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.