Thursday, August 9, 2007

Hydrazine sulfate, does it work--or not?

Many of you know me as the developer--the "inventor"--of the anticancer drug hydrazine sulftate, a drug that combats cancer cachexia, the weight loss and debilitation seen in advancing cancer, induces tumor stabilization and regression and promotes increased survival time and quality of life. There has been much pro and con talk on the internet about this drug. The question is--does it work or not?

On one side of the line is the NCI--the U.S. National Cancer Institute. The NCI says its studies--published in a well regarded, peer-reviewed cancer journal--show hydrazine sulfate is ineffective. On the other side, Harbor-UCLA Medical Center and the N. N. Petrov Research Institute of Oncology (St. Petersburg) say their studies--published in equally prestigious, peer-reviewed cancer journals--show that this drug is safe and effective in many different types of cancer and at all stages.

What else does the NCI say about hydrazine sulfate?

NCI has not seen fit to confine its point of view about hydrazine sulfate to cancer journals, but has gone directly to the American (and world) public. It currently states on the internet:

"There is only limited evidence from animal studies that hydrazine sulfate has anticancer activity."

The clear meaning of this statement is there have been no human studies that have documented the anticancer activity of this drug, and its proponents are hanging on to slim evidence generated solely from animal studies--and who should know better than this nation's top cancer agency?

But in actual fact there have been ten (10) controlled human studies of hydrazine sulfate, all showing anticancer activity, all known to the NCI since 1975. A sampling of these studies follows:

"A definite stabilizing effect exerted against tumor growth was noted in 21% of patients. Antitumor effects were observed in a total of 19 of 95 (20%) of patients. The symptomatic [anti-cachexia] action of the drug...was expressed in appreciable improvement of general status and appetite, reduction of severe weakness characteristic of the pretreatment period, reduction or complete elimination of pain." (Gershanovich, et al., Cancer Treatment Reports 60:933-936, 1976.)

"This experience with hydrazine sulfate in an advanced cancer population points to a...role for this drug in maintaining weight in patients with cancer cachexia." (Chlebowski, et al., Cancer 59:406-410, 1987.)

"Our results suggest that hydrazine sulfate can favorably influence the abnormal metabolism associated with weight loss in patients with cancer." "The proposal that cancer patient survival may be increased by improving host metabolism represents a fundamentally new direction in cancer management." (Chlebowski, et al., Cancer Research 44:857-861, 1984; Chlebowski, et al., Journal of Clinical Oncology 8:9-15, 1990.)

"Hydrazine sulfate resulted in tumor stabilization and regression in 71% of 38 patients with glioblastoma [brain cancer]....Hydrazine sulfate prolongs patient survival and improves quality of life in this category of cancer patients." (Filov, et al., Voprosy Onkologii 40:332-336, 1994.)

"Treatment with hydrazine sulfate resulted in complete tumor regression in 6 of 740 patients (0.8%), partial [>50%] tumor regression in 25 patients (3.4%), up to 25% tumor regression in 47 of the patients (6.4%), tumor stabilization in an additional 263 patients (35.5%) and accompanying symptomatic [anti-cachexia] improvements in 344 (46.5%) of the patients." (Filov, et al., Investigational New Drugs 13:89-97, 1995.)

No human studies? No anticancer activity?

But the NCI wanted to make sure doctors got the message of no valid anticancer activity in human studies, so they added:

"Hydrazine sulfate has shown no anticancer activity in randomized clinical trials."

Randomized clinical trials--better known as RCTs--are the "gold-standard" of clinical trials. In actual fact, 4 out of the 5 Harbor-UCLA trials, published in the peer-reviewed medical literature, were randomized clinical trials, all of which showed anticancer activity, and all of which were known to the NCI. A sampling illustrates:

"Using a randomized, placebo-controlled, double-blind [study] design...hydrazine sulfate treatment resulted in significant improvement in the abnormal glucose metabolism [i.e., cancer cachexia] seen in patients with weight loss and cancer." (Chlebowski, et al., Cancer Research 44:857-861, 1984.)

"These data demonstrate an association between...hydrazine sulfate administration and body weight maintenance [i.e., anti-cachexia effect] in patients with cancer." (Chlebowski, et al., Cancer 59:406-410, 1987.)

"Hydrazine sulfate [combats] subnormal protein synthesis in skeletal muscle, believed to be the primary cause of loss of muscle mass and weight loss [i.e., cachexia] in lung cancer patients." (Tayek, et al., The Lancet 2:241-244, 1987.)

"In a randomized clinical trial...a statistically significant increase in median survival time was associated with hydrazine sulfate addition to chemotherapy." (Chlebowski, et al., Journal of
Clinical Oncology 8:9-15, 1990.)

Thus, NCI's internet message to the public--that only animal studies (no human studies) have hinted at the anticancer activity of hydrazine sulfate--is misleading, incorrect and false.

Why would the NCI misrepresent this easisly verifiable information to the public? Because it knows the public will take its 'authoritative' word and won't go to the medical libraries--or do an internet search--to look up the studies themselves. Because it wants the public to believe the curative effect of hydrazine sulfate is a "myth."

An unsolicited letter-to-the-editor in an upstate New York newspaper reads: "The cure of hydrazine sulfate for cancer is not a myth, but a fact. I was given a death sentence in 1994 by three top doctors and three top hospitals in Syracuse and Rochester. I had a cancerous tumor that was squeezing my bile duct and was inoperable because of its location. All the doctors told me I had two months to live and to prepare myself for my funeral.

"Shortly after starting on the hydrazine sulfate, my appetite returned. The weakness lessened and I regained my strength slowly but surely. That was 10 years ago. The tumor has completely disappeared and I'm feeling marvelous." (Syracuse Post-Standard, April 7, 2004).

Is it possible that the federal government would thwart a cancer drug that it knows--or suspects--to be effective and safe? Would go on the internet with misrepresentations at every turn to the public?

It would appear to be medical schizophrenia to answer "yes" to the above question. For the federal government--in this instance the National Cancer Institute--was put in place to help guarantee effective treatments for the disease which torments people the world over. Why would the NCI want deliberately to squelch a drug which competent studies indicate shows promise as a safe and effective treatment for all kinds of cancer?

Consider the scenario: It was learned by a small number of doctors that certain fruits, eaten in sequential order, possessed anticancer qualities that none of the fruits had separately. This was discovered from the dietary habits of an isolated Tibetan community located at an elevation of eleven thousand feet in the Himalayas that had no cancer. The doctors--environmental oncologists--had visited the community as a result of an international medical exchange program.

When the doctors returned to their home base in the U.S., they determined to--quietly--test a small number of patients with the diet. Twenty patients--with different types of progressive cancer--were administered oranges, bananas, strawberries, kiwi, kumquats and mangoes sequentially, and instructed to repeat this every three days.

At the end of one month the doctors looked at each other warily. Their patients, still with cancer, displayed none of the progressive features of their disease apparent one month ago. At the end of two months, none of the 20 patients had any findings of clinical cancer. The doctors sent their 20 patients to 5 different scanning facilities, so as not to arouse suspicion. All C-T scans, MRI scans and PET scans showed no signs of cancer in any of the 20 patients.

The environmental oncologists became very excited and highly enthusiastic. They realized they had hit on a cure for the most vicious disease the world had ever known. And consisting of common and plentiful foods, to boot! No more dangerous, harmful and ever-more expensive cancer drugs! No more big regional cancer centers! No more need for cancer education and fund-rasing organizations. No more need for ever-greater cancer appropriations from Congress. No more seats of individual cancer power and authority to dictate treatments that are largely ineffective. No more need for cancer specialists, cancer administrators, cancer czars.

The environmental oncologists were aware, however, that they had tested their treatment in only 20 patients. What they needed was a test in thousands of study patients. A double-blind, placebo-controlled, prospectively randomized multicentric epidemiologic clinical test. A test that could only be funded by the National Cancer Institute--involving large numbers of cancer clinicians and scientists and administrators--in what could possibly be their last job. Of course, the justification by the small group of environmental oncologists for this large study was that if the clinical results obtained in the first 20 patients held up in the thousands of patients, cancer could be erased from the face of the earth.

Do you think the NCI would approve a grant application for such a study? That the large private-sector cancer centers, the cancer hospitals and clinics, the national cancer education and fund-raising organizations, the pharmaceutical industry, the cancer research and treatment organizations, the leadership of cancer doctors, cancer nurses and cancer administrators--a $200 billion conglomerate in the U.S. each year, which maintain close liaison with the NCI--would give their concurrence?

This is the first blog on hydrazine sulfate. There will be many more. For the antipathy of the NCI to this drug extends over 30 years. And its message to the public has always been--from the very beginning--that of an adversary.