Numerous bulletins to the public from time to time have announced our progress in the fight against cancer, advising of breakthroughs or significant inroads against this disease, in the form of new drugs and treatments, preventive measures, dietary updates, major discoveries and advances and financing. And much of the population has become involved in this fight. Such activities as the Race for the Cure and similar events have attracted hundreds of thousands nationwide to become personally involved in the ongoing endeavor to defeat this disease.
As a result it is felt by many that these activities, in combination with the frequent communiques that the incidence of one form or another of cancer was decreasing--was being trimmed--by major advances, that the "cure" was just around the corner, that we are on the verge of significantly silencing this ruthless killer.
But is this the case?
Unfortunately, it is not. In an investigative report to the public in the April 24, 2009, issue of The New York Times, respected science writer Gina Kolata reports that 'As Other Death Rates Fall, Cancer's Scarcely Moves.' In this article the author indicates that in the last 60 years, for example, the death rate--the number of deaths adjusted for population age and size--has plummeted for heart disease, stroke and other disease modalities. But for cancer it has hadly budged.
Kolata indicates the decrease in death rate for cancer in those 60 years is only 5 percent, compared to a decrease of 67 percent for heart disease in that same time.
But is death rate a credible measure of progress in cancer? Yes, researchers say. While death rates are not perfect, they are considered the most valid measure, used by the American Cancer Society and the National Cancer Institute to assess progress in this disease.
But why?-- Why has there been virtually no progress in cancer death rates in the last half-century or more? Because of the lack of "transforming discoveries" in prevention and treatment, according to scientists quoted in this New York Times article. What is a "transforming discovery?" It is a major discovery capable of interdicting a disease or disease process. An example of a 'transforming discovery' in treatment would be the advent of insulin, whose discovery virtually normalized the lives of millions of diabetics the world over. A 'transforming discovery' in prevention would be the Salk polio vaccine, the first medical treatment which prevented the contraction of poliomyelitis in millions of people worldwide and brought this disease to a virtual standstill in every nation on earth. Transforming discoveries have the capacity to beneficially affect great portions of the population.
Have there been any 'transforming discoveries' in cancer? In order to have a transforming discovery, one has to first undertand the disease. In the case of cancer, we don't even know what cancer is. Is it a disease? Is it more than one disease? Is it caused by heredity? By diet? By viruses? Bacteria? DNA mutations? Environmental pollution? We don't know. And until we know--and can understand--we are not likely to come up with a 'transforming discovery.'
So which is correct? The constant barrage of promising new advances that are causing cancer mortality and incidence to decrease in the general population, that we are on the verge of curing major cancers? --Or that the death rate in cancer has virtually not improved in the last 50 years--i.e., since the advent of modern cancer treatment?
Have the messages meted out to the public by the cancer establishment--the cancer organizations, the pharmaceutical industry, the academic institutions, the medical news media--been misleading, evasive?
We must decide this. If we decide that the decades-long death rates in this disease have remained stationary, we must send a message to our cancer leadership: and that message must be that we will no longer be duped into believing significant progress is being made, when statistics show it is not. That we will no longer contribute our energies, our resouces or acceptance to another decade of pursuing the same tired, old methods in defeating this disease.
We must send a message to our cancer leadership that the reason the death rate in this disease has remained the same--is that obviously there is something wrong with the way we understand cancer. Something wrong in what our comprehension of this disease is. Something wrong perhaps with our equation of the tumor with cancer.
For the past half-century or more our attention has been focused on the tumor. But all attempts to treat the tumor--to kill the tumor and therefore wipe out the disease--have in general been futile. Cytotoxic chemotheray, the major weapon to defeat cancer in the last 50 years, has succeeded in killing cancer cells, but in killing normal cells, too, and has been itself a cause of cancer mortality. Even the newer methods of treating this disease, genetic, monoclonal (antibodies) and other recombinant therapies, are posing limitations due to drug resistance and major drug toxicity. Every "push" we have made against the cancer, the cancer has seemed to "push back" harder.
In the case of diabetes we have made a basic understanding that the clinical symptoms of this disease--which kill patients--are due to a basic lack of insulin. A lack of a hormonal agent that facilitates the entry of glucose into a cell. We did not make the mistake of thinking that in diabetes it was the cells themselves that were "resistant" to the entry of glucose. That there was some pathologic process inherent in the body's cellular makeup that caused the cells to resist the passage of glucose. We did not spend our nation's entire bankroll or direct our country's almost total research programs to "fixing" the cell so that it would admit glucose. The discovery of insulin was indeed a "transforming discovery."
We must now do the same with cancer. It is obvious that treatment of the"tumor" will bring us more of the same, as in the last 50 years. It is obvious that the "tumor" is but the endpoint of the cancerous process, that the "tumor" is not the same as "the cancer." It is obvious that what have 'led up' to the tumor--the biochemical processes that have "caused" the tumor--are the vulnerable aspects of cancer where drug therapy may indeed be effective in stopping or reversing the cancerous process. Until we can understand cancer on a more 'intimate' basis--its biochemical or metabolic underpinnings--a "transforming discovery" in this disease is not likely to occur.
When we can finally turn our attention to the reality that even though it is the "tumor" that kills, it is in an understanding of those processes that lead up to tumor formation--its metabolic and biochemical fundamentals--that the war on cancer will truly be won.
Thursday, August 5, 2010
Wednesday, June 16, 2010
SCRI Newsletter
Dear Readers,
It has been some time since a new entry has been placed on MedTruth, and this has been due to a new paper I have been writing for publication, "What Is Cancer?" This paper details a new causation for cancer and, based on this, new treatment options. More details will be forthcoming upon publication of this paper.
Meantime I thought it might be of interest to enter on MedTruth the Syracuse Cancer Research Intitute's latest semi-annual Newsletter.
Syracuse Cancer Research Institute
600 East Genesee Street
Syracuse, NY 13202
June 2010
Dear Friend,
Summer of 2010 is upon us and I am happy to inform you that the use of hydrazine sulfate for general cancer is beginning to spread rapidly worldwide. That is because more and more doctors are becoming acquainted with the controlled clinical trials of hydrazine sulfate in the medical literature, performed in accordance with international standards, and their specific results of efficacy and safety. And the reason this has happened is that the Internet has called special attention of the medical profession that these studies exist and should be consulted as part of any treatment-making decision.
I want to emphasize to each and every one of you that if you or a friend or loved one has cancer, the doctor should consider a course of hydrazine sulfate--whether or not other treatments are used, such as chemotherapy, radiation or some of the newer recombinant pharmaceuticals. Consider the statistics: those controlled clinical trials, done in conformity with the "generally accepted standards" rule (the Helsinki Declaration) demonstrate that for every million late-stage, unresponsive cancer patients given hydrazine sulfate, 500,000 will show measurable symptomatic improvements, 400,000 will have their tumors stop growing or regress and some will go on to long term (>10 years) survival. These are "factually terminal" patients. No studies have yet assessed earlier patients, who are known to respond more favorably to almost all drugs.
These hard-to-believe results are becoming known to many physicians, since they are now reportedly seeing these results in their own initial patients. And this is a worldwide phenomenon. Overseas Pharmsynthez, a pharmaceutical company, has been registering and marketing hydrazine sulfate as an approved drug in European countries and also in Canada, under the trade name Sehydrin. And in the United States the drug remains obtainable by a doctor's prescription.
It is really regretful that progress on this drug has moved so slowly. But for those who are regular readers of this Newsletter, the reasons for this are well known. Nevertheless, no matter what the past bottlenecks, hydrazine sulfate is now beginning to emerge globally as a drug capable of helping patients with common and recently diagnosed cancers, those who are advanced and those who literally have no further treatment options available.
I urge that if you or a loved one are diagnosed with cancer, that you consult your doctor about the advisability of including hydrazine sulfate in whatever treatment option may be considered. The actual statistics of permissibly performed studies indicate that doing so may well tip the scale of clinical response in your favor.
If we can be of help in providing you or your doctor with information or with clinical studies, please let us know. In the meantime we would appreciate your remembering us with a mid-year gift, as these gifts are the fuel that makes possible our continuing work.
With every best wish.
Sincerly,
Joseph Gold, M.D.
Director
P.S. Your gifts are tax-deductible to the extent allowed by law.
Visit us at: scri.ngen.com
Tuesday, January 5, 2010
If you have cancer, you may have an added adversary: the National Cancer Institute
Preposterous? Think it couldn't happen? Yes, the National Cancer Institute has historically been involved in multiple scandals. Scientific. Financial. Administrative. But treatment-wise? --The NCI, part of the federal government, established to battle cancer? To aid the cancer patient? To work tirelessly to devise new treatments, drugs, vaccines? To fund research efforts nationwide devoted to new--what the NCI has deemed effective--cancer treatments? What it has decreed acceptable to the nation's welfare? Acceptable to the nation's--i.e., NCI's--national cancer program? And preserve its stringent control over all cancer funds and its central position in the constellation of all cancer efforts?
Could NCI be exerting its resources--its dominance over all cancer undertakings--against the cancer patient?
Sometimes--actually not infrequently--organizations set up for one purpose go 'over the line' to its opposite purpose, because of a 'confusion of power.'
Is it possible that the NCI--set up to safeguard this nation's cancer program and the development of adequate treatments that might ameliorate this disease--has grown so powerful as to exclude any therapy which it might perceive threatening to its existence?
The answer to this vexing question is 'yes.' The NCI has been an adversary to a cancer drug--hydrazine sulfate--which controlled clinical trials performed in accordance with internationally accepted standards of biomedical research have demonstrated to be safe and effective in most types, and stages, of cancer. This drug is inexpensive, active by itself or in combination with chemotherapy or radiation therapy and is free from serious clinical side effects.
Our NCI? Against this drug? The agency that is supposed to be acting to help cancer patients?
This adversarial relationship to hydrazine sulfate--and therefore to cancer patients--is long-standing, beginning in the mid 1970s.
On March 8, 1976, because of concerns 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 many important subcommittees) requested a "status report" on hydrazine sulfate from the director of the National Cancer Institute. 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." Congressman Hanley forwarded the reply to the Syracuse Cancer Research Institute.
Shortly after receiving the reply, the SCRI received--from Leningrad--an unexpected, unsealed, registered manilla envelope in the mail. Inside of this 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."
It was the same Russian study to which the NCI reply to Congressman Hanley referred--only it said exactly the opposite of what was communicated to Congressman Hanley. 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.
Translation of the entire study of 48 "factually terminal" (stage 4) patients--with different types of cancer--revealed the following therapeutic effects. "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 disappearance of pain, increase in strength, disappearance of hemoptysis [spitting of blood in patients with lung cancer], increased overall performance status [ability to ambulate and perform work], tumor stabilization [no further increase in tumor size], tumor regression [tumor shrinkage]." 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? A drug that took away much of the patients' harsh symptomatology, improving them greatly and--with some patients--took away the disease itself?
As to the question of whether the NCI's 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 had already known for months these data were positive.
What was the meaning of the 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 of Congress, 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 dominance, centrality--and preeminence--over all cancer endeavors and cancer funding. In its opposition to hydrazine sulfate, NCI gave little thought it could be jeopardizing the lives of millions of cancer patients the world over.
Over the ensuing years the NCI hardened its resistance to hydrazine sulfate, referring in cancer textbooks to the ever-enlarging and positive Russian controlled clinical trials--demonstrating statistically significant antitumor and anti-cachexia effects in otherwise unresponse cancer patients--as showing only "hints of subjective activity," while at the same time totally ignoring 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 more than 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 its adversarial position on hydrazine sulfate might be believed by the scientific and medical communities. Accordingly, in 1989 the 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 borders of the United States of America.
Before proceeding further--and in order to have a more complete understanding of clinical studies--it is necessary to become acquainted with the Helsinki Declaration.
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 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," requiring all human biomedical research to conform to its stated principles, and to so acknowledge in all written experimental protocols and published studies.
Controlled clinical trials performed in accordance with the Helsinki Declaration have--without exception--demonstrated the efficacy and safety of hydrazine sulfate. These include the 17 years of multicentric Phase II Russian (Petrov) studies (with participation of the Herzen Institute of Oncology, Moscow; Oncological Institute of Lithuania, Vilnius; Institute of Oncology of the Ukrainian Academy of Sciences, Kiev; and Rostov Institute of Oncology and Radiology, Rostov an Donau) 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 non-efficacy of this drug--were three nationwide studies sponsored by the National Cancer Institute, parts of which were performed at various cancer centers and hospitals throughout the U.S. However, these were in violation of the Helsinki Declaration (the "generally accepted standards" rule) by virtue of their use of incompatible agents (medication) with the test drug and therefore declared by this Declaration to have no scientific standing. (Use of incompatible agents in a drug study is virtually unknown in human biomedical testing, since such use can result in the grave illness--or death--of a patient, as well as cause a negative drug study.) No written statement appears affirming that the protocols or published studies of NCI's sponsored trials were designed or carried out in conformity with the Helsinki Declaration.
The combined Russian and Harbor-UCLA studies, the only controlled clinical trials performed in accordance with the Helsinki Declaration, state that of every million late-stage, unresponsive cancer patients treated with hydrazine sulfate, more than 500,000 would receive measurable symptomatic improvement, 400,000 would demonstrate a halt or regression of tumor growth, and some would go on to long term (>10 years) "complete response," i.e., survival.
But the NCI continues its practice of knowingly misleading the worldwide lay and medical community. On the Internet it states there are no human studies of hydrazine sulfate that show anticancer activity: "There is only limited evidence from animal studies that hydrazine sulfate has anticancer activity." (Factually, there are 15 published human studies of hydrazine suflate that show anticancer activity, dating from 1975.) NCI states there are no randomized clinical trials (the "gold-standard" of clinical trials) of hydrazine sulfate that show anticancer activity: "Hydrazine sulfate has shown no anticancer activity in randomized clinical trials." (In reality, four of the five Harbor-UCLA studies are randomized clinical trials. All show clinical anticancer activity.)
The NCI has shown clearly and repeatedly it intends to defeat hydrazine sulfate as a valid anticancer drug by whatever means possible. Whether by lying to representatives of Congress, whether by placing distorted and untrue information on the Internet, whether by omission to the lay and medical public that its sponsored studies of hydrazine sulfate--the ones it uses in citing this drug's "ineffectiveness"--were all in violation of the Helsinki Declaration, using medical procedures well known to cause a negative drug study (and gravely ill patients), whether by failing to call attention of the medical profession and lay public to the 17 years of controlled clinical trials by the Petrov Group and the 10 years of controlled clinical trials by Harbor-UCLA Medical Center, all performed in conformity to the internationally accepted Helsinki Declaration's principles of medical research conduct--and all showing the efficacy and safety of hydrazine sulfate in cancer.
Regarding this drug, which may be life-restorative to you, no matter how advanced your cancer, the NCI--our own federal government--has been dealing you low. In this special instance the National Cancer Institute, the agency charged to safeguard your health, has been your long time adversary, acting to dissuade you from a drug which it has discredited for years, but one which competently performed clinical trials have explicitly demonstrated may help save your life.
Could NCI be exerting its resources--its dominance over all cancer undertakings--against the cancer patient?
Sometimes--actually not infrequently--organizations set up for one purpose go 'over the line' to its opposite purpose, because of a 'confusion of power.'
Is it possible that the NCI--set up to safeguard this nation's cancer program and the development of adequate treatments that might ameliorate this disease--has grown so powerful as to exclude any therapy which it might perceive threatening to its existence?
The answer to this vexing question is 'yes.' The NCI has been an adversary to a cancer drug--hydrazine sulfate--which controlled clinical trials performed in accordance with internationally accepted standards of biomedical research have demonstrated to be safe and effective in most types, and stages, of cancer. This drug is inexpensive, active by itself or in combination with chemotherapy or radiation therapy and is free from serious clinical side effects.
Our NCI? Against this drug? The agency that is supposed to be acting to help cancer patients?
This adversarial relationship to hydrazine sulfate--and therefore to cancer patients--is long-standing, beginning in the mid 1970s.
On March 8, 1976, because of concerns 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 many important subcommittees) requested a "status report" on hydrazine sulfate from the director of the National Cancer Institute. 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." Congressman Hanley forwarded the reply to the Syracuse Cancer Research Institute.
Shortly after receiving the reply, the SCRI received--from Leningrad--an unexpected, unsealed, registered manilla envelope in the mail. Inside of this 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."
It was the same Russian study to which the NCI reply to Congressman Hanley referred--only it said exactly the opposite of what was communicated to Congressman Hanley. 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.
Translation of the entire study of 48 "factually terminal" (stage 4) patients--with different types of cancer--revealed the following therapeutic effects. "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 disappearance of pain, increase in strength, disappearance of hemoptysis [spitting of blood in patients with lung cancer], increased overall performance status [ability to ambulate and perform work], tumor stabilization [no further increase in tumor size], tumor regression [tumor shrinkage]." 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? A drug that took away much of the patients' harsh symptomatology, improving them greatly and--with some patients--took away the disease itself?
As to the question of whether the NCI's 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 had already known for months these data were positive.
What was the meaning of the 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 of Congress, 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 dominance, centrality--and preeminence--over all cancer endeavors and cancer funding. In its opposition to hydrazine sulfate, NCI gave little thought it could be jeopardizing the lives of millions of cancer patients the world over.
Over the ensuing years the NCI hardened its resistance to hydrazine sulfate, referring in cancer textbooks to the ever-enlarging and positive Russian controlled clinical trials--demonstrating statistically significant antitumor and anti-cachexia effects in otherwise unresponse cancer patients--as showing only "hints of subjective activity," while at the same time totally ignoring 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 more than 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 its adversarial position on hydrazine sulfate might be believed by the scientific and medical communities. Accordingly, in 1989 the 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 borders of the United States of America.
Before proceeding further--and in order to have a more complete understanding of clinical studies--it is necessary to become acquainted with the Helsinki Declaration.
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 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," requiring all human biomedical research to conform to its stated principles, and to so acknowledge in all written experimental protocols and published studies.
Controlled clinical trials performed in accordance with the Helsinki Declaration have--without exception--demonstrated the efficacy and safety of hydrazine sulfate. These include the 17 years of multicentric Phase II Russian (Petrov) studies (with participation of the Herzen Institute of Oncology, Moscow; Oncological Institute of Lithuania, Vilnius; Institute of Oncology of the Ukrainian Academy of Sciences, Kiev; and Rostov Institute of Oncology and Radiology, Rostov an Donau) 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 non-efficacy of this drug--were three nationwide studies sponsored by the National Cancer Institute, parts of which were performed at various cancer centers and hospitals throughout the U.S. However, these were in violation of the Helsinki Declaration (the "generally accepted standards" rule) by virtue of their use of incompatible agents (medication) with the test drug and therefore declared by this Declaration to have no scientific standing. (Use of incompatible agents in a drug study is virtually unknown in human biomedical testing, since such use can result in the grave illness--or death--of a patient, as well as cause a negative drug study.) No written statement appears affirming that the protocols or published studies of NCI's sponsored trials were designed or carried out in conformity with the Helsinki Declaration.
The combined Russian and Harbor-UCLA studies, the only controlled clinical trials performed in accordance with the Helsinki Declaration, state that of every million late-stage, unresponsive cancer patients treated with hydrazine sulfate, more than 500,000 would receive measurable symptomatic improvement, 400,000 would demonstrate a halt or regression of tumor growth, and some would go on to long term (>10 years) "complete response," i.e., survival.
But the NCI continues its practice of knowingly misleading the worldwide lay and medical community. On the Internet it states there are no human studies of hydrazine sulfate that show anticancer activity: "There is only limited evidence from animal studies that hydrazine sulfate has anticancer activity." (Factually, there are 15 published human studies of hydrazine suflate that show anticancer activity, dating from 1975.) NCI states there are no randomized clinical trials (the "gold-standard" of clinical trials) of hydrazine sulfate that show anticancer activity: "Hydrazine sulfate has shown no anticancer activity in randomized clinical trials." (In reality, four of the five Harbor-UCLA studies are randomized clinical trials. All show clinical anticancer activity.)
The NCI has shown clearly and repeatedly it intends to defeat hydrazine sulfate as a valid anticancer drug by whatever means possible. Whether by lying to representatives of Congress, whether by placing distorted and untrue information on the Internet, whether by omission to the lay and medical public that its sponsored studies of hydrazine sulfate--the ones it uses in citing this drug's "ineffectiveness"--were all in violation of the Helsinki Declaration, using medical procedures well known to cause a negative drug study (and gravely ill patients), whether by failing to call attention of the medical profession and lay public to the 17 years of controlled clinical trials by the Petrov Group and the 10 years of controlled clinical trials by Harbor-UCLA Medical Center, all performed in conformity to the internationally accepted Helsinki Declaration's principles of medical research conduct--and all showing the efficacy and safety of hydrazine sulfate in cancer.
Regarding this drug, which may be life-restorative to you, no matter how advanced your cancer, the NCI--our own federal government--has been dealing you low. In this special instance the National Cancer Institute, the agency charged to safeguard your health, has been your long time adversary, acting to dissuade you from a drug which it has discredited for years, but one which competently performed clinical trials have explicitly demonstrated may help save your life.
Wednesday, October 28, 2009
Would the government lie about the existence of an effective treatment for cancer?
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....
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....
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.
Tuesday, December 9, 2008
Can the pharmaceutical profit motive be subdued?
Are pharmaceutical companies today uncontrolled in their lust for profits--at the expense of drug utility and safety? In our nightly television news broadcasts the frequent pharmaceutical ads must portray, by FDA rule, the side effects of each drug. In many instances the side effects are horrific--but in practically each instance the drug advertised is very expensive and this, not its "therapeutic" effect, is the reason it is being promoted. Do pharmaceutical companies really care about the welfare of patients, or is patient welfare merely the excuse to amass large profits?
A few weeks ago there was an Internet report that one of our largst pharmaceutical companies, Pfizer, Inc.. was "shifting its research focus to diseases that have high potential for high profits," such as in "oncology [cancer], pain and Alzheimers disease." What happens to lesser illnesses that affect major portions of the populations--illnesses that may not perhaps require expensive medications? Do they go by the boards? Suppose a drug company or companies developed a drug that could adequately treat a common illness--but there was no or little profit in it? Would they go ahead with it? Would they place expensive ads on television dramatizing its curative effects? Full-page ads in the medical journals, in consumer-read national magazines? Not according to the pharmaceutical news reports appearing in the media. Not according to the constantly escalating prices of commonly used and expensive drugs--heartburn medications, hormones, anti-arrhythmia medications--which have been on the market for years, some of which force especially older people to choose between paying for these expensive medications and buying food.
Years ago the drug manufacturing profession used to be known as the "ethical pharmaceutical industry," in contradistinction to patented or other preparations hawked to the public by commercial promoters ("Carters Little Liver Pills"). Ethical pharmaceuticals included companies primarily engaged, under federal regulation and supervision of law, in manufacturing and fabricating drugs--in the form of pills, ampules, ointments, powders and suspensions--to the medical, dental and veterinary professions, which have been shown to be medically useful to the public and to veterinary patients. The word "ethical" embraced this industry's image for product honesty and portrayal of sincere helpfulness to humanity as the primary purpose of its business undertakings.
Today?
Is there anyone in the drug industry that cares about the public? Is there any CEO, CFO, COO or company chairman or president that knows anything about the drug trade? About drugs per se? Who is not primarily a business person? Who is not primarily concerned--obsessed--with profits? Who does not think the term "ethical" laughable--an appellation that belongs in the last century?
The announcement by Pfizer, Inc., that it will now concentrate on drugs only with a high profit potential--is now industry-wide. Only with few exceptions all pharmaceutical companies are adopting this financial strategy. What effect will it have on you? What effect on the population? On businesses and industry? On our national welfare?
There are two aspects of drug pricing that need to be addressed and--in my estimation-- immediately corrected. Runaway drug 'caps.' And, in many cases, initial--obscene--drug pricing.
As part of current, federal health laws, there are no 'caps'--upper limits--on prescription drug prices. Thus while those enrolled in various health plans may pay only a fraction of retail drug prices for their prescriptions, there is no cap on the drugs' retail pricing. The drug companies are free to charge whatever they want. People, for example, in a drug plan paying only a modest amount for a prescription item, may find their out-of-pocket expense for it double by the next year. And people who are in no prescription plan--or those who have reached the 'doughnut hole' of their plans--might no longer be able to afford the same prescribed drug one year later. From a pricing point of view the pharmaceutical companies are not primarily concerned whether people are in a drug plan, they--the companies--are free to raise the price of their drugs as often and to the exent they see fit.
As to the pricing of new drugs, especially those for treating cancer, the sky's the limit. For example, the drug Erbitux was initially priced at $12,000 per month and was subsequently raised to $18,000 per month (even though studies showed it to be only minimally useful). The drug Avastin was priced at $46,000 to $56,000 per-patient cost; Vectibix, $36,000; Lucentis, $48.000; Revlimid, $67,000; Sutent, $46,000; even single injections of simple colony-stimulating agents, for example those to increase a patient's production of red or white blood cells, $2,000 to $7,000 per injection. Do you mean to say most individuals can afford these obscene and unneeded payments? No, they can't. But the health insurance plans all authorize them. So the payments are spread among the entire membership of these plans, among the businesses and industries that underwrite these plans for their employees and among the federal and state governments.
Thus, in their pricing--and in their unbridled avarice--the pharmaceutical companies are succeeding in bringing down the average individual, in reducing--to unncecessary lengths--
the financial wherewithal of individuals to bring up families and to otherwise enjoy life's many directions.
But obscene pharmaceutical prices are not only bringing down individuals and their families, they are also contributing to the demise and "foreclosure" of business and industry. Many of the country's businesses--large and small--have either collapsed or left these shores because costs in underwriting the health and prescription plans of their employess have constituted the "straw that broke the camel's back.' And, in like manner, ever-increasing health and prescription costs are eroding the national welfare, helping to create a negative impact on the country's gross domestic product and services.
How can we "rescind" the excess profit motive of this industry? How can we restore the "ethical" to pharmaceuticals? How can we damp the greed of our health insurers--whose executives, often controlling the medical decisions of physicians, frequently walk away with millions of dollars they have managed to squeeze from their hapless memberships annually?
There is a way. And that is that this runaway "health machine" must be regarded in the same way as a war. If our nation can contribute billions to an actual war, it can contribute these kind of funds to what is actually an ongoing war--health costs eating up the wherewithal of people and the industrial backbone of this nation. We must bring into being a type of universal health care whereby people no longer have to worry about having sufficient money to cover their families' health and prescription costs, whereby businesses and industry are freed from the constraint of underwriting health costs for their employees in order to stay in business.
And at the same time, we must tame these costs. We must rescind them to levels that are commensurate with reasonable profits. We must regulate them and not allow the genie of greed to run rampant in today's health sector of society.
Health care is one of the most important issues that will confront the new administration. There is every hope that this new administration and its determined president will devote its considerable resources to finding a way of adequately resolving this demanding question.
A few weeks ago there was an Internet report that one of our largst pharmaceutical companies, Pfizer, Inc.. was "shifting its research focus to diseases that have high potential for high profits," such as in "oncology [cancer], pain and Alzheimers disease." What happens to lesser illnesses that affect major portions of the populations--illnesses that may not perhaps require expensive medications? Do they go by the boards? Suppose a drug company or companies developed a drug that could adequately treat a common illness--but there was no or little profit in it? Would they go ahead with it? Would they place expensive ads on television dramatizing its curative effects? Full-page ads in the medical journals, in consumer-read national magazines? Not according to the pharmaceutical news reports appearing in the media. Not according to the constantly escalating prices of commonly used and expensive drugs--heartburn medications, hormones, anti-arrhythmia medications--which have been on the market for years, some of which force especially older people to choose between paying for these expensive medications and buying food.
Years ago the drug manufacturing profession used to be known as the "ethical pharmaceutical industry," in contradistinction to patented or other preparations hawked to the public by commercial promoters ("Carters Little Liver Pills"). Ethical pharmaceuticals included companies primarily engaged, under federal regulation and supervision of law, in manufacturing and fabricating drugs--in the form of pills, ampules, ointments, powders and suspensions--to the medical, dental and veterinary professions, which have been shown to be medically useful to the public and to veterinary patients. The word "ethical" embraced this industry's image for product honesty and portrayal of sincere helpfulness to humanity as the primary purpose of its business undertakings.
Today?
Is there anyone in the drug industry that cares about the public? Is there any CEO, CFO, COO or company chairman or president that knows anything about the drug trade? About drugs per se? Who is not primarily a business person? Who is not primarily concerned--obsessed--with profits? Who does not think the term "ethical" laughable--an appellation that belongs in the last century?
The announcement by Pfizer, Inc., that it will now concentrate on drugs only with a high profit potential--is now industry-wide. Only with few exceptions all pharmaceutical companies are adopting this financial strategy. What effect will it have on you? What effect on the population? On businesses and industry? On our national welfare?
There are two aspects of drug pricing that need to be addressed and--in my estimation-- immediately corrected. Runaway drug 'caps.' And, in many cases, initial--obscene--drug pricing.
As part of current, federal health laws, there are no 'caps'--upper limits--on prescription drug prices. Thus while those enrolled in various health plans may pay only a fraction of retail drug prices for their prescriptions, there is no cap on the drugs' retail pricing. The drug companies are free to charge whatever they want. People, for example, in a drug plan paying only a modest amount for a prescription item, may find their out-of-pocket expense for it double by the next year. And people who are in no prescription plan--or those who have reached the 'doughnut hole' of their plans--might no longer be able to afford the same prescribed drug one year later. From a pricing point of view the pharmaceutical companies are not primarily concerned whether people are in a drug plan, they--the companies--are free to raise the price of their drugs as often and to the exent they see fit.
As to the pricing of new drugs, especially those for treating cancer, the sky's the limit. For example, the drug Erbitux was initially priced at $12,000 per month and was subsequently raised to $18,000 per month (even though studies showed it to be only minimally useful). The drug Avastin was priced at $46,000 to $56,000 per-patient cost; Vectibix, $36,000; Lucentis, $48.000; Revlimid, $67,000; Sutent, $46,000; even single injections of simple colony-stimulating agents, for example those to increase a patient's production of red or white blood cells, $2,000 to $7,000 per injection. Do you mean to say most individuals can afford these obscene and unneeded payments? No, they can't. But the health insurance plans all authorize them. So the payments are spread among the entire membership of these plans, among the businesses and industries that underwrite these plans for their employees and among the federal and state governments.
Thus, in their pricing--and in their unbridled avarice--the pharmaceutical companies are succeeding in bringing down the average individual, in reducing--to unncecessary lengths--
the financial wherewithal of individuals to bring up families and to otherwise enjoy life's many directions.
But obscene pharmaceutical prices are not only bringing down individuals and their families, they are also contributing to the demise and "foreclosure" of business and industry. Many of the country's businesses--large and small--have either collapsed or left these shores because costs in underwriting the health and prescription plans of their employess have constituted the "straw that broke the camel's back.' And, in like manner, ever-increasing health and prescription costs are eroding the national welfare, helping to create a negative impact on the country's gross domestic product and services.
How can we "rescind" the excess profit motive of this industry? How can we restore the "ethical" to pharmaceuticals? How can we damp the greed of our health insurers--whose executives, often controlling the medical decisions of physicians, frequently walk away with millions of dollars they have managed to squeeze from their hapless memberships annually?
There is a way. And that is that this runaway "health machine" must be regarded in the same way as a war. If our nation can contribute billions to an actual war, it can contribute these kind of funds to what is actually an ongoing war--health costs eating up the wherewithal of people and the industrial backbone of this nation. We must bring into being a type of universal health care whereby people no longer have to worry about having sufficient money to cover their families' health and prescription costs, whereby businesses and industry are freed from the constraint of underwriting health costs for their employees in order to stay in business.
And at the same time, we must tame these costs. We must rescind them to levels that are commensurate with reasonable profits. We must regulate them and not allow the genie of greed to run rampant in today's health sector of society.
Health care is one of the most important issues that will confront the new administration. There is every hope that this new administration and its determined president will devote its considerable resources to finding a way of adequately resolving this demanding question.
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