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Gonzalez protocol

The Gonzalez protocol is a cancer treatment created by Nicholas Nicholas Gonzalez, M.D.James Gonzalez, M.D. and is available only to his patients. The treatment involves taking about 150 supplements of vitamins, minerals, and pancreatic enzymes (from pigs); daily coffee enemas and special diets allegedly tailored to the patient's metabolic system.

According to the National Cancer Institute, "clinical data concerning the effectiveness of the Gonzalez regimen as a treatment for cancer are limited with conflicting results." This claim is a bit misleading, since the positive results came from Gonzalez himself. An independent study, while not perfectly designed, found that among 55 patients who had inoperable pancreatic cancer, the 23 who chose chemotherapy survived more than three times as long (14.0 versus 4.3 months) and had better quality of life than those who chose the Gonzalez protocol.

The fact is that it would be immoral to do a randomized control group study on a cancer therapy that has virtually no plausibility given what is known about cancer and its treatments. Thus, we have to rely on observational studies that compare people with certain kinds of cancers getting conventional treatment with those getting the Gonzalez treatment. What is certain at this point is that the Gonzalez method has not been shown to be an effective cancer treatment. Furthermore, there is no reason to believe that it could work.

William Donald Kelley, O.D.Gonzalez got the idea for his treatment from the work of an orthodontist who came up with idea that wrong diets cause cancer and right diets prevent and cure cancer. How did a dentist come up with the idea for a cancer treatment? In this case, the history is known and pretty simple. William Donald Kelley (1925-2005) was diagnosed with pancreatic cancer in 1962 and told there was no treatment for him. He had seen his doctor because he was having pains, losing weight, and depressed. The doctor told him he had three months to live. Kelley died at age 79 after being hospitalized with an upper respiratory infection. He died of a heart attack. His doctor was obviously wrong about how long Kelley had to live. This was not the first time, nor will it be the last time, a doctor erred in diagnosis and predicting the future. In my view, Kelley was misdiagnosed, but he believed he had cancer and tried Gerson therapy along with a few experimental dietary moves of his own. Since he got better and didn't die in three months, he came to believe he had discovered a cure for cancer. Naturally, he wrote a book or two about his cure. Others, including Gonzalez, who believed Kelley was correctly diagnosed, also came to believe in his notion that diet is the key to preventing and treating cancer.

Some of Kelley's advice is healthy, e.g., quit eating junk food and eat plenty of fresh fruit, vegetables, nuts, seeds and whole grains. Some of his advice is unproven to be effective in slowing the growth of cancer tumors, e.g., pig enzymes. Coffee enemas are often advised by those who believe unspecified "poisons" cause cancer and "detoxification" is needed. Since these poisons that are being detoxed are never named or identified, it is impossible to prove that the claims are false. They appear to be meaningless, however. As two researchers into these questionable procedures note:

Another basic tenet in many of these [so-called alternative cancer treatment] systems is "detoxification." This is based on the concept that increased amounts of toxic materials are derived from tumors and that these induce illness; ergo, if one rids the body of such "poisons" the patient will be better. "Detoxification'" is supposed to stimulate the liver by ingestion of liver and herb extracts, pancreatic enzymes, and special diets low in animal protein, assisted by periodic fasting. The specific nature of the toxins and the chemical changes in detoxification are not stated. No one has been able to demonstrate the existence of specific "toxins" as a clinical factor in human cancer. Preoccupation with "detoxification" and "purification" has led to the advocacy of coffee and other enemas to cleanse the bowel of toxins. A recent report cites two deaths following administration of coffee enemas associated with hyponatremia and hypokalemia.*

Kelley became convinced the coffee enemas were getting rid of his cancer after he started getting sick with flu-like symptoms while taking the pig enzymes.

Dr. Kelley got started taking coffee enemas in 1963 when he became sick with flu-like symptoms — seven months into his original therapy of eating mostly raw fruits and vegetables, water soaked nuts, beans and brown rice (which is the correct way to eat for his metabolic type) and taking handfuls of freeze dried porcine-based pancreatic enzymes with and between meals. By the third day of feeling sick he started throwing up — every time he took the enzymes he would throw them up. When he realized it might be the enzymes that were making him throw up and feel like he had the flu he decided to stop taking them for a few days to test if that was true. In a few days he was feeling better and began taking the enzymes again. For two or three days he felt okay and then he got the flu symptoms back again. He also noticed that when he was not taking the enzymes he could feel (with his hands) the tumor in his pancreas get bigger and when he went back on the enzymes he could feel it get smaller. This really baffled him as he thought he should feel sick when the tumor was growing and feel better when it was shrinking.

Wanting desperately to continue to shrink his tumor he stayed awake day and night searching for the answer. He figured it out by comparing himself to a cancer patient who is throwing up while on chemotherapy. It was (and is) believed that people on chemotherapy throw up because 1.) Chemo is toxic, and 2.) The tumors that the chemo breaks up are toxic. The trick to successful chemotherapy is to kill the cancer before the chemo and the tumor debris kills the patient. Since he wasn’t taking chemo, Dr. Kelley figured he was throwing up because the enzymes were dissolving the tumor and the dissolving tumor material was toxic.

After he figured that out he went back to the medical journals searching for a way to detoxify himself while the enzymes dissolved his tumor. (Bonnie O'Sullivan)

There are several things wrong with this account. Neither Kelley nor anyone else knows for sure why he was throwing up. Maybe he had food poisoning or gastroenteritis. Chemo does kill healthy cells as well as cancer cells, but the debris is not "toxic" in any meaningful sense regarding the spread of cancer. Did Kelley actually feel a pancreatic tumor with his hand and feel it shrink? He may have felt something, or thought he felt something, that he interpreted as his tumor, but he was just guessing and probably wrong. The pancreas is located deep in the belly between the stomach and the backbone. It is surrounded by the liver, intestine, and other organs. Because of where it is located, pancreatic cancer is often not detected until it has progressed significantly. Given the location of the pancreas and its size (about 6 inches long in an adult male), the likelihood of feeling a tumor with one's hand, or even feeling it growing or shrinking inside you, is highly unlikely. Finally, there is no reason to believe that the pig enzymes were dissolving Kelley's tumor. But this is what he believed and the rest, as they say, is history.

The medical establishment declared that Kelley's treatment was quackery, and the myth of the lone genius persecuted by the powers-that-be was born. He was given a few months to live by a doctor who diagnosed him with pancreatic cancer. He took pig enzymes, coffee enemas, lots of vitamins and minerals, and ate a diet he designed for himself. He lived another forty-three years before dying of a heart attack. What more proof does one need that his method cures cancer? Well, it's much more probable that he was misdiagnosed than that his methods--which have no basis in science--cured him of cancer. But, many people want to believe that they can be in control of their cancer no matter what the science says. Such people are vulnerable to self-deception and to placing a higher value on their interpretations of personal experience than on what has been established beyond a reasonable doubt by scientists. They are also vulnerable to bogus therapies offered by the likes of Kelley and Gonzalez.

See also alkaline diet, Jon Barron and the Barron effect, Russell Blaylock, M.D., Rashid Buttar, The China Study, Hulda Clark, Phillip Day, electromagnetic field (EMF), electro-sensitives, faith healing, Gerson therapy, Ernst Hartmann, John of God, Matthias Rath, William C. Rader, radionics, shark cartilage, vibrational medicine, vitamin supplements, and Robert O. Young.

further reading

by Robert Todd Carroll

Diets, Supplements, and Health: It's Complicated

Cure Cancer the Natural Way....NOT!

Cell Phones May NOT Cause Cancer

Cellphones, brain cancer, and other cheery thoughts

Deception on the Burzynski Clinic Success Story Page?

ACCC drops the ball in faith healing case

The Paralyzing Precautionary Principle

book reviews

The Emperor of All Maladies: A Biography of Cancer by Siddhartha Mukherjee (2010)

How Doctors Think
by Jerome Groopman, M.D. (Houghton Mifflin 2007)

The Cure Within: A History of Mind-Body Medicine
by Anne Harrington (W. W. Norton 2008).

Snake Oil Science: The Truth about Complementary and Alternative Medicine
 by R. Barker Bausell (Oxford 2007).

others

Hall, Harriet M.D. 2012. "CAM for Cancer: Preying on Desperate People," Skeptic, Volume 17 number 4.

Questionable Cancer Therapies by Stephen Barrett, M.D. and Victor Herbert, M.D., J.D.

Tumorex, by Stephen Barrett, M.D.

The Bizarre Claims of Hulda Clark by Stephen Barrett, M.D.

Why Bogus Therapies Often Seem to Work by Barry L. Beyerstein, Ph.D.

How People Are Fooled by Ideomotor Action by Ray Hyman, Ph.D.

Quack Cures and Radionic Ouija Boards by Ken Raines (1966, updated 1999)

Suckers: How Alternative Medicine Makes Fools of Us All by Rose Shapiro

Trick or Treatment: The Undeniable Facts about Alternative Medicine by Edzard Ernst and Simon Singh

websites

Unproved Dietary Claims in the Treatment of Patients with Cancer by Maurice E. Shils, M.D. and Mindy G. Hermann, R.D. Memorial Sloan-Kettering Cancer Center New York, New York

National Cancer Institute on the Gonzalez Regimen

The Gonzalez protocol: Worse than useless for pancreatic cancer by Orac

Nicholas Gonzalez (Wikipedia)
"The American Cancer Society notes that there is "no convincing scientific evidence that [the Gonzalez treatment] is effective in treating cancer" and that some portions of the treatment may be harmful. A review article from the Journal of Clinical Gastroenterology is cited that notes the clinical efficacy of coffee enemas has not been proven and the therapy is associated with severe adverse effects previously described in a few case reports. Gonzalez's study published in Nutrition and Cancer in 1999 was criticized by an expert in integrative oncology research methods for its small sample size, selection bias, and failure to account for confounding variables.

Gonzalez was featured in Suzanne Somers' book Knockout."

In March of 2001, actress Suzanne Somers announced that she was going to take Iscador as part of her treatment for breast cancer. She also announced that she was going to forego chemotherapy. She is still alive more than a decade later. Her book, The Sexy Years: Discover the Hormone Connection--The Secret to Fabulous Sex, Great Health, and Vitality, for Women and Men, came out in March of 2004 and was the 89th best selling book of the year.*  However, it should be noted that before forgoing chemotherapy, she had part of her breast removed (lumpectomy) and had undergone radiation treatment. The lump was discovered not by a mammogram, which missed it, but by ultrasound, which had been recommended by her physician. "Her sentinel node biopsy showed no lymph node involvement, and one of her physicians felt she did not need preventive chemotherapy. Another physician recommended it, and a third physician she consulted was 'on the fence.'"* Chemotherapy was an option, but was not presented to her as an essential and required part of treatment. All we can say for sure is what we already knew before she took the Iscador: It may not do her any harm, but, according to Dr. Edzard Ernst, "some studies suggest that serious harm might be caused by mistletoe injections. Rather than suppressing cancer, mistletoe might promote tumour cell growth in some malignancies."

Did Iscador help Somers remain free of cancer detection? We don't know. Had she done nothing after the radiation treatment, scientific tests might not have been able to detect any cancer cells anyway, but there is no way to know for sure. (Note: there is a big difference between being 'cancer-free', which is something we cannot know at present, and being unable to detect cancer cells in one's body.)

William Donald Kelley (Wikipedia)

Dr. William D. Kelley Died on Jan. 30, 2005 at 79 by Bonnie O’Sullivan (She describes Kelley as her "friend and mentor." O'Sullivan presents the history of Kelley's experiences and his interpretations of the interventions he took. She doesn't question the correctness of his thinking or beliefs about having and curing pancreatic cancer.)

Prince Charles and Gerson therapy

Gerson regimen (Sloan-Kettering Cancer Center)

Questionable Cancer Therapies by Stephen Barrett, M.D. Victor Herbert, M.D., J.D.

"Why Bogus Therapies Often Seem to Work" by Barry L. Beyerstein, Ph.D.

The Scientific Review of Alternative Medicine and Aberrant Medical Practices

Coffee enema (Wikipedia)

COFFEE: THE ROYAL FLUSH From The Cancer Chronicles #6 and #7 Autumn 1990 by Ralph W. Moss, Ph.D.

Now Charles backs coffee cure for cancer

Dr. Max by Giuliano Dego by Ralph Moss (Skeptics will especially like the part about Gerson's son-in-law and EVP. Dego claims Gerson spoke to him from the dead via radio and told him that he didn't die of pneumonia (as his death certificate stated) but that he was poisoned with arsenic. Gerson's widow is said to have verified the claim that high levels of arsenic were found in Gerson's body and that he was in perfect health when he died. Hmmm. Arsenic-laced coffee?) Ralph Moss, Ph.D. (in classical languages) is a story in himself. He claims to be some sort of expert on a variety of medical treatments.

The Gerson Institute

Press notes for "The Beautiful Truth"

a view from the other side

I recommend the reader take a look at a blogger's defense of Kelley and Gonzalez. The work is a classic example of motivated reasoning. The author is completely taken in by the anecdotes that support the cancer treatment. He has no criticism of note to make regarding Kelley's reasoning from his experience. But the author goes to extreme lengths to find fault with a study that found that pancreatic cancer patients do much better with conventional chemotherapy than with the Gonzalez protocol. It is clearly possible and legitimate to criticize this study, but it should be remembered that it would be unethical to do a randomized control group study on the Gonzalez protocol. In my opinion, the authors of the study did the best they could under the circumstances. It must be granted, though, that this study did not prove that chemotherapy is superior to the Gonzalez protocol. The fact that there is no plausible reason why the Gonzalez protocol should have any beneficial effect on either the cause or the cure of any kind of cancer should be considered before any more money is wasted testing this treatment.

see also

The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed by Kimball Atwood

"We now know considerably more than we did in May. The Gonzalez trial was stopped early, in 2005, after the DSMC found that the data convincingly demonstrated that the regimen was inferior to standard treatment for cancer of the pancreas. This information has been available to the public since June 2, 2008, but until now could be found only in the esoteric OHRP determination letter. The reason that the results of the trial have not been reported in the usual way, or otherwise made public by the relevant sponsoring and investigating institutions or individuals, appears to be that Gonzalez or someone close to him, likely with the aid of lawyers and “friends in Congress,” has managed to suppress them. Ironically, Gonzalez (or his surrogate) seems to have shot himself in the foot: the unsuccessful appeal to the OHRP to cast doubt on the trial results is the only reason we know that the trial was “terminated due to predetermined stopping criteria.”"

Last updated 29-Jan-2014

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