Full Investigation · A Disproven Cancer Drug
Hydrazine Sulfate: Tested Four Times, Failed Four Times, Still Sold
An industrial chemical related to rocket fuel was promoted for fifty years as a way to stop cancer patients wasting away, and then as a cure. Four randomized trials found it did not help, and in one it shortened lives. A man who bought it online died of liver and kidney failure. In 1998 Canada's medical journal told doctors it was legally available here.
The idea
In the late 1960s Joseph Gold, a Syracuse physician, reasoned from Otto Warburg's observation that tumours burn glucose inefficiently. If cancer patients waste away because their livers are making glucose for the tumour, he argued, then blocking that process should both slow the tumour and stop the wasting. Of the chemicals he tested, hydrazine sulfate blocked the relevant liver enzyme best. He began recommending it for cachexia, and in time for every kind of cancer.
The theory was tidy. Cancer wasting is not. It involves inflammation, appetite and muscle breakdown as well as glucose. And National Cancer Institute laboratory studies in the 1980s found no meaningful anti-tumour activity, apart from a borderline result in one rat tumour.
The trials
The positive evidence came from uncontrolled Russian case series — more than 700 patients at the Petrov Institute in St. Petersburg — in which a few per cent showed some tumour shrinkage and about half said they felt better. Without a comparison group, there is no way to tell how much of that was the drug. So it was tested properly.
| Trial | Patients | Result |
|---|---|---|
| Chlebowski et al., 1990 | 65 · advanced lung cancer, with chemotherapy | No survival or tumour-response benefit. A later subgroup claim of benefit was criticized in the same journal. |
| Kosty et al. (CALGB), 1994 | 291 · advanced lung cancer, with chemotherapy | No difference in survival, response or nutrition. Quality of life significantly worse on hydrazine sulfate. |
| Loprinzi et al. (NCCTG), 1994 | 128 · advanced colorectal cancer, drug alone | Survival significantly shorter on hydrazine sulfate. No benefit for weight, appetite or quality of life. |
| Loprinzi et al. (NCCTG), 1994 | 243 · newly diagnosed lung cancer, with chemotherapy | No difference in survival or quality of life. |
Gold's response was that the trials had not strictly banned alcohol, barbiturates and tranquillizers, which he said interfere with the drug. Supporters, led by Kathy Keeton of Penthouse's publishing company, who used it for her own breast cancer, accused the NCI of burying a cure. In 1995 the U.S. General Accounting Office reviewed the trials and found them sound. Later reviews describe the evidence against hydrazine sulfate for cancer wasting as strong, and call it a disproven cancer therapy.
The people
A 55-year-old man who bought it online
He had squamous-cell cancer of the maxillary sinus and declined surgery, radiation and chemotherapy. Instead he found a website promoting hydrazine sulfate, bought it from a source the site pointed to, and took 180 mg a day for about four months without medical supervision. He developed a rash and stopped.
Two weeks later he was admitted to hospital with liver failure, kidney failure, uncontrolled bleeding and confusion from the failing liver. He died a week after that. At autopsy his liver showed widespread tissue death. The Annals of Internal Medicine published the case in December 2000 with an editorial warning about cancer remedies bought on the Internet; the editorial pointed out that hydrazine is also the toxic breakdown product blamed for liver damage from the tuberculosis drug isoniazid.
Linda Malone
After a breast tumour was removed in September 1997, she was afraid of chemotherapy and turned to the Internet. For three years she took hydrazine sulfate under the care of a local naturopath, on the understanding that it would kill any tumour that tried to appear. During those three years the cancer returned in her breast and spread to her liver. In January 2001, aged 58, she told a reporter that it had been made to sound like a miracle cure.
Other case reports describe severe nerve damage treated with vitamin B6, the antidote used for hydrazine poisoning. Hydrazine sulfate is also a monoamine-oxidase inhibitor: it reacts with alcohol, sedatives, some painkillers and aged cheeses and other tyramine-rich foods, which matters a great deal to a patient already on a hospital drug chart.
The Canadian angle
The review did report that randomized trials had found no benefit. But it gave real weight to Gold's objections and to the uncontrolled Russian series, described the side effects as mild and transient, concluded that the drug might reduce wasting and improve quality of life, and called for more research in collaboration with Gold. Every one of the four negative trials had been published before it appeared.
Hydrazine sulfate was also on the intake form of Ottawa's Canadian Cancer Research Group, among more than thirty methods prospective clients could tick as a “specific interest”. A Canadian patient looking for it in 1999 could find it promoted by a private cancer business and described as permitted in the national medical journal, in the same year.
Its status with Health Canada today has not been confirmed for this page. It should be checked before anyone relies on it.
What the case shows
Hydrazine sulfate is as close to a settled question as alternative cancer medicine gets: a plausible theory, a decade of enthusiasm, a fair test, a clear answer, and a federal audit confirming the test was fair. None of that stopped its sale. A negative trial does not reach the people who buy a remedy because they have stopped trusting trials — and in 2000, the only things that reached the man in the Annals report were a website and a mail-order supplier.
Related on QuackeryWatch
Sources
- National Cancer Institute. Hydrazine Sulfate (PDQ®) — Health Professional Version. Last updated 23 August 2018; no longer updated.
- Hainer MI, et al. “Fatal hepatorenal failure associated with hydrazine sulfate.” Annals of Internal Medicine 2000;133:877–880.
- Black M, Hussain H. “Hydrazine, cancer, the Internet, isoniazid, and the liver.” Annals of Internal Medicine 2000;133:911–913.
- Chlebowski RT, et al. Journal of Clinical Oncology, 1990. Kosty MP, et al. J Clin Oncol, 1994. Loprinzi CL, et al. J Clin Oncol, 1994 (two trials).
- U.S. General Accounting Office. Report HEHS-95-141, 1995, on the NCI-sponsored hydrazine sulfate trials.
- Kaegi E, for the Task Force on Alternative Therapies of the Canadian Breast Cancer Research Initiative. “Unconventional therapies for cancer: 4. Hydrazine sulfate.” CMAJ 1998;158:1327–30.
- National Toxicology Program. Report on Carcinogens: hydrazine and hydrazine sulfate.
- News report on Linda Malone, January 2001, as reproduced on this site's original cancer page.
- Canadian Cancer Research Group intake form, as documented by Quackwatch.
The 55-year-old man is not named in the published case report and is not named here. Corrections are welcome and are recorded on the page.