The Shady History of Royal Lee and
Standard Process Laboratories

Stephen Barrett, M.D.

Royal S. Lee (1895-1967), a nonpracticing dentist, founded and operated the Vitamin Products Company, which sold food supplements, and the Lee Foundation for Nutritional Research, which distributed literature on nutrition and health. The company, still family owned and operated, is now called Standard Process, Inc. and located in Palmyra, Wisconsin. Glassdoor estimates the company's annual gross sales to be between $100 and $500 million. Its catalogs have described the ingredients of its products as vitamins, minerals, protein isolates, glandular extracts, organ extracts, dried tissues, plant material, and plant extracts, singly or in various combiunations. It currently sells supplements [1] , herbal products {2], and veterinary products [3].

A biographical sketch on the Standard Process Web site described Lee as a prolific inventor who registered more than 70 patents on equipment, processes, internal combustion engines, and food products [4]. He founded Standard Process in 1929 and his foundation in 1941.

Lee's first product was Catalyn, a patent medicine composed of milk sugar, wheat starch, wheat bran, and other plant material. During the early 1930s, a shipment of Catalyn was seized by the FDA and destroyed by court order because it had been marketed with false claims of effectiveness against goiter, hardening of the arteries, heart trouble, high blood pressure, insomnia, prostate trouble, and other serious ailments.

In 1945, the FTC ordered Lee and the Vitamin Products Company to discontinue illegal claims for Catalyn and other products. In 1956, the Post Office Department charged Lee's foundation with fraudulent promotion of a book called Diet Prevents Polio. The foundation agreed to discontinue the challenged claims.

From 1961 through 1965, Lee received help in "research development and marketing" from Kurt W. Donsbach, D.C., who did literature research and gave nutrition seminars, primarily to chiropractors who were interested in marketing the company's products to their patients [5]. In 1962, Lee and Vitamin Products were convicted of misbranding 115 special dietary products by making false claims for the treatment of more than 500 diseases and conditions. Lee received a one-year suspended prison term and was fined $7,000. [6] Lee also consented to a permanent injunction prohibiting his use of claims for the products as well as claims such as "Arthritis and tooth decay are caused by the eating of cooked foods"and "Some 700,000 people a year die of preventable and curable heart disease caused by deficiency of natural vitamins." [7]

Lee had another brush with the FDA in connection with his marketing of a device he invented in 1937 called the Endocardiograph. The Endocardiograph (photo courtesy of the Bakken Library and Museum) was an electrical amplifying and recording stethoscope used by chiropractors and other practitioners to "diagnose" disease and prescribe Lee's vitamin preparations as treatment. Literature describing the use of the device also claimed that practitioners could use it to "detect and analyze" enlargement of the heart, heart muscle fatigue, and diseases caused by nutritional deficiencies (which Lee alleged to include virtually all diseases). In 1963, the FDA initiated a seizure of three Endocardiographs in the possession of the Vitamin Products Company of Maryland (a distributor) along with promotional literature shipped by Lee's organizations. The Government charged that the labeling of the device contained statements that falsely represented it as effective in detecting vitamin deficiencies, high blood pressure and many other disease conditions [5]. In a speech on the day after the seizure had been made, Kenneth Milstead, Deputy Director of the FDA Bureau of Enforcement, described Lee as "probably the largest publisher of unreliable and false nutritional information in the world." [8]

Despite the conviction, Standard Process continued to market its products for the treatment of disease. In 1975, Sidney Wolfe, M.D., gave this testimony at a Congressional hearing on vitamin regulation:

Although Standard Process Laboratories itself has allegedly stopped using a catalog, in a recent meeting at the National College of Chiropractic in Illinois, a booklet was distributed in which the students could fill in the blanks with the diseases to be treated by their companies after hearing an oral presentation by the company's detailmen. The "health appraisal" form, given out by the vitamin company salesmen is ostensibly to be used for the taking of the patient's history, and helps the chiropractor and any other person to elicit symptoms of gastroenterologic disease, nervous system diseases, and so forth. On the third page of this exhibit, the connection is made between symptoms elicited and vitamin—drugs that should be used. . . .

In addition to these materials, companies also use a catalog . . . in which the disease is listed alphabetically. Again, this whole catalog reviews every known condition and prescribes certain cures for the treatment. This catalog is similar to the Standard Process catalog . . . which caused the FDA to secure the consent decree against the company [9].

From about 1978 to 1980, a 15-hour course called The Doctor's Seminar on Nutrition was conducted by Richard Murray, D.C., and John Courtney. Brochures for the seminar described them as "the two most knowledgeable men in nutrition available on the American scene today." Murray was said to practice "more nutrition than any other doctor in America," using "in excess of $200,000 of Standard Process products each year." Courtney was identified as a vice president of Standard Process Laboratories and "the most knowledgeable man in nutritional research today." The brochures also said that Courtney had "worked closely with Dr. Lee for more than 30 years" and that in 1978, "nearly a thousand doctors listened to Dr. Murray in seminar." One of the seminar's subjects was "successful handling of multiple sclerosis, muscular dystrophy, impotency and mental disorders." [10] Food supplements have no legitimate role in the treatment of these conditions, but one of Lee's principles, listed in Standard Process's booklet "Applications of Nutritional Principles for the Chiropractic Profession" was: "A fact need not be 'proved' to be useful." Tapes of the seminar were also offered to chiropractors for $175.

In the 1980s, I also saw several manuals that practitioners could use to guide their product selection. Some involved the use of symptom questionnaires; others were "cookbooks" that matched health problems to products. Some manuals were published by people who hoped to profit from selling them. Other manuals were assembled and distributed free of charge by distributors who expected to benefit from product sales. None of the materials identified the company as their publisher, but one manual was sent by a regional distributor when I responded to an ad by Standard Process in a chiropractic journal. All made unsubstantiated claims that would be illegal on product labels, but independent authors generally have First Amendment protection and cannot be prosecuted for what they write.

One of the most explicit systems included a 197-item symptom questionnaire [11] and a 55-page spiral-bound book that listed Standard Process products for each symptom in the questionnaire [12].

Since the mid-1980s, I have seen no evidence that Standard Process is making therapeutic claims directly. Instead, the claims have been made through distributors, lecturers, and publishers rather than directly through company publications. The company publicizes and/or sponsors many seminars for practitioners, but I don't know whether it could be held legally responsible for their contents.

Independent Promotion

Bruce West, D.C., of Monterey, California, is an independent publisher who produces Health Alert newsletter and markets supplements doing business as Immune Systems. Some mailings have contained explicit (and illegal) therapeutic claims for more than 50 Standard Process products that he was selling. Similar claims have been posted to his Health Alert Web site.

Another aggressive promoter was Dick A. Versendaal, D.C., of Holland, Michigan, whose seminars taught an elaborate pseudoscientific system of diagnosis and treatment called Contact Reflex Analysis (CRA). Versendaal claimed that a wide range of diseases can be diagnosed by testing the patient's arm strength while touching various "reflex points" on the patient's body. The findings were then used to prescribe regimens of Standard Process products that cost several dollars a day. Versendaal claimed that his approach could generate a million dollars a year working only 15 hours a week [13].

In 2000, I noted that a company called Nutricom was marketing "software for the professional" that provided supplement recommendations in response to various tests. Its "Symptom Survey"—available online—asked 197 questions about the frequency of symptoms, most of which have little or nothing to do with diet or nutrition. Other tests interpreted (or misinterpreted) the significance of various laboratory blood tests. The recommended "nutrition support protocols" were composed of products made by Standard Process. Nutricom claimed that the products facilitated "healing and cell regeneration."

Another prolific promoter is John R. Brady III of San Diego, California, who directs the International Foundation for Nutrition and Health (IFNH) and also does business as the Acoustic CardioGraph Company. INFH markets reprints of Lee's writings and a computer program called Nutritec Software, which can help practitioners determine which products to recommend. In 2007, the software package included a "Symptom Survey" module with more than 200 questions about the patient's medical history and current symptoms. The manual for the software contains a disclaimer that statements mentioned in the software about Standard Process supplements "are not expressed as the opinion of Standard Process" or made by the company itself. Based on the results, the software recommends a program of dietary supplements and herbs that the practitioner can sell. Some "symptoms" are typical of various illnesses; others are not. To explore the test, I gave positive answers to "sensitive to cold," "hungry between meals,"and "slow pulse, below 65." My sensitivity to cold temperatures and hunger between meals are not abnormal. My pulse is slow—54 at rest—because I am extremely fit. Yet, based on these answers, the Nutritec report suggested that I had significant glandular and "sugar handling" problems and recommended 15 products, the total cost of which would be $7 per day! [14]

Brady's other company markets the Acoustic CardioGraph, which is said to be a modern (transistorized) version of Lee's Endocardiograph [15,16]. The company's Web site claims that the the $6,600 device "provides a readable signature of heart sounds" that "measures the heart as a reflection of balanced body chemistry" and thus serves as an adjunct for recommending nutritional programs [17].

The Symptom Survey Maestro, developed by Greene Software, is similar to Nutritec but may be more closely connected to Standard Process. The comopany's Web sites stated that the software evaluates the forms and "suggests Standard Process and MediHerb supplementation based on a modified systems group analysis, actual clinical experience, and traditional application of whole-food nutrition and whole-extract herbal therapies." The practitioner also gets pre-filled order forms that iut can send to Standard Process [18].

Ava Frick, DVM, CVC, FAIS, of Eureka, Missouri, was a "veterinary product marketing consultant" to Standard Process, Inc., from 2011 to 2011, during which time she presented seminars to veterinarians and chiropractors who practiced "veterinary chiropractic." [19] In a lengthy video, she indicated that Standard Process's veterinary products are supported by an elaborate system of sales tools and instructional manuals [20].

The Bottom Line

Standard Process products have been promoted with dubious claims for more than 50 years. After the company and its founder were prosecuted for criminal misbranding, the claims gradually became less traceable to the company. The products have been promoted for many conditions that are outside the legitimate scope of the practitioners (mainly chiropractors) who prescribe them. I advise people to avoid both the products and anyone who sells them.

References

  1. Product Guide. Standard Process, March 2018.
  2. MediHerb Product Catalog. Standard Process, Feb 2018
  3. Veterinary Professional's 2017/2018 Product Guide. Standard Process, Feb 2018.
  4. Our founder—The life of Dr. Lee. Standard Process Web site, accessed April 20, 2006.
  5. Barrett S. The shady activities of Kurt Donsbach. Quackwatch, April 17, 2011.
  6. FDA Notices of Judgment under the food Drug, and Cosmetic Act, 1962, pp 138-140.
  7. Smith RL. The amazing facts about a "crusade" that can hurt your health. Today's Health, Oct 1966, pp 31-36.
  8. Milstead KL. Quackery in the medical device field. Presentation at the Second National Conference on Quackery, Chicago, Oct 25, 1963.
  9. Wolfe SL. Testimony to the Subcommittee on Health of the Committee on Labor and Public Welfare, U.S. House of Representatives. Hearing on Food Supplement Regulation, Aug 22, 1974, pp 894.
  10. Barrett S, Herbert V. The Vitamin Pushers: How the "Health Food" Industry Is Selling America a Bill of Goods. Amherst, NY: Prometheus Books, 1994, pp 292-293.
  11. Symptom survey form, copyright 1987, Standard Process Laboratories.
  12. Downey DS. A Manual for Metabolic / Nutritional Evaluatiion of the Symptom Survey Form. Balancing Body Chemistry with Nutrition Seminars, 6th printing, Jan 1988.
  13. Barrett S. Contact reflex analysis. Chirobase, Aug 27, 2009.
  14. Nutritional program report for Patient Xxx Xxx. Generated March 27, 2007.
  15. The history of the Acoustic CardioGraph. Acoustic CardioGraph Web site, accessed March 27, 2007.
  16. ACG - Nutritional cardiograph. drkaslow.com Web site, accessed May 21, 2018.
  17. ACG home page, accessed May 24, 2018.
  18. Features. Systems Survey Maestro Web site, accessed May 24, 2018.
  19. Curriculum vitae of Ava Frick, Feb 16, 2016.
  20. Ava Frick DVM System (Survey for Animals), undated, posted to Vimeo in 2012.

This article was revised on May 30, 2018.

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