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What Did We Know...And When Did We Know It?

Opposition to Efforts of the
Food and Drug Administration (FDA)
to Regulate Nutritional Supplements

Testimony to the FDA by Alyce Ortuzar, President
The Well Mind Association of Greater Washington

In 1949, Dr. Frederick Klenner documented his success at reversing polio, without any lingering paralysis or impair- ment, using high-dose intravenous Vitamin C. He continued to publish throughout the 1970s, treating measles, chickenpox, third-degree burns and advanced cases of pneumonia, using over 200 grams in a 24-hour period when needed. (A six-hour, 70 gram drip reversed my Lymes Disease.)

Klenner considered Vitamin C to be the safest, most effective antibiotic because of its anti-bacterial, anti-microbial, and anti-viral properties, and recommended it as the treatment of choice in the emergency room if the doctor was not sure what was wrong with the patient. He was highly critical of the American Medical Association (AMA) and the FDA for ignoring his results, and for either recommending a dose too low to be effective, or for discrediting the treatment outright.

In the 1950s, psychiatrists Osmond and Hoffer published their double-blind studies, showing reversal of acute schizophrenia using high doses of Vitamins C, B₃, and B₆. Also in the 1950s, the Shute brothers documented the use of Vitamin E to prevent and treat heart disease. Data also indicated that intravenous magnesium could reduce deaths from heart attacks.

A 1996 article entitled, "Relative Hypoglycemia as a Cause of Neuropsychiatric Illness," published in the National Medical Association Journal, indicated that most mental illnesses have an underlying physical cause; and that focusing on the brain or on drugs will not resolve the problems. This article documents the claim that "relative hypoglycemia mimics any psychiatric disorder." Treatment with a strict high-protein, low-carbohydrate, free of sugar and caffeine coupled with calcium-glycerophasphate injections, achieved an 85 percent response rate of recovery or significant improvement.

Bill W., co-founder of Alcoholics Anonymous, attributed his success to niacin supplements plus a high-protein, low-carbohydrate diet. In 1968, he documented the benefits of megavitamins for a wide range of mental and physical disorders.

Also in 1968, Dr. John Tintera published his book Hypoadrenocorticism, documenting his ability to reverse alcoholism, hypoglycemia, arthritis and certain types of schizophrenia using a high-protein, low-carbohydrate diet along with adrenal cortical extract (ACE). He stated that his only failures were with patients who had been on prednisone first, which he found to be very toxic.

In 1974, Dr. Ben Feingold removed foods with sugar, dyes, additives, pesticides and other synthetic chemicals--all approved by the FDA, Environmental Protection Agency (EPA), or US Department of Agriculture (USDA)--from children’s diets and had about an 80 percent response rate with behavior and learning problems.

In the 1980s, parole officer Barbara Reed, PhD, wrote Food, Teens, and Behavior, wherein she documented an 85 percent reduction in recidivism among 1000 parolees, including violent offenders, when she put them on a high-protein, low-carbohydrate diet; eliminated sugars, food dyes and additives; and focused on nutrition.

Studies claiming to refute these outcomes were paid for by the chemical and/or sugar industry, and were found to have serious design flaws. Dr. Linus Pauling, Nobel Prize recipient in chemistry, showed how claims by the National Institutes of Health (NIH) and others of harm from high doses of Vitamin C, were not chemically possible.

In 1978, the FDA submitted false data, characterized by then Congressman Barry Goldwater, Jr. as "sloppy and suspect," to justify removing adrenal cortical extract (ACE) from the marketplace, in order to make the public a captive audience for prednisone, which the FDA said was safe. For forty years, Physicians Desk Reference recorded no adverse effects from ACE. Today mainstream medical journals identify prednisone as very toxic, even on a short-term basis.

In 1985, Dr. Ralph Moss publicly revealed that Sloan-Kettering had falsified laetrile studies data, deliberately misleading the public with reports that there was no evidence of efficacy when, it fact, animal studies had demonstrated effectiveness.

In 1988, an FDA consumers’ publication falsely stated that intravenous vitamin treatments were useless. The 1989, an FDA "Health Fraud Kit" further misled the public about the safety and efficacy of vitamins.

The FDA ignored evidence that folic acid could prevent certain serious birth defects until 1994, and still refuses to recommend supplements. Instead, the FDA had it added to foods, which I believe will result in a false and dangerous sense of security among women who intend to get pregnant, and who will believe that they are consuming enough, when they really can't know the quantity of folic acid in what they are eating. Also, it is suspected that the iron added to foods, mandated by the FDA, is resulting in excesses that are causing heart attacks.

When the FDA removed natural l-tryptophan from the market, the public was not informed that it was a genetically modified product that had caused the harm. Natural l-tryptophan had been used for decades with no record of adverse events.

The FDA recall rate over a ten-year period is 52 percent. The book The Great White Lie by Wall Street Journal reporter Walt Bogdanich, documents between 10,000 and 50,000 deaths a year from a certain family of heart drugs the FDA had refused to take off the market.

A November, 1994 issue of Newsweek concluded that FDA approval does not ensure safety nor effectiveness. A June 19, 1998 article in the Journal of the American Medical Association (JAMA) acknowledged that over 100,000 people die each year from FDA-approved drugs taken as directed, and many more are maimed by these drugs. Vitamin proponent Dr. Earl Mandell, M.D., poured over Centers for Disease Control data in the 1980s and could not find even one death attributed to vitamins. So much for the FDA's "gold standard" and "sound science."

Existing safety and truth-in-advertising laws already cover supplements. Many lives would be saved if the FDA enforced these laws against the drug industry; toxic treatments with unacceptably low outcome data, such as chemotherapy and radiation, would and should be banned.

These adverse safety data for drugs reveal that the wrong questions are being asked and flawed parameters are being imposed. People are dying as a result of the FDA's betrayal of its mandate for safety, which has been subsumed by the more ambiguous standards for efficacy in the FDA's power grab on behalf of the chemical, food and drug industries, documented in the 1993 exposé Racketeering in Medicine by Tulane Medical School Professor James Carter, MD.

The most infamous example is that of Michael Taylor, a lawyer for Monsanto, who was hired by the FDA to write the rules for genetically modified foods, which Monsanto manufactures. The rules prohibit labeling of GM foods and Monsanto to sue stores that displayed products labeled "BgH free" until Ben and Jerry's challenged those FDA rules in court.

The FDA has also abused its authority and misused its limited resources by spending millions in an attempt to destroy Dr. Burzynski, whose only "crime" is curing serious organ cancers with a nontoxic chemotherapy treatment from which the drug companies, National Institutes of Health (NIH), the National Cancer Institute (NCI) and the American Cancer Society (ACS) can't profit. (NCI randomly looked at seven of Dr. Burzynski's cases and said that in all seven, his treatments appeared to have been effective.) And the so-called "peer reviews" the FDA insists on are shams, having involved shameful scandals for failing to disclose the authors’ financial interests in the companies whose products they were reviewing. The publications themselves depend on the drug industry for funding.

Many holistic practitioners view double-blind studies as unethical, because they entail withholding treatments from participants that practitioners have found to be effective. There is so much good research and outcome data on these natural treatments. Practitioners have developed protocols, safety measures and efficacy dose ranges, knowing that individual needs and variations are critical to their successful outcomes. The highly imperfect FDA paradigm treats everyone the same, and therefore should not be the benchmark for research standards in this country.

The FDA should leave holistic medicine to holistic practitioners and acknowledge the wealth of research and outcome data supporting claims for vitamin, herbal and numerous other treatment options. Testifying before Congressman Burton's FDA oversight committee in 1998, Dr. Peter Matthiessen, Chief of Witten University Medical Service in Germany, presented the pluralistic German medical system as a model for the United States to replicate. Using scientifically reproducible data for quality, efficacy, and cost effectiveness, modalities such as phytotherapy, homeopathy, and anthroposophical medicine are respected and reimbursed.

In 1995, the State of Maryland released a legislative study comparing allopathic with holistic treatments for six disorders, looking at outcome, side effects and cost, based on documentation found in the medical literature. Holistic medicine dramatically outperformed the allopathic treatments.

In summary, the FDA should be a clearinghouse for verifiable research and outcome data from practitioners, researchers and consumers, and labels should reflect this information. What works for one may not work for another, and people will not continue to use what does not help them. But for the FDA to suppress, deny and distort this information is unethical.

Neither the Dietary Supplement Health Education Act (DISHEA) nor the Pearson court case against the FDA would have been necessary if a non-corrupt FDA had been serving the public, adhering to the "First Do No Harm" paradigm. I believe research shows that for every drug (which all have mild to serious side effects), there is a natural, nontoxic alternative.

References

1. Klenner, F. Significance of High Daily Intake of Ascorbic Acid in Preventive Medicine. Journal of Preventive Medicine, v. 1, n. 1: 45-69, Spring 1974; Williams and Kalita, eds. A Physician's Handbook on Orthomolecular Medicine, 51-59, 1973.
2. Bland, J., ed. Medical Applications of Clinical Nutrition, Nutrition and Behaviorby Abram Hoffer, 222-251. New Canaan, CT: Keats Publishing, 1983.
3. Shute, Wilfred. Dr. Wilfrid E. Shute's Complete Updated Vitamin E Book. New Canaan, CT: Keats Publishing, 1975.
4. Gaby, A. Magnesium: How an important mineral helps prevent heart attacks and relieve stress, 16-18. New Canaan, CT: Keats Publishing, 1994.
5. Salzer, H. Relative Hypoglycemia as a Cause of Neuropsychiatric Illness. Journal of the National Medical Association, v.58, n.1, 12-17, Jan 1966.
6. Bill W. The Vitamin B-3 Therapy: A Second Communication to A.A.'s Physicians. February, 1968.
7. Feingold, B. Why Your Child Is Hyperactive. New York: Random House, 1974.
8. Pauling, L. Crystals in the Kidney. The Linus Pauling Institute of Science and Medicine Newsletter, v. 1, n. 11: 1-2, 1981.
9. The letter from Congressman Barry Goldwater, Jr., is in the archives of the Hypoglycemia Association.
10. Brown, S. Prednisone May Be Unsafe in Rheumatoid Arthritis. Internal Medicine News, Jan 13, 1996, p.43.
11. Dr. Ralph Moss, Ph.D. presented testimony about the falsified Laetrile data released by Sloan-Kettering, at Congressman Dan Burton's House Government Oversight Committee Hearings on FDA abuses held in April and May of 1998; he also documents it in his books.
12. Evidence that folic acid might prevent certain birth defects, was presented to the FDA by the Life Extension Foundation around 1985.
13. Bogdanich, W. The Great White Lie: Dishonesty, Waste, and Incompetence in the Medical Community. New York: Simon & Shuster, 1991. (His discussion of the heart drugs was discussed during an interview about his book on the Diane Rehm National Public Radio Show.)
14. Horwin, R. No Rights for a Child Diagnosed with Cancer (scientific evidence documenting the uselessness of and harm from chemotherapy.) Townsend Letter for Doctors and Patients, #201, April 2000, 68-73, 126-129.
15. Carter, J. Racketeering In Medicine: The Suppression of Alternatives.Norfolk: Hampton Roads, 1993.
16. The role of Michael Taylor at Monsanto and the FDA has been reported by numerous investigative journalists, including Pacifica Radio's Democracy Now.
17. A summary of Dr. Burzynski's case can be found in the Well Mind Association of Greater Washington Newsletter #226, pp. 1-3, April 1997. An expose of the American Cancer Society by Dr. Samuel Epstein is in the book Project Censored 2000, www.projectcensored.org
18. The 1995 Maryland Commission On Complementary Medical Methods Report is available from the Maryland State Department of Health and Mental Hygiene.

About the Author

Alyce Ortuzar is President of the Well Mind Association of Greater Washington, a holistic medicine information clearing house. The association offers free practitioner referrals. This testimony would not have been possible without the help of the late Dorothy Schultz, co-founder and guiding spirit of the Hypoglycemia Association, Inc. For further information, contact WMAGW 18606 New Hampshire Avenue, Ashton, MD 20861, phone (301) 774-6617.

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