Hoxsey Detailed Scientific Review

Overview

Background

Although he was not a doctor, Harry Hoxsey treated thousands of cancer patients. For nearly 40 years he treated them with a tonic of potassium iodide and nine herbs that had been passed onto him by his great grandfather. He opened his first clinic in Taylorville, Illinois, in the 1920s, but was forced to move to Dallas following hostile encounters with the local American Medical Association (AMA). In 1949, he sued the Hearst publications, the AMA and Morris Fishbein, editor-in-chief of the Journal of the American Medical Association (JAMA), for libel and slander after a negative article. The judge found in favor of Hoxsey, but only awarded him $2¹. Attitudes concerning the Hoxsey treatment compared to the conventional treatments available at the time are explored in a newly published collection of letters written to the FDA¹¹.

By the 1950s, Hoxsey had a center in Dallas with branches in 17 states. However, he was forced to close all clinics in 1960 rather than fight separate state court battles with the FDA. When he closed the last clinic in Dallas, he gave the formula for the tonic to one of his nurses, Mildred Nelson, who reported that her mother had been cured of cancer at the Hoxsey clinic in 1946¹. In 1963, Ms. Nelson set up a clinic in Tijuana, Mexico, where she and a full medical staff treated cancer patients. Ms. Nelson died in 1998, but the clinic is still operational. In the middle 1990s it  saw approximately 1200 patients annually for cancer and other conditions², but its current operations and potential for research are unknown⁸.

According to the legend, the list of ingredients in the Hoxsey formula originated with his great grandfather who had observed one of his horses with a tumor eating weeds in a corner of the pasture where he did not normally eat. Within about three months, the tumor reportedly dried up and separated from the healthy tissue. His great grandfather listed the plants eaten by the horse, added other popular ingredients from home remedies of his day, developed some external salves and began treating the tumors of other animals and then people¹.

Francis Brinker, N.D., states that a formula similar to the Hoxsey formula for oral use, minus the buckthorn bark and with more cascara sagrada/amarga and prickly ash, was listed in the U. S. National Formulary fifth edition (1926) and sixth edition (1936) as an official remedy³. This remedy, known as "Compound Fluidextract of Trifolium", was first described in 1898 in the King's American Dispensatory. (Potassium Iodide has been variously included and omitted.) It was recommended as an alterative (drug to favorably alter the course of an illness) and "widely prescribed for scrofulosis and cutaneous affections . . . in secondary and tertiary syphilis". Although exact dosages are unknown, a comparison by Duke⁴ of the dosages that Hoxsey turned over to the court (JAMA 1954, 1551:667-8 cited by Ward) were low compared to estimated needs per the 1898 Dispensatory⁴. A 2002 survey of naturopathic physicians in the U. S. and Canada treating patients with breast cancer reported that the Hoxsey formula was used by 29% of the 161 responders treating localized breast cancer and 24% of the 72 responders treating metastatic breast cancer⁷.

External pastes used in the Hoxsey treatment may contain zinc chloride, antimony trisulfide, arsenic trisulfide and/or bloodroot. The same ingredients were also used in a technique known as “Moh’s surgery” that was developed during the 1930s. This technique “fixed” tumors with an external paste and then removed them surgically for microscopic examination of succeeding layers of skin until no further evidence of malignancy was seen. However, the developer, Frederick Mohs, MD, stopped using external pastes because of excessive damage and unreliability and these are rarely used in modern surgery^9,10.

Toxicity

No toxicity associated with the Hoxsey tonic has been reported, but the potential of toxicity exists from some of its components. For example, buckthorn bark in large quantities can cause nausea and vomiting, and cascara can cause diarrhea. Barberry root administered to rabbits (dose unspecified) caused swelling of the kidney and cardiotoxicity. Potassium iodide can cause adverse reactions in sensitive patients. Components of the external salves such as zinc chloride, antimony trisulfide, arsenic trisulfide and blood root can cause irritation and damage to normal skin^9,10.

Proposed Mechanisms of Action

External Pastes

The external pastes are said to differentiate between malignant and normal tissue, but recurrence of skin cancers and damage to normal skin have been reported with use of external pastes^9,10. 

Herbal Tonic

Many of the individual components of the herbal tonic have been used in other folk remedies and/or studied through in vitro or animal studies that are described in The Constituents of the Hoxsey Formula (pdf).

Scientific studies concerning the Hoxsey treatment is provided in the Summary of Research.

Summary of Research

Amount and Type of Research

Searches of the medical literature (SCOPUS, OVID, Pubmed) between June 1, 2003, and July 31, 2006, identified three articles relevant to the use of Hoxsey treatments for cancer^8,10,11.

A previous search of the Medline database between April 1, 2001, and June 30, 2004, identified two articles concerning the Hoxsey formula. Both of these articles concerned a survey of complementary and alternative medicine use by naturopathic physicians for patients with breast cancer. No actual studies of the effectiveness of the Hoxsey formula were identified.

A previous search between January 1, 1997, and March 31, 2001, had identified and retrieved two references applicable to cancer. The searches prior to 1997 had identified 169 references, of which 94 (56%) were applicable to cancer, and 55 (59%) of those references were retrieved.

Combining the results of all searches yields totals for all literature reviews to 101 references applicable to cancer. Of these, we retrieved 62 (61%) and classified the references in the following types of information:

Note: An additional 56 articles concerning individual plants used in the Hoxsey formula were identified between 1/1/1997 and 12/31/01. These articles are reviewed in Hoxsey Constituents.

Of the human related Hoxsey articles, we coded the studies (4) by the following study designs:

*Not an NCI designated best case series

Summary of Human Research

Four human studies have been identified in the literature. The first study was a prospective study with no controls. That study assessed survival for 39 patients with a variety of histologically verified cancers, who had been treated at the Bio-Medical (Hoxsey) Center clinic in Tijuana, Mexico⁵. Of these 39 patients, 23 were lost to follow-up, 10 died after an average of 15.4 months and six remained disease-free with an average follow-up of 48 months. Sites of cancers for these six patients were lung (n=2), melanoma (n=2), recurrent bladder cancer and one labial vulva cancer.

The second human study was a retrospective (historical) cohort study that identified all new patients registered at the Bio-Medical Center during the first quarter of 1992. The clinic and the study investigators then attempted to determine the five-year survival status as of 1997 for the 149 patients with cancer. For these 149 patients, 17 (11.4%) were alive, 68 (45.6%) deceased and 64 (43%) unknown. Because of the large proportion lost to follow-up (45.6%), it was not possible to compare the survival of this cohort of patients to the survival of other cohorts of cancer patients reported in the literature².

The third study was a best case series in a pamphlet provided by the clinic that was not verified by independent outside review⁶. That series consisted of nine cancer patients who had survived 10 or more years after being treated with the Hoxsey formula. Seven of the nine had either previous or concurrent conventional treatment.

A set of seven case reports are reported in a recently published book that chronicles the development of the Hoxsey treatment. The author interviewed seven people with biopsy proven cancer whose doctors had predicted that they had a year or less of life remaining, but they lived beyond that. At the time of interview, six people had survived from five to 24 years, but the actual survival time of the seventh person was not stated¹.

Conclusions

No peer-reviewed studies have been published that enable one to draw definitive conclusions about the Hoxsey tonic. However, anecdotal reports of unexpectedly long-term survivals of individual patients indicate a need for documented follow-up by the clinic of all patients and additional controlled studies with large enough numbers of patients to be able to draw conclusions.

This table provides abbreviated summaries of the results of human studies.

Hoxsey Summary of Human Studies Table (pdf)

Study descriptions and sources for this review are available in the Annotated Bibliography.

Annotated Bibliography

Human studies for patients treated at the Bio-Medical (Hoxsey) Center in Tijuana, Mexico

⁵Austin S, Dale EB, DeKadt S. Long-term follow-up of cancer patients using Contreras, Hoxsey and Gerson therapies. Journal of Naturopathic Medicine 1994;5(1):74-6.

Purpose: Survival
Type of Study: Prospective cohort with no controls
Methods: (Various) During 1983-84, a sample of 39 patients attending the Biomedical Center (Hoxsey) clinic in Tijuana was interviewed. (Medical Records were not available.) The patients were questioned as to location of the primary tumor, biopsy confirmed or not, diagnosed in the U. S. or Mexico, and whether the cancer was known to have spread to lymph nodes or distal organs. Those who were diagnosed by the Mexican clinics or by means other than biopsy were excluded. Patients were queried by letter once a year thereafter (and/or the relatives were queried if the patient stopped responding). Patients were followed for four to five years or until death.
Results: Twenty-three (59%) of the 39 were lost to follow up. Ten of the 16 remaining patients died after an average of 15.4 months. The six remaining survivors claimed to be disease-free with an average follow up of 48 months. These six survivors included two lung cancer patients (one with advanced disease), two melanoma patients (one level 5), one patient with recurrent bladder cancer and one with vulval cancer.

²Richardson MA, Russell NC, Sanders T, Barrett R, Salveson C. Assessment of outcomes at alternative medicine cancer clinics: a feasibility study. J of Alternative & Complementary Medicine. 2001;7(1):19-32.

Purpose: Survival
Type of Study: Retrospective cohort with historical controls
Methods: The medical records were reviewed of patients with cancer initially registering at the clinic during the first quarter of 1992. Information was recorded for diagnosis, pathological confirmation of diagnosis, previous treatment and extent of disease at arrival according to the criteria of the National Cancer Institute’s population-based cancer registry, SEER. The clinic subsequently mailed letters to these patients to introduce the study. An investigator from the former University of Texas Center for Alternative Medicine then attempted to learn of any patients who had died through the U. S. Social Security death index. Phone calls were then made to any patients who were not known to have died and these patients were interviewed concerning their experience and opinions concerning the Hoxsey tonic and diet and any additional conventional treatment that they might have received.
Results: Of 149 patients with cancer, 17 were still alive (11.4%), 68 had died (45.6%) and the status of 64 was unknown (43%). Because of the high percentage of patients lost to follow-up, it was not possible to compare the survival of this cohort to comparable cohorts of patients from the U. S. treated solely with conventional medicine.

⁶Biomedical Center. Information on the Hoxsey therapy. (Pamphlet from Hoxsey Clinic).

Purpose: Survival/quality of life.
Type of Study: Best cases.
Methods & Results: Case reports of nine cancer survivors treated at the Bio-Medical Center clinic follow:

*Not verified by National Cancer Institute or other independent review

Caution Concerning This Report: This report was not published in a peer-reviewed journal; that is, it was not reviewed by experts in the field to determine that there was sufficient data to support the conclusions.

¹Ausubel K. When Healing Becomes a Crime. Rochester, VT: Healing Arts Press, 2000.

Purpose: Survival
Type of Study: Case reports
Methods & Results: The author located and interviewed seven "people who got well when they weren’t supposed to." 

Caution Concerning This Report: This report was not published in a peer-reviewed journal; that is, it was not reviewed by experts in the field to determine that there was sufficient data to support the conclusions.

Full citations are provided in the Reference List.

Reference List

1. Ausubel K. When Healing Becomes a Crime. Rochester, VT: Healing Arts Press, 2000.
2. Richardson MA, Russell NC, Sanders T, Barrett R, Salveson C. Assessment of outcomes at alternative medicine cancer clinics: a feasibility study. Journal of Alternative & Complementary Medicine. 2001;7(1):19-32.
3. Brinker F. The Hoxsey treatment: Cancer quackery or effective physiological adjuvant. Journal of Naturopathic Medicine 1995;6(1):9-23.
4. Duke J. The synthetic bullet vs. the herbal shotgun shell. HerbalGram 1988 Fall-1989 Winter;18-19:12-3.
5. Austin S, Dale EB, DeKadt S. Long term follow-up of cancer patients using Contreras, Hoxsey and Gerson therapies. Journal of Naturopathic Medicine 1994;5(1):74-6.
6. Bio-Medical Center. Information on the Hoxsey therapy.
7. Standish LJ, Greene K, Greenlee H, Kim JG, Grosshans C. Complementary and alternative medicaltreatment of breast cancer: a survey of licensed North American naturopathic physicians. Alternative Therapies in Health & Medicine 2002;8(5):68-75.
8. Moss RW. Tijuana Cancer Clinics in the Post-NAFTA Era. Integrative Cancer Therapies 2005;4(1):65-86.
9. McDaniel S, Goldman GD. Consequences of using escharotic agents as primary treatment for nonmelanoma skin cancer. Arch Dermatol 2002 Dec;138:1593-96.
10. Elston DM. Escharotic agents, Fred Mohs, and Harry Hoxsey. J Am Acad Dermatol 2005;53(3):523-25.
11. Cantor D. Cancer, quackery and the vernacular meanings of hope in 1950s America. J of the History of Medicine and Allied Sciences 2006;61(3):324-68.