1. Immuno-Augmentative Therapy BY: Chloe Sorvino and Helen Daifotis

2. How does immuno-augmentative therapy work? What meachisms does it affect? Developed by Lawrence Burton, Ph.D., the immuno-augmentative therapy (IAT) treatment consists of a series of daily injections of processed human blood products. This therapy is based on the principal that cancer cells multiply when four factors of the immune system do not fight off the cancer effectively. The goal of immuno-augmentative therapy is to enhance the bodies’ immune system in order to enable it to fight off cancer on its own. Essentially, it puts the part of the immune system that destroys tumors on steroids. The basis of IAT is to enhance sera present in the blood. When the blood is processed, it is injected with three proteins to help battle the tumors. These proteins are tumor necrosis factor (TNF), tumor complement factor (TCF), and de-blocking protein factor (DPF). Blocking protein factor (BPF) is also present in the blood, however it is only measured and not administered to patients. By processing human blood and infusing these enhanced sera it is proposed that the immune system will be able to fight off the tumors. Tumor necrosis factor is a protein, which induces the death of tumor cells, however it also has many pro-inflammatory responses. While tumor necrosis factor begins the death of the cells, tumor complement factor triggers the manufacturing of antibodies to complete the necrosis of the cells. The de-blocking protein factor maintains the steadiness of the tumor's kill rate. It neutralizes the blocking protein, which is naturally found in vivo. The blocking protein factor protects tumor cells from attack, regulating the rate of tumor cell death. When tumor cells are present, tumor antibodies are signaled by the tumor complement factor, which initiates the destruction of the tumor cells. One common side effect is a problem in the patient’s liver when these cells are killed irregularly. When this process is either altered or over run the individual is known to be immuno-suppressed or immunodeficient. An example of this imbalance occurs when there are too many blocking protein factors or not enough de-blocking protein factors and/or tumor complement factors.

3. Why is this therapy not approved? Why is this therapy not currently being used?  Immuno-augmentative therapy gained a large following in the 1970s and 1980s, but since then, much of the science behind the therapy has been disproven and no concrete explanations have ever been produced by Dr. Burton. Burton never actually published clinical reports on his statistics or methodology. When he attempted to gain recognition for his new therapy from the FDA, his proposal was rejected because of this lack of evidence to support his claims. Not only did he have no evidence, but also, in July 1986 a ban was placed to outlaw importing IAT into the United States. This was put into effect because upon the examination of numerous samples of IAT, many were found contaminated with hepatitis B and other blood transmitted diseases. Furthermore, after more extensive research into the field of cancer, it is now understood that there is no such thing as a blocking factor. However, despite all this, research is still being done at the IAT Clinic in Freeport, Bahamas.

4. What are the costs of manufacturing and administering IAT?  Immuno-augmentative therapy is administered as an outpatient treatment and consists of a series of subcutaneous injections. The first four weeks of initial and intensive therapy cost roughly $7,500. Every week thereafter costs approximately $700. This lasts for around 12 weeks on average, however a maintenance program must be followed once this initial treatment has been completed. This program costs around $50 per week. However, the costs do not cover special medications or nutrients, laboratory or other tests performed outside of the clinic, other physician or hospital services, and medical aids or equipment not prescribed or provided by the clinic. The costs and procedures used to manufacture IAT are relatively uncertain because never published any reliable scientific records on his procedures.

5.  “In 1980, Burton received an enormous boost when CBS-TV's "60 Minutes" gave him favorable publicity. During the program, a prominent physician stated that one of his patients treated by Burton appeared to have miraculously recovered. The patient died within two weeks after the program was shown, but "60 Minutes" never informed viewers of this fact” (Barrett).

6. “Saul Green, a biochemist who did cancer research at Memorial Sloan-Kettering Hospital, has examined the patent applications. Dr. Green concluded that Burton's postulated ‘tumor complement,’ ‘tumor antibody,’ ‘deblocking protein,’ and ‘blocking proteins’ in fact, have ‘never been identified as components of human blood much less of the immune system in the human’” (Barrett).

7.  “There have been claims made that some samples of the blood products used in IAT were contaminated with bacteria, hepatitis and HIV” (BC Cancer Agency).  “No independent analysis of IAT treatment materials has been carried out on samples provided by Burton. Nor has Burton published any results of analyses he has done on the nature and contents of the protein fractions he says he uses to treat patients” (Barrett).

8. Works Cited  Barrett, Stephen, M.D. "Immuno-Augmentative Therapy (IAT)." QuackWatch. 9 Nov. 1999. 1 Apr. 2008  BC Cancer Agency. "Immunoaugmentative Therapy." Patient Info. Feb. 2000. Provincial Health Services Authority. 1 Apr. 2008 <http://www.bccancer.bc.ca/PPI/UnconventionalTherapies/ ImmunoaugmentativeTherapy.htm>.  "Immuno-augmentative Therapy." CancerWeb. Oct. 1999. National Cancer Institute. 1 Apr. 2008. .