HYDRAZINE SULFATE

Hydrazine Sulfate

Hydrazine sulfate, a simple, off-the-shelf chemical, dramatically reverses cachexia (ka-KEK-si-a), the wasting-away process that kills two-thirds of all cancer patients. This inexpensive drug, with little or no side effects, also has a clinically documented antitumor action. It causes malignant tumors to stop growing, to reduce in size, and, in some cases, to disappear. A growing number of cancer patients diagnosed as terminal have experienced tumor stabilization and remission through hydrazine sulfate therapy.

About half of all patients who take hydrazine sulfate experience weight gain, restored appetite, extended survival time, and a significant reduction in pain and suffering. Many patients report an increase in vigor and strength and the disappearance of symptoms of the disease, along with feelings of well-being and optimism.

While hydrazine sulfate may not be a sure-fire cancer cure, large-scale clinical trials suggest that it affects every type of tumor at every stage. It can be administered either alone or in combination with cytotoxic chemotherapy or radiation to make the cancer more vulnerable to these standard forms of treatment.

Hydrazine sulfate is now undergoing Phase III trials sponsored by the National Cancer Institute. It is available to patients as a “compassionate IND [Investigational New Drug],” a designation conferred by the Food and Drug Administration on a case-by-case basis, so it is no longer, strictly speaking, an “unconventional therapy.” Yet even though hundreds of patients across the country are using the drug, it is not widely discussed or disseminated among practicing physicians and its promise remains largely untapped twenty-four years after it was first proposed as an anticancer treatment by Dr. Joseph Gold. Meanwhile, hydrazine sulfate is widely available in the Commonwealth of Independent States (formerly the Soviet Union), where researchers have followed up on Gold’s pioneering work with over ten years of investigation supporting the drug’s effectiveness.

“We’ve gone from a red light to a yellow light, and hopefully will go to a green light,” says Dr. Gold, director of the Syracuse Cancer Research Institute in Syracuse, New York, which he founded in 1966. Since his discovery in 1968 that hydrazine sulfate can prevent the wasting-away process in cancer patients and inhibit tumor growth, Gold has waged a courageous uphill battle to win acceptance for his nontoxic chemotherapy by the medical establishment.

The American Cancer Society put hydrazine sulfate on its Unproven Methods blacklist in 1976. It condemned and stigmatized the drug following a clinical trial on twenty-nine patients at Memorial Sloan-Kettering Cancer Center in New York. But it is now widely acknowledged that the Sloan-Kettering tests were botched.

When Dr. Gold made an unannounced visit to the hospital in 1974, he discovered, to his horror, that “many patients in the study were either being underdosed or overdosed. Some people who were beginning to show anticachexia response were suddenly being given 90 to 100 milligrams at one time. All this was in dear violation of the drug protocols and of our joint agreements,” said Gold.1 The study’s protocol called for patients to receive 60 milligrams once a day for the first three days, twice a day for the next three days, and three times a day for the following six weeks. Therefore, some patients were getting a 67 percent overdose.

In a letter of protest to Sloan-Kettering,2 Gold pointed out that some patients were receiving a massive, single dose of approximately 120 to 190 milligrams a day (instead of the usual two or three 60-milligram doses), “which quickly wiped out whatever good response they were beginning to show.” The study was so poorly executed that it could never be published today, he maintains.

Nevertheless, the damage was done. The ACS’s blacklisting of hydrazine sulfate caused Gold’s funding to dry up and scared away other researchers from following up on his early papers.

But Gold refused to give up. In 1975, he did a study of the drug’s effects on eighty-four advanced cancer patients. A total of 70 percent of them experienced weight gain (or the cessation of weight loss) and reduced pain. Only 17 percent showed tumor improvements. Meanwhile, Russian scientists at Leningrad’s Petrov Research Institute were getting impressive results. In one study of forty-eight terminal cancer patients treated with hydrazine sulfate, 35 percent had tumor stabilization or regression and 59 percent showed “subjective response” (ability to function normally, complete disappearance or marked reduction of pain, and so forth).

As a result of these and other favorable studies, the American Cancer Society announced in 1979 that it was removing hydrazine sulfate from its official blacklist. Only four other “unproven methods” that were once stigmatized on the ACS list as “quackery” have been removed from it. However, the ACS included hydrazine sulfate in the 1979 edition of the Unproven Methods list, and that edition continued to be circulated until 1982. Hydrazine sulfate was finally removed from the list the next time the list was revised, in July 1982.3

Tim Hansen, now in his early twenties, of Minneapolis, Kansas, is one person grateful for the existence of hydrazine sulfate therapy. In August 1984, when he was eleven years old, Tim was diagnosed with three inoperable malignant tumors that were growing quickly in his brain. He was placed on radiation therapy, but his health steadily deteriorated until, by early 1985, his weight had dropped to fifty-five pounds. “The radiation harmed his mental functioning, and in January 1985 the surgeon told me that Tim had one week to live,” says Gloria Hansen, Tim’s mother.

In February, after reading a short item about hydrazine sulfate in McCall’s, Gloria and her husband, Ray, got in touch with Dr. Gold, and Tim was put on hydrazine sulfate therapy by his physicians in Kansas. By August, his weight was up to seventy-five pounds. By early 1987, two of Tim’s tumors had completely vanished. In January 1991, a computerized axial tomograph (CAT scan) revealed further shrinkage of the remaining tumor, located in the base of the brain. Dr. Gold plans to keep Tim on the hydrazine sulfate protocol until the tumor is completely gone. Tim graduated from high school in 1990 and is now studying electronics at a trade school, getting A’s and B’s.

Dr. Gold first stumbled upon hydrazine sulfate’s anticancer properties during his methodical quest for a specific type of therapy. Cancer has two principal devastating effects on the body. One is the invasion of the tumor into the vital organs, with the destruction of the organs’ functions-the most common cause of cancer death in the public’s mind. In reality, however, this accounts for only about 23 percent of the country’s half-million annual cancer deaths.

The other devastating effect of cancer is cachexia, the terrible wasting away of the body, with its attendant weight loss and debilitation. In cancer, as in AIDS, patients succumb to the accompanying illnesses, which they would otherwise survive if not for the wasting syndrome.

“In a sense, nobody ever dies of cancer,. notes Dr. Harold Dvorak, chief of pathology at Beth Israel Hospital in Boston. “They die of something else-pneumonia, failure of one or another organs. Cachexia accelerates that process of infection and the building-up of metabolic poisons. It causes death a lot faster than the tumor would, were it not for the cachexia.”4

Halting the wasting syndrome instead of directly attacking the cancer cells with poison was Dr. Gold’s plan of attack. As he explains, “Each of these processes [the tumor invasion of vital organs and cachexia] has its own metabolic machinery, each is amenable to its own therapy, and each is to some degree functionally interdependent on the other. In the interest of treating the totality of malignant disease, each of these processes warrants intervention. Such an approach, dealing with both major underpinnings of the cancerous process-mitogenic and metabolic-affords the greatest promise for eliciting long-term, symptom-free survival and the potential for disease eradication.”5

But what causes cachexia? Cancer cells gobble up sugar ten to fifteen times more than normal cells do. The sugar consumed by the cancer cells is generated mainly from the liver, which converts lactic acid into glucose. (Normal cells are far more efficient users of glucose, which they derive from the food we eat, not from lactic acid.) When cancer cells use sugar (glucose) as fuel, they only partially metabolize it. Lactic acid-the waste product of this incomplete combustion- spills into the blood and is taken up by the liver. The liver then recycles the lactic acid (and other breakdown products) back into glucose, and the sugar is consumed in ever-increasing amounts by voracious cancer cells. The result is a vicious cycle, what Dr. Gold calls a “sick relationship” between the liver and the cancer. The patient’s healthy cells starve while the cancer cells grow vigorously. Some healthy cells even dissolve to feed the growing tumor.

To break this sick relationship, Gold reasoned, all he needed was to find a safe, nontoxic drug that inhibits gluconeogenesis (the liver’s recycling of lactic acid back into glucose). In 1968, he outlined his theory in an article published in Oncology. “The silence was deafening,” he recalls.

A year later, by a remarkable coincidence, Gold heard biochemist Paul Ray deliver a paper explaining that hydrazine sulfate could shut down the enzyme necessary for the production of glucose from lactic acid. Gold had chanced upon an eminently logical way of starving cancer. He immediately tested hydrazine sulfate on mice and found that in accord with his theory, the drug inhibited both gluconeogenesis and tumor growth.

Over the years, many dramatic remissions in patients on hydrazine sulfate therapy have been reported. In one case, a sixty-two-year-old woman with widely disseminated cancer of the cervix, in a very debilitated condition, was put on the drug. After one week, a secondary tumor the size of an orange had completely disappeared, much to the amazement of the woman’s doctors, and neck nodes had become markedly smaller. After three weeks on the therapy, the patient had gained weight and was active and in good spirits. The woman was discharged from the hospital a short time later.6

In 1987, Erna Kamen, a sixty-three-year-old lung cancer patient, was administered hydrazine sulfate after her discharge from a Sarasota, Florida, hospital. “Basically, my mother was sent home to die,” says Jeff Kamen, an Emmy-winning television reporter. “She’d lost a significant amount of weight by then, and she had no appetite and virtually no will to do anything.”

A doctor had told Jeff’s father, Ira Kamen, that hydrazine sulfate offered at least “a shot in the dark.” So one Monday in August 1987, a home nurse gave Mrs. Kamen one hydrazine sulfate pill shortly before serving lunch. “On Tuesday morning,” recalls Jeff, “there was a commotion in the house. My mother had risen from her bed like the phoenix rising from the ashes. She was demanding that the nurse bring her downstairs so that she could have breakfast with me…. When people you love get into this kind of facedown with death, you’re just incredibly grateful for each moment.”7

As Jeff describes his mother’s recovery, “her searing pain was gone; her appetite returned at a gallop.” Within three weeks, her racking cough had vanished and she could walk unaided. “In the months before her death, she went on television with me to tell the nation about hydrazine sulfate. The National Cancer Institute stopped trashing hydrazine sulfate and began referring inquiries to the UCLA Medical School team whose work had validated the effectiveness of the drug long before Erna Kamen began taking it.”8 Jeff attributes his mother’s death months later to her being “mistakenly taken off hydrazine sulfate and subjected to an unproven experimental substance.”

With cancer patients, hydrazine sulfate is usually administered orally in 60-milligram capsules or tablets, approximately one to two hours before meals. It is given at first once a day for several days, then twice a day, then three or four times daily, depending on the patient’s response and the physician’s judgment. On such a regimen, many terminal and semiterminal patients have derived considerable benefit, although patients in the early stages of the disease derive the most benefit from the treatment.

Approximately half of the patients to whom the drug is properly administered in the early stages of the disease show an almost immediate weight gain and reversal of symptoms; in some instances, the tumor eventually disappears. The common types of cancer most frequently reported to benefit from hydrazine sulfate therapy are recto-colon cancer, ovarian cancer, prostatic cancer, lung (bronchogenic) cancer, Hodgkin’s disease and other lymphomas, thyroid cancer, melanoma, and breast cancer. Some less common types of cancer also benefit.

“Whether hydrazine sulfate should be used in conjunction with other agents seems to be dependent on whether these agents are doing the patient any demonstrable good,” according to Dr. Gold. “In the instances in which these agents have been doing good, hydrazine sulfate should be used in conjunction with them. However-and especially with those cases on toxic drugs-in instances in which the drugs have been doing no evident good, it is probably best to withdraw such drugs and use hydrazine sulfate alone.” Many alternative therapists disagree. They see hydrazine sulfate as mainly an adjunctive treatment, albeit a potentially powerful one.

Critics have made much of the fact that hydrazine sulfate, a common industrial chemical, is found in such products as rocket fuel, insecticides, and rust-prevention agents. For medical purposes, however, the salt is refined, purified, and used in reagent-equivalent grades. Given to patients in minuscule amounts, it occasionally produces mild, transient side effects such as nausea, dizziness, itching of the skin, drowsiness, and euphoria, but such side effects are minimal, especially when compared with the devastating effects of standard chemotherapy.

A very small percentage of patients undergoing long-term, high-dosage hydrazine sulfate therapy experience pain or temporary numbness in their extremities, but this condition is quickly controlled by reducing the dosage and administering vitamin B6. In no known cases has hydrazine sulfate depressed or destroyed white blood cells or bone marrow, as conventional chemotherapy often does. In general, toxicity has been exceedingly low or nil.

The most recent study of this drug, however, concluded that hydrazine sulfate appears not to be beneficial and may even have neurological side effects. This study involved a nationwide, twenty-month trial with 291 advanced non-small-cell lung cancer patients, all of whom received chemotherapy. In the double-blind phase, half were given hydrazine sulfate, while the other half received a placebo. Patients receiving hydrazine sulfate had a median survival of 7.62 months, while the comparable figure for those on placebo was 7.5 months. Hydrazine sulfate had no effect on cancer cachexia, according to Michael Kosty, M.D., an oncologist with Scripps Clinic and Research Foundation in La Jolla, California, who was the study’s principal investigator, nor were differences noted between the two groups in anorexia or weight gain. Furthermore, the placebo group rated their quality of life higher than did those patients taking hydrazine sulfate, and some hydrazine sulfate patients experienced loss of sensation and motor function. “Therefore, the best we can say about this drug is that it has no effect and may even be deleterious,” Dr. Kosty was quoted as saying in a summer 1992 issue of ASCO Highlights, a publication of the American Society of Clinical Oncology.

Dr. Rowan Chlebowski, director of a UCLA research project on hydrazine sulfate, conservatively estimates that the drug could benefit about half a million cancer patients each year in the United States alone.9 His team has conducted many clinical studies of hydrazine over two decades. Dr. Chlebowski says that the drug’s indirect mode of action against tumors is problematic to more cautious investigators. “We found that hydrazine sulfate was an anticachexia agent that indirectly induced antitumor responses without much toxicity. Its action is not directed at cancer cells yet it may profoundly affect them.”10

Dr. Chlebowski and his colleagues at the Harbor-UCLA Medical Center in Torrance, California, recently found evidence that hydrazine sulfate added to conventional chemotherapy improves the nutritional status and prolongs the life of patients with non-small-cell lung cancer, especially deadly forms of the disease. In the January 1990 issue of the prestigious Journal of Clinical Oncology, he reports that earlier-stage patients have a median survival time of at least 328 days, compared to 209 days for the placebo group. There is no curative therapy for this type of lung cancer, so the results, if confirmed, seem promising.

The wasting syndrome seen in cancer patients is also a prime risk factor for AIDS patients with Kaposi’s sarcoma. There is evidence that hydrazine sulfate’s capacity to stop cachexia may save many AIDS patients. Currently, Dr. Chlebowski is planning a study to test hydrazine sulfate as an anticachexia agent in patients who are infected with HIV and have lost weight.

Even though hydrazine sulfate is now undergoing extensive Phase III trials sponsored by the National Cancer Institute, resistance to this inexpensive, nontoxic chemotherapy in orthodox medical circles persists. Dr. Vincent DeVita, former director of the NCI, told a Washington Post reporter in 1988 that he thought hydrazine was a “ho-hum idea.” Dr. Gold, until recently, has been frozen out of the “war on cancer.” Two articles on cachexia published in duly 1990 in the prestigious Cancer Research journal fail to reference any of Gold’s path-breaking work, and one even denies there is any effective treatment for the wasting-away syndrome.

Dr. Gold, who does not treat patients, says that the cost of hydrazine, at most, should be nominal-comparable to the daily cost of insulin and other supplies for diabetics. “Until a pharmaceutical company sponsors the drug through the FDA, it will not be widely in use,” he predicts, adding, “However, with the new studies, drug companies have suddenly begun to take notice of this most exemplary drug.”

References
1. Lawrence Linderman, “Finding a Magic Bullet,” Penthouse, July 1989, p. 110.
2. Quoted in Ralph W. Moss, The Cancer Industry (New York: Paragon House, 1989), pp. 192-193.
3. Robert G. Houston, Misinformation From OTA on Unconventional Cancer Treatments, invited review for the U.S. Congress, Office of Technology Assessment (Otho, IA: People Against Cancer, 1990), p. 27.
4. Moss, op. cit., p. 205.
5. Joseph Gold, “Hydrazine Sulfate: A Current Perspective,” Nutrition and Cancer, vol. 9, nos. 2 and 3, 1987, pp. 64-65.
6. Joseph Gold, M.D., “Cancer Therapy With Hydrazine Sulfate,” Cancer Control Journal, vol. 1, no. 4, November-December 1973, p. 16.

7. Linderman, op. cit., p. 112.
8. Jeff Kamen, “Finally, Attention for Cancer Wonder Drug,” West Side Spirit, New York, 24 July 1990, pp. 9, 34.
9. Kamen, op. cit., p. 34.
10. Naomi Pfeiffer, “Studies Spur New Look at Low-Cost Anti-Cachexia Drug,” Oncolog, Times, vol. 12, no. 6,June 1991, p. 14.