ACS :: Immuno-Augmentative Therapy

Other common name(s): immunoaugmentative therapy, immuno-augmentative therapy, immune augmentative therapy, immune augmentation therapy, immuno-augmentation therapy, IAT

Immuno-augmentative therapy (IAT) is promoted as an alternative form of cancer treatment. It consists of daily injections of a protein mixture made from human blood in an attempt to allow the immune system to attack the cancer. Components of the blood products are claimed to contain anti-tumor antibodies and "deblocking proteins" from healthy donors.

Available scientific evidence does not support claims that IAT is effective in treating cancer. The existence of "blocking" and "deblocking" proteins has not been verified by other labs. Some patients developed infections while receiving this treatment in the past, although currently this does not seem to be a problem.

IAT should not be confused with mainstream cancer immunotherapy, which uses cytokines (immune system hormones), antibodies, vaccines and other methods to boost the immune system's attack on cancer cells.

Proponents claim IAT causes cancer to stabilize or go into remission. It is not promoted as a cure for cancer, but as a long-term treatment of daily injections. Like diabetics, IAT patients are told that they can live normal lives as long as they continue to have daily injections.

Practitioners of IAT believe that cancer cells begin to grow and multiply when a person's immune system is out of balance. The components of IAT, derived from human blood, consist of anti-tumor antibodies to attack the cancer and "deblocking proteins" to remove a "blocking factor" that prevents the patient�s immune system from detecting the cancer.

Proponents claim IAT is a safe, non-toxic, and effective treatment for all types of cancer.

This therapy involves daily injections under the skin of a protein mixture made from human blood. The first IAT session requires a trip to an IAT clinic. At the clinic, a patient is given a physical exam and blood and urine tests. The results of these tests are fed into a computer program to determine the patient's immune system status.

Once this is done, the IAT treatment begins. Patients are given IAT injections each day according to their particular situation. Blood tests are done once or twice a day, 5 days a week, to measure "immune response" and to find out the dose of treatment to be given the next day. Treatment continues until the practitioner believes that the patient's cancer is controlled.

The initial treatments require patients to stay in the area of the clinic for an average of 2 to 3 months. The patient is then shown how to self-inject and is sent home to continue treatment, although further clinic visits may be needed.

According to a 1991 review article in CA, A Cancer Journal for Clinicians, a biologist named Lawrence Burton, PhD, developed IAT in the early 1970s, based on his research with fruit flies and mice. He developed a mixture of blood proteins that he believed would slow or stop the growth of cancer cells. He claimed that IAT caused cancer in mice to go into remission. However, a 1990 report from the US Office of Technology Assessment (OTA) said that the results of these experiments were questioned and that the study could not be repeated by other researchers.

According to the OTA report, Dr. Burton first offered his treatment to cancer patients in 1973, when he and some sponsors established the Immunology Research Foundation in Great Neck, NY. In 1974, the CA article notes that Dr. Burton submitted an investigational new drug (IND) application to the Food and Drug Administration (FDA) in order to begin human trials with IAT. He later withdrew his application when the FDA asked for further details about his experimental evidence.

In 1977, Dr. Burton closed his New York clinic and opened the Immunology Researching Centre (IRC) in the Bahamas. According to the OTA report, representatives of the Bahamian Ministry of Health and the Pan American Health Organization visited his facility in 1978 and reviewed the charts of several patients. The report they filed concluded that, "no consistent treatment effect has been achieved when assessed by objective criteria." The report also states:

The material being used to treat patients is similarly a totally unknown quantity. Although the various fractions are referred to by Dr. Burton as 'antibody fractions' and 'complement fractions,' there is in fact no evidence that any of these fractions do contain antibody of any relevance to the tumor involved or that in fact there are any active or even inactive complement components.

The OTA report mentioned that the representatives noted that the "IRC was not carrying out its stated intent�to evaluate IAT as a cancer treatment." The group's report concluded that "the present procedures of the Center do not permit any meaningful evaluation," and recommended that the clinic be closed. The clinic remained open despite these findings. The OTA report states that Bahamian health authorities closed the clinic in 1985 on charges that the compounds used for IAT injections may have been contaminated with hepatitis B virus and HIV, after samples were tested by the State of Washington's Health Department and the CDC. The clinic reopened less than a year later. In the late 1980s Dr. Burton opened additional clinics in West Germany and Mexico.

The OTA report notes that, during the late 1970s and early 1980s, National Cancer Institute (NCI) officials contacted Dr. Burton asking to evaluate his IAT techniques. No agreement could be reached on research methods and Dr. Burton never disclosed his technique for isolating the blood proteins in IAT, which he had patented. In 1986, the US Office of Technology Assessment, working with Dr. Burton, developed procedures for a clinical trial of IAT on patients with colon cancer. Communication between Dr. Burton and the OTA eventually broke down and the OTA�s final report stated that "no reliable data are available on which to base a determination of IAT�s efficacy."

The OTA report states that the FDA imposed a ban on the import of IAT drugs in 1986 "due to the direct hazards that have been associated with IAT agents."

Dr. Burton died in 1993 but his clinic in the Bahamas continues to operate. Though the clinic has a different name since 2003, the clinic's web page notes that it is part of the IRC.

The concept that cancer can be treated by enhancing activity of the immune system is reasonable, and is the basis for mainstream immunotherapy. Unlike IAT, conventional immunotherapy is founded on scientific principles of immunology and is tested in clinical trials. It has been shown to be useful in treating melanoma, lymphoma, kidney cancer, bladder cancer, and others.

However, available scientific evidence does not support claims that IAT is effective in treating people with cancer. Success stories associated with the treatment are based mainly on individual (anecdotal) reports provided by Dr. Burton�s clinics, and they include little or no supporting evidence.

No outside labs have confirmed the existence of the "blocking" or "deblocking" proteins, which are an essential part of Dr. Burton�s theory and treatment. The 1991 CA article notes that a contract between Dr. Burton and MetPath (now Quest Diagnostics), a large biomedical laboratory firm, was terminated in December 1980.

According to a 1981 letter from Paul Brown, M.D., Chairman of the Board of MetPath at the time of the interaction with Burton, MetPath was unable to develop a reliable test based on Burton�s information and �extensive laboratory testing.� There were 25 percent false positives in patients without cancer, and 25 percent false negatives in patients with cancer.

There have been no published reports of randomized controlled clinical trials or of any type of prospective (forward looking) studies of IAT.

Dr. Burton published one "best-case" series of 11 patients with mesothelioma (a cancer of the lining surrounding the lungs or other organs) in 1988. The extent of the cancers was not described. According to the report, the average survival time on IAT was about 30 months, which is longer than is normally seen in these patients. This was a small group of selected patients, and no formal studies have been done to confirm these results.

Another small best-case series was conducted for the Agency for Healthcare Research and Quality to determine if IAT warranted further study. Researchers looked at the medical records of 60 cancer patients treated at the IAT clinic in the Bahamas. Of these, 9 were found to have had positive outcomes and enough verified data to be considered in the series, although the researchers noted that even some of these records were not complete. While this was a selected best-case series and not a pre-designed study, the overall suggestion was that there was enough evidence "to recommend that a random controlled trial could be considered."

Researchers from the University of Kentucky evaluated the results of 46 cancer patients treated consecutively at an IAT clinic in Mexico during 1989, and published their findings in June 2003. While no significant side effects were noted, none of the patients� tumors shrank. In 40 (87%) of the patients, the cancer progressed, and 25 of these patients died within 6 months. Quality of life got worse in 35 of the 46 patients during the 3 months of treatment, although overall, 38 of the patients decided to continue getting IAT. The researchers concluded that the study did not justify the continued use of IAT.

The safety of IAT has not been established in clinical studies. Based on individual (anecdotal) reports from patients who have received IAT, side effects appear to be minor and include fatigue, pain at the injection site, and flu-like symptoms. Some medical professionals fear that infectious agents, such as HIV and hepatitis B virus, may contaminate the unregulated compounds used in IAT, which come from human blood. While there were reports of such exposures in the 1980s, none have been reported in recent years.

Relying on this type of treatment, and avoiding or delaying conventional medical care, may have serious health consequences.

The following information on complementary and alternative therapies may also be helpful to you. These materials may be ordered from our toll-free number (1-800-ACS-2345).

American Cancer Society. Questionable methods of cancer management. Immuno-augmentative therapy (IAT). CA Cancer J Clin. 1991;41:357-364.

Coulter I, Hardy M, Shekelle P, et al. Best-Case Series for the Use of Immuno-Augmentation Therapy and Naltrexone for the Treatment of Cancer. Evidence Report/Technology Assessment No. 78 (Prepared by Southern California-RAND Evidence-based Practice Center under Contract No 290-97-0001). AHRQ Publication No. 03-E030. Rockville, MD: Agency for Healthcare Research and Quality. April 2003. Available online at: www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat1a.chapter.31876. Accessed June 28, 2007.

Clement RJ, Burton L, Lampe GN. Peritoneal mesothelioma. Quantum Medicine: A J Comp Thera 1988;1:68-73.

Green S. Immunoaugmentative therapy. An unproven cancer treatment. JAMA. 1993;70:1719-1723.

Pfeifer BL, Jonas WB. Clinical evaluation of "immunoaugmentative therapy (IAT)": An unconventional cancer treatment. Integr Cancer Ther. 2003 Jun;2(2):112-119.

US Congress, Office of Technology Assessment. Unconventional Cancer Treatments. Washington, DC: US Government Printing Office; 1990. Publication OTA-H-405. Available online at: www.wws.princeton.edu/ota/ns20/alpha_f.html. Accessed June 28, 2007.

Note: This information may not cover all possible claims, uses, actions, precautions, side effects or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for consultation with your doctor, who is familiar with your medical situation.

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