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This declaration was filed by Joseph Pizzorno, N.D., in F.T.C. v. Western Dietary Products Co (Skookum) et al. (C01-818R, W.D., Washington), a case in which the Federal Trade Commission sued a company that was marketing devices and herbal products based on recommendations by Hulda Clark.
Michael Milgrom and Brinley Williams of the Federal Trade Commission have requested I review the validity of claims made by Western Herb & Dietary Products, Inc. (WHD) of Blaine, Washington. Following are my qualifications, description of my process and review of the claims made by WHD.
I am widely recognized as one of the world's leading authorities on science-based natural medicine. My formal education includes a B.S. in Chemistry in 1969 from Harvey Mudd College in Claremont, CA and an N.D. (Doctor of Naturopathic Medicine) degree in 1975 from National College of Naturopathic Medicine, now located in Portland, OR. I have been licensed (#NT00000369) as a naturopathic physician, with prescriptive authority, in Washington State since 1975.
As the founding president, now president emeritus, of Bastyr University, the first fully accredited, multidisciplinary university of natural medicine in the United States, I have been very active in the academic and research advancement of natural medicine. As senior editor of the Textbook of Natural Medicine (Churchill-Livingstone 1999) the most authoritative textbook on natural medicine currently available, I have helped set the standard for alternative medicine education. Over the years, I have taught naturopathic philosophy, clinical diagnosis, nutrition, environmental medicine, and integrative therapeutics, and supervised students in the Bastyr University teaching clinic.
I have significant experience in public health and health care policy. I have been a member of the Seattle/King County Board of Health since 1996 (as far as I know, I am the first natural medicine practitioner ever to have received such an appointment), chair of the special primary interest group in alternative medicine of the American Public Health Association since 1999, and appointed in December 2000 by the President to the White House Commission on Complementary and Alternative Medicine Policy. In October 2000, 1 was an invited participant in the Josiah Macy, Jr., Foundation Conference on Education of Health Professionals on Complementary and Alternative Medicine. The conference generated a consensus recommendation on complementary and alternative medicine education in conventional medical schools. I have provided expert consultation on natural medicine education and research to governmental agencies internationally, including Argentina, Canada, China, Great Britain, Japan, and Taiwan.
Over the past several weeks, I have performed the following:
I believe this process has resulted in my undertanding the WHD claims, the quality and validity of the substantiation they provided and the current standards of evidence required for the claims they made.
To substantiate a cure, I utilized the following criteria:
As requested by the FTC, I have evaluated the following claims found on the WHD website:
The Clark books contain numerous unevaluated theories, unsubstantiated clinical observations, invalid diagnostic procedures and unproven therapies. As detailed below, no reasonable health care professional would consider her books to provide substantiation of the WHD claims.
Clark is apparently a graduate in naturopathy from Clayton College, a correspondence school located in Alabama. As far as I know, the naturopathy decree issued by Clayton College is not considered a valid credential by any state licensing naturopathic doctors. It is also not considered a sufficient credential to sit for the national naturopathic licensing examination (NPLX). The standard of education in the United States for N.D. degree licensure is an accredited four-year, residential graduate program. I am unaware of any state licensing body that would consider a distance-learning program of a few hundred hours adequate for clinical practice.
There is no competent and reliable evidence that the WHD formulas and packages effectively treat or cure cancer.
The curecancer.com website makes explicit claims to cure not only every type of cancer, but also AIDS, Alzheimer's disease, arthritis, back problems, diabetes and heart diseases. The claims are explicitly to cure, not prevent mitigate or treat disease. The WHD rationale for these claims is the works of Hulda Clark. In fact, the curecancer.com web pages appear to be directly transcribed from the Hulda Clark books. On its first page,  the website provides a quote from Clark  which asserts:
Cancer is caused by a certain parasite, for which evidence has been found in every form of cancer. So lung cancer is NOT caused by smoking, Colon cancer is NOT caused by a low roughage diet, Breast Cancer is NOT caused by a fatty diet, Retinal Blastoma is NOT caused by a rare gene, and Pancreatic cancer is NOT caused by alcohol consumption. Although these are all CONTRIBUTING FACTORS, they are not THE cause.
Clark's books make a very large number of unfounded assertions and claims. In general, Clark claims a parasite, the fluke Fasciolopsis buskii  is the cause of many chronic diseases. She asserts to have found it in every case of cancer, HIV infection, Alzheimer's disease, Crohn's disease, Kaposi's sarcoma, endometriosis, and in many people without these diseases. Clark asserts that the high level of toxins in the human body allows the parasite to complete its full life cycle without requiring the intermediate snail host. This in-human life cycle process then causes, according to Clark the production of a "mitotic stimulant" She also asserts several other parasites am endemic in the U.S. as well, but F. buski is her primary culprit The following appear to be the core elements that comprise her theories:
Fasciolopsis buski and human disease
Parasite infections in humans have long been associated with specific types of cancers. For example, Schistosoma hematobium is a known inducer of urinary bladder cancer, Helicobacter pylori is a gastric carcinogen, and hepatitis B virus is a causative agent of liver cell cancers. However, the claim that all cancers (let alone all AIDS, etc.) are caused by Fasciolopsis buski is unsubstantiated and extremely unlikely.
Fasciolopsis buski is a recognized snail-transmitted, intestinal, food-borne human intestinal fluke . It is found in many parts of Asia and principally parasitizes the intestines of pigs. The prevalence of infection in children ranges from 57% in mainland China to 25% in Taiwan and from 50% in Bangladesh and 60% in India to 10% in Thailand . Human infection, fasciolopsiasis, is acquired by ingesting water plants such as water chestnuts, which bear metacercariae of the parasite. Light infection is asymptomatic, while heavy infection is associated with abdominal pain, ulceration, hemorrhage, intestinal obstruction and facial and generalized edema. Diagnosis is made by finding adult flukes or, more commonly, by finding F. buski eggs in the feces. In light infections, even without treatment, spontaneous cure normally occurs within one year. Current conventional treatment is with praziquantel. There is no research documenting the association of F. buski with cancer or any disease other than fasciolopsiasis. Considering the well-documented level of infestation in these other countries, if the Clark theory was true we'd see an equally high level of cancer, which we don't.
Isopropyl alcohol, role in disease, body burden, and sources
Isopropyl alcohol exposure is common: rubbing alcohol, window cleaner solution, cosmetics, hair tonics, etc. It is considered to be about twice as toxic as ethanol. Isopropyl alcohol is readily absorbed from the intestines. The main problems are acute toxicity, typically from. ingestion, and potentiation of the toxicity of some other chemicals, such as carbon tetrachloride. The half time for the elimination of isopropyl alcohol by the dog and rat is 4 and 2 hours, respectively. There is no research support for its persistence in the body, association with any parasitic infections, nor any association with cancer or any other disease. According to the National Library of Medicine's ToxNet, isopropyl alcohol is not classified as a carcinogen in either animals or humans.
Aflatoxin B and isopropyl alcohol
There is no research demonstrating any relationship between aflatoxin and isopropyl alcohol. Nor is there any research showing a relationship between these chemicals and chorionic gonadotropin.
Human chorionic gonadotropin (HCG) is a chemical secreted in large amounts by pregnant women and by some cancers. I was unable to find any research that HCG induces cancer.
While tyrosine kinases are involved in some carcinogenic processes, I was unable to document the significance (i.e., cancer growth stimulant and measure of cancer) attributed by Clark to "ortho-phospho-tyrosine." Tyrosine phosphorylation is one of the key covalent modifications that occur in multicellular organisms as a result of intercellular communication during embryogenesis and maintenance of adult tissues. The enzymes that carry out this modification are the protein tyrosine kinases (PTKs), which catalyze the transfer of the phosphate of AIP to tyrosine residues on protein substrates. Phosphorylation of tyrosine residues modulates enzymatic activity and creates binding sites for the recruitment of downstream signaling proteins. Because PTKs are critical components of cellular signaling pathways, their catalytic activity is strictly regulated. Many growth factor receptors and retroviral transforming proteins share the property of phosphorylating proteins on tyrosine. Protein tyrosine kinase also plays an important role in the viability of several parasites. None of this appears to provide support for the Clark theories.
Herbal eradication of parasites
The herbs recommended by Clark for eliminating parasites have some tradition of use as anthelmintics (worm-killing agents). [7-10]
The only botanical medicine for which I found research demonstrating efficacy against Fasciolopsis buski is the alcohol extract of the root-tuber of Flemingia vestita (not recommended by Clark). 
Although the dosages recommended by Clark are unclear and the research has only assessed their efficacy in round worms, the recommended herbs may be effective in the treatment of Fasciolopsis buski. There is no evidence they have any efficacy in patients with cancer or other diseases.
No research is presented demonstrating that the Syncrometer is a valid diagnostic device or that it correlates with any accepted cancer or other disease diagnostic procedure.
No research is presented demonstrating that the Zapper has any physiological effects, let alone ability to kill parasites or cure cancer. The claim that mild electrical shocks to the skin can eliminate intestinal parasites is, frankly, preposterous.
The Clark book The Cure for All Cancers presents about
a hundred cases, some numbered and some not Since most of the
cancer cases are diagnosed with the Synchrometer, not a standard
or accepted diagnostic procedure, they do not provide substantiation
of the validity of the theories or efficacy of the treatments.
Those with accurate diagnoses appear to have either been successfully
treated with conventional interventions or fared uniformly poorly.
The patients that appeared to respond had no documentation of
cancer other than the Syncrometer. Clark intermixes what appear
to be accurately conventionally diagnosed cancer patients with
patients diagnosed only with the Syncrometer. It gives the superficial
appearance of cancer treatment efficacy, but close reading reveals
a very clear distinction in outcomes: proper diagnosis -- no results,
Syncrometer diagnosis -- results. Peppered throughout the case
discussions are such outrageous diagnoses as a patient being "full
of fiberglass because she was coughing a lot" and that an
elevated alkaline phosphatase level was due to the presence of
a dye (DAB) when this is a well known sign of bone cancer metastases!
Clarks's The Cure for All Advanced Cancers is a more sophisticated book. It provides about a hundred citations for various aspects of her theories and the "cured" cancer cases are provided in far more detail. Many of the individual statements she makes are consistent with the current scientific knowledge. For example, many environmental toxins (e.g., polycyclic aromatic hydrocarbons) do cause cancer, heavy metals do damage immune function, iron deficiency does decrease cytochrome P450 activity, mycotoxins do increase the risk of certain cancers, etc. However, such statements of common knowledge, while seeming to provide science, do not provide substantiation of her theories.
For analysis of the validity of the "cured cancer cases, I consulted an oncologist, Dr. Aron Primack. At my request, he reviewed The Cure for All Advanced Cancers. He makes several observations:
He assessed the diagnostic procedures and outcomes in many of the cases. In summary, he did not find adequate diagnostic evidence indicative of cures. In particular, he found many examples where changes in radiological or other reports were either misinterpreted, or not the appropriate diagnostic tool for the interpretations presented. For example, changes in bone scans or x-rays were often cited as documentation of the presence and remission of cancer. However, without proper biopsies, the lesions described could indicate a tumor, metastasis, infection, inflammtion, or simply a developmental abnormality.
As can be see from the above analysis, there is no significant substantiation for the Clark theories, diagnostic procedures, therapies or claimed clinical successes.
Claim B. WHD's herbal formulas, care packages, herbal care packages and the Zapper Electrical Unit are effective in treating and curing Alzheimer's Disease.
There is no competent and reliable evidence that the WHD formulas and packages effectively treat or cure Alzheimer's disease.
There is no competent and reliable evidence that the WED formulas and packages effectively treat or cure diabetes.
There is no competent and reliable evidence that the WHD formulas and packages effectively treat or cure arthritis.
Clark's theory of the causes and treatment of all diseases is essentially the same as for cancer. It suffers from the deficiencies noted above. Her claims of cure also suffer from the same problems of invalid diagnostic and evaluative procedures which provide no substantiation for either the presence of the disease or its eradication and therapies with no reliable documentation of efficacy.
On the front page of this book Clark sets the stage with the
assertion: "Electricity can now be used to kill bacteria,
viruses, and parasites in minutes, not days or weeks as antibiotics
require." Other than describing her "discovery process",
she provides no substantiation for this assertion. If her electrical
device could indeed kill these microorganisms, it would be simple
to perform and reproduce this effect in any microbiology laboratory
or biology classroom.
This is followed by the equally undocumented assertion of cause on page 2: "No matter how long or confusing is the list of symptoms a person has, from chronic fatigue to infertility to mental problems, I am sure to find only two things wrong: they have in them pollutants and/or parasites. I never find lack of exercise, vitamin deficiencies, hormone levels or anything else to be a primary causative factor." This statement appears to simply ignore hundreds of thousands of studies published in the peer-reviewed research literature to the contrary.
For Alzheimer's disease, Clark adds to the basic theory the assertion that xylene and toluene, from decaffeinated powders and carbonated drinks, are "brain-seeking" toxins, as are aluminum, mercury, freon, thallium, and cadmium and the bacterium Shigella. While these solvents and heavy metals are indeed toxic to the brain, there is no substantiation of their presence, other than the Syncrometer. The therapies recommended are unlikely to be toxic (except the excessively high dosage of vitamin B2); they are also unlikely to have an effect unless the patient was deficient in one or more of them, not uncommon in an elderly population. The four case histories given are not at all compelling, with only one showing possible improvement Considering the variability of Alzheimer's disease, such cases need to be followed objectively for months before efficacy can be assessed.
For diabetes, Clark adds infestation of the pancreas with Eurytrema pancreatum, a cattle fluke, as a cause. She also asserts that methanol is a toxin found in all patients with diabetes. There is no research to support either of these claims. However, several of the therapies recommended may help some patients with adult onset (NIDDM) diabetes. Specifically, fenugreek seeds and the trace mineral chromium may be beneficial in improving blood sugar levels and bilberry extract may decrease the vascular damage seen in patients with diabetes. The case results presented suggest possible improvement in several, and could be the result of improved diet and supplementation with these natural therapies. However, longer term monitoring would be required to assess actual outcomes. The WHD diabetes formula (black walnut, wormwood, cloves, l-arginine, l-ornithine, african bird cayenne, burdock root, and marshmallow root) does not contain any of the herbs or nutrients known to improve diabetes.
For rheumatoid arthritis, Clark asserts that the worms actually live in the joints. For osteoarthritis, she asserts that chronic, undetected staph and strep infections are responsible. She also believes that excessive phosphates (from meat, soft drinks and grams) are a problem in this condition. There is no substantiation for these theories. The case histories presented were diagnosed based only on symptoms, not standard diagnostic procedures. Without an accurate diagnosis, it is impossible to determine if there is any significance to the very modest clinical improvements in a few of the cases. There was no apparent pattern in the therapies, so I am unable to determine if they've any valid theoretical basis. However, one therapy, recommending the avoidance of nightshade family foods, does have some research support for patients with osteoarthritis.
There is no competent and reliable evidence that the WHD formulas and packages effectively treat or cure HIV/AIDS. In addition, I believe the WHD claim and the Clark book pose a serious public health hazard. The risk of contagion of the deadly HIV virus is well documented.
Clark's theory for the cause of HIV/AIDS is essentially the same as for other diseases. For HIV/AIDS, she adds the assertion that the HIV virus is found in the snail stage of the Fasciolopsis lifecycle and develops into the human version due to accumulation of benzene in the thymus. She further asserts the fluke is necessary for the HIV virus to maintain its presence in the body and that "benzene is the cause of AIDS .
Clark's theory has no validity. There is no research documenting the presence of the any type of HIV virus in snails, no research supporting the unusual prevalence of a fluke such as Fasciolopsis buski in HIV positive patients, no evidence of benzene contamination in HIV positive patient, no evidence that benzene preferentially accumulates in the thymus, no evidence that a parasitic infection is necessary for the maintenance of an HIV infection and no evidence that benzene has any relationship to HIV.
Clark asserts to have cured HIV/AIDS based on 58 numbered and approximately 30 unnumbered patients in her book The Cure for HIV and AIDS. Virtually all were "diagnosed" as HIV positive based on her Syncrometer, not standard blood tests. There is no substantiation of the validity of the Syncrometer as an accurate measure of HIV virus, let alone being able to determine in which organs it resides. Of these 88 reported cases, only 14 actually had blood tests. The test results were typically reported by the patient and not confirmed by Clark and most of them were not reported in enough detail to determine their validity. Of the 14 with a blood test, three were actually negative, even though reported positive by the Syncrometer. One of these apparently became IHV positive during therapy. Of the 11 with possibly accurate diagnoses, only 3 reported the type of test performed. Of those reported to have become HIV negative according to "clinical tests," the type of blood test was only stated in 4. While PCR has validity in tracking the viral load of an HIV positive patient, to be valid it needs to be performed serially by the same laboratory using the same methodologies, due to the highly variable genetics of the virus. Of particular significance, however, is that during the early 90s when these tests were run, PCR was a new procedure with low reliability.
The clinical results of the 11 with a possibly accurate diagnosis are highly variable, ranging from continued progression of the disease, to patient-reported subjective improvements to those who left before completion of therapy. The information provided does not document actual improvement, let alone cure, and the concomitant use of conventional therapy was not reported.
The therapies recommended have no research supporting their efficacy in the eradication of the HIV virus. The "Zapper" does not appear to have been subjected to any objective research evaluation and the idea that an electrical current will selectively destroy specific viruses has no credibility. As discussed above, the "deworming" therapies may be effective in eliminating some parasites, but have no research supporting elimination of the HIV virus.
To diagnose a person as HIV positive based on an unproven device
without a confirmatory blood test is unconscionable. The needless
worry and suffering this causes is appalling, as is the anguish
of the spouses who thought they were in a monogamous relationship
and parents with no understanding of how their young children
could have become infected. Asserting cure because this device
no longer reports the disease is not in anyway credible.
Not only is there no substantiation for these diagnostic and therapeutic claims, I believe this website and the Clark books pose a serious public health hazard. HIV is a deadly communicate virus whose incidence of infection is again increasing. Convincing an HIV positive patient that he or she is HIV negative after a few weeks of ineffective therapy, implying he or she no longer needs to practice safe sex is outrageous. This is likely to increase the spread of the disease and undermine the efforts of public health departments across the country to contain it.
As discussed above, there is no competent and reliable evidence that the WHD formulas and packages effectively treat or cure cancer. Therefore the recommendation that these interventions make surgery or chemotherapy unnecessary is equally inappropriate and may deter a patient from obtaining an accurate diagnosis and potentially life-saving therapy.
Not only is there is no competent and reliable evidence that the WHD formulas and packages effectively treat or cure cancer, AIDS or other serious diseases, I believe their claims pose a substantive public health danger. This ranges from: allowing serious disease to progress untreated to the increased risk of the spread of the deadly virus due to HIV-infected individuals mistakenly believing their virus is eradicated.