Quackwatch Home Page
This declaration was filed by Aron Primack, M.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.
Aron Primack, M.D., pursuant to 28 U.S.C. § 1740, hereby states as follows:
1. My name is Aron Primack. I am a United States citizen over the age of 18. I currently reside in Silver Spring, Maryland.
2. I earned a B.S. degree from Northwestern University in 1964, an M.D. degree from Northwestern University Medical School in 1967 and an M.A. degree in medical anthropology from Catholic University in 1986. 1 am licensed as an M.D. in Maryland and the District of Columbia.
3. I am board certified in Internal Medicine and Medical Oncology. Medical Oncology is the branch of medicine concerned with the medical treatment of the various forms of cancer. Currently, I serve as Associate Professor of Preventive Medicine and Biometrics at the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, Maryland. I also serve as a preceptor in several programs at USUHS and at George Washington University Medical Center. I have served as a senior investigator for the National Cancer Institute, both in Bethesda and in Kampala, Uganda, in East Africa, where I designed and conducted clinical trials with new drugs and new combinations of drugs. I also did laboratory research studying drug metabolism. I have served as a consultant to the Office of Alternative Medicine in the Office of the Director of the National Institutes of Health (NIH).
4. I have published numerous articles and written several chapters in textbooks, including a chapter entitled "Alternative Medicine and Cancer" for Alternative Medicine: an Evidence Based Approach, a medical school textbook published in 1999. I co-edited a publication for NIH entitled "The Collection and Evaluation of Clinical Research Data Relevant to Alternative Medicine and Cancer", published in 1996. I have substantial experience in the evaluation of alternative treatments for diseases, particularly for cancer. My full CV is attached.
5. I have been asked by the Federal Trade Commission to provide an opinion concerning substantiation for the following claims made by Western Herb & Dietary Supplements, Inc. (WHD):
a. WHD's herbal formulas, cure packages and herbal cure packages are effective in treating and curing cancer;
b. WHD's herbal formulas, cure packages, herbal cure packages and the Zapper Electrical Unit are effective in treating and curing Alzheimer's Disease;
c. WHD's herbal formulas, cure packages and herbal cure packages are effective in treating and curing diabetes;
d. WHD's herbal' formulas, cure packages and herbal cure packages are effective in treating and curing arthritis; and e. WHD's herbal formulas, cure packages and herbal cure packages and the Zapper Electrical Unit are effective in treating and curing AIDS and HIV infection,
f. WHD's herbal formulas, cure packages and herbal cure packages, when used by persons with cancer, make surgery and chemotherapy unnecessary.
6. I have visited WHM's website at www.curecancer.com and reviewed an earlier version of the website provided by the FTC, in order to become familiar with the specific packages that WHD offers as a claimed cure for each of the above illnesses and to become familiar with the representations. I understand that WHI) has said that the basis for its claims is the work of Hulda Regehr Clark. I have reviewed the following works by Hulda Regehr Clark: The Cure for All Diseases, The Cure for all Cancers, The Cure for HIV and AIDS, The Cure for All Advanced Cancers and Syncrometer Science Laboratory Manual. These are all the books by Hulda Clark sold by New Century Press, a publishing house that specializes in the sale of her books (see http://www.newcenturypress.com/titles.html).
7. In my professional opinion the books by Hulda Clark listed above do not provide competent and reliable scientific evidence in support of the claims listed above. Moreover, in my opinion, apart from Hulda Clark's books, the claims are not supported by competent and reliable scientific evidence anywhere.
8. The basis for my opinion is as follows:
a. Hulda Clark's books, listed above, describe her own method of diagnosing and curing all diseases. She claims to have developed her own diagnostic tool, called the Syncrometer, which works on the principle of "resonance" (The Cure for All Diseases, pp 5, 465). The operator of the device must compare two sounds to see if they resonate in order to provide a Yes or No diagnosis Id. p 462) The Syncrometer provides the basis for her entire work. However, there is no scientific basis for the use of the Syncrometer. Its use has not been verified or tested in any scientific manner and the conclusions that Clark reaches from its use (see subparagraph [b] below) are implausible to begin with and contrary to documented research. Assuming that a person actually had a parasitic infestation, there is no scientific reason to believe that this device could detect it, let alone diagnose which parasite was causing the infestation, the lifecycle stage of the parasite or its location within the body, all of which Clark claims to be able to do.
b. As a result of her use of the Syncrometer, Hulda Clark claims that all diseases are
caused by parasites, particularly the intestinal fluke whose activities may be caused or aggravated, according to her theories, by pollutants. For example, she claims that Myasthenia Gravis is probably caused by flukes in the thymus gland, that Alzheimer's Disease and multiple sclerosis result from flukes in the brain, and that diabetes is caused by flukes in the pancreas. She also claims that cancer and HIV/AIDS are caused by intestinal flukes. She even claims that HIV is not a virus in humans but only in flukes and that the virus disappears when the flukes are killed. These claims are demonstrably false. For example, the brains of Alzheimer Disease patients have been studied and there has been no indication of parasitic infection. The same is true for the thymus glands of Myasthenia Gravis patients. (Removal of the thymus is the standard treatment for this disease and the universal practice in medicine is to study a removed organ microscopically.) Diabetes is caused by an abnormality of insulin production and of insulin usage and uptake by cells, not by parasitic infestation of the pancreas. This has been shown through light microscopic and electron microscopic study. The HIV virus is now observed directly in humans and replicates in humans without the need for a fluke host which is not found in HIV/AIDS patients. Cancer is caused by a variety of known and unknown factors. Flukes and other parasites have been associated with a few, relatively rare forms of cancer, namely: a) There is a very rare type of adenocarcinoma of the liver caused by liver flukes, and b) bladder cancer in places with highly endemic schistosomiasis (e.g Egypt) is related to this disease. However, even in such cases, it does not follow that killing the flukes eliminates the cancer and the overwhelming majority of cancers are neither caus6d by flukes or similar parasites nor are flukes or similar parasites associated with them. If they were present, such flukes certainly would have been found by ordinary pathology techniques.
c. With regard to cancer, Clark also claims that a substance called "ortho-phospho-tyrosine" that she detects with her Syncrometer is an infallible cancer or malignancy marker. (The Cure for All Cancers, pp 8, 59,203-4; The Cure for All Diseases, p. 9) This is simply an assertion for which no evidence is provided in her books, nor is it supported by any competent and reliable evidence. Clark seems only to have found or tested for "ortho-phospho-tyrosine" with the Syncrometer. In her book, The Cure for All Advanced Cancers, in which she includes a large number of blood test results, she never shows results for this substance. Thus, Clark's theories of cancer diagnosis and cure are completely unsupported by scientific evidence on at least two counts: intestinal flukes as the cause of all cancers and "ortho-phospho-tyrosine" as a marker for all cancers.
d. Clark claims that a device she has invented called the Zapper can kill the flukes within the body and cure the diseases using an electric current of the right frequency. However, her books provide no competent scientific evidence that this device does what she claims or even that it has any effect on the body. In any event, the premise for its use is completely false, since the diseases are not caused by parasites. Nor does any body of scientific literature anywhere else support the theory that these diseases can be cured with such a device.
e. In Hulda Clark s system a combination of herbs and other dietary supplements, which WHD sells as herbal packages and cure formulas, supplement use of the Zapper to cure the diseases. However, her books provide no competent scientific evidence that such combinations of herbs and other dietary supplements are, in fact, effective for this purpose. There is no scientific literature to support the use of herbal remedies in the treatment of flukes, even if these were present. And, as with the Zapper, the premise for using these herbs and other substances is false since the diseases are not caused by parasites. Nor are such claim supported by any body of scientific literature outside of Hulda Clark's books.
f. Hulda Clark uses specific cases to exemplify the success of her unorthodox and unproven methods. But these are also undocumented cases. They are glibly stated without supporting evidence. While there are rare cases of severe disease that show spontaneous regression and improvement, the cases in Clark's books are expounded without proper documentation of the treatment or of the response. It is impossible for me to verify either the diagnosis, treatment or cure from the information presented. In her first three books, The Cure for all Cancers, The Cure for All Diseases, and The Cure for HlV and AIDS, all her diagnoses and cures are premised on testing with the Syncrometer. There is no scientific reason to believe that either the diagnoses or cures are reliable.
g. Clark's fourth book, The Cure for All Advanced Cancers, contains more detailed case histories than the previous three (though these are selected, rather than a random sample or a complete accounting, p. 251) and does not rely entirely on Syncrometer data. However, in virtually all cases the data are still insufficient to confirm either a diagnosis or a cure. Inflammatory lesions of all organs occur and these can mimic cancer in every respect. These lesions heal with time regardless of any intervening therapy. In order to diagnose cancer biopsy proof is required. Biopsy proof is also needed in order to diagnose metastasis (the spread of the cancer). For example, in case #1 (p. 251), Clark appears to have diagnosed bone cancer and renal (kidney) cancer on the basis of a bone scan and kidney scan. This is not sufficient for such a diagnosis. Bone scans show abnormalities in patients with chronic arthritis or other bone disease, much more commonly benign than malignant, in which there is inflammation of the bone. Hot spots on bone scans can indicate an infection, but not necessarily. In case #6 (p. 272) several X-rays are shown but these are also insufficient to diagnose cancer. In case #8 (p. 282) an MRI is shown, but this is insufficient to diagnose cancer. It is noted that the patient had refused to have the swelling biopsied before visiting Clark's clinic. Without a biopsy, it is impossible to tell if this is cancer. A lymph node can, and should, swell and then recede in size as an inflammatory reaction. The other cases all show a similar lack of documentation sufficient either to diagnose cancer or to document a cure.
9. I am particularly concerned about WHD's suggestion that patients forego standard medical treatments in favor of purchasing its remedies. By way of illustration:
a. People suffering from cancer will be harmed by foregoing standard medical treatment in favor of the remedies promoted by WHD. Many forms of cancer respond to surgery, chemotherapy and/or radiation treatment. They do not, however, respond to no treatment, which is what WHD's suggested remedies amount to.
b. HIV/AIDS; is caused by a virus that is measurable in the blood stream of patients. It is now controllable with medical treatment. HIV/AIDS patients had a life expectancy of under six months from the time of diagnosis to death in the first decade and a half after the disease was discovered. That time is now over two years. This is a major breakthrough. There is no question that it is a terrible and life-threatening practice to tell patients to forego the use of modern, dramatically successful medical treatment for the methods expounded in Clark's books.
c. Allopathic treatment of arthritis relieves the suffering (e.g. using ibuprofen and other Non-steroidal products) and reverses much of the relentless inflammation (e.g. using cox-1 inhibitors). It would be a major regression for patients to forego the use of these products in favor of treatments expounded in Clark's books.
10. In my opinion the claims at the website www.curecancer.com are based on erroneous information and can cause patients to do themselves harm when thinking they are helping themselves.
I declare under penal of perjury, that the foregoing statement is true and correct. Executed this 26th day of April, 2001 at Bethesda, Maryland.