Hoxsey Therapy

Overview
The Hoxsey Therapy or Hoxsey Method is a alternative medical treatment promoted as a cure for cancer. The alternative cancer treatment consists of a caustic herbal paste for external cancers or an herbal mixture for "internal" cancers, combined with laxatives, douches, vitamin supplements, and dietary changes. Reviews by major medical bodies, including the U.S. Food and Drug Administration (FDA), the National Cancer Institute, the American Cancer Society, M. D. Anderson Cancer Center, and Memorial Sloan-Kettering Cancer Center, have found no evidence that the Hoxsey Therapy is an effective treatment for cancer. The sale or marketing of the Hoxsey Method was banned in the United States by the FDA on September 21, 1960 as a "worthless and discredited" remedy. Currently, the Hoxsey Method is primarily marketed and practiced by the Bio-Medical Center in Tijuana, Mexico. The Hoxsey Therapy is also marketed over the Internet; in June 2008, the FDA National Health Fraud Coordinator noted that "There is no scientific evidence that it has any value to treat cancer, yet consumers can go online right now and find all sorts of false claims that Hoxsey treatment is effective against the disease."

History
The Hoxsey Therapy, a mixture of herbs, was first marketed as a purported cure for cancer in the 1920s by Harry Hoxsey, a former coal miner and insurance salesman, and Norman Baker, a radio personality. Hoxsey himself traced the treatment to his great-grandfather, who observed a horse with a tumor on its leg cure itself by grazing upon wild plants growing in the meadow. John Hoxsey gathered these herbs and mixed them with old home remedies used for cancer. In common with many advocates of unconventional therapies, Hoxsey considered cancer a systemic disease, however localized its manifestations might appear to be. Among the claims made in his book, he purports his therapy aims to restore "physiological normalcy" to a disturbed metabolism throughout the body, with emphasis on purgation, to help carry away wastes from the tumors he believed his herbal mixtures caused to necrotize.

Harry initially opened a clinic in Taylorville, Illinois for the sale and use of his treatment, one of 17 that he would eventually open. Dogged in many states by legal trouble for practicing medicine without a license, Hoxsey frequently shut down and reopened the clinics in new locations. In 1936, Hoxsey opened a clinic in Dallas, Texas which became one of the largest privately owned cancer centers in the world. At one point in the 1950s, Hoxsey's gross annual income reached $1.5 million from the treatment of 8,000 patients. Hoxsey published several books advertising his methods and clinics, and received support from prominent right-wing conservatives and fundamentalist Christians such as Gerald Winrod and H. L. Hunt.

The United States National Cancer Institute (NCI) and Food and Drug Administration (FDA), as well as the American Medical Association (AMA), began a series of efforts to restrict Hoxsey's clinic operations, viewing them as providing "false hope". Regarding the rationale for this campaign, John Heller, director of the NCI, wrote in 1953: "Our efforts in cancer control are directed toward reduction of the intervals between onset and diagnosis of cancer, and between diagnosis and the application of effective treatment. People who fall victims to quacks are diverted from this narrow course for the best clinical management of cancer."

The American Medical Association condemned Hoxsey's "caustic pastes" and tonics as fraudulent. In 1949, Hoxsey sued the Journal of the American Medical Association (JAMA) and its editors for libel and slander. Hoxsey won the case, but was awarded only $2; the judge concluded that since Hoxsey's promotion of his treatment depended largely upon claims that the AMA was persecuting him, he had suffered little or no damage from the JAMA articles. A review of 400 patients treated by Hoxsey found no verifiable cures.

In 1950, Hoxsey submitted case histories of 77 patients to the National Cancer Institute (NCI), claiming that they were "fully documented with clinical records and pathological reports" and that they would demonstrate his treatment's effectiveness. However, the NCI found that of these 77 reports, only 6 included actual tissue biopsies. Of the 2 biopsies from patients described by Hoxsey as having "internal cancer", neither showed any evidence of actual malignancy. The NCI concluded that Hoxsey's records did not contain sufficient information to evaluate his treatment. Hoxsey argued that it was the NCI's responsibility to seek out the information necessary to verify his case reports, and attributed the failure to do so to a conspiracy on the part of the NCI and AMA.

In 1956, the FDA sent an investigator to Hoxsey's clinic posing as a patient. The investigator was told by Hoxsey's clinic that he had cancer (he did not), and that it would take a "long time" to cure him. The U.S. government banned the sale of the Hoxsey herbal treatment in 1960. Hoxsey was also forced to close all of his U.S. clinics. In 1963, Mildred Nelson, a nurse who had worked closely with Hoxsey, established the Bio Medical Clinic in Tijuana, Mexico with Hoxsey's approval. Hoxsey himself chose this site in 1963, when his last operation in the US was shut down. Just before Nelson's death in 1999, the clinic was taken over by her sister, Liz Jonas.

In 1967, Hoxsey developed prostate cancer, and his own treatment failed to cure it. Because he failed to respond to his eponymous therapy, Hoxsey underwent surgery and standard medical treatment. He died seven years later, in 1974.

Treatment
Hoxsey herbal treatments include a topical paste of antimony, zinc and bloodroot, arsenic, sulfur, and talc for external treatments, and a liquid tonic of licorice, red clover, burdock root, Stillingia root, barberry, Cascara, prickly ash bark, buckthorn bark, and potassium iodide for internal consumption.

In addition to the herbs, the Hoxsey treatment now also includes antiseptic douches and washes, laxative tablets, and nutritional supplements. A mixture of procaine hydrochloride and vitamins, along with liver and cactus, is prescribed. During treatment, patients are asked to avoid consumption of tomatoes, vinegar, pork, alcohol, salt, sugar, and white flour products.

In 2005, the cost of initial evaluation and treatment with Hoxsey Therapy at the Bio-Medical Center in Tijuana, Mexico was reported to be between $3,900 and $5,100, though this price did not include the recommended purchase of an unspecified number of dietary supplements and 3 years of return visits.

Side-effects

 * The topical paste is highly caustic, and can burn or scar the skin.
 * The oral treatment can cause:
 * nausea
 * vomiting
 * diarrhea
 * anxiety
 * trembling
 * abdominal cramps
 * heart block


 * Pokeweed has caused deaths in children.
 * Red clover may increase the risk of bleeding for people who take anticoagulants. It also mimics the behavior of the hormone estrogen, and thus is unsuitable for women with estrogen-responsive breast tumors.

Effectiveness
No peer-reviewed medical or scientific research has been published which would allow any conclusions about the effectiveness of the Hoxsey Therapy. The Bio-Medical Center in Tijuana, Mexico claims a success rate of 50–85%, though these figures have not been independently evaluated and the parameters of "treatment success" are undefined. Mildred Nelson, director of the Bio-Medical Center, has claimed an 80% success rate, and attributed treatment failures to a "bad attitude" on the part of the patient.

Studies by major medical bodies
The American Cancer Society and the National Cancer Institute do not advise the use of the Hoxsey Therapy, as neither have found any objective evidence that the treatment provides tangible benefit to people with cancer. Reviews by the Memorial Sloan-Kettering Cancer Center and M. D. Anderson Cancer Center found no evidence that the Hoxsey Therapy is effective as a treatment for cancer. A controlled experiment in lab mice did not find any difference in tumor growth between untreated mice and those given the Hoxsey tonic. An FDA review of 400 people claiming to have been cured by the Hoxsey method found that many of the patients never in fact had cancer, or had received successful medical treatment elsewhere before being treated with the Hoxsey Therapy. Those who had cancer at the time of the Hoxsey Therapy were uniformly either deceased or alive with active cancer. There were no cases of actual cures among those promoted as such by the Hoxsey clinic.

In 1957, a group from the University of British Columbia visited Hoxsey's Mexican clinic and obtained records for 71 Canadian patients treated by Hoxsey. The University panel found that: "For over one-half of the [cancer] patients from British Columbia, the result [of treatment with the Hoxsey method] has been either death or progression of the disease. In nearly one-quarter there was no proof that the patient ever had cancer. Nearly one in ten of the patients had curative treatment before going to the Hoxsey Clinic. In only one case, an external cancer, was there any evidence at all that the Hoxsey treatment had an effect on the disease; in that case, better results could have been obtained by orthodox means." The panel reported that in the one case of demonstrable cure, a patient with a skin cancer of the ear, Hoxsey's treatment had resulted in disfigurement which could have been avoided with standard surgical excision.

In 1998, the Office of Technology Assessment issued a report on herbal cancer treatments. This group found that while many elements of the Hoxsey Therapy had antitumor activity in vitro, the complete Hoxsey tonic had never been tested in animal models or in human clinical trials.

Alternative medicine literature
Several books on herbalism have claimed that some of the herbs in the therapy have anti-tumor effects in vitro. According to botanist James A. Duke of the United States Department of Agriculture, eight of the nine Hoxsey-tonic herbs have some anti-tumor activity in animal models, five have antioxidant effects, and all nine have antimicrobial activity that may be linked to cancer-fighting effects. Duke's assessment was that the Hoxsey tonic ingredients showed very significant chemical and biological anticancer activity.

A 1994 article in the Journal of Naturopathic Medicine followed 39 patients treated with the Hoxsey Therapy in Tijuana. Patient interviews were used to confirm the existence and stage of cancer; most patients were unaware of the stage of their tumor and medical records were not available. Most patients were lost to follow-up; of the patients successfully followed, 10 died and 6 were alive at their last follow-up. Review of this study pointed out its "obvious flaws", including "the majority of patients lost to follow-up, lack of access to detailed medical records, and reliance upon patients for disease stage information"; the authors themselves regarded the results as unclear.

A 2001 analysis published in the alternative-medicine literature explored the feasibility of using the Bio Medical Center's records in Tijuana as the basis for outcomes research on the Hoxsey Therapy. Of 149 patients treated for cancer at the Bio Medical Center in 1992, the authors found that less than half of these patient records contained pathology reports verifying a cancer diagnosis. Additionally, 60%–90% had already received "conventional" treatment such as surgery, chemotherapy, or radiation therapy with a possible curative effect. The authors were able to verify survival status in only 57% of the treated patients, due to lack of documentation, follow-up, and identifying information in the Bio Medical Center charts. Of the cohort of 149 patients, 11% were still alive 5 years after treatment with the Hoxsey Therapy; 46% had died; and 43% could not be located and their status could not be determined. The authors concluded that it was not possible to reliably assess the Bio Medical Center's outcomes because of the lack of documentation, limited follow-up, and failure to confirm in many cases the existence or stage of cancer.

Notable cases
The treatment gained wide press coverage in 2006 due to a court dispute between the family of Starchild Abraham Cherrix and Social Services of the State of Virginia. Cherrix has requested to undergo Hoxsey Therapy to treat a recurrence of Hodgkin disease. Because at the age of 16 he was still a minor, Social Services considered the parents to be negligent and sought to have Cherrix undergo conventional chemotherapy and radiotherapy. On August 16 2006, Circuit Judge Glen A. Tyler announced that both sides had reached an agreement that the parents did not act in a way that was medically neglectful. In addition, it stipulated that Starchild would be treated by an oncologist of his choice who was both board-certified in radiation therapy as well as interested in alternative methods to treat Hodgkin disease.

Promotional

 * The Hoxsey Clinic in Tijuana, Mexico

Scientific reviews

 * American Cancer Society: Hoxsey Herbal Treatment
 * British Columbia Cancer Agency: Hoxsey's Herbal Tonic
 * Overview of Hoxsey Herbal Therapy from the Memorial Sloan-Kettering Cancer Center
 * Overview of the Hoxsey Therapy from M. D. Anderson Cancer Center

Narratives

 * Hoxsey: How Healing Becomes a Crime (1987), 1987 documentary film written and directed by Ausubel
 * The Medical Messiahs: A Social History of Health Quackery in Twentieth-Century America, by James Harvey Young
 * The Medical Messiahs: A Social History of Health Quackery in Twentieth-Century America, by James Harvey Young