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Unconventional Cancer Treatments Chapter 5 Pharmacologic and Biologic Treatments CONTENTS Page Stanislaw Burzynski: Antineoplastons . 91 claims .. .. .. .. .. .. .. .. ... ... ....+... +. .. .. .. .., .. .$ .. .,~. +.......+ ... ..*+*.-* 93 Published Clinical Studies . 93 Attempts at Evaluating Antineoplastons . 95 Cellular Treatment . 97 Dimethyl Sulfoxide (DMSO) . 99 Hydrazine Sulfate .;. .. 100 Laetrile . ...,$... 102 Adverse Effects . ● 103 Attempts at Evaluat.ing Laetrile . ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ 103 The Livingston-Wheeler Regimen . ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ 107 Treatment Regimen . ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ 109 Claims of Efficacy . ...0 ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ 110 Hans Nieper . ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ 111 Oxygen Treatments . ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ ✎ 113 Emanuel Revici and “Biologically Guided Chemotherapy” . 114 Revici’s Cancer Treatment Regimen . 117 claims . 118 Attempts at Evaluating the Revici Treatment Regimen . 118 Vitamin C . 120 claims . ● . 121 Potential Adverse Effects . 122 Attempts at Evaluating High-Dose Vitamin C in Cancer Treatment . 122 Chapter 5 Pharmacologic and Biologic Treatments A large and diverse group of unconventional include Ernesto Contreras, Robert Bradford, Jimmy cancer treatments has as its central component a Keller, and Kurt Donsbach. Some of the major pharmacologic or biologic substance, including components of the ‘metabolic’ treatments (vitamin biochemical agents, vaccines, blood products, and C, laetrile, DMSO, cellular treatment, hydrogen synthetic chemicals. Some of these pharmacologic peroxide, and ozone) are also discussed in this and biologic treatments are offered at single sites chapter. The treatments are presented in alphabetical under the direction of a developer or other chief order according to the name of the main practitioner proponent. Others are more widely available, are not or the substance used. necessarily associated with particular proponents, and may be used in combination with a variety of other unconventional and conventional treatments. STANISLAW BURZYNSKI: Examples of unconventional pharmacologic or ANTINEOPLASTONS biologic cancer treatments associated with a single In the late 1960s, Stanislaw R. Burzynski, M.D., practitioner include: “Antineoplastons” offered by proposed that a naturally occurring and continuously Stanislaw Burzynski, M.D., Ph.D., at his clinic in functioning biochemical system in the body, distinct Houston; an autogenous vaccine developed by the from the immune system, could “correct” cancer late Virginia Livingston, M.D., at her clinic in San cells by means of ‘special chemicals that reprogram Diego; “eumetabolic” treatment offered by Hans misdirected cells. He called these chemicals ‘Anti- Nieper, M.D., in Hannover, West Germany; and neoplastons, and defined them as naturally occur- “biologically guided chemotherapy” practiced by ring peptides1 and amino acid derivatives that inhibit Emanuel Revici, M.D., at his office in New York. the growth of malignant cells while leaving normal Each of these treatments is discussed in detail below. cells unaffected (124,133). Burzynski developed a Another pharmacologic treatment, “Immuno- treatment regimen for cancer based on the adminis- Augmentative Therapy” offered by Lawrence tration of various types of Antineoplastons, which he Burton, Ph.D., at his clinics in the Bahamas, West originally isolated from urine and subsequently Germany, and Mexico, is discussed in chapter 6. synthesized in the laboratory. He currently treats patients with Antineoplastons at his clinic and Examples of pharmacologic approaches offered at research facility in Texas. a number of places, either singly or in combination, include laetrile, megavitamins, dimethyl sulfoxide Burzynski received his M.D. in 1967 and his (DMSO), cell treatment, digestive enzymes, hydro- Ph.D. in biochemistry the following year, both from gen peroxide, ozone, and a variety of other agents. the Medical Academy of Lublin in Poland. He When used in various combinations and with special moved to the United States in 1970, and obtained a diets, enemas, and instructions about avoiding license to practice medicine in Texas in 1973. From substances thought to be harmful, these treatments 1970 until 1977, he held the positions of research become part of a general approach often referred to associate and assistant professor at the Baylor as ‘metabolic therapy,’ a non-specific term used by College of Medicine in Houston. In 1977, he left many unconventional practitioners to refer to a Baylor to establish his own research institute. He is combination of unconventional approaches aimed at now president of the Burzynski Research Institute in improving the physical and mental condition of Stafford, Texas, where he and his colleagues con- cancer patients (96). Many of the best known duct in vitro and animal research on Antineoplas- ‘‘metabolic clinics’ are located in or near Tijuana, tons. Burzynski’s clinical practice focuses on treat- Mexico, not far from the U.S. border, e.g., Centro ment of cancer patients with Antineoplastons, which Medico del Mar, American Biologics, the Manner he administers at his outpatient clinic in Houston. clinic, St. Judes International, and Hospital Santa His current regimen for cancer patients includes oral Monica. Practitioners associated with these clinics and intravenous use of approximately 10 types of Ipeptides area broad category of molec~es, including many biologically active proteins, that are made Up of combinations of amino acids. -91- 92 ● Unconventional Cancer Treatments Antineoplastons, all of which are manufactured at identified as Antineoplastons AS2-1 and AS2-5 the Burzynski Research Institute. (130), have also been administered to cancer patients (see discussion below). From 1974 to 1976, Burzynski received funding from the National Cancer Institute (NCI) for re- Burzynski believes that a variety of Antineoplas- search involving gel filtration techniques to isolate tons are present naturally in the tissue and body peptides from urine and for testing their ability to fluids of healthy people, but that, possibly as a inhibit in vitro growth of several types of cultured consequence of cachexia (a metabolic process that human cells (142). In 1976, Burzynski applied results in physical wasting), cancer patients excrete unsuccessfully for renewal of this grant, although he excessive amounts in the urine, leaving them with did receive supplemental finding until July 1977 low circulating levels. He states that treatment with (245). In 1983, he applied to the Food and Drug Antineoplastons reduces the amount of endogenous Administration (FDA) for an Investigational New Antineoplastons excreted, and that excretion of Drug exemption (IND), which would allow him to Antineoplastons decreases with tumor regression use Antineoplastons in human studies designed to (133). Burzynski hypothesizes that Antineoplastons determin e the efficacy and safety of Antineoplas- may act by interfering with the action of certain tons. That application was put on “clinical hold,” enzyme complexes (methylation complex isozymes) the action taken by the FDA in cases where data that allow malignant cells to gain a growth advan- submitted are insufficient to just@ the investiga- tage over normal cells (546). He has also suggested tional use of a substance in cancer patients. In March that Antineoplastons may interact directly with 1989 the clinical hold was removed for one study, DNA (524). allowing a study of the oral form of Antineoplaston Burzynski believes that Antineoplastons repre- A10 in a small number of women with advanced, refractory, breast cancer (125). That study, which sent a “completely new class of compounds’ (516). It is unclear whether or how Burzynski’s Antineo- was planned to be conducted at a U.S. medical plastons relate to a variety of known growth factors center, was later “delayed,” according to a public notice from Burzynski’s staff, “due to the high and inhibitors that are the focus of considerable mainstream research in biochemistry and oncology. cost’ ‘ of conducting clinical trials in the United Burzynski’s theory of a biochemical antitumor States (858). To date, no form of Antineoplaston has surveillance system in the body mediated by en- received FDA approval for use on patients outside of dogenous Antineoplastons has not been recognized that specific study. in the broader U.S. scientific community. However, Burzynski first isolated Antineoplastons from Burzynski has recently supplied some scientists with blood and then the urine of individuals without Antineoplastons which they are testing for biochem- cancer. 2 He reportedly obtained dozens of fractions ical and physiologic properties, particularly anti- (128), each containing many different Antineoplas- tumor activity, in cultured tumor cells and in animal tons (133). Burzynski and other researchers reported tumor models (see discussion below). testing each fraction for anticancer activity in Burzynski’s Treatment Regimen cultured human cells and then for toxicity in animals. His first fraction, Antineoplaston A, which At present, oral and intravenous forms of 10 types he used to treat 21 cancer patients at a hospital in of Antineoplaston are made by the Burzynski
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