En excerpt from the book :
"ALTERNATIVES
IN CANCER THERAPY"
by Ross, R.Ph. Pelton, Lee Overholser
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17
Hydrazine Sulfate
WHEN HYDRAZINE SULFATE was introduced in the early 1970s, it was hailed as a dramatic breakthrough in chemotherapy. Much of the excitement surrounding its introduction was due to the fact that it was a new, relatively nontoxic therapy that fights cachexia.
Cachexia is the medical term for the severe weight loss and general wasting away of the body that are frequently seen in cancer patients. It is a horrible condition that reduces a dying patient to skin and bones while tumors continue to nourish. The deterioration caused by cachexia is one of the primary causes of death from cancer.
Background
Traditional medical treatments for cancer place tremendous demands on the body's reserves. Most chemotherapeutic agents are powerful poisons that kill cells during their phase of cellular division; since cancer cells multiply and divide rapidly, far more cancer cells than healthy cells are killed. Unfortunately, cells in the gastrointestinal tract, in hair follicles, and in bone marrow also divide rapidly and are therefore damaged by chemotherapeutic agents. Damage to gastrointestinal cells and hair follicles causes severe nausea and hair loss. Since both red and white blood cells are produced in the bone marrow, chemotherapy causes anemia and compromises the immune system.
In the 1960s Dr. Joseph Gold, director of the Syracuse Cancer Research Institute in Syracuse, New York, set out to develop a nontoxic form of chemotherapy. Dr. Gold started his search with two goals. First, he knew that cachectic wasting is a prime cause of death in cancer. If a way could be found to stop cachexia, the patient would surely be stronger and survive longer. Second, he knew from the Nobel Prize-winning research of Otto Warburg that cancer cells have a different type of cellular metabolism.
Dr. Gold discovered that cachexia is the result of the way cancer cells produce energy through metabolism. Cancer cells get much of the energy needed for their voracious metabolic process by recycling their own waste products. However, this process creates a condition that robs the host's body of energy and results in cachexia. (12, 13)
Healthy cellular metabolism unites oxygen with glucose (sugar) to produce energy. Cancer metabolism also uses glucose, but only partially metabolizes it, leaving lactic acid as a byproduct. Lactic acid is a toxin, and the liver expends a significant amount of energy in converting lactic acid back to glucose.
Cancer creates a cycle in which the body is continually expending energy to clear lactic acid. As the cancer grows, more lactic acid is produced, creating an even greater energy drain, and the body simply wastes away.
In one of his early papers Dr. Gold wrote:
Cachexia is but the end result of an insidious process— unrecognizable at first, but slowly taking its toll of the body's reserves until a "point of no return" is reached. Cachexia begins with the very first cancer tissue. What we need is a way to stop the vicious cycle and thereby put a halt to the leading cause of death in cancer: cachexia. (9)
Dr. Gold set out to find a method of interrupting this vicious energy-wasting cycle. He eventually found that an inexpensive chemical compound called hydrazine sulfate is able to block an important enzyme in the liver that catalyzes the conversion of lactic acid into glucose.
Early Studies
In 1973 Gold reported the results of his animal studies with hydrazine sulfate. (11) Hydrazine effectively inhibited the growth of several different types of experimental tumors in laboratory animals. It also seemed to enhance the effectiveness of several , different types of chemotherapy. (10, 14)
Hydrazine sulfate is not a killer of cells. Instead, it works by blocking a liver enzyme, to cut off a significant amount of the energy that tumors usually depend on for their metabolic growth. (13)
In 1973 Dr. Gold addressed the annual New York Academy of Sciences convention on the topic of hydrazine sulfate and cancer. A number of physicians began using the drug with some of their terminal cancer patients and noted that some of these critical patients improved quickly when they started taking hydrazine sulfate.
The news about hydrazine sulfate spread quickly in the medical and scientific community. In August 1973 only about twenty cancer patients were taking it. In September hundreds of patients were taking it, and by October the number had reportedly grown to over one thousand. (18)
Hydrazine sulfate's early success in the medical and scientific community prompted the FDA to issue Investigative New Drug (IND) permits to several companies, authorizing regulated research with hydrazine sulfate.
Dr. Burk's Memo
Dr. Dean Burk, one of the top scientists at NCI, called hydrazine sulfate "the most remarkable anticancer agent I have come across in my forty-five years of experience in cancer." (18) He released a memorandum to the scientific community on August 10, 1973, detailing the case histories of some of the early successful treatments with hydrazine sulfate:
Since April 1, 1973, upwards of 30 cachectic or "terminal" cancer patients have been treated with gelatin capsules containing 60 mg of hydrazine sulfate three to four times a day (at intervals of about 6 hours). Usually within 24-48 hours there is a marked return of appetite followed by continued increase in weight, remarkably restored physical activity, and eventually decrease in tumor size, decrease in pain, and related decrease in symptomatology.
One patient, a young man with Hodgkin's disease, was bedridden and severely underweight. After receiving only two doses of hydrazine sulfate he was able to get out of bed and care for himself. After five days of treatment he actually left the hospital for a brief trip. There appeared to be no side effects from the low dosage of the drug employed, and one patient who had a previously inoperable cancer experienced sufficient tumor regression to be operated on. (1)
The Sloan-Kettering Study
In September 1973 Dr. Gold began a joint research effort with researchers at the Memorial Sloan-Kettering Cancer Center. However, according to reports, the project did not go well.
Dr. Gold learned that many of the patients chosen for the study were within days of dying. This was a violation of the original protocol, which called for patients with a longer life expectancy in order to have time to observe hydrazine sulfate's effects. Also, Sloan-Kettering allegedly did not follow the agreed dosages that were to be administered.
In mid-1974 Sloan-Kettering publicly announced the results of the study, claiming that none of the patients had shown a positive response to hydrazine sulfate and that some of the patients experienced neurotoxic side effects. Dr. Gold strongly disagreed with these findings and pointed out that the negative results were due to Sloan-Kettering's failure to follow the agreed-upon protocol. (18)
Impressive Results
In 1975 Dr. Gold published a paper in Oncology, evaluating the results of hydrazine sulfate in eighty-four patients with various types of advanced cancer. (15) The study showed that 70 percent of the patients reported subjective improvements, such as increased strength, improved performance, decreased pain, and increased appetite, accompanied by weight gain or cessation of weight loss. Also, 17 percent of the patients experienced objective improvement, such as measurable tumor regression, disappearance of or decrease in cancer-associated disorders, and long-term (over one year) "stabilized condition."
This study showed that treatment with hydrazine sulfate alone is capable of producing a high degree ofanticancer activity and improvement in patients who are in the terminal and pre-terminal stages of different types of cancer.
Public Demand Kills Hydrazine Sulfate
In 1974 Dr. Gold spoke about the benefits of hydrazine sulfate therapy at one of the National Health Federation (NHF) conventions. The NHF is an organization that promotes alternative or unapproved therapies and frequently opposes the FDA and the AMA on matters of health policy. The FDA and the AMA consider the NHF and its members to be quacks and medical heretics.
Hydrazine sulfate's popularity grew like wildfire, due to the publicity generated at the 1974 NHF convention. Cancer patients are more concerned about getting well than they are about whether a drug has been approved by the FDA. Many people began going directly to chemical companies to buy their own hydrazine sulfate.
The FDA responded by blocking access to the drug, withdrawing the INDs, and making it illegal for chemical companies to sell hydrazine sulfate directly to the public. (5) Subsequently the traditional medical and scientific community began to ignore and shun hydrazine sulfate. Most of the funding dried up, and companies withdrew their interest in researching the drug.
The establishment's rejection of hydrazine sulfate was made official in March 1976, when the American Cancer Society placed it on the list of unproved methods. The ACS's unproved-methods list is essentially a list of therapies that have been rejected by the traditional medical establishment. This has often been the kiss of death, ending or severely hindering further research or development of a listed substance.
Research in Russia
In the fifteen years since the PDA and ACS withdrew support for hydrazine sulfate, research on it has not stopped completely. In 1975 a study conducted at a large cancer center in the Soviet Union confirmed Dr. Gold's findings that hydrazine sulfate can retard the growth of several types of cancers in animals. (21)
The same study reported results with forty-eight terminal cancer patients who were given hydrazine as a last resort. Tumor growth ceased in 15 percent of the cases, and another 20 percent experienced measurable tumor regression; 58 percent of the patients reported subjective improvements, such as reduction or disappearance of bone pain, increased appetite, and a marked improvement in general well-being.
In 1979 Dr. Michael Gershanovich, director of medical oncology at the Petrov Research Institute of Oncology in Leningrad, was invited to come to the United States and speak at the annual meeting of the American Association for Cancer Research. Dr. Gershanovich had conducted the first large-scale study of hydrazine sulfate (225 patients over four years). Curiously, at the last moment U.S. officials denied him the chance to speak. However, in the previously published abstract of his paper he stated, "Initial studies ... indicate hydrazine sulfate to be clinically effective in reversing cachexia and producing disease stabilization in late-stage cancer patients." (7)
A larger, more recent Soviet study investigated hydrazine sulfate's effectiveness in 740 cancer patients from age sixteen to seventy-two. Of these, 200 had lung cancer, 138 had cancer of the stomach, 66 had breast cancer, 63 had Hodgkin's disease, and 31 had melanoma. In most of these patients, conventional treatment options had been exhausted prior to treatment with hydrazine sulfate. (6)
The authors reported tumor stabilization or regression in 50.8 percent of the patients, while 46.6 percent of the patients reported symptomatic improvement, such as decrease in fever, fewer respiratory problems, and disappearance of edema. (8) The symptomatic improvements from hydrazine sulfate included a pronounced improvement in overall general condition, improved appetite and strength, and decrease or complete elimination of pain, occasionally allowing cessation of narcotic painkillers. This generalized improvement normally takes place after two to three weeks of therapy.
The decrease in pain was even noted in cases of metastatic bone cancer. In some patients with bone metastases the improvement was so great as to permit these patients once again to walk and care for themselves.
Independent Confirmation
Recently another scientist has started to champion the cause of this controversial drug. Dr. Rowan Chlebowski, M.D., Ph.D., and his colleagues at the University of California at Los Angeles have published a number of papers that document hydrazine sulfate's ability to prevent weight loss in cancer. (2, 3) This strongly supports Dr. Gold's earlier work showing hydrazine sulfate to be an anti-cachexia drug.
In another study by Dr. Chlebowski and his colleagues, patients with inoperable lung cancer were divided into two groups. One group received traditional chemotherapy (cisplatin) with hydrazine sulfate, while the other group received cisplatin along with a placebo. Patients who were critically ill showed only marginal response. However, when patients who were in better condition at the beginning of the study were evaluated, 42 percent of those taking hydrazine sulfate were alive after one year, compared to only 18 percent of the non-hydrazine sulfate group. (4)
This study shows that hydrazine sulfate can be used to enhance the survival and overall well-being of patients who are being treated with traditional chemotherapy.
Current Status
A significant body of research has been published about hydrazine sulfate over the past twenty years. Although several studies of small groups of patients published in the 1970s reported little or no improvement with hydrazine sulfate (17, 19, 22), the majority of the research on hydrazine sulfate has reported very favorable results. (16)
Advocates of hydrazine sulfate contend that the drug's initial classification as an anti-cachexia agent rather than an anticancer agent caused it to be ignored by the medical establishment. Also, its status as a cheap, nonpatentable substance has reduced the pharmaceutical industry's interest and willingness to develop it.
In 1988 the Washington Post published an interview with Vincent DeVita, former director of the National Cancer Institute. DeVita voiced the cancer industry's attitude toward hydrazine sulfate by stating:
You have to distinguish between good ideas and bad ideas and ho-hum ideas. And hydrazine, I think, is a ho-hum idea. The key thing is not to prevent people from losing weight while they die; the key thing is to get rid of their cancer, and that was always the issue. The trouble was nobody saw the value of pumping a lot of resources into a therapy that gave you plumper people by the time they died. (20)
These statements reflect the attitude of the medical establishment that the fight against cancer is just that—a fight. Making life better for the patients is a minor concern. What matters is winning the fight, no matter what the cost to the patient may be. Also, when a drug lacks unpleasant side effects, it tends to be viewed as ineffective.
Toxicity and Side Effects
Hydrazine sulfate is a new type of cancer treatment that is remarkably nontoxic. It even has a positive side effect, frequently producing a mild euphoria in patients after two to three weeks of administration.
The other side effects of hydrazine sulfate are very minor and seldom occur at normal dosage levels. They include mild numbness (particularly of the fingers and toes), nausea, vomiting, and slight drowsiness. Polyneuritis (nerve inflammation) occasionally occurs in cases of prolonged and continuous treatment. Dr. Gold pointed out that this condition can be diminished or eliminated by dosage reduction and/or addition of vitamin B6(13).
Most of the published research on hydrazine sulfate suggests that it can provide benefits to cancer patients who are receiving only alternative therapies, who are combining traditional cancer therapy with alternative options, and who were previously receiving only conventional treatment.
Dosage
The normal dosage for hydrazine sulfate is one 60-mg tablet, taken three times daily. (17) Hydrazine sulfate is relatively inexpensive when compared to other drugs used in chemotherapy. One hundred 60-mg tablets, approximately a month's supply, cost about $25.
Currently hydrazine sulfate is not approved by the FDA for cancer therapy. However, many of the foreign clinics offering alternative cancer therapies do make it a regular part of their protocol. It can also be ordered from some of the overseas companies offering alternative cancer medications by mail order.