Dec. 4 A controversial compound favored by
some cancer patients and available for purchase
on the Internet has been blamed for causing the
death of a 55-year-old man.
BUT ONE of the compounds proponents is highly critical of the report,
which is igniting a new dispute over whether the substance is harmful, and
rehashing the discussion of whether it even works.
Hydrazine sulfate, a component of rocket fuel thats available in pill
form, has been embroiled in controversy since its application against
cancer in the 1960s. Supporters cite medical studies that show it counters
both cancer and the wasting caused by the disease, called cachexia. But
opponents, including the National Cancer Institute, insist there is no
evidence of effectiveness, pointing to three NCI-sponsored studies.
This latest report, which appears in Tuesdays issue of the Annals of
Internal Medicine, is unlikely to quell the controversy.
In the journal, Dr. Mark I.
Hainer of Moncrief Community Army Hospital in Fort Jackson, S.C., and
colleagues describe the case of a 55-year-old cancer patient who died of
liver failure at the hospital. The man had been diagnosed with cancer of
the left sinus cavity. He declined conventional therapies, including
radiation, surgery and chemotherapy.
Instead, he selected the alternative therapy hydrazine sulfate, which he
reportedly obtained on the Internet, and took about 180 milligrams per day
for four months after his diagnosis.
When he arrived at Moncrief Community Army Hospital, he had a rash,
itching, progressive malaise and jaundice for two weeks.
As soon as the rash had appeared, the patient stopped taking the hydrazine
sulfate. Hainer noted in the case report that he could not obtain samples
of the compound the man had taken, nor did he test his blood for the
presence of hydrazine sulfate.
The man was admitted to the hospital for liver and kidney failure, and
later died. An autopsy revealed destruction of the kidney and liver
tissue. But, wrote Hainer, No evidence showed tumor metastasis or
preexisting liver disease. Hainer concluded the mans liver and kidney
failure most likely were caused by the ingestion of hydrazine sulfate. He
based this on direct and indirect evidence, namely that versions of
hydrazine have been linked to liver damage. Also, Hainer wrote that the
autopsy descriptions of the patients liver and kidney damage are
consistent with direct kidney and liver injury from the ingestion of a
toxin. But Dr. Joseph Gold, director of Syracuse Cancer Research
Institute, Inc. in New York (not affiliated with Syracuse University),
isnt convinced. He first proposed using hydrazine sulfate to treat cancer
patients in the 1960s.
Theres never been a report of liver failure or death since its inception
in clinical use in 1973, he said.
Gold faulted the case report on several grounds: No samples of the compound
were analyzed, the mans blood was not tested, and the form of hydrazine
Hainer said was toxic to the liver is different from the hydrazine used in
the hydrazine sulfate alternative therapy.
Theres no direct or indirect evidence [that hydrazine sulfate caused the
death], he said. They didnt even do the blood studies. In an
accompanying editorial, Dr. Martin Black of Temple University Hospital in
Philadelphia, noted that reports of hydrazine toxicity to the liver and
kidneys in humans are scant. He said that hydrazine is considered to be
free of toxic effects in humans. In some ways, this is a fluke, he said.
But Hainer and Black used this case as a warning against patients
self-medicating with drugs, especially those that have not been approved by
the Food and Drug Administration. Taking this drug without supervision
thats not a wise thing to do, Black said.
Gold agreed with this point. We dont believe in any patient taking the
drug other than under a doctors supervision, he said.
Anybody who purchases the drug on the Internet is crazy, Gold added,
recommending people instead obtain hydrazine sulfate from compounding
pharmacists.
Gold asserted this wouldnt be an issue if it were not for resistance by
the National Cancer Institute. That hydrazine sulfate has been forced to
[resort to] the Internet is the fault of the NCI and the FDA, he said.
Gold pointed to clinical trials that he said support the ability of
hydrazine sulfate to either arrest the growth of cancer and/or limit the
effects of cancer-linked cachexia.
But three NCI-sponsored clinical trials reportedly showed no significant
survival or anti-cachectic benefits.
All three were negative, said Mary McCabe, director of the NCIs office
of education and special initiatives.
Three randomized studies have been done. Those studies were negative.
Advertisement In the continuing back-and-forth of this debate, Gold
criticized the design of these studies, which he said neutralized the
effects of hydrazine sulfate, while McCabe cited a government review that
backed the study design.
Gold stated that the NCI and doctors are attempting to suppress the drug
because it is inexpensive, while McCabe countered that the NCI is always
interested in finding new and promising approaches to fight cancer.
This dispute is common when the issues of drugs, life-threatening diseases
and cures collide, Black observed.
You get groups that champion an unproven remedy, and people continue to
hold on to hope, he said. And with cancer, people
