The Cancer Empire Strikes Back
Article by Jeff Kamen
April 1993

In the United States, the government says the drug is useless and blocks dying patients' access to it. In Russia, where the same American-developed drug, hydrazine sulfate, is approved for general use against even the worst cases of cancer, a new report says it saved the lives of 56 brain-tumor patients after all other treatments had utterly failed. "What," you are probably asking yourself, "is going on here?" The answer is simple. Americans are undergoing unnecessary pain, suffering, and death from the very same cancers that are being benefited in Russia. For instance, the kind of lymphatic cancer that killed Jacqueline Kennedy Onassis has been treated successfully by hydrazine sulfate at the Petrov Research Institute of Oncology in St. Petersburg for more than ten years. But the U.S. National Cancer Institute's long campaign to discredit hydrazine sulfate has poisoned the minds of most American oncologists, so you can bet that when Mrs. Onassis came down with lymphoma, she received the best doctoring money can buy. That means she most surely would not have been given hydrazine sulfate--and a chance to live. It's not that her physicians would have consciously denied her the shot at life the drug offers; they wouldn't even have considered offering it to her because of the endless drumbeat of condemnation of this pioneering drug, which has come from the leaders of the N.C.I. since the late 1960s. Now that drumroll has reached a thundering crescendo.
Fourteen years after Penthouse first reported on the existence of the low-cost, highly effective, and safe anticancer agent, researchers working under grants from the N.C.I. (our federal government) have declared hydrazine sulfate ineffective. As a direct result, the government has made it impossible for physicians to obtain the drug for their patients through a compassionate-use program, which had been run by the Food and Drug Administration.

The N.C.I., the most powerful and prestigious cancer-research and treatment organization on earth, has just made public the results of three taxpayer-funded studies of the drug hydrazine sulfate, and it reports that the drug is inactive. "Three Stakes in Hydrazine Sulfate's Heart" gloats an editorial in the Journal of Clinical Oncology, which published the negative findings of the three Phase III clinical trials.

That would seem to be it--case closed. But while the Cancer Empire has struck back at hydrazine sulfate, the Empire itself--the National Cancer Institute--is under investigation precisely because of its handling of those supposedly fair and honest tests of the drug. The probe is being done by the U.S. General Accounting Office, the investigative arm of Congress, and full public hearings with sworn testimony loom as a possibility. Depending on how they answer investigators' questions, some N.C.I. officials could be doing research behind bars. The G.A.O. investigative team is made up of the same kind of people who work for the I.R.S.--perhaps not very exciting, but irritatingly thorough and relentless.

While the G.A.O. investigators' timely concern is the Phase III clinical trials, their attention may likewise focus on the N.C.I.'s failure to pursue questions raised by the highly positive reports of the drug's success against many forms of cancer in Russia. Oncologists in Russia told me they could not understand why the N.C.I. has disregarded their wide-ranging and fully documented data. Unlike the Russians, American researchers have looked only at hydrazine sulfate's effects against cancers of the lung and colon. Moreover, when previous, smaller clinical trials were conducted at Harbor-U.C.L.A. Medical Center for over a decade in accordance with the standard protocol--excluding alcohol, tranquilizers, and sleeping pills--the drug worked the same way it did in Russia: It stopped the tumor-induced starvation in more than 50 percent of the patients receiving it and increased patients' survival.

When two geographically widely separated clinical trials using identical protocols, without any coordination between research teams, report essentially identical results, that is a highly regarded demonstration of the validity of the drug being tested. "It is impossible to give hydrazine sulfate together with alcohol, with ... sleeping pills, and so on," says Professor Michael Gershanovich, the chief of chemotherapy at the Petrov Institute and a member of both the Russian Academy of Sciences and the Russian equivalent of the F.D.A. So it was no small matter that the N.C.I.'s Phase III clinical trials violated the established protocol and failed to tell patients not to drink any alcohol and not to take any sleeping pills or tranquilizers. For the record, animal-study results provided to the N.C.I. prior to the start of its three Phase III studies included this alarming information: When the tumor-bearing rats were given hydrazine sulfate together with widely used tranquilizers known as benzodiazepines, 100 percent of the rats went into coma, and 50 to 60 percent of them subsequently died; rats receiving either the hydrazine sulfate or the tranquilizers alone had neither of those frightening outcomes. Similar responses in human subjects could be predicted based upon on those animal studies.

That documented information was passed on to all officials involved in directing the N.C.I.'s Phase III clinical trials of hydrazine sulfate. Nevertheless, it was the benzodiazepine tranquilizers that were given to many patients in the clinical trials. Dr. Michael Kosty, the principle investigator of the first of the N.C.I. studies, told me face-to-face that "Lorazepam"--a benzodiazepine--was the "major tranquilizer" used by the patients. But in his published report, Kosty makes no mention of Lorazepam and notes only that "virtually no patients received phenothiazine-type tranquilizers." That is like saying there were no signs of pinpricks in Nicole Simpson's body while ignoring the gaping wounds that killed her.

In Kosty's study of 266 patients, the supervising physicians also failed to warn patients away from alcohol. In the published study, they write: "Data regarding alcohol consumption were not routinely collected." It was therefore impossible to determine the degree to which this incompatible agent was used by patients in the study.

Two other issues of equal concern are the apparent use of advanced and hopelessly advanced cancer patients, and irregularities in statistical reporting. A physician associated with the huge North Central Cancer Treatment Group team, which conducted two of the three N.C.I. Phase III studies, is reported to have remarked that some of the patients in these studies "were so far-gone, they had one foot in the grave, the other on a banana peel." Late-stage patients are known to respond poorly to practically all treatments, and they are almost never used to evaluate a new therapy that could be of potential value to millions worldwide. Likewise, a careful reading of the Kosty study indicates that more than ten percent of the patients were late-stage, in violation of the published study protocol itself. Similarly, even a superficial reading of the statistical reporting in the three N.C.I. studies suggests the possible concealment of favorable results and an overall anti-hydrazine sulfate bias.

Last June I stated to G.A.O. investigators: "The use of benzodiazepine tranquilizers and the unrestricted use of alcohol in conjunction with hydrazine sulfate can account for the negative studies.... This outcome was predicted to the N.C.I. before the studies were commenced." Indeed, this outcome was predicted in my initial report in Penthouse last year, at which time I emphasized that the deck was stacked. And that the N.C.I. was dealing from the bottom. The result of this continuing outrage is that patients suffer and die needlessly and prematurely. Hundreds of thousands in America alone are consigned to this fate annually. It is the direct fallout of a continuing N.C.I. policy to protect its turf--and save face for the cancer establishment elite, who have been attempting to destroy this drug for the last 20 years.

What is clearly called for is an independent audit of all three N.C.I. Phase III clinical trials by a team of experienced and unbiased auditors--unconnected with the N.C.I. or its grantee institutions--who would examine all the case reports for patient response, use of incompatible agents, irregularities of study design and presentation, and outright fraud. In the meantime, you can help by asking your representatives in Washington to demand the F.D.A.'s immediate reinstatement of its compassionate-use program for hydrazine sulfate and to strengthen the ongoing G.A.O. investigation in every way possible with an eye toward full public hearings. Anything less only compounds the agony of cancer sufferers and their families around the world.