CURRENT CONTROVERSIES
Hydrazine sulfate is an anti-cachexia drug which acts to reverse the metabolic processes of debilitation and weight loss in cancer and secondarily acts to stabilize and regress tumors. Hydrazine sulfate is a monoamine oxidase (MAO) inhibitor and is incompatible with tranquilizers, barbiturates, alcohol and other central nervous system depressants. Foods high in tyramine, such as aged cheeses and fermented products, are also incompatible with MAO inhibitors. The use of tranquilizers, barbiturates and/or alcoholic beverages with hydrazine sulfate destroys the efficacy of this drug and increases patient morbidity.
In the U.S. National Cancer Institute (NCI)-sponsored studies of hydrazine sulfate (Journal of Clinical Oncology, June 1994), which were reported as negative, the NCI denied the concurrent use of tranquilizers, with the exception of "short-term" use of Compazine. However, under pressure of an investigation of these studies by the U.S. General Accounting Office ordered by Congress, the NCI in a subsequent paper (Journal of Clinical Oncology, June 1995) admitted to the widespread use of tranquilizers, in 94 percent of all study patients. Approximately half of these patients were given these tranquilizers on a long-term basis, and some on a continual basis. It was further admitted by the NCI that concomitant drug use (such as tranquilizers, alcohol, barbiturates, etc.) was not computerized and patient records were "incomplete."
There is an abundance of published, positive, peer-reviewed studies of hydrazine sulfate in the medical literature, performed without the use of agents (medications) incompatible with MAO inhibitors or with no other study irregularities. These data emanate both from the United States (randomized, double-blind, placebo-controlled studies) and Russia (large-scale, Phase II multicentric controlled clinical trials). These studies demonstrate efficacy and safety of hydrazine sulfate in all instances.
Hydrazine sulfate has been shown to produce only few and transient side effects. There have been no instances of bone marrow, heart, lung, kidney or immune system toxicity, or death. Hydrazine sulfate has never been shown to be carcinogenic in humans.
In the December 2000 issue of the respected medical journal Annals of Internal Medicine, there was a 'Brief Communication' regarding a single case of "fatal hepatorenal failure" due to hydrazine sulfate. Although the journal chose to editorialize this "Brief Communication," there is no proof presented in this paper that the patient in question ever took hydrazine sulfate. The authors of the 'Brief Communication' state: "We could not obtain samples of the product [the patient] ingested for laboratory analyses." This means that there was no possibility of direct examination of what it was the patient was taking. The authors further state: "His blood was not tested for the presence of hydrazine." This statement cannot be easily reconciled, for there are simple spectrophotometric blood tests that can confirm even the smallest residues of hydrazine sulfate ingested even months prior.
It must be stressed that no medical journal anywhere-of high repute or not-would publish an article and editorial based on only one case calling attention of the medical and lay public to the potential toxicity of a drug, without incontrovertible, verifiable, iron-clad proof that the patient in question ever took the drug in the first place. No journal would have the temerity-the ethical recklessness-to publish an article having far-reaching repercussions on the public health, without absolute proof of its basic, fundamental assumptions.
The authors of the article and editorial, basing their warning of hydrazine sulfate toxicity to the liver and kidney on but one unverifiable patient, were nevertheless conversant with the large-scale National Cancer Institute-sponsored studies of hydrazine sulfate-in which hundreds of patients verifiably received the drug-which showed the complete absence of any organ toxicity, including liver and kidney toxicity: "There were no significant differences between the protocol treatment arms with regard to myelodepression, gastrointestinal toxicity, renal toxicity, cardiopulmonary toxicity, or neurotoxicity."
Hydrazine sulfate has been in clinical use since 1973. Thousands of study patients have been published in the medical literature. And many more thousands the world over have been treated by their individual doctors. There has never been a single case of hepatorenal failure reported.
The Syracuse Cancer Research Institute therefore judges that this single case report recently issued in regard to hydrazine sulfate, is simply not credible.