Immuno-augmentation therapy

Definition

Immuno-augmentation therapy (IAT), also called immuno-augmentative or immuno-augmentive therapy, is a cancer treatment aimed at restoring the immune system with injections of a mixture of blood factors.

Origins

The theory behind IAT was formulated in the 1950s by Dr. Lawrence Burton. After earning his doctorate in experimental zoology in 1955 from New York University, Burton moved to the California Institute of Technology (Caltech) as a postdoctoral fellow in the laboratory of H. K. Mitchell. There, he and his coworkers discovered a tumor-inducing factor (TIF) in fruit flies. A few years later, Burton and his colleague, Dr. Frank Friedman, joined the cancer research staff of Dr. Antonio Rottino at St. Vincent's Hospital in New York City. Rottino was one of the first scientists to conclude that there was a connection between the body's immune system and cancer.

Burton and the development of IAT

After Burton and his colleagues reported finding an inhibitor of fruit-fly TIF in mice and human tissue, Mitchell published a retraction of the papers he had coauthored with Burton. Mitchell claimed that Burton's assay for TIF—on which Burton was basing his recent work—could not be repeated independently. Undeterred, Burton continued using fruit flies and mice to develop a mixture of blood proteins to slow or stop the proliferation of cancer cells.

By the mid-1960s, Burton was making sensational presentations. In 1966, at an American Cancer Society (ACS) seminar for science writers, Burton injected mice with his "unblocking factor." Their tumors shrunk in less than an hour. Although newspaper headlines read "15-Minute Cancer Cure," the medical community was unconvinced. Professional journals refused to publish Burton's papers and he eventually lost his research funding. The American Cancer Society (ACS) placed Burton's IAT on its list of unproven methods.

In 1973, Burton and Friedman left St. Vincent's and, with independent funding, founded the Immunology Researching Foundation in Great Neck, New York. They began treating cancer patients with IAT. The following year they submitted an investigational new drug application to the United States Food and Drug Administration (FDA) in order to begin clinical trials of IAT. However, when FDA officials asked Burton for his experimental evidence, he withdrew his application.

Burton and Friedman eventually patented four substances that they claimed to have isolated from human blood:

• deblocking protein
• tumor antibody 1
• tumor antibody 2
• tumor complement

Burton claimed that when used in the correct combination, these substances restored normal immune function in cancer patients.

During the 1970s and early 1980s, the National Cancer Institute (NCI) tried to evaluate IAT. Burton refused to disclose his methods for isolating his blood substances, and an agreement regarding evaluation methods could not be reached.

The Bahamian clinic

Hostility from the medical establishment drove Burton to close his New York clinic in 1977. With private funding, he founded the Immunology Researching Centre (IRC), Ltd. in Freeport on Grand Bahama Island. This not-for-profit organization was licensed to treat people who had been diagnosed with cancer. In 1978, representatives from the Bahamian Ministry of Health and the Pan American Health Organization found violations in admissions, treatment, and evaluation of the clinic's patients. They could not determine the blood components used in IAT, and found no records of patient survival rates. They concluded that there was no evidence that IAT was effective, and recommended that the facility be closed.

However, the Bahamian health authority did not close the clinic until 1985. At that time it was announced that blood supplies across the United States were contaminated with the human immunodeficiency virus (HIV). Burton's clinic was no exception. Indeed the clinic had treated Kaposi's sarcoma in patients with acquired immune deficiency syndrome (AIDS ). Although no HIV infections were ever traced to the clinic, and some scientists questioned the HIV screening used by the authorities, the sera used in IAT were found to carry hepatitis virus and infectious bacteria. At least two cases of hepatitis were traced to the sera. The Bahamian government, at the apparent insistence of the FDA and the NCI, closed the clinic for seven months, until screening and sterilization methods for serum production were improved. IAT had been legalized in Florida and Oklahoma in the early 1980s; however, Florida rescinded its law when the clinic closed. In 1986, the FDA banned the import of IAT drugs.

The closing of Burton's clinic and the ban on sera import enraged many patients and their families. They formed the Immuno-Augmentative Therapy Patient Association (IATPA), later renamed People Against Cancer, and began lobbying the United States Congress. In 1986, the Office of Technology Assessment (OTA), then a research branch of Congress, was told to investigate alternative cancer therapies. OTA worked with Burton to develop procedures for an IAT clinical trial on colon cancer patients. However the arrangement broke down, and the OTA concluded that there was no reliable data with which to evaluate IAT.

During the 1990s, the IRC opened additional clinics in Germany and Mexico. Burton died in 1993 and his long-time associate, Dr. R. John Clement, took over IRC operations. In 2003, Clement founded the ITL Cancer Clinic, a new operating company for the IRC. This new, expanded clinic offered additional mainstream and alternative treatments combined with IAT.

Benefits

As of 2004, no one claims that IAT cures cancer. Proponents claim that the therapy can stop the spread of many cancers and may send the cancer into remission. They claim that by treating deficiencies or imbalances in the immune system, the body is able treat itself, resulting in an extended lifespan and enhanced quality of life. Sometimes the disease has spread too far within the body to respond to IAT. Furthermore, if chemotherapy or radiation treatment has over-suppressed the immune system, response to IAT may be slow.

IAT is claimed to have about a 19% effectiveness rate. Various cancers respond differently to IAT:

• Bladder cancer responds favorably.
• Brain cancer: astrocytomas (noncapsulated brain tumors arising in brain cells called astrocytes), grades I and II, respond favorably; grade III does not respond well; glioblastoma multiforme (the fastest-growing type of brain tumor) is not a candidate for IAT.
• Breast cancer: all types respond, although inflammatory cancers respond poorly.
• Cervical cancer: responds in early stages; mixed results in late stages.
• Colorectal cancer: good response in most stages; metastasis to the liver disqualifies it for IAT.
• Head and neck cancers respond favorably.
• Leukemias: adult chronic types respond to IAT.
• Lung cancers: adeno- and squamous-cell (large-cell) cancers and mesotheliomas respond well to IAT; small-cell, oat-cell, and undifferentiated cancers are not candidates for IAT.
• Lymphoma: responses vary.
• Melanomas: extremely variable responses.
• Myeloma responds well, even at late stages.
• Pancreatic cancer: good response in some cases, although IAT may be inappropriate because of disease complications.
• Prostate cancer responds at all stages.
• Skin metastases do not respond to IAT.

Description

Both conventional cancer immunotherapy and IAT are based on enhancement of the immune system. Sometimes called immune enhancement or immune modulation, conventional immunotherapy is used at many U. S. clinics. Clinical trials have found it useful for treating various cancers, including melanoma, lymphoma, kidney, and bladder cancers.

IAT components and treatment

Three serum factors are used in IAT:

• Tumor antibody factor (TAF), more commonly called tumor necrosis factor (TNF), may induce antibodies that destroy tumors.
• Tumor complement factor (TCF) is said to induce antibody formation.
• Deblocking protein factor (DPF) is claimed to remove an endogenous blocking protein that prevents the immune system from detecting the cancer.

TAF and DPF are isolated from the blood of healthy donors. TCF is isolated from the clotted blood of cancer patients.

IAT patients are screened for imbalances in immune system components. During the initial treatment, blood factors are measured once or twice per day, five days per week. In addition to measuring the serum factors used in treatment, the blood is analyzed for blocking protein factor (BPF). High levels of BPF and low levels of DPF and TCF are claimed to cause immunosuppression or immunodeficiency, enabling the cancer to grow and spread. Based on this data, a computer calculates the amount of each serum to be injected into the patient.

Treatment varies from one to 12 daily injections. Treatment is on an outpatient basis for an average of 10–12 weeks. Following outpatient treatment, patients are given supplies of sera and a computerized prescription for home injections. Home treatment may last weeks, months, or the rest of one's life. Patients typically return to the clinic for about two weeks, every four to six months. They undergo measurements of tumor activity and IAT responses, in conjunction with conventional methods for determining tumor regression, and symptom and disease remission.

Approximate costs

IAT is expensive:

• Four weeks of initial and intensive therapy—$7,500.
• Each week thereafter—$700.
• Costs for megadoses of oral supplements. Metabolic therapies , including vitamins, minerals, animal or plant extracts, or other nutrients, are prescribed on an individual basis and administered orally or intravenously. Intravenous infusions cost about $150 each.
• Home maintenance supplies—$50 per week.

These fees do not include:

• Special medications or nutrients not used in routine IAT.
• Laboratory or other tests performed outside of the clinic.
• Outside physician or hospital services.
• Medical aids or equipment not prescribed or supplied by the clinic.
• Transportation, lodging, and living expenses during outpatient treatment.

IAT usually is not covered by insurance.

Preparations

Under Bahamian law, IAT patients must have been previously diagnosed with cancer. Patients are screened to determine if IAT is appropriate for their type of cancer. Typically, patients travel to an IAT clinic, where they are given a physical exam, and blood and urine tests, to determine the status of their immune system. IAT appears to be more effective on patients who have not had chemotherapy.

IAT patients are asked to abstain from tobacco and to limit alcohol consumption during treatment. Lung cancer patients must have stopped smoking prior to treatment at the IRC. In addition, patients should:

• avoid dietary animal fats
• avoid excess vitamin C
• take antioxidant supplements that are recommended

Precautions

Proponents of IAT claim that it is nontoxic, safe, and effective. However, there have been no controlled clinical studies of IAT, and scientists have not been able to replicate Burton's original results with mice. In addition:

• IAT sera have not been tested for safety by accepted medical standards.
• Some medical practitioners caution that the unregulated IAT sera may contain infectious agents transmitted in human blood.
• Relying on IAT in place of conventional cancer treatments may have serious health consequences.

Side effects

Anecdotal reports from patients indicate that the side effects of IAT are minor and include:

• fatigue
• pain at the injection site
• flu-like symptoms
• pain and edema (fluid accumulation) during IAT given to bone cancer patients

Research & general acceptance

There is no scientific evidence that IAT is an effective cancer treatment. Nor is there scientific evidence that IAT sera contain specific components. In 1980, Met-Path, a biomedical firm, terminated a contract with Burton after they could not identify or measure a substance that Burton claimed was present in IAT serum. Most anecdotal claims and testimonials for IAT's effectiveness against cancer are without supporting evidence.

In 1984, researchers at the University of Pennsylvania Cancer Center collected data from 79 patients who had received IAT at Burton's clinic. They concluded that reliable comparisons with those receiving conventional cancer treatment were not possible; however, their survey did find extended survival times among the IAT patients. They suggested that a well-controlled prospective study be performed.

In April 2003, the United States Agency for Healthcare Research and Quality (AHRQ) issued a report on IAT. Using criteria developed by the NCI, they conducted a "best-case series" to examine nine cancer patients treated with IAT. Their cancers included:

• hodgkin's lymphoma
• non-small cell carcinoma of the lung
• poorly-differentiated nodular lymphoma
• peritoneal mesothelioma (two cases)
• ovarian adenocarcinoma
• squamous cell carcinoma of the vocal cords (two cases)
• adenocarcinoma of the colon

The report concluded that IAT warranted further study. It recommended either a random controlled clinical trial or a prospective case series with treatment protocol and documentation established prior to treatment.

KEY TERMS

Metastasis, pl. metastases

—A secondary tumor; the process by which cancerous cells form secondary tumors in distant parts of the body.

Training & certification

IAT practitioners are usually medical doctors.

Resources

BOOKS

Cassileth, B. The Alternative Medicine Handbook. New York: W. W. Norton & Co., 1998.

Pelton, Ross, and Lee Overholser. Alternatives in Cancer Therapy: The Complete Guide to Non-traditional Treatments. New York: Fireside, 1994.

Sackman, Ruth. Rethinking Cancer: Non-Traditional Approaches to the Theories, Treatments and Prevention of Cancer. Garden City Park, NY: Square One Publishers, 2003.

PERIODICALS

Green, Saul. "Immunoaugmentative Therapy." Journal of the American Medical Association (JAMA) 270, no. 14 (October 13, 1993): 1719-24.

ORGANIZATIONS

ITL Cancer Clinic (Bahamas) Ltd. P.O. Box F-42689, Freeport, Grand Bahama, Bahamas. (877) 785-7460. 242-352-7455. [email protected]. [email protected]. <http://www.iatclinic.com>. <http://www.immunemedicine.com>.

People Against Cancer. 604 East Street, P.O. Box 10, Otho, IA 50569. (515) 972-4444. [email protected]. <http://www.peopleagainstcancer.net>.

OTHER

"Best-Case Series for the Use of Immuno-Augmentation Therapy and Naltrexone for the Treatment of Cancer. Summary." Evidence Report/Technology Assessment: No. 7. AHRQ Publication No. 03-E029. April 2003 [cited April 29, 2004]. <http://www.ahrq.gov/clinic/epcsums/immaugsum.htm>.

&"Immuno-Augmentative Therapy." Cancer Facts. National Cancer Institute. October 27, 1999 [cited April 29, 2004]. <http://cis.nci.nih.gov/fact/9_15.htm>.

"Immuno-Augmentive Therapy." Making Treatment Decisions. American Cancer Society. 2000 [cited April 29, 2004]. <http://www.cancer.org/docroot/ETO/content/ETO_5_3X_Immuno-Augmentive_Therapy.asp?sitearea=ETO>.

Margaret Alic