"Do not use with MAO inhibitors." The NCI acts criminally in its investigation of hydrazine sulfate.

How many times have you heard--usually recited quickly--at the end of a pharmaceutical ad on television, "Do not use this medication with an MAO inhibitor." What's an MAO inhibitor? And why shouldn't the advertised medication be used with it? Because the two together can harm you. Because the two together can even kill you.

An MAO inhibitor is an inhibitor of the enzyme MonoAmineOxidase. Monoamines, such as dopa, play key roles in neurotransmission, and the enzyme MAO keeps these neurotransmitters from accumulating in the brain. MAO inhibitors (MAOIs), on the other hand, can cause an accumulation of these substances in the brain, which accounts for their therapeutic--i.e., anti-depressive--action. But MAOIs can also amplify the side effects of some medications and cause these medications to become a clinical hazard, in some instances resulting in severe illness and even death.

Thus the effect of mixing an incompatible medication with an MAOI can be very dangerous to a patient, and if the MAOI in question also has a therapeutic function, mixture of an incompatible agent (medication) can also destroy the therapeutic action of the MAOI; if the MAOI is being used as a test medication in a drug study, mixture of an incompatible agent can result in a negative study.

Pharmaceutical companies therefore do not wish you to use any of their products in the presence of an MAOI--just in case their products happen to be incompatible with MAOIs--or just in case you happen to be in a drug study, or on a drug protocol, with one of their products. These companies simply don't want you to end up incapacitated or a sure death.

Many of you know I--and the Syracuse Cancer Research Institute--am the developer of the anticancer drug hydrazine sulfate. The drug that competently performed controlled clinical trials have shown to be safe and effective in many different types and in all stages of cancer. And that the National Cancer Institute (NCI)--this country's top federal cancer treatment, investigative and funding agency--has found to be ineffective in its sponsored studies. But did you also know hydrazine sulfate is an MAO inhibitor? A powerful--i.e., irreversible--MAOI?

More importantly, did the NCI know that hydrazine sulfate was an MAO inhibitor--a powerful one? In an investigation of the NCI-sponsored studies of hydrazine sulfate ordered by Congress, the NCI claimed--over and over again--that hydrazine sulfate was not an MAOI (inhibitor). Even though pharmacology textbooks over the last three decades indicated it was a potent MAO inhibitor. Even though author of the prominent textbook on drug interactions, A Primer of Drug Action, Robert M. Julien, M.D., Ph.D., an acknowledged expert in the field of drug interactions, indicated hydrazine sulfate was "an irreversible MAO inhibitor" (Dr. Julien's emphasis). Even though NCI received a faxed letter from its Russian counterparts, in response to a specific NCI inquiry, "Hydrazine sulfate is a modulator of biologic reaction and functions as an inhibitor of monoamine oxidase [MAO]." Even though studies throughout the medical literature identified hydrazine sulfate as a specific "mitochondrial MAO" inhibitor.

What was the reason the NCI denied to Congressional investigators that hydrazine sulfate was an MAO inhibitor--despite overwhelming evidence that it was? Because in its sponsored studies of hydrazine sulfate--the only controlled trials to ever show hydrazine sulfate was ineffective--the NCI used tranquilizers, sleeping pills (barbiturates), alcohol--all of which are known to be incompatible with MAO inhibitors. Acknowledgment by the NCI of MAO inhibition by hydrazine sulfate would be tantamount to an admission by NCI that NCI wittingly or unwittingly used known incompatible agents--negative bias factors--in its hydrazine sulfate studies, and thus by definition its studies were intrinsically flawed.

While NCI officials were vigorously denying that hydrazine sulfate could be an MAO inhibitor--challenging established scientific fact--did they really know all along that it was? Was NCI's use of incompatible agents witting or unwitting?

It must be considered that the NCI--as the world's leading cancer agency--had the top expertise available to it and that experts in the field could hardly not advise NCI that hydrazine sulfate was a known and acknowledged MAO inhibitor and that tranquilizers, barbiturates and alcohol could not be used with it. Thus, incompetence could not have been the reason for NCI's use of incompatible agents. But there are only two reasons that investigators would use a test drug in the presence of an incompatible agent: incompetence or deliberateness.

Deliberateness? Did NCI know all along that hydrazine sulfate was an MAO inhibitor? Four years after the Congressionally-mandated investigation of NCI's sponsored studies of hydrazine sulfate had safely passed, NCI issued a multipage newsletter on complementary and alternative medicine, (PDQ Complementary/Alternative Medicine, Hydrazine Sulfate, National Cancer Institute, November 25, 1999), discussing hydrazine sulfate. Its opening line was: "Hydrazine sulfate is an MAO inhibitor..."

Did NCI know all along that hydrazine sulfate was an MAO inhibitor? NCI's level of expertise available to it and its PDQ publication would indicate--beyond the shadow of a doubt--that it knew from the beginning that hydrazine sulfate was an MAO inhibitor. Yet it went ahead and used tranquilizers, barbiturates and alcohol freely with it, knowing full well that the medical literature identified these substances as constituting a "clinical hazard" with MAO inhibitors--capable of making test patients ill or worse, capable of bringing down a (causing a negative) study. In violation of a multinational agreement on the conduct of experimental medical studies. And nowhere mentioned in the informed consent forms patients were required to understand and sign prior to being enrolled in the studies.

Deliberately causing a negative study? Deliberately causing illness and mortality in test patients? Is it possible the NCI would use known incompatible agents with an MAO inhbitor? Is it possible that the NCI did not know hydrazine sulfate was an MAO inhibitor?

Is it possible that the federal government--the NCI--would act to defeat a cancer drug it knows--or suspects--to be safe and effective?

To the extent that the captains of our cancer leadership knew and understood that hydrazine sulfate was an MAO inhibitor--knew and understood that use of tranquilizers, barbiturates and alcohol with it would bring down patients and the study--yet went ahead anyway with this study design-- it seems to me that rather than "disinform" the American people that hydrazine sulfate is useless and thus engage in the worst type of medical untruth imaginable-- they must criminally answer for the pain, suffering and premature deaths they have knowingly and needlessly inflicted, and continue to inflict, on spouses, children, grandparents, uncles and aunts, friends, loved ones, your neighbors--and mine--the world over.