Kenneth R. Daub, D.C., Enzymatic Therapy, and Their Oral Chelation Program

Stephen Barrett, M.D.
August 20, 2019

“Oral chelation” products are vitamin concoctions claimed to prevent or treat cardiovascular diseases. There is no scientific evidence that they work, and they cannot be legally marketed in the United States.

In 1982, Vascular Associates of Rockford, Illinois issued a 24-page booklet called “Owner’s Manual for a healthy circulatory system.” The booklet’s author—”Dr. Kenneth R. Daub”— said that in 1976 he “began intensive studies of circulatory diseases” and, in 1978 (his “21st year in family practice”), he read an article about the use of Doppler ultrasound to detect vascular disease and began using an oral treatment that he called “vascular rehabilitation.” He then states:

As much as I would like to take credit for the vascular rehabilitation program that I have used so successfully since 1981, I must give credit where it belongs; to Dr. Hans Nieper who has been treating circulatory diseases in Germany for more than eighteen years. I have simply adapted Dr. Nieper’s use of certain glandulars and amino acids as the basis for the products that we now call MVP.

As I treated more and more patients for circulatory problems with this oral procedure, the benefits of this program began to multiply. And as these patients traveled around the country, I began receiving phone calls from doctors literally all over the U.S. wanting to know more about the program. One by one, I consented to travel to many doctors’ offices and train them and their staff in this vascular rehabilitation program. After training less than a dozen doctors, I realized I simply could not reach enough people as quickly as I felt necessary by training one doctor at a time.

That is when I began to explore the possibility of taking these formulations to the general public. The rest of the story should soon be history. I hope you will join us in our commitment to the MVP program [1].

The booklet says that the products, MVP-1, MVP-2, MVP-3, and MVP-4 contain “regulatory substances,” nutrients to “nourish the cells,” enzymes needed to complete digestion,” and “glandular material.” The back cover of the booklet states that Daub had “30 years in private practice” and was an active member in the Society of Non-Invasive Vascular Technology.

Several things were noteworthy:

  • The dates Daub provided did not fit together. The Illinois Department of Financial and Professional Regulation database indicates that his chiropractic license was issued in 1967. He has also been licensed in Iowa, but that board’s database doesn’t indicate when he received it.
  • The booklet does not mention that Daub was a chiropractor. Chiropractic schools do not prepare their graduates to manage or treat cardiovascular disease.
  • Dr. Nieper was not trustworthy. National Council against Health Fraud president William T. Jarvis, Ph.D., characterized him as a “proponent of crank theories.” The American Heart Association and American College of Cardiology issued strong warnings against products he promoted for cardiovascular disease. The FDA banned importation of his products. [2]. During the mid-90s, the FDA initiated a seizure of Nieper products in Nevada and secured a conviction against the sellers [3].
  • Daub’s MVP products included megadoses of several ingredients, some of which could be harmful. Some recommendations in his one-page “low fat food guide” were aligned with modern medical advice, but others were not.
  • Doppler ultrasound tests use high-frequency sound waves to measure the amount of blood flow through the arteries and veins, usually those that supply blood to the arms and legs. Such tests are valuable for diagnosing and managing several type of vascular problems, but whether Daub used them appropriately is questionable.
  • The Society of Non-Invasive Vascular Technology—now called the Society for Vascular Ultrasound—is a respectable professional organization of vascular technologists, surgeons, cardiologists, lab directors, academics, students, and other professionals involved in the practice of vascular ultrasound, about 20% of whom are physicians. Its membership application does not appear to require any mention of relevant education or expertise.
The FDA Objects

Products marketed in interstate commerce for the prevention or treatment of disease are subject to federal regulation. Section 321(g)(1) of the Federal Food, Drug, and Cosmetic Act defines “drug” as any article (except devices) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or function of the body.” Marketing a drug product without FDA approval is illegal. Regulation 201.5 requires labeling to contain adequate directions for all intended uses. Labeling includes any written, printed or graphic material that accompanies a product. Intended use is determined by the facts at hand. Drugs not generally recognized as safe and effective by experts are “new” drugs. Marketing an unapproved (by FDA) new drug in interstate commerce is a federal crime. Marketing a drug without adequate directions for use is also a federal crime (misbranding).

In 1987, the FDA notified Daub and his company, Total Concepts in Health, that claims made in its promotional material that its Vascular Maintenance and Prevention Program (VMP) was effective against vascular disease and other problems made it an unapproved new drug and misbranded. The letter ordered him to stop marketing the product within ten days. A lawyer representing the company replied that it discontinued the brochures and was “revising its labels to delete the ‘VMP’ nomenclature.” [4] The program’s name was changed to MVP. Enzymatic Therapy took over the distribution, but Daub continued to promote it through “sales training seminars” for health food store retailers.

Promotion by Enzymatic Therapy

In 1990, Ira Milner, R.D., a registered dietitian, attended one of the training seminars. The invitation to the seminar said that Daub had “developed a special nutritional protocol to combat arterial disease.” Milner reported:

On March 25, 1990, I joined more than 100 retailers and a few chiropractors at a seminar in New Jersey to learn about [Enzymatic Therapy] and its products. Before the program began, we were asked to sign a “guarantee” that we were not agents of the FDA, the Better Business Bureau, or any other consumer protection agency and would not tape the seminar for any government agency to use against Enzymatic Therapy. The statement also acknowledged that the sole purpose for attending was to obtain”educational information.”

The third speaker at the seminar was Kenneth Daub, D.C ., clinic director of Vascular Associates International Corp., in Rockville, Illinois. His topic, “The Management of Arterial Disease,” was a rambling account of his views on atherosclerosis and some of the patients he has treated. Daub is the developer of MVP, a supplement program he says was adapted from the work of Hans Knieper At the seminar, Daub distributed a booklet titled Owners Manual for a Healthy Circulatory System, which claims that MVP can “help the body nutritionally cleanse itself of the life-threatening plaque in the arteries.”

Daub also encouraged attendees to request his videotape, which makes similar claims and contains testimonials from people who say his product was effective against high blood pressure, obesity, numbness of the hand and leg, chest pain, fatigue, and lack of energy. The tape, which he sells for $20, appears intended to interest people in marketing the product as well as using it. At one point, the narrator even refers to “a lifetime of financial freedom,” words multilevel companies typically use to attract distributors.

A note accompanying the videotape states that it was made in 1985 when Daub’s program was called VMP, which stood for Vascular Maintenance and Prevention. “Our friends in the FDA didn’t like that name so they made us change it,” the note said. “It would have been too costly to re-make the videotape, therefore when VMP is mentioned . . . you’ll know why it has been changed to MVP.”

Actually, the FDA objected to a bit more than the product’s name. The regulatory letter Daub received m June 1987 ordered him to stop stating or suggesting that VMP was useful against occlusive vascular disease, strokes, heart attacks, elevated cholesterol levels, high blood pressure, arthritis and other forms of inflammation, eczema, hyperactivity in children, and “problems from alcoholism to obesity to cancer.” At that time Daub was marketing his program through a company called Total Concept in Health Corporation. Currently the exclusive distributor is Enzymatic Therapy. The slogan “Don’t be bypassed, use MVP,” appears in both the company’s brochure and on refrigerator magnets distributed at the meeting [5].

An Enzymatic Therapy flier distributed at the seminar mentioned no specific diseases but stated that the MVP program was “specially formulated to support proper circulation” and invited prospective users to “nourish your blood and circulatory system—and live with a healthy heart.” [6] A 1990 Enzymatic Therapy booklet for distribution in health food stores described the MVP Program as “complete support for healthy circulation.” [7] A 1991 wholesale catalog listed MVP’s ingredients. The retail price of the program was $90 for a 30-day supply.

Seminar participants also received a copy of The Professional Guide to Nutritional and Herbal Formulas, a 156-page looseleaf manual that described Enzymatic Therapy products and listed more than 80 health problems for which they were recommended. The manual—which said “For Professional Use Only” on its cover—also contained “protocols” for using various products against AIDS, multiple sclerosis, cancer, arthritis, and other serious diseases. Each product was listed by number on a separate page, with ingredients, “clinical indications,” dosage, contraindications/adverse effects, and “supporting formulas.” There was also space for notes. The manual’s text did not identify Enzymatic Therapy or any of its products by name. However, the product numbers and ingredients matched those of the company’s formulas [8].

FDA Actions against Enzymatic Therapy

Enzymatic Therapy, which was founded in 1981, probably holds the record for the quantity and variety of promotional material used to make illegal health claims for its products [9]. An article in the March 1993 FDA Consumer states that the FDA began investigating Enzymatic Therapy in 1985 after receiving complaints from three people who believed they had been harmed by Enzymatic Therapy products [10]. During the next six years, the FDA conducted many inspections and ordered the company to stop marketing a few products and to stop distributing violative literature. Although the company complied with some of these orders (or said it did), FDA undercover investigations—including attendance at one of the retailer training seminars—found that a pattern of violations persisted. The FDA initiated injunction proceedings in 1991 [11] and, in 1992, obtained a consent decree barring Enzymatic Therapy from marketing products with unproven therapeutic claims. The court order also barred the company from manufacturing or marketing fifty-six listed products—including MVP products—unless new promotional material for them was approved by the FDA [12]. I have seen no evidence that MVP products were marketed after the injunction was issued.

References
  1. Daub KR. Dr. Daub’s maintenance program—how it all began. In Owner’s Manual for a healthy circulatory system, Rockford, IL: Vascular Associates, 1982.
  2. Barrett S. Be wary of Nieper therapy. Cancer Treatment Watch, June 25, 2006.
  3. Nordenberg T. Seizers keepers, criminals weepers. FDA Consumer 31(6):32-33, 1997.
  4. Masters GA. Regulatory letter to Kenneth R. Daub, D.C., June 4, 1987, and reply from Attorney Dennis M. Gronek, Aug 14, 1987.
  5. Milner I. Devious claims: Anatomy of a marketing scam. Nutrition Forum 7:41-44, 1990.
  6. Total concept in health: MVP. Flier, Enzymatic Therapy, Green Bay, Wisconsin, 1988.
  7. Formulas for health. Enzymatic Therapy catalog, 1990.
  8. Murray M. The Professional’s Guide to Nutritional and Herbal Formulas. Published and Distributed by Vital Communications, Bellevue, WA.
  9. Barrett S. The Vitamin Pushers: How the Health Food Industry Is Selling America a Bill of Goods. George F. Stickley Co., Philadelphia, 1993, pp 385-392.
  10. Segal M. Six-year investigation ends sale of unapproved drugs. FDA Consumer, March 1993.
  11. Complaint for injunction. USA v Enzymatic Therapy, Biotherapeutics Ltd., Lem’s Contract Printing Shop, Vital Communications, Inc; Terrence J. Lemerond, Bay Natural Foods, and Bradley Lemerond. U.S. District Court for the Eastern District of Wisconsin Case No. 91-C-1174, filed Nov 1, 1991.
  12. Consent decree of permanent injunction. USA v Enzymatic Therapy et al. U.S. District Court for the Eastern District of Wisconsin Case No. 91-C-1174, filed Nov 5, 1992.

This article was posted on August 20, 2019.