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.

The only contrary results to the Russian and Harbor-UCLA positive studies of Hydrazine sulfate have been three trials sponsored by the National Cancer Institute (NCI), commending in 1990 and ending in 1992. However, these trials were compromised by the use of incompatible agents (medications)—tranquilizers, sleeping pills, alcohol—with the test drug, hydrazine sulfate.

The use of incompatible medications with a test drug is virtually unknown in human biomedical testing, since it can result in the grave illness—or death—of a patient, can cause a negative drug study and is in clear violation of multiple warnings against such use in the medical literature—and in violation of the Helsinki Declaration.

The Helsinki Declaration is a multinational ratification of principles governing human biomedical research studies, to which the United States is a principle signatory, which was put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. Principle 1 of the Helsinki Declaration states: “Biomedical research involving human subjects must conform to generally accepted scientific principles and be based on a thorough knowledge of the medical literature.” Perhaps most important of generally accepted scientific principles in the conduct of human biomedical research is that no incompatible agents (medications) be used in a drug trial. This document lies at the very heart of internationally accepted standards for biomedical research and is at the very core of all clinical trials and informed consent. As such, the Helsinki Declaration represents the international “law of the land” and requires all human biomedical research to conform to its stated principles.

The Russian and Harbor-UCLA studies of hydrazine sulfate were in full conformity with the Helsinki Declaration.

The NCI-sponsored trials of hydrazine sulfate were out of compliance with the Helsinki Declaration. None of the published NCI-sponsored studies referenced this document.

Despite the NCI-sponsored studies being out of compliance with the Helsinki Declaration and their failure to even reference this document in its protocols or published studies, the NCI is the largest and most influential cancer agency in the world—and its “credentials” are most respected among many in the world medical community. Consequently, NCI’s differing results from the Russian and Harbor-UCLA trials were sufficient to envelop hydrazine sulfate in ongoing “controversy.”

The Syracuse Cancer Research Institute has devoted much energy and many resources to counteracting the controversy that has arisen as a result of the NCI-sponsored studies—and continues to work to make this inexpensive medication available to doctors and patients throughout the world. At present this medication is available by doctor’s prescription in the United States and elsewhere.