Would the government deny that competent, controlled clinical trials have demonstrated there is a drug that is effective against most types--and stages--of cancer, that is safe, inexpensive and free from serious clinical side effects?
The answer is 'yes.' The drug's name is hydrazine sulfate. If you're a reader of the blog MedTruth, you've already seen several articles on this drug. But perhaps you'd like to witness the actual commencement of this official lying and opposition to this drug.
The year was 1976, the date, March 8. Because of my concern regarding controversy and irregularities by cancer authorities in the early stages of clinical testing of the drug hydrazine sulfate, developed by the Syracuse (New York) Cancer Research Institute, veteran Syracuse Congressman James M. Hanley (Chair of the House Post Office and Civil Service Committee and a member of several important subcommittees, including Manpower and Civil Service, Housing and Community Development, Institutions and Finance, Small Business Oversight and Minority Enterprise, Small Business Administration Legislation), requested a "status report" on hydrazine sulfate from the director of the National Cancer Institute (NCI)--part of the federal government and this country's, and the world's, most influential cancer agency. Within two weeks he received a reply that stated: "Hydrazine sulfate has been tested in the Soviet Union at the Petrov Institute in Leningrad [St Petersburg]. In a clinical study directed by Dr. Michael Gershanovich, no evidence of meaningful anticancer activity was reported. This information was communicated to the NCI under the Joint U.S.-U.S.S.R. Health Agreement of 1972." Congresman Hanley forwarded me the reply.
The letter was devastating to me personally. Although I had known that cancer scientists in the Soviet Union were performing mouse and rat studies with hydrazine sulfate (they had picked up from our original work published in the medical literature), I had no idea they had already performed human studies--and that these studies were negative. Reading this letter--and what it said--constituted the lowest point in my professional career. I was dejected the entire day, unable to believe the contents of the letter.
The very next day a scenario occurred that could only have been fashioned in Hollywood. The mailman came to the large plate-glass front doors of our reception suite (where I was at the time) and I could see he was holding a five-by-seven inch shiny manilla envelope in his hand, the kind one used to see in the Depression days of the 1930s, and to boot it was totally unsealed. He entered the suite and handed the receptionist the envelope, for which she had to sign. It was registered and postmarked "Leningrad." We did not know anybody in Leningrad, nor were we expecting mail from Leningrad. The receptionist handed me the unsealed envelope and we all--several of our laboratory staff had gathered in the reception area--looked at each other puzzled. I removed the contents of the envelope. It was a reprint of a scientific study--all in Russian, except for the English abstract (summary) at the end of the article. The principal investigator was indicated as Dr. Michael L. Gershanovich and the study site as the N. N. Petrov Research Institute of Oncology. The title of the paper was "Experimental and Clinical Data on Antitumor Action of Hydrazine Sulfate," and the English summary read:
"Clinical observations enabled us to state a definite
therapeutic effect of hydrazine sulfate in patients
with lymphogranulomatosis [Hodgkin's and non-
Hodgkin's lymphoma] and malignant tumors of
various localizations in far-advanced stages, where
other measures of specific therapy failed." [The
summary added that because of the favorable
outcome, the study was being enlarged immediately.]
I was stunned to read this summary. It was from the same Russian study to which the NCI reply to Congressman Hanley referred--only it was exactly opposite of what was communicated to Congressman Hanley. Upon translation of the entire study, the following therapeutic effects of hydrazine sulfate in 48 "factually terminal" [stage 4] patients--with different types of cancer--were detailed: "diminution or disappearance of pleural effusions and ascites [fluid accumulation in the chest cavity and abdomen, containing individual cancer cells], lowering of fever, normalization of laboratory indices, diminution or disappeance of pain, increased appetite with cessation of weight loss or weight gain, increase in strength, disappeance of hemoptysis [spitting of blood in patients with lung cancer], increased overall performance status [ability to ambulate and perform work], tumor stabilization [no increase in tumor size], tumor regression." Therapeutic benefits were registered without significant clinical side effects: "Pharmacological characteristics of this compound demonstrate that the antitumor effect is observed in doses which do not produce toxicity."
No meaningful anticancer activity?
As to the important question whether the NCI response to Congressman Hanley represented an innocent error on the part of the NCI or a deliberate fabrication, a further letter from the NCI, dated June 22, 1976, stated: "An abstract [summary] of the Gershanovich study appeared in Cancer Therapy Abstracts (Vol. 16: No. 4 75-2046), a journal published under contract to the NCI." This published abstract antedated the NCI's response to Congressman Hanley by more than six months. Thus, at the time the NCI was writing to Congressman Hanley that the Soviet data were negative, the NCI already knew these data were positive.
Why the deception?
What was the meaning of this misinformative response by the NCI?
Hydrazine sulfate was the first drug for generalized--any type of--cancer. It was developed by the Syracuse Cancer Research Institute, a small, private cancer research organization with an annual budget not exceeding $200,000. If you were a member of the House or Senate Appropriations Committees, would you authorize billions of dollars annually, as a result of the National Cancer Act of 1971, directly to the NCI--in the face of a small private laboratory which had just come up with the first useful drug for all cancers, on a budget of less than $200,000? You'd have to say "Whoa--let's reevaluate this whole situation."
Thus, in framing a deliberate lie to Congressman Hanley--in turning its guns against hydrazine sulfate--the NCI was fighting for its life. In perceiving hydrazine sulfate as a threat to its existence, the NCI was fighting to preserve its hegemony over the network of all cancer funds and its central position in the constellation of all cancer efforts.
As many readers of MedTruth know, over the ensuing years the NCI maintained its resistance to hydrazine sulfate, referring in cancer textbooks to the ever-enlarging Russian controlled clinical trials demonstrating statistically significant antitumor and anti-cachexia effects (see above) in otherwise unresponsive patients--as showing only "hints of subjective activity," while at the same time not even acknowledging the published Phase III randomized, double-blind Harbor-UCLA studies demonstrating, again statistically significantly, that hydrazine sulfate normalizes the abnormal metabolism associated with cancer cachexia--(i.e., associated with over 70 percent of all cancer deaths).
But not until 1989 did it occur to NCI that it would have to undertake controlled clinical trials of its own which might counter the Russian and Harbor-UCLA studies before the scientific and medical communities might believe its adversarial position on hydrazine sulfate. Accordingly, in 1989 NCI took over all clinical testing of hydrazine sulfate in the U.S., prohibiting (by grant denial) Harbor-UCLA--which up to that time had performed and published almost 10 years of increasingly positive studies on hydrazine sulfate--and by association any other U.S. cancer center from any further clinical study of hydrazine sulfate. Thus, in 1989 the NCI became the only player in the clinical testing of hydrazine sulfate within the United States.
The NCI sponsored three studies of hydrazine sulfate, parts of which were performed at various cancer centers and hospitals throughout the U.S. But before going further, it is necessary for you to become acquainted with the Helsinki Declaration.
The Helsinki Declaration--a multinational ratification of principles governing human biomedical research studies, to which the U.S. is a major signatory-- is an outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered the heinous human medical "experiments" inflicted on helpless human beings by the Nazis, put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. This document lies at the very heart of all clinical studies and informed consent--and as such represents the international "law of the land," requiring all human biomedical research to conform to its stated principles, and to so acknowledge in all experimental protocols and published studies.
All controlled clinical trials performed in accordance with the Helsinki Declaration indicate--without exception--the efficacy and safety of hydrazine sulfate. These include the 17 years of multicentric Phase II Russian studies and the 10 years of Harbor-UCLA randomized Phase III studies--performed by scientists considered among the most outstanding and experienced clinical cancer investigators in the world and published chiefly in leading U.S. peer-reviewed cancer and medical journals.
The only controlled clinical trials to indicate the non-efficacy of this drug were those sponsored by the National Cancer Institute. However, these were in violation of the Helsinki Declaration (the "generally accepted standards" rule) by virtue of their use of incompatible agents (medications) with the test drug and therefore declared by this Declaration to have no scientific standing. (Use of incompatible medication in the presence of a test drug can result in the grave illness--or death--of a patient, as well as cause a negative drug study. Use of incompatible agents in a drug study is virtually unknown in human biomedical testing.)
Most major media science writers and personnel are reluctant--even fearful--to touch this story. The idea that there could be an existent, effective cancer treatment--which the government refuses to acknowledge--is almost preposterous. But in those instances where reporters and other media representatives have made inquiries to the National Cancer Institute, stating their plans for a possible story on hydrazine sulfate, they receive the following type of reply:
"How could you perpetrate such a cruel hoax on the American people? You would be giving hundreds of thousands of people false hope."
Here is the 'cruel hoax': The combined Russian and Harbor-UCLA studies, the only controlled clinical trials performed in conformity with the Helsinki Declaration, state that of every million late-stage, unresponsive cancer patients treated with hydrazine sulfate, more than half a million would receive measurable symptomatic improvement, 400,000 would demonstrate a halt or regression in tumor growth, and some would go on to long term (> 10 years) "complete response," i.e., survival.
This 'cruel hoax' must out. NCI's well-kept 'secret' must out. The major media must have the courage to take on this difficult story and inform the American people that there is an effective cancer treatment out there, one that competently performed clinical trials have identified as capable of extending benefits to even very advanced cancer patients.
I am asking each of you who reads this communication to send a copy to anyone you know who has cancer, to anyone you know who may be in a position to majorly publicize--to "break"--this story. To your doctor. Your health care provider. To the earnest people in hospice who care for human beings in their last weeks and months of life. To your Congressmen and Congresswomen. Ask them to do something about this tragic situation which keeps really ill people from a drug which competently performed clinical studies say might help them and only incompetently performed studies say otherwise....