Heel-BHI: The World's Most
Outrageous Homeopathic Marketer

Stephen Barrett, M.D.

In 1982, physicians throughout the United States began receiving multiple mailings of a large softcover booklet called Biological Therapy with Homeopathic Remedies [1]. The booklet described what it called the practice of "homotoxicology" and offered 53 products intended for treating cancer, gallstones, glaucoma, kidney failure, multiple sclerosis, smallpox, syphilis, tuberculosis, and more than a hundred other diseases and conditions. The mailings came from Biological Homeopathic Industries (BHI), of Albuquerque, New Mexico, whose president, Dr. Hans-Heinrich Reckeweg, was said to have done "extensive research" since the late 1920s [1]. In 1985, the Albuquerque Tribune reported that BHI had distributed nearly 200,000 of its booklets [2].

In response to this promotion, the U.S. Food and Drug Administration concluded that BHI was one of the most flagrant law violators among homeopathic marketers [3]. Acting on this belief, the agency issued a regulatory letter [4] and banned the importation of BHI products that it considered unapproved new drugs. Despite these actions, however, BHI (now called Heel, Inc.) has continued to violate the law and now offers more than a thousand products. This article traces the company's history and states what I believe should be done to protect consumers.

Background History

Hans-Heinrich Reckeweg, MD (1905-1985), was a German physician who practiced homeopathy. The Heel Web site states that he founded Biologische Heilmittel Heel GmbH in Berlin 1936 and moved the company to its present location in Baden-Baden in 1953. Between 1936 and 1979, he developed 1,000 combination homeopathic remedies in Germany. In 1979, Reckeweg relocated to Albuquerque and created Biological Homeopathic Industries (BHI) and began manufacturing combination remedies in tablet form. In 1981 he founded Menaco Publishing Company, which published books and "journal" called "Biological Therapy" (now called the Journal of Biomedical Therapy). In 1997, the Albuquerque company was renamed Heel Inc, which now manufactures and distributes both BHI products and Heel products [5,6]. Heel products are primarily marketed to practitioners, whereas BHI products are primarily marketed to consumers,

According to Reckeweg:

Illness is the expression of self-healing. The afflicted organism attempts to regulate its functions through the body's greater defense system by activating detoxification and excretion. Inflammation and fever are not necessarily "bad" signs but rather serve to detoxify and eliminate toxins. This occurs according to the chemical processes as defined and demonstrated in homotoxicology. Through this, the physician is provided a different perspective of illnesses as many puzzles are clarified and methods of treatment are re-established. Inflammation need not be suppressed by antibiotics and/or chemotherapy as this often provokes retoxification and therapeutical damage that should be avoided. By suppression the illness is propelled towards dangerous retoxic cellular phases that manifest themselves as chronic and/or lingering diseases. BHI homeopathic remedies stimulate the five systems that comprise the great corporal defense system as defined in homotoxicology [6].

Reckeweg further claimed that his methods worked by converting homotoxins into nontoxic substances that he called "homotoxons" [7].

The principles of "homotoxicology" do not conform to what is scientifically known about the body in health and disease. I have found nothing about Reckeweg or homotoxicology by searching MEDLINE and very few mentions of him or his work from sources not commercially affiliated with Heel-BHI. Although Reckeweg is said to have conducted extensive research, I can find no evidence that he published anything significant about this. BHI's magazine has described a few studies of Heel products, but these involved no control groups and mean absolutely nothing. Reckeweg's methods are also promoted by the British Society for Homotoxicology & Anti-Homotoxic Therapy

The claims made for Heel-BHI products are available on several Web sites. Heel-BHI has a copy of its 210-page Routine Therapy guide for Heel products [8] and its 132-page Homeopathic Therapy guide for BHI products [9]. Homotoxicology.net has posted Heel's 669-page Biotherapeutic Index, which describes how to use products to treat more than 400 conditions [10]. A 1993 edition of the book, which was distributed at an osteopathic convention in 1998, was smaller but contained 12 pages on "neoplasia and neoplastic phases of disease." (Neoplasm is a medical term for tumor.) These volumes contain most brazen set of bogus therapeutic claims I have ever seen.

To illustrate the extent of the claims, I have posted the entry for Lyphomyosot® in the Biotherapeutic Index, which states that the product is useful for asthma, "blood purifying," bronchitis, chronic gastritis, cystitis, dermatoses, diarrhea, eczema, flatulence, gallbladder disease, heel pain, herpes, kidney stones, liver disease, nasal polyps, rickets, swollen glands, tuberculosis, and several other problems.

Use By Practitioners

Practitioners can learn about how to use Heel products through educational events sponsored by the company and/or its distributors. In recent years, the Heel USA Web site has listed more than 50 seminars, teleconferences, and Web-based programs each year. The seminar fee includes a copy of Heel's Practitioner's Handbook. Some of the seminars are co-sponsored by Vibrant Health International Technologies, of Quebec, Canada, which also markets EAV devices. These devices are fancy galvanometers that measure skin resistance [11]. They are not FDA-approved for diagnosis and cannot be legally marketed in interstate commerce as diagnostuc devices. Many of the doctors who prescribe Heel products use such devices. In 2007, I got a glimpse into such use through a complaint from a man whose wife had consulted Jarir Nakouzi, M.D., a member of Heel's speaker's bureau. Nakouzi practices internal medicine and homeopathy in Bridgeport Connecticut. His Web site describes him as "an expert in oncology." [12] The Vibrant Health Web site describes him as "Heel International's most accomplished oncology expert." [13] He is not board certified but says he took a three-year fellowship in oncology after graduating from medical school in Italy. The patient had received standard treatment for breast cancer but was terminally ill. Nakouzi treated her for twelve weeks beginning in October 2002. The charges totaled more than $41,000, which included about $8,500 for worthless "bioresonance therapy" and "quadrant analysis and balancing" with an EAV device.

FDA Enforcement Actions

In 1984, FDA officials concluded that BHI was one of the three most flagrant violators because they marketed products for very serious disease conditions [14]. Soon afterward the agency warned Reckeweg that it was "unaware of any substantial scientific evidence which demonstrates that any of your marketed homeopathic drugs are generally recognized as safe and effective for their intended use" and that "continued marketing of these drugs is a serious violation of the Federal Food, Drug, and Cosmetic Act." [4] A few months later, the Albuquerque Tribune stated that the company had stopped selling "anticancer, antivirus, artery, regeneration, and stroke pills" and would modify how it marketed the rest [2].

An FDA Enforcement Report indicates that in 1991 BHI recalled 1,055 bottles and 33,333 finished bulk tablets of BHI Infection Homeopathic Remedy Tablets because they were "subpotent." [15]

Between October 1993 and September 1994, the FDA warned BHI to stop making claims that BHI Cold, which contained sulfur and pulsatilla, was effective against mumps, whooping cough, chronic respiratory diseases, herpes zoster, all viral infections, and measles. In addition, when combined with other BHI remedies, it had been illegally claimed to be effective against otitis, pleurisy, bronchitis or pneumonia, conjunctivitis, and tracheitis [16].

In January 2005, the FDA ordered Heel Inc. to stop making illegal for five products claimed to be effective in preventing or treating influenza [17].

In addition to warning letters, the FDA has issued import alerts to try to prevent most BHI products from being imported. Between October 1983 and April 1985, the agency made 10 detentions on grounds that the products were unapproved new drugs [18]. Since 1995, additional Heel products have been blocked because of illegal therapeutic claims and failure to abide by good manufacturing practices [19]. The blockage includes all products labeled "sterile" or for injection [20]. There may have been other detentions, but I do not have access to such information.

Questionable Tax Break

In October 2003, the Bernalillo County (New Mexico) Commission approved a deal under which Heel could obtain an $8 million industrial revenue bond that would be repaid within 20 years. During the repayment period, it would not have to pay property taxes and certain gross-receipts taxes. Proponents argued that subsidies of this type help create jobs and are good for the local economy, but critics noted that some companies have left the state before such agreements have expired [20]. I wondered whether the Commission knew or cared about the nature of Heel's business. It turned out, however, that Heel decided not to use the bonds.

The Bottom Line

Heel-BHI has been marketing products with outrageous and illegal claims for more than 25 years. The vast majority are irrationally formulated and have not been scientifically tested. Using them instead of proven therapy is a waste of money and could lead to delay in getting appropriate treatment. The FDA should take forceful action to rid the marketplace of these products. Since there is no logical reason to use the products, consumers should avoid practitioners who prescribe them.

References

  1. Biological Therapy with Homeopathic Remedies. Albuquerque, NM: Menaco Publishing Company, 1981, 1983.
  2. Uhlman M. FDA cracks down in city 'homeopathic' drug factory. Albuquerque Tribune March 14, 1985.
  3. Rados B. Riding the coattails of homeopathy's revival. FDA Consumer 19(2):30-34, 1985.
  4. Michels D. Regulatory letter to Dr. Hans Heinrich Reckeweg, Dec 11, 1984.
  5. Story of Heel. Heel-BHI Web site, accessed March 14, 2007.
  6. Reckeweg HH. Foreword to Homeopathic Therapy: Physicians Reference. Albuquerque, NM: Heel, Inc., 1998.
  7. Reckeweg HH. Scientific basis of biological and homeopathic therapy. (Booklet) Baden-Baden: Aurelia Verlag, 1979.
  8. Routine Therapy: Practitioner's Handbook of Homotoxicology, Second Edition . Albuquerque, NM: Heel, Inc., 2005.
  9. Homeopathic Therapy: Physicians Reference. Albuquerque, NM: Heel, Inc., 1998.
  10. Biotherapeutic Index, 5th revised English edition. Baden-Baden, Germany: Biologische Heilmittel GmbH, 2000, p 4.
  11. Barrett S. Quack "elecrodiagnostic devices. Quackwatch, Sept 5, 2007.
  12. Dr. Jarir Nakouzi, M.D. drjarirnakouzy.com, accessed Dec 3, 2007.
  13. Workshops. Vibrant Health International Technologies Web site, accessed Dec 3, 2007.
  14. Chastonay RJ. Request for limited inspection Re: Homeopathic Products. Memo, Oct 26, 1984
  15. FDA Enforcement Report, March 25, 1992, p 6.
  16. Health Fraud Actions, October 1993 - September 1994. Rockville, MD: FDA, 1994, p 3.
  17. Malarkey MA. Warning letter to Chris Rusnock. Jan 3, 2005
  18. Drugs detention for FY 84 to date. FDA computer printout. Oct 10, 1985.
  19. Details can be located by searching the FDA Web site for "Heel," "BHI," "Biologische Heilmittel" and "Heel GmbH."
  20. Import alert #66-40. Detention without physical examination of drugs from firms which have not met drug GMPs. Revised Aug 17, 2007.
  21. Sanchez JW. Duke city ≠company to get IRB. Albuquerque Tribune, Oct 14, 2003.

This article was revised on November 15, 2008.

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