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 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.