For 30 years, studies have shown that an inexpensive chemical compound stops the physical wasting ultimately responsible for many cancer deaths, says Joseph Gold, MD. So why is the compound not readily available to cancer patients? And why do the powers that be insist that claims about its therapeutic value are false?
The Hydrazine Sulfate and Cachexia Link
The substance in question is hydrazine sulfate, which according to the National Toxicology Program and the International Agency for Research on Cancer, is used to refine metals, conduct blood analyses, and help analyze minerals. It is also used as an antioxidant for soldering and as a biocide for fungi and molds. According to the same agencies, “Hydrazine and hydrazine sulfate are reasonably anticipated to be human carcinogens based on sufficient evidence of carcinogenicity in experimental animals [however] there is inadequate evidence for the carcinogenicity of hydrazine and hydrazine sulfate in humans.”(1)
In addition to its industrial uses, hydrazine sulfate inhibits an enzyme produced by the human body that is responsible for gluconeogenesis. In simple terms, gluconeogenesis is the process by which the body – primarily the liver and kidneys – creates glucose, a type of sugar. Why is this important in cancer? Because it relates to cachexia which can cause death in cancer patients.
Cachexia, also known as “wasting” is a complex syndrome that combines weight loss, lipolysis, loss of muscle and visceral protein, anorexia, chronic nausea, and weakness. According to the American Cancer Society, approximately 20% of cancer deaths overall are attributable to cachexia and the incidence of cachexia varies by tumor type.”(2)
One cause of cachexia is abnormal glucose metabolism. There is increased glucose use by the tumor as the tumor switches to glucose as its primary fuel source. Gluconeogenesis goes into overdrive as cancer develops and spreads, “using up a lot of energy and accounting for much of the fatigue, lack of appetite, and weight loss we often see in cancer patients. Hydrazine sulfate interrupts this host energy wasting process,” explains Dr. Gold, the developer of hydrazine sulfate as an anticancer drug.
“Hydrazine sulfate is an anti-cachexic, and because it stops the wasteful energy cycle in body, it keeps the body living,” Gold says. “This is critical, because when you can stop cachexia, you can do something good for a lot of cancer patients.”
The Goal is Stabilization, Not the Killing of Cells
Hydrazine sulfate is not a cytotoxic agent, meaning that it does not kill cancer cells – although it does stabilize their growth, Gold explains. It also spares healthy cells. “Hydrazine sulfate doesn’t directly cause tumor regression or stabilization, but it does result in that indirectly, and studies show this,” he says. “And because it doesn’t kill normal cells like chemotherapy does, hydrazine sulfate doesn’t produce the horrendous side effects of chemotherapy.”
The concept of stabilization is not new. In fact, unlike cell-killing therapies like radiation and chemotherapy, the goal of most alternative therapies is not to kill and eliminate the cancer, but to manage it so that the cancer does not grow or spread and patients can continue with their lives. “NCI rejected the idea of stabilization years ago, but now it’s the goal [of many cancer treatments],” Gold adds. “What difference does it make if cancer tissue is still in the body if it’s not going anywhere?”
Side Effects
As for the side effects of hydrazine sulfate, Gold says that “a few percent” of people experience itching, minor nausea, and peripheral neuritis – “which occurs only after a long period of uninterrupted hydrazine sulfate treatment. Papers that are critical of hydrazine sulfate say that neuropathy is a big problem, but studies have not shown this.”
Gold writes that “although hydrazine sulfate is carcinogenic in some weanling mice given the drug in their drinking water since birth, there has never been a case of human cancer reported as a result of hydrazine sulfate therapy [since its use in humans began in 1973]. In contrast, routinely administered chemotherapy drugs are commonly carcinogenic – and can produce up to 26 percent of ‘second cancers.'”
Less Than a Penny Per Dose
And then there is the cost. It is commonly known that the cost of cancer treatment care can be prohibitive for many patients. Gold attributes this to “the cancer conglomerate,” the $200 billion a year industry responsible for cancer treatment, care, research, and administration in the U.S. Clearly, less costly ways of fighting the disease are badly needed. “Hydrazine sulfate is very inexpensive,” Gold says. “Highly purified hydrazine sulfate is sold at about three-quarters of a cent per dose – or about $20-$60 for an average course of treatment.”
Controversy
This all sounds very promising. So what’s the problem?
The problem, says Gold, is that although numerous rigorous studies – detailed on http://www.hydrazinesulfate.org in an essay he wrote – have supported the therapeutic value of hydrazine sulfate in treating cancer, the National Cancer Institute (NCI) and the Food and Drug Administration (FDA) have refused to declare the compound a viable treatment for cancer for some 30 years.
In fact, throughout the 1980’s and early 1990’s, various studies appearing in peer reviewed medical journals suggested that hydrazine sulfate was a potentially safe and effective cancer therapy. For example:
· Researchers concluded in a 1984 article that appeared in the peer reviewed journal Cancer Research, “Our results suggest that hydrazine sulfate can influence the abnormal carbohydrate metabolism associated with weight loss in patients with cancer.”(3)
· In a 1987 article that appeared in the medical journal Cancer, which is published on behalf of the American Cancer Society, data demonstrated “an association between one month of hydrazine sulfate administration and body weight maintenance in patients with cancer…”(4)
· In a 1989 article from the Oncology Section of the VA Medical Center in Buffalo, New York, the researchers stated, “Positive results in the management of weight loss and anorexia have been achieved with hydrazine sulfate…”(5)
· In 1990, researchers from the Department of Medicine, at Harbor-UCLA Medical Center, in California, concluded that, “Hydrazine sulfate may favorably influence nutritional status and clinical outcome of patients with NSCLC. Further definitive studies of hydrazine sulfate addition to therapeutic regimens in NSCLC are warranted.”(6)
Despite these encouraging reports, in 1994, the NCI sponsored three randomized clinical trials that suggested that hydrazine sulfate was not only ineffective but also potentially unsafe. Gold challenged these studies as being invalid because they allowed patients to take other drugs that were incompatible with hydrazine sulfate.
Today, the voices of the cancer establishment are not in unison when it comes to this substance. For example, the FDA website has a PowerPoint presentation that concludes with the statement, hydrazine sulfate has shown a “lack of efficacy, reduction of life expectancy, worsening of quality of life, and increased toxicity in subjects… “(7) But, according to the summary about hydrazine sulfate that appears on the National Cancer Institute website, “In some randomized trials, however, hydrazine sulfate was reported to be helpful in treating anorexia and cachexia caused by cancer.”(8) And a 1998 review of the medical literature published by the Canadian Medical Association concludes that, “There is good evidence that [hydrazine sulfate] inhibits gluconeogenesis. Therefore, it may play a role in reducing the severity of cachexia and in improving the quality of life of cancer patients…”(9) One might ask how a substance that worsens quality of life (according to the FDA) can also reportedly help treat anorexia and cachexia caused by cancer (according to the NCI and suggested by the Canadian Medical Association).
Gold says that despite the inaccurate and misleading pronouncements from the establishment “when doctors themselves develop cancer and want hydrazine sulfate, they call and get it for themselves – and believe me, a lot of them do that.”
So why should Gold be believed? Who is he, and what are his credentials?
The Birth of a Conflict-Ridden Drug
After earning a medical degree from Syracuse University, Gold completed his post-graduate studies at the University of California, Berkeley. In the 1960s, he was enlisted by NASA to conduct heat resistance testing as part of the astronaut-selection process for the Mercury space missions.
In 1966, Gold founded the Syracuse Cancer Research Institute (SCRI), and in 1968, he published the first paper (10) to propose that gluconeogenesis is the mechanism behind cachexia.
“I was the first to come up with a good chemical hypothesis for treating cachexia,” Gold says. “I knew that any compound that could inhibit gluconeogenesis irreversibly would be a good anti-cachexia drug.”
While at an experimental biology conference in 1970, Gold heard a paper about hydrazine sulfate – which had nothing to do with cancer – that was published by researchers at the University of Wisconsin Enzyme Institute.
“This research was about hydrazine sulfate inhibiting the very enzyme I had written about in 1968!,” Gold recalls. “Needless to stay, I didn’t stay for the rest of the conference. We headed home to Syracuse, put hydrazine sulfate into our tumor screens, and asked researchers at several cancer labs to do the same thing. Two weeks later, we learned that hydrazine sulfate not only inhibited cachexia, it also restricted tumor growth.”
In 1970, Gold developed hydrazine sulfate for use as an anti-cachexia drug in cancer patients. He still holds several patents for this use, but despite seventeen initial contacts from major and minor pharmaceutical companies over the years, “none of them were ever taken, and all are running out,” he says, adding that in at least one case, this initial interest was withdrawn after the NCI threatened to cease financial support of the company if it pursued hydrazine sulfate any further.
Was Hydrazine Sulfate Blacklisted?
To say that Gold is cynical about the state of cancer research, development, and treatment in the U.S. is an understatement. It all comes down to money and academic prestige, he says, which is why the extremely low-cost hydrazine sulfate has been blacklisted by the government for so many years.
In short, Gold is adamant that “big money and successful cancer medicine do not mix.”
“It’s about who can get the most money from funding agencies, who can exert the most pressure on Congress. The big breakthroughs that are promised fade, but the big business remains. All kinds of medicine have progressed greatly in the last 30 years, but not oncology.”
“The average oncologist makes two-thirds of his or her annual revenue by selling high-cost drugs to patients – and that’s known as the cancer concession,” Gold continues. “Why do cancer doctors follow the NCI blindly? Because those doctors get paid by the NCI to do those protocols – and very few of them are going to kill the goose that lays the golden egg. Many people suspect this goes on, but cancer doctors don’t want to admit it. It’s all about The Two Es: ego and economics.”
In fact, the regulatory history supports Gold’s claims. The FDA has never approved a drug for cancer that was not patented or marketed or produced by a major pharmaceutical company. And today the trend is towards more expensive cancer therapies with some costing up to $50,000 per patient per year. At less than a penny per dose, hydrazine sulfate is relatively unprofitable compared to the average chemotherapy regimen. If this is the reason why hydrazine sulfate has been rejected by the cancer industry, as Gold contends, then millions of people have suffered and died and will continue to suffer and die because profitability, not efficacy and safety, is ultimately determining what cancer therapies are available to patients.
Endnotes
(1) Hydrazine and Hydrazine sulfate: CAS Nos. 302-01-2 and 10034-93-2 Available here.
(2) The Lethal Phenotype of Cancer: The Molecular Basis of Death Due to Malignancy Loberg, Robert D., et al., CA Cancer J Clin. 2007 Jul-Aug;57(4):225-41. Available here.
(3) Chlebowski RT, et al., Influence of hydrazine sulfate on abnormal carbohydrate metabolism in cancer patients with weight loss. Cancer Res. 1984 Feb;44(2):857-61. Abstract available here.
(4) Chlebowski RT, et al., Hydrazine sulfate in cancer patients with weight loss. A placebo-controlled clinical experience. Cancer. 1987 Feb 1;59(3):406-10. Abstract available here.
(5) Spaulding M., Recent studies of anorexia and appetite stimulation in the cancer patient. Oncology (Williston Park). 1989 Aug;3(8 Suppl):17-23. Abstract available here.
(6) Chlebowski RT, et al., Hydrazine sulfate influence on nutritional status and survival in non-small-cell lung cancer. J Clin Oncol. 1990 Jan;8(1):9-15. Abstract available here.
(7) Saul Malozowski, MD, PhD, MBA, Medical Officer, Division of Endocrine and Metabolic Drug Products, FDA (undated) available here.
(8) NCI Website available here.
(9) Kaegi E., Unconventional therapies for cancer: 4. Hydrazine sulfate. Task Force on Alternative Therapies of the Canadian Breast Cancer Research Initiative. CMAJ. 1998 May 19;158(10):1327-30 Available here. Elizabeth Kaegi, MB, ChB, MSc. was Director of Medical Affairs and Cancer Control of the National Cancer Institute of Canada and the Canadian Cancer Society, Toronto, Ont., from 1993 to 1996.
(10) Gold, J., Proposed Treatment of Cancer by Inhibition of Gluconeogenesis. Oncology 22:185-207, October 1968.