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 [19]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....
Wednesday, October 28, 2009
Thursday, June 25, 2009
Meditated manslaughter
Today I want to inform you of a recent occurrence, one of the most diabolical happenings in medicine I have ever been aware of, that has the capacity to negatively affect the life of anyone who has cancer and indirectly negatively impact the life of every man, woman and child in this nation, even abroad.
In the June 1, 2009 issue of Newsweek magazine there was an insert of the Syracuse (NY) Cancer Research Institute in the cancer care section, calling attention to the last blog on MedTruth, "If you have cancer, even advanced, studies show this drug may help save your life...." The drug referred to was hydrazine sulfate, developed by the SCRI, though the insert did not name the drug. The blog reviewed in detail the advantages of especially late stage cancer patients having a trial on the drug, based on controlled clinical trials performed in accordance with internatiionally authorized biomedical procedures, as well as the National Cancer Institute's (NCI's) historical opposition to it. This insert appeared in Newsweek's New York state, Northern New Jersey and Washington, D.C's editions.
Those of us responsible for this insert thought that the potential for many cancer patients and their families to read this blog was high, and therefore we undertook to place comprehensive information on hydrazine sulfate on-line. To that end we published on Wikipedia--the Internet's encyclopedia--a full informational statement on hydrazine sulfate, inclusive of scientific background, clinical indications, clinical trials, side effects, drug incompatibilities, costs and a Reference list from the medical literature. We strived and hopefully succeeded in providing non-biased, 'even-handed' information, so that readers of this important statement might have a well-balanced idea of this drug and its expectations.
This statement lasted on Wikipedia only 24 hours. Approximately one day later, it was replaced by a totally new statement--not of our doing--which retained only vestiges of our original statement. The new statement was seemingly the work of National Cancer Institute (NCI)-oriented forces arrayed against hydrazine sulfate for many years and aroused by the Newsweek's insert appearance in the Washington, D.C. area, home of the NCI (Bethesda, MD).
But these NCI-oriented forces did not want readers to see the non-prejudicial and medically and scientifically correct material we originally published on Wikipedia. Rather they wished to publish their own statement, and to that end they convinced the editors of Wikipedia to remove our statement totally and substitute one of their own.
The new statement was startling in its content of misinformation, in its wholesale substitution of fiction for fact, as well as presentation of slanted innuendos, aspersions and outright fabrications.
The "new" Wikipedia piece states: "The California [Harbor-UCLA Phase III randomized, placebo-controlled clinical] trials saw no statistically significant effect on survival from the treatment." But what the California studies actually reported in their published, peer-reviewed paper was exactly the opposite: "For the PS [Performance Status] 0-1 patients [earlier patients] survival was [statistically] significantly prolonged with hydrazine sulfate compared with placebo (P = .05) [measure of positive statistical significance]. The survival at 1 year was also significantly increased (P = .05) for hydrazine sulfate compared with placebo (42% alive v 18%, respectively)" (Journal of Clinical Oncology 8:9-15, 1990). We e-mailed this direct quote of the California studies to Wikipedia twice. The result? Wikipedia continued to publish its statement that the California studies showed no statistically significant survival increase from hydrazine sulfate treatment.
In another example, the new, substituted Wikipedia piece stated:
"Later randomized controlled trials failed to find any improvement in survival, with some trials finding...poorer quality of life." These "later" trials are the NCI-sponsored studies of hydrazine sulfate. Those of you who read our previous blog referred to above will remember that these are the same studies found to be in violation of the "generally accepted standards" rule, Principle 1, of the Helsinki Declaration, by virtue of their use of incompatible medications (alcohol, tranquilizers, sleeping pills) in the presence of a test drug (hydrazine sulfate, an irreversible MAO inhibitor).
The Helsinki Declaration--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--is a multinational ratification of principles governing human biomedical research, to which the United States is a major signatory, put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. This document lies at the heart of all clinical studies and informed consent--and as such represents the international "law of the land"--and requires all human biomedical research to conform to its stated principles and to so state in all published studies and research protocols.
Principle 1, the paramount principle, 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 scientific literature." 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, since such use 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.
By virtue of NCI's use of incompatible medications in its sponsored, "later" studies of hydrazine sulfate, the Helsinki Declaration declares that these "later" studies have no scientific standing and that the results of these trials are null and void. The Helsinki Declaration further states, regarding these studies (Principle 8): "Reports of experimenation not in accordance with the principles laid down in this Declaration should not be accepted for publication."
The new, substituted Wikipedia statement omits entirely any mention of the Helsinki Declaration, or of these "later" trials being in violation of this Declaration, or of the fact that in none of these "later," published studies or research protocols (#'s 8931, 89-24-51, 89-49-51) is there any statement that these studies were carried out, or to be carried out, in accordance with the Helsinki Declaration. Yet by allowing these NCI-oriented forces' assertion that these "later" trials failed to find any survival benefit and knowing that this assertion was incorrect, and in making no mention of the Helsinki Declaration, Wikipedia did not seemingly care that a startlingly erroneous impression was being made on the American public, with potentially very serious consequences.
The effect of misrepresentations such as the above is two-fold. Foremost, it promotes increased physical and psychological distress and ill-health in cancer patients by sending an incorrect signal to the lay and medical public. To doctors and patients alike it says that hydrazine sulfate is not effective and may even be harmful. Whereas the peer-reviewed medical literature in fact documents that controlled clinical studies, performed in conformity with the Helsinki Declaration, indicate--without exception--the efficacy and safety of hydrazine sulfate in cancer patients of all kinds and at all stages. These properly controlled clinical trials demonstrate that of every million late stage, unresponsive cancer patients given hydrazine sulfate, more than 500,000 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.
The effect of the Wikipedia misrepresentations--by dissuading cancer patients (and their doctors) from a trial on hydrazine sulfate and thus a 50 percent chance of improvement in their status--is to promote increased suffering and death. As such--by acquiescing to NCI-oriented pressures (e.g., change of the actual medical literature from reading "statistically significant increase in survival" to non-efficacy)--Wikipedia makes itself a direct participant in the 'meditated manslaughter' of cancer patients all over the world.
Of perhaps equal consequence, misrepresentations such as the above send a message to the public that its institutions promoting and safeguarding First Amendment rights, such as Wikipedia, are susceptible and vulnerable to government-sponsored pressure to change truth to fiction, without an investigation of the merits of these changes. The presentation of false and/or misleading information as truth not only acts to dupe the public but, more importantly, to dilute the integrity and reliability of our public institutions.
What can be done to rectify this unfortunate situation? Undue, if not improper, government-sponsored pressure must be corrected at government levels. We can each contact our representatives and senators in Congress, calling attention to the sponsorship of governmental forces threatening to destroy what have become our free institutions, such as Wikipedia, and their dissemination of factual information to the American people, especially in regard to the public health. You will find that many of our Congressmen and Congresswomen will be responsive to this concern.
In the June 1, 2009 issue of Newsweek magazine there was an insert of the Syracuse (NY) Cancer Research Institute in the cancer care section, calling attention to the last blog on MedTruth, "If you have cancer, even advanced, studies show this drug may help save your life...." The drug referred to was hydrazine sulfate, developed by the SCRI, though the insert did not name the drug. The blog reviewed in detail the advantages of especially late stage cancer patients having a trial on the drug, based on controlled clinical trials performed in accordance with internatiionally authorized biomedical procedures, as well as the National Cancer Institute's (NCI's) historical opposition to it. This insert appeared in Newsweek's New York state, Northern New Jersey and Washington, D.C's editions.
Those of us responsible for this insert thought that the potential for many cancer patients and their families to read this blog was high, and therefore we undertook to place comprehensive information on hydrazine sulfate on-line. To that end we published on Wikipedia--the Internet's encyclopedia--a full informational statement on hydrazine sulfate, inclusive of scientific background, clinical indications, clinical trials, side effects, drug incompatibilities, costs and a Reference list from the medical literature. We strived and hopefully succeeded in providing non-biased, 'even-handed' information, so that readers of this important statement might have a well-balanced idea of this drug and its expectations.
This statement lasted on Wikipedia only 24 hours. Approximately one day later, it was replaced by a totally new statement--not of our doing--which retained only vestiges of our original statement. The new statement was seemingly the work of National Cancer Institute (NCI)-oriented forces arrayed against hydrazine sulfate for many years and aroused by the Newsweek's insert appearance in the Washington, D.C. area, home of the NCI (Bethesda, MD).
But these NCI-oriented forces did not want readers to see the non-prejudicial and medically and scientifically correct material we originally published on Wikipedia. Rather they wished to publish their own statement, and to that end they convinced the editors of Wikipedia to remove our statement totally and substitute one of their own.
The new statement was startling in its content of misinformation, in its wholesale substitution of fiction for fact, as well as presentation of slanted innuendos, aspersions and outright fabrications.
The "new" Wikipedia piece states: "The California [Harbor-UCLA Phase III randomized, placebo-controlled clinical] trials saw no statistically significant effect on survival from the treatment." But what the California studies actually reported in their published, peer-reviewed paper was exactly the opposite: "For the PS [Performance Status] 0-1 patients [earlier patients] survival was [statistically] significantly prolonged with hydrazine sulfate compared with placebo (P = .05) [measure of positive statistical significance]. The survival at 1 year was also significantly increased (P = .05) for hydrazine sulfate compared with placebo (42% alive v 18%, respectively)" (Journal of Clinical Oncology 8:9-15, 1990). We e-mailed this direct quote of the California studies to Wikipedia twice. The result? Wikipedia continued to publish its statement that the California studies showed no statistically significant survival increase from hydrazine sulfate treatment.
In another example, the new, substituted Wikipedia piece stated:
"Later randomized controlled trials failed to find any improvement in survival, with some trials finding...poorer quality of life." These "later" trials are the NCI-sponsored studies of hydrazine sulfate. Those of you who read our previous blog referred to above will remember that these are the same studies found to be in violation of the "generally accepted standards" rule, Principle 1, of the Helsinki Declaration, by virtue of their use of incompatible medications (alcohol, tranquilizers, sleeping pills) in the presence of a test drug (hydrazine sulfate, an irreversible MAO inhibitor).
The Helsinki Declaration--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--is a multinational ratification of principles governing human biomedical research, to which the United States is a major signatory, put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. This document lies at the heart of all clinical studies and informed consent--and as such represents the international "law of the land"--and requires all human biomedical research to conform to its stated principles and to so state in all published studies and research protocols.
Principle 1, the paramount principle, 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 scientific literature." 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, since such use 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.
By virtue of NCI's use of incompatible medications in its sponsored, "later" studies of hydrazine sulfate, the Helsinki Declaration declares that these "later" studies have no scientific standing and that the results of these trials are null and void. The Helsinki Declaration further states, regarding these studies (Principle 8): "Reports of experimenation not in accordance with the principles laid down in this Declaration should not be accepted for publication."
The new, substituted Wikipedia statement omits entirely any mention of the Helsinki Declaration, or of these "later" trials being in violation of this Declaration, or of the fact that in none of these "later," published studies or research protocols (#'s 8931, 89-24-51, 89-49-51) is there any statement that these studies were carried out, or to be carried out, in accordance with the Helsinki Declaration. Yet by allowing these NCI-oriented forces' assertion that these "later" trials failed to find any survival benefit and knowing that this assertion was incorrect, and in making no mention of the Helsinki Declaration, Wikipedia did not seemingly care that a startlingly erroneous impression was being made on the American public, with potentially very serious consequences.
The effect of misrepresentations such as the above is two-fold. Foremost, it promotes increased physical and psychological distress and ill-health in cancer patients by sending an incorrect signal to the lay and medical public. To doctors and patients alike it says that hydrazine sulfate is not effective and may even be harmful. Whereas the peer-reviewed medical literature in fact documents that controlled clinical studies, performed in conformity with the Helsinki Declaration, indicate--without exception--the efficacy and safety of hydrazine sulfate in cancer patients of all kinds and at all stages. These properly controlled clinical trials demonstrate that of every million late stage, unresponsive cancer patients given hydrazine sulfate, more than 500,000 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.
The effect of the Wikipedia misrepresentations--by dissuading cancer patients (and their doctors) from a trial on hydrazine sulfate and thus a 50 percent chance of improvement in their status--is to promote increased suffering and death. As such--by acquiescing to NCI-oriented pressures (e.g., change of the actual medical literature from reading "statistically significant increase in survival" to non-efficacy)--Wikipedia makes itself a direct participant in the 'meditated manslaughter' of cancer patients all over the world.
Of perhaps equal consequence, misrepresentations such as the above send a message to the public that its institutions promoting and safeguarding First Amendment rights, such as Wikipedia, are susceptible and vulnerable to government-sponsored pressure to change truth to fiction, without an investigation of the merits of these changes. The presentation of false and/or misleading information as truth not only acts to dupe the public but, more importantly, to dilute the integrity and reliability of our public institutions.
What can be done to rectify this unfortunate situation? Undue, if not improper, government-sponsored pressure must be corrected at government levels. We can each contact our representatives and senators in Congress, calling attention to the sponsorship of governmental forces threatening to destroy what have become our free institutions, such as Wikipedia, and their dissemination of factual information to the American people, especially in regard to the public health. You will find that many of our Congressmen and Congresswomen will be responsive to this concern.
Friday, February 27, 2009
If you have cancer, even advanced, studies show this drug may help save your life....
A year ago, on February 21, 2008, I placed a blog on MedTruth, "A Dog Has a Better Chance of Recovering from Cancer Than You Do," in which I attempted to show, in dramatic fashion, that the public is being "hoodwinked" from using hydrazine sulfate for human cancer, principally by the U.S. National Cancer Institute--part of the federal government--whereas the veterinary industry is largely immune from this constraint, using hydrazine sulfate on animals sick with cancer, many of whom, as a result of this treatment, are being reported to have staged significant or complete recovery. I went on in this blog to show that it was our National Cancer Institute (NCI) which was knowingly spreading misinformation on this drug to the public and to the medical profession, in an attempt to keep it from becoming adopted for routine use in human malignancy.
The reason for the present blog is to emphasize the great possibilities for improvement and curative effect by this drug for individuals with cancers of almost all types--and at all stages--whether hydrazine sulfate is used by itself, with chemotherapy or radiation therapy, or with other modalities of cancer treatment, and eliminate, to the extent possible, the "contest" imposed on this drug by the NCI.
Controlled clinical trials, done in conformity with the Helsinki Declaration, show 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.
These are truly late-stage patients--i.e., those who have become refractory to their treatments or were never responsive to them in the first place. (It would be expected that in "earlier" patients the foregoing very favorable results would be even improved.)
These clinical results emanate from 17 years of Phase II multicentric clinical trials headquartered at the Petrov Research Institue of Oncology in St. Petersburg (with participation of the Herzen Institute of Oncology, Moscow; Oncological Institute of Lithuania, Vilnius; Institute of Oncology of the Ukranian Academy of Sciences, Kiev; and Rostov Institute of Oncology and Radiology, Rostov-an Danou)--and 10 years of randomized, double-blind Phase III clinical trials at Harbor-UCLA Medical Center in California, 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 scientific journals.
The Helsinki Declaration--an outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered the hideous human medical "experiments" inflicted on helpless human beings by the Nazis--is a multinational ratification of principles governing human biomedical research studies, to which the U.S. is a major signatory, 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" and requires all human biomedical research to conform to its stated principles.
The only controlled clinical trials to find this drug non-effective were those sponsored by the U.S. National Cancer Institute--which were in violoation of the Helsinki Declaration by their use of incompatible agents in the presence of a test drug. The paramount principle--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 scientific literature." 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, since such use 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.
In the blog, "A Dog Has a Better Chance...." it was shown that the NCI-sponsored studies, out of conformity with the Helsinki Declaration by violation of the "generally accepted standards" rule (Principle 1), were also under the leadership of inexperienced or ethically compromised investigators, were not "juried" in the usual manner (it was not clear whether they were subject to outside, independent peer-review prior to publication), were "interconnected"--i.e., not independent of one another (thus no independent conformation was possible), and were subject to an accompanying NCI editorial containing blatant, unscientific language, referring to hydrazine sulfate as a "vampire," thus impairing their "legitimacy" as impartial, objective scientific investigations.
In contrast, the Petrov and Harbor-UCLA studies were in full compliance with the Helsinki Declaration, were carried out by experienced, world-class investigators not involved in any irregularities or conflicts of interest, were subject to outside, independent peer-review before winning publication, were not "interconnected" and thus constituted independent confirmation of one another (reinforcing the validity of their individual data). These studies were carried out in strict accordance with internationally established and recognized principles and contained no additions or modifications which might act to dilute or question their scientific, impartial, objective integrity.
It is important to note that while the NCI is the largest cancer agency in the world and its scientific opinions considered most authoritative and regarded by the medical profession in the highest repute, once a study is incompetently performed--in this case in violation of "generally accepted scientific principles," in violation of an international Agreement of principles governing allowable human biomedical research procedures, to which the United States is a signatory--it doesn't matter what the "credentials" of the sponsoring organization are or in what esteem it is held, its studies are invalid. Period. Science declares they are null and void and must be excluded from any treatment options.
There are only two sets of valid, controlled clinical trials--those which are in full compliance with the Helsinki Declaration--on hydrazine sulfate: the Russian (Petrov) and the Harbor-UCLA data. Both sets of studies show the same results: In late-stage patients who are or have become refractory to all treaments, hydrazine sulfate produces an approximate 50 percent response rate. 50 percent of these "factually terminal" patients respond with "moderate-to-marked" symptomatic improvements (decrease in weakness, pain and other cancer-specific symptoms, return of appetite, well-being), tumor stabilization (no tumor progression), tumor regression, or a combination of these effects. These benefits will persist from months to years, and in some cases will endure long term (>10 years), accompanied by complete response (total remission of disease).
These results are not a bad "scorecard" for those who have only "30 to 60" days to live, who are in the throes of weakness, pain and organ failure. The point is, there are no valid, controlled clinical data to disagree with these results.
Then why wouldn't--shouldn't--all patients with cancer want an immediate try on hydrazine sulfate? The results suggest that all unresponsive patients--or those growing weaker on their present therapy--who have no further treatment options available, should. Even earlier patients whose disease is stable or in remission, should consult their physicians regarding the advisability of adding hydrazine sulfate to their present regimens.
This move could be life-sparing or life-saving to you if you have a malignant disease. Regarding this drug's toxicity, since hydrazine sulfate is not a cytotoxic agent (cell-killer), side effects have been characterized as "mild" and frequently transient. Controlled clinical trials have demonstrated no incidence of carcinogenicity or documentation of organ failure as a result of hydrazine sulfate therapy: "There were no significant differences between the protocol arms with regard to myelodepression, gastrointestinal toxicity, renal toxicity, cardiopulmonary toxicity, or neurotoxicity."
Many of you know me as the developer of hydrazine sulfate as an anticancer agent and therefore it would be expected to be in my--"Dr. Gold's"--interest to promote this drug. But it is not Dr. Gold talking. Not Dr. Gold making these recommendations. It is the studies. The contr0lled clinical trials performed within the confines of the Helsinki Declaration. The controlled clinical trials performed in accordance with internationally accepted scientific principles of experimental biomedical study conduct. Dr. Gold is merely quoting the results of these studies.
These studies in essence suggest that it would be sheer insanity for a cancer patient failing current therapy, not to try hydrazine sulfate. To wait until his/her disease becomes truly terminal, from which there is no return.
But when consulting your doctor, you may hear remarks in good faith such as: "The National Cancer Institute has tested this drug and found it to be ineffective." "This drug's been around a long time. If it were any good, we'd know about it." "This drug is very toxic." "There is no credible evidence that this drug has anticancer activity." Remarks such as these from a trusted medical advisor can serve only to discourage and dissuade you from a try on this drug.
Know, however, there is but one judgment--the controlled clinical trials--that can advise whether a drug trial may be beneficial. The controlled clinical trials properly done--i.e., the Petrov and Harbor-UCLA studies. Your doctor may be unaware of these. Your doctor may be aware of only the incompetently performed National Cancer Institute-sponsored studies, those in violation of the Helsinki Declaration.
You can present your health care provider with copies of the actual Petrov and Harbor-UCLA studies, performed in compliance with the Helsinki Declaration, by visiting the Web site scri.ngen.com and clicking onto "Articles." To the left of each listed article is an icon. By clicking onto the icon, a one-paragraph summary ("abstract") of the published study will appear. By clicking onto the title of the study to the right of the icon, the entire published study will appear. Either the summary or the entire article, as they appear in the medical literature, can be downloaded and then presented to your physician.
Your physician will then have the opportunity to review the pertinent data--the results of properly controlled clinical trials--he/she may not have been previously aware of, and then discuss with you any recommendations as to the appropriateness of hydrazine sulfate as a treatment option for you.
Hydrazine sulfate is presently available by a doctor's prescription filled in a compounding pharmacy. A listing of compounding pharmacies nearest you may be obtained from The International Academy of Compounding Pharmacists, Houston, Texas, 800-927-4227.
As a last word, I know it sounds almost absurd to have a cancer drug that can induce significant anticancer response, largely ignored by the medical establishment and by specific cancer organizations and agencies, such as the National Cancer Institute. But the reality is that the only controlled clinical trials of this drug not in conflict with the internationally ratified Helsinki Declaration--the Petrov and Harbor-UCLA data--say this is the case: That upwards of 50 percent of all cancer patients, even those who are late-stage, can expect an improvement in their cancer status as a result of this treatment.
The reason for the present blog is to emphasize the great possibilities for improvement and curative effect by this drug for individuals with cancers of almost all types--and at all stages--whether hydrazine sulfate is used by itself, with chemotherapy or radiation therapy, or with other modalities of cancer treatment, and eliminate, to the extent possible, the "contest" imposed on this drug by the NCI.
Controlled clinical trials, done in conformity with the Helsinki Declaration, show 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.
These are truly late-stage patients--i.e., those who have become refractory to their treatments or were never responsive to them in the first place. (It would be expected that in "earlier" patients the foregoing very favorable results would be even improved.)
These clinical results emanate from 17 years of Phase II multicentric clinical trials headquartered at the Petrov Research Institue of Oncology in St. Petersburg (with participation of the Herzen Institute of Oncology, Moscow; Oncological Institute of Lithuania, Vilnius; Institute of Oncology of the Ukranian Academy of Sciences, Kiev; and Rostov Institute of Oncology and Radiology, Rostov-an Danou)--and 10 years of randomized, double-blind Phase III clinical trials at Harbor-UCLA Medical Center in California, 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 scientific journals.
The Helsinki Declaration--an outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered the hideous human medical "experiments" inflicted on helpless human beings by the Nazis--is a multinational ratification of principles governing human biomedical research studies, to which the U.S. is a major signatory, 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" and requires all human biomedical research to conform to its stated principles.
The only controlled clinical trials to find this drug non-effective were those sponsored by the U.S. National Cancer Institute--which were in violoation of the Helsinki Declaration by their use of incompatible agents in the presence of a test drug. The paramount principle--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 scientific literature." 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, since such use 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.
In the blog, "A Dog Has a Better Chance...." it was shown that the NCI-sponsored studies, out of conformity with the Helsinki Declaration by violation of the "generally accepted standards" rule (Principle 1), were also under the leadership of inexperienced or ethically compromised investigators, were not "juried" in the usual manner (it was not clear whether they were subject to outside, independent peer-review prior to publication), were "interconnected"--i.e., not independent of one another (thus no independent conformation was possible), and were subject to an accompanying NCI editorial containing blatant, unscientific language, referring to hydrazine sulfate as a "vampire," thus impairing their "legitimacy" as impartial, objective scientific investigations.
In contrast, the Petrov and Harbor-UCLA studies were in full compliance with the Helsinki Declaration, were carried out by experienced, world-class investigators not involved in any irregularities or conflicts of interest, were subject to outside, independent peer-review before winning publication, were not "interconnected" and thus constituted independent confirmation of one another (reinforcing the validity of their individual data). These studies were carried out in strict accordance with internationally established and recognized principles and contained no additions or modifications which might act to dilute or question their scientific, impartial, objective integrity.
It is important to note that while the NCI is the largest cancer agency in the world and its scientific opinions considered most authoritative and regarded by the medical profession in the highest repute, once a study is incompetently performed--in this case in violation of "generally accepted scientific principles," in violation of an international Agreement of principles governing allowable human biomedical research procedures, to which the United States is a signatory--it doesn't matter what the "credentials" of the sponsoring organization are or in what esteem it is held, its studies are invalid. Period. Science declares they are null and void and must be excluded from any treatment options.
There are only two sets of valid, controlled clinical trials--those which are in full compliance with the Helsinki Declaration--on hydrazine sulfate: the Russian (Petrov) and the Harbor-UCLA data. Both sets of studies show the same results: In late-stage patients who are or have become refractory to all treaments, hydrazine sulfate produces an approximate 50 percent response rate. 50 percent of these "factually terminal" patients respond with "moderate-to-marked" symptomatic improvements (decrease in weakness, pain and other cancer-specific symptoms, return of appetite, well-being), tumor stabilization (no tumor progression), tumor regression, or a combination of these effects. These benefits will persist from months to years, and in some cases will endure long term (>10 years), accompanied by complete response (total remission of disease).
These results are not a bad "scorecard" for those who have only "30 to 60" days to live, who are in the throes of weakness, pain and organ failure. The point is, there are no valid, controlled clinical data to disagree with these results.
Then why wouldn't--shouldn't--all patients with cancer want an immediate try on hydrazine sulfate? The results suggest that all unresponsive patients--or those growing weaker on their present therapy--who have no further treatment options available, should. Even earlier patients whose disease is stable or in remission, should consult their physicians regarding the advisability of adding hydrazine sulfate to their present regimens.
This move could be life-sparing or life-saving to you if you have a malignant disease. Regarding this drug's toxicity, since hydrazine sulfate is not a cytotoxic agent (cell-killer), side effects have been characterized as "mild" and frequently transient. Controlled clinical trials have demonstrated no incidence of carcinogenicity or documentation of organ failure as a result of hydrazine sulfate therapy: "There were no significant differences between the protocol arms with regard to myelodepression, gastrointestinal toxicity, renal toxicity, cardiopulmonary toxicity, or neurotoxicity."
Many of you know me as the developer of hydrazine sulfate as an anticancer agent and therefore it would be expected to be in my--"Dr. Gold's"--interest to promote this drug. But it is not Dr. Gold talking. Not Dr. Gold making these recommendations. It is the studies. The contr0lled clinical trials performed within the confines of the Helsinki Declaration. The controlled clinical trials performed in accordance with internationally accepted scientific principles of experimental biomedical study conduct. Dr. Gold is merely quoting the results of these studies.
These studies in essence suggest that it would be sheer insanity for a cancer patient failing current therapy, not to try hydrazine sulfate. To wait until his/her disease becomes truly terminal, from which there is no return.
But when consulting your doctor, you may hear remarks in good faith such as: "The National Cancer Institute has tested this drug and found it to be ineffective." "This drug's been around a long time. If it were any good, we'd know about it." "This drug is very toxic." "There is no credible evidence that this drug has anticancer activity." Remarks such as these from a trusted medical advisor can serve only to discourage and dissuade you from a try on this drug.
Know, however, there is but one judgment--the controlled clinical trials--that can advise whether a drug trial may be beneficial. The controlled clinical trials properly done--i.e., the Petrov and Harbor-UCLA studies. Your doctor may be unaware of these. Your doctor may be aware of only the incompetently performed National Cancer Institute-sponsored studies, those in violation of the Helsinki Declaration.
You can present your health care provider with copies of the actual Petrov and Harbor-UCLA studies, performed in compliance with the Helsinki Declaration, by visiting the Web site scri.ngen.com and clicking onto "Articles." To the left of each listed article is an icon. By clicking onto the icon, a one-paragraph summary ("abstract") of the published study will appear. By clicking onto the title of the study to the right of the icon, the entire published study will appear. Either the summary or the entire article, as they appear in the medical literature, can be downloaded and then presented to your physician.
Your physician will then have the opportunity to review the pertinent data--the results of properly controlled clinical trials--he/she may not have been previously aware of, and then discuss with you any recommendations as to the appropriateness of hydrazine sulfate as a treatment option for you.
Hydrazine sulfate is presently available by a doctor's prescription filled in a compounding pharmacy. A listing of compounding pharmacies nearest you may be obtained from The International Academy of Compounding Pharmacists, Houston, Texas, 800-927-4227.
As a last word, I know it sounds almost absurd to have a cancer drug that can induce significant anticancer response, largely ignored by the medical establishment and by specific cancer organizations and agencies, such as the National Cancer Institute. But the reality is that the only controlled clinical trials of this drug not in conflict with the internationally ratified Helsinki Declaration--the Petrov and Harbor-UCLA data--say this is the case: That upwards of 50 percent of all cancer patients, even those who are late-stage, can expect an improvement in their cancer status as a result of this treatment.
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