in the United States (894). This may be contrasted with 149,000 cancers of the lung, 98,000 cancers of the colon, 42,000 cancers of the rectum, and 90,000 cancers of the prostate (25). Under the best of circumstances, even if patients with more advanced disease were included, it would take years to accrue sufficient numbers of patients for even a modest clinical trial in this disease. If IAT were a treatment used exclusively on patients with peritoneal mesothelioma, then there would be no choice, but since it is used widely, and is reported successful by Burton for patients with a wide range of cancers, the preferable choice is a commonly-occurring cancer.

The Working Group went on to consider other approaches to an IAT clinical trial and cancers other than mesothelioma. According to IRC literature, patients with virtually all types of cancer are treated and for most types, IRC reports that more than 50 percent benefit from treatment (430). The Working Group stressed the need to study patients with common cancers who have measurable and followable disease (e.g., primary or metastatic lung cancer, colon cancer with followable lung, liver, or intra-abdominal masses, or primary renal carcinoma).

It was concluded that it might be possible to study NHL patients with particular types of tumor (i.e., tumors consisting of predominantly certain cell types) and particular stages. There was little enthusiasm for this, however, as these can be difficult cancers to follow and patients often receive considerable palliative treatment during the course of their illness, which would complicate following them over the relatively long period of time (on the order of six months to a year) needed on treatment with IAT for a fair evaluation of its effect. The Working Group expressed the strong opinion that a solid tumor (e.g., colon cancer) be included in the study as well, if a trial in patients with NHL were to be planned.

It was OTA's belief that the first of these objectives was met: an agreement was reached that patients with advanced colon cancer with measurable disease would be studied. The entire meeting with Burton, planned for two days, lasted only a few hours. There was no opportunity to observe the IAT production process. The FDA biologics expert discussed the general requirements for an IND and explained what is done with the information filed with FDA. Burton and his then-current representative (the original representative to the IAT Working Group had died by this time) did not pursue this discussion in detail.

Burton expressed his wish to have a "pre-test," in which patients with advanced colon cancer with measurable disease (the same criteria as for the clinical trial) would be treated at the clinic in the Bahamas and their progress monitored in the United States. Burton stated that this would require patients to be recruited in the United States by NCI or another clinical trial sponsor and sent to the clinic. OTA made it clear that this would not be considered part of the clinical trial and that NCI was unlikely to cooperate in such a venture.

Patients with metastatic cancer of the colon with measurable disease would be eligible, specifically a diagnosis of "Dukes' D colorectal carcinoma." This is a relatively common cancer, and one for which treatment options are limited. To the extent possible, patients would have had no previous chemotherapy or radiotherapy, a condition set by Burton to preclude the possibility that responses during the trial could be attributed to the previous treatment rather than IAT. However, response to prior treatment would not be a problem because the control group would provide a check on late responders to previous treatment.

The Health Center for Better Living of Naples, Fla., promotes Colon Helper and an amusing theory: "It has been proven by medical authorities that nearly half of all sickness starts in the colon . . . when the colon is kept clean, disease in the body is very rare." After this the dieter might choose their Trim Fast pills, Herbal Food Combination Weight Loss Formula #59, Dieter's Delight Herbal Tea, or Good-Bye Cellulite.

In the second paper, another patient in "complete remission" is described as having "adenocarcinoma of the colon, status post resection," meaning that the tumor had been removed surgically before the patient started treatment with Antineoplastons:

Burzynski presented them with about 12 cases at the clinic, and sent them additional cases afterward. According to the report, there were original X-rays for only one case; for two others, selected CT scans were available. The case with X-ray evidence was a patient with metastatic nodules in the lung from a colon cancer, which, from his history, appeared to be a slowly progressing disease. The consultants concluded that the X-rays showed no documentable change, though there were difficulties in interpretation because the films were reportedly taken on different machines with different magnifications. They also concluded that the two patients for whom some CT scans were available showed no definite response to Antineoplaston treatment. In those cases, they believed that the views on the scans were not the same, making direct comparison impossible.

Laetrile alone and in combination with beta glucosidase has also been tested for antitumor activity in human tumor xenografts in athymic (nude) mice. Using MX-1 mammary or CX-2 colon tumor xenografts in these mice, no antitumor effects of laetrile with or without the enzyme were found (701).

Other immunologic treatments included in the regimen are mixed bacterial vaccines, antibiotics, and various commercially prepared nonspecific immune stimulators, such as levamisole (a conventional antiparasitic agent also used as an immune stimulant and recently shown effective in treating patients with colon cancer), and tuftsin (an experimental agent noted for various immune stimulating properties).

It is widely believed that a clean colon is pivotal for optimal health. These capsules have proven themselves to have the ability to clean out impacted matter from the colon and thus revitalize the entire digestive and assimilation process.

Digestion is basically a process of burning food and insufficient oxygen in the colon leads to incomplete burning/digesting of food which is then often stored as fat for later digestion. You thus still feel hungry and eat some more. Which again ends up being stored as fat and the cycle continues. It is not uncommon for substantial weight loss to occur within a few weeks of initiating a program of OxCgen cleansing.

During normal digestion, foods are broken down in the stomach and small intestine so that their nutrients can be absorbed into the body. Undigested or partially digested portions—mostly in liquid form—then enter the large intestine (colon) where most of the water is reabsorbed. Movement through the intestines results from peristalsis, a wavelike contraction of muscles in the intestinal walls that propel their contents forward. When all is well, the end result is stool that is solid but soft enough to be excreted easily.

A thorough history and physical examination should be obtained. The extent of further evaluation depends on the patient's age, general health, and symptoms. If symptoms have been present a long time and have a typical pattern, the doctor may rely mainly on the patient's description to diagnose IBS. If symptoms are recent in origin, testing may be needed to be certain that an infection, inflammation, or tumor is not responsible for the symptoms. The tests may include blood tests, stool tests, x-ray examinations, and endoscopy (examination of the colon with a hollow tubular instrument inserted from below).

Unnecessary delay in defecation should be avoided. When an urge is felt, leaving the stool in the colon may contribute to constipation because the longer the contents remain, the more fluid may be absorbed. Use of certain laxatives can perpetuate constipation because the large intestine can become dependent on them. People with IBS should not take strong laxatives.

541. Levi, J.A., Aroney, R.S., Woods, R.L., et al., "A Double- blind Randomised Evaluation of Ascorbic Acid and Placebo in Advanced Adenocarcinoma of the Colon and Rectum," (protocol for evaluation) typescript, Department of Oncology, Royal North Shore Hospital, Sydney, Australia, undated.

701. Ovejera, A.A., Houchens, D.P., Barker, A.D., et al., "Inactivity of DL-amygdalin Against Human Breast and Colon Tumor Xenografts in Athymic (Nude) Mice," Cancer Treat. Rep. 62(4):576-578, 1978.

793. Segal, I., Tim, L.O., Hamilton, D.G., et al., "Ritual Enema-Induced Colitis," Dis. Colon Rectum 22:195-199, 1979.

The widespread use of chemotherapy among classes of patients unlikely to benefit, or for which benefits have not yet been demonstrated, also has drawn criticism from respected researchers (147). The cancer research community itself has been reexamining the value of long-accepted chemotherapy for certain types of cancer. An example is adjuvant treatment of cancers of the colon and rectum, the most common types of cancer in the United States.

108,204) with opinions strongly held for and against the value of adjuvant treatment, based on differing interpretations of the same data. (This debate preceded the dissemination of the results of advanced colon cancer treatment with a new combination of agents, which has shown a survival advantage.)

Calcium intake is an important factor in bone health and may play some role in the prevention of colon cancer. Barefoot has embellished these simple facts to create an elaborate scheme to promote his publications and coral calcium products. His current video is the most outrageous infomercial I have ever seen. Your best bet is to completely ignore what he says and follow a medically approved program that includes adequate calcium and other measures for preventing osteoporosis. The National Academy of Sciences advises Americans and Canadians at risk for osteoporosis to consume between 1,000 and 1,300 milligrams of calcium per day . This can be done with dairy products, supplements, or both. Readily absorbable supplements need not cost more than a few cents a day.

Colonic irrigation (also called colon hydrotherapy) is typically performed by passing a rubber tube into the rectum for a distance of up to 20 or 30 inches. Warm water is pumped in and out through the tube, a few pints at a time, typically using 20 or more gallons. Some practitioners add herbs, coffee, or other substances to the water. The procedure is said to "detoxify" the body. Its advocates claim that, as a result of intestinal stasis, intestinal contents putrefy, and toxins are formed and absorbed, which causes chronic poisoning of the body. This "autointoxication" theory was abandoned by the scientific community during the 1930s. No such "toxins" have ever been identified, and careful observations have shown that individuals in good health can vary greatly in bowel habits.

Ulcerative colitis —chronic inflammatory disease of the colon and rectum

The results with Iscador preparations have been mixed. Significant antitumor activity of Iscador was found in some animal tests (Lewis lung carcinoma, colon adenocarcinoma 38, and C3H mammary adenocarcinoma C6/C) (475). No antitumor activity was found in other tests (leukemia L1210 (475,928), leukemia L5222 (75), leukemia P388 (928), Ehrlich ascites carcinoma of the mouse (475), B16 melanoma (475,928), Walker 256 rat carcinoma (75), and a separate test of Lewis lung carcinoma (928).) In a test using autochthonous primary mammary carcinomas (see footnote 13) in Sprague-Dawley rats (475), nonsignificant growth inhibition was observed 6 weeks after Iscador treatment, but no difference in median survival time was found.