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Hydrazine sulfate and cachexia.

Cachexia, a condition in which the body seems to waste away, accounts for about 30% of cancer deaths, according to the American Cancer Society, Significant weight loss, lipolysis (the breakdown of fats), muscle and visceral protein loss, anorexia, chronic nausea, and weakness define this condition. One of the metabolic abnormalities that produce cachexia is gluconeogenesis, a process that creates glucose from the products of anaerobic metabolism. Cancer cells thrive in anaerobic conditions and feed on sugar (glucose). Joseph Gold, MD, founder of the non-profit Syracuse Cancer Research Institute, hypothesized that cachexia occurs because "[g]luconeogenesis goes into overdrive as cancer develops and spreads, using up a lot of energy and accounting for much of the fatigue, lack of appetite, and weight loss we often see in cancer patients," according to CancerWire. He determined that gluconeogenesis requires the action of the enzyme phosphoenolpyruvate carboxykinase (PEP-CK), At a conference in 1970, Dr. Cold learned that hydrazine sulfate (HS), an inexpensive compound, inhibits PEP-CK. He began testing HS on rodents with transplanted tumors and found that the chemical did, indeed, prevent cachexia. In addition, tumor growth slowed (and sometimes regressed), and the animals' survival rates increased. For over 30 years, Dr. Gold has recommended that hydrazine sulfate be used as an adjuvant treatment for cancer.

Hydrazine sulfate trials involving cancer patients were performed in Russia (then the Soviet Union) and by researchers at Harbor-UCLA Medical Center during the 1970s and 1980s. A 1979 Soviet study with 225 patients reported a 65% anti-cachexia response (improved appetite, less/no weakness, less/no pain, and movement toward normal laboratory findings) and 44% antitumor response (either reduction of tumor volume or three to six months of tumor stabilization). Harbor-UCLA researchers performed a trial, involving 38 patients with advanced cancer and weight loss, in 1984. They found that "the rate of total glucose production was significantly decreased after 30 days of hydrazine sulfate compared to placebo treatment (2.46 mg/kg/min versus 3.07 mg/kg/min, respectively; p<0.05)."

Another double-blind, placebo-controlled study performed by Harbor-UCLA researchers involved people with advanced, unresectable non small cell lung cancer (NSCLC) who had had no prior chemotherapy. All 65 patients received the same chemotherapy and dietary counseling, but some got 60 mg of oral hydrazine sulfate, three times/day, and the rest took a placebo. The HS group showed "significantly greater caloric intake and albumin maintenance (p<0.05)." The HS group also had a longer median, but not statistically significant, survival time (292 v 187 days). Instead of gaining the interest of conventional oncology, this Harbor-UCLA study, published in the journal of Clinical Oncology in 1990, was denigrated by an accompanying editorial. Dr. Steven Piantadosi, a member of FDA's Oncology Drug Advisory Committee at the time and physician at Johns Hopkins Oncology Center, criticized the study for being "too small." The same journal issue contained eight trials with fewer patients than the Harbor-UCLA study. Only the hydrazine sulfate study was criticized.

Three multicentric phase III studies, conducted by the National Cancer Institute (NCI) and published in 1994, virtually buried HS as a treatment for cachexia. The NCI studies said that hydrazine sulfate had no benefit. However, investigation by the US General Accounting Office forced the NCI to admit that 94% of all patients involved in the studies were taking tranquilizers, barbiturates, or alcohol, which are incompatible with hydrazine sulfate. HS is a monoamine oxidase (MAO) inhibitor. "The use of tranquilizers, barbiturates, and/or alcoholic beverages with hydrazine sulfate destroys the efficacy of this drug," says Dr. Gold, "and represents a clear clinical hazard [e.g., severe hypertension]." The NCI studies, given so much clout in the US, were designed to fail.

Even though NCI and the FDA have refused to accept hydrazine sulfate as an anti-cachexia therapy, Russia and other countries--particularly in Europe--permit its use. It is also legal in Canada. Hydrazine sulfate is sold as Sehydrin[R] by the Russian manufacturer Pharmsynthez.

Cancer Wire. Hydrazine sulfate. September 2007. Available at: www.cancermonthly.com. Accessed. September 24, 2007.

Chlebowski RT, Bulcavage L, Grosvenor M, Oktay E, et al. Hydrazine sulfate influence on nutritional status and survival in non-small-cell lung cancer (abstract), journal of Clinical Oncology. 1990:8;9-15.

Chiebowski RT, Heber D, Richardson B, Block JB. Influence of hydrazine sulfate on abnormal carbohydrate metabolism in cancer patients with weight loss. Cancer Research. February 1984;44:857-861.

Gold I. The truth about hydrazine sulfate--Dr. Gold speaks. (July 14, 2004; amended February 21, 2008). Available at: www.hydrazinesulfate.org. Accessed May 8, 2008.

Kaegi E. Unconventional therapies for cancer: 4. Hydrazine sulfate. CMAJ. May 19, 1998: 1 58(10]: 1327-1 330. Available at: www.pubmedcentral.nih.gov/picrender.fcgi?artid = 1229327&blobtype-pdf. Accessed May 8, 2008.

Pharmsynthez. Sehydrin[R]. Available at: www.pharmsynthez.com/en/info_page__details.php3?info-27&detail = 17. Accessed)une 10, 2008.

Syracuse Cancer Research Institute. Hydrazine sulfate. Available at http://scri.ngen.com/. Accessed May 9, 2008.
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Title Annotation:Shorts
Author:Klotter, Jule
Publication:Townsend Letter
Geographic Code:1USA
Date:Aug 1, 2008
Words:823
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