"Where are your double-blind studies?" is the usual response to proponents
of alternative cancer therapies. And, indeed, there are few rigorous clinical
studies of most unconventional treatments. The difficulties of launching
such studies and getting them published often seem insurmountable.
One exception to this rule has been hydrazine sulfate. Since it was proposed
as a cancer treatment by Joseph Gold, M.D., nearly twenty years ago, hydrazine
has taken the orthodox route. Gold treats no patients. His salary comes from
a small non-profit corporation. He solely tries to foster good scientific
studies of this non-toxic, readily-available chemical.
This approach is more difficult for the establishment to deal with than the
wild claims of some unconventional practitioners. Gold has been subjected
to a barrage of negativity. The director of the NCI once claimed, "We throw
away better drugs than hydrazine sulfate."
In the January 1990 issue of the Journal of Clinical Oncology, one of the
most prestigious cancer journals in the world, Dr. Rowan T. Chlebowski and
colleagues at UCLA offer evidence that hydrazine sulfate, added to conventional
chemotherapy, improves the nutritional status and prolongs the life of patients
with non-small-cell lung cancer (NSCLC). Considering all patients, survival
was 292 days in the hydrazine group vs. 187 in the placebo-treated group.
This was not statistically significant. But in the earlier stage patients,
median survival was at least 328 days compared to 209 in the placebo group.
This was statistically significant. Since there is no curative therapy available
for this type of lung cancer, you would think the results would be greeted
with enthusiasm.
They weren't. In the same issue of the JCO, Dr. Steven Piantadosi of the
Johns Hopkins Oncology Center, Baltimore, launched into Chlebowski's study.
In a three page editorial, he questioned the value of "small trials in
heterogeneous populations." But a dozen smaller studies in the same issue
went unscathed. He claimed "Statistics cannot resolve whether the observed
benefits of hydrazine sulfate are true or false...." Although he acknowledges
that "many readers will doubtless be reassured by the apparent comparability
of treatment groups," Piantadosi is not. "Tabulations such as these are common
fare for comparative clinical trials," he writes. "Unfortunately, they really
tell the investigator very little."
He raises a number of technical questions about the way data is presented
and then says, "we must seriously question the results of Chlebowski et al....The
skeptic would be justified in concluding that hydrazine is of no benefit."
He is disturbed by the unconventional rationale behind hydrazine's use. Twice
he repeats that the "biological reasons offered for believing in therapeutic
effects of this size due to hydrazine are not compelling."
Many of the alleged `flaws' he sees in the hydrazine study are common to
most clinical trials published in peer review journals like the JCO. So why
pick on hydrazine? Isn't this a classic double standard? It's as if someone
said to developers of new cancer treatments: "Give us your double-blind studies.
But even when you do, we still won't believe you." --end--
Cf. Journal of Clinical Oncology Vol 8, No 1 (January), 1990: pp.1-3; pp.
9-15.
Hydrazine sulfate is a non-toxic treatment for cachexia, the wasting syndrome
that kills many people with cancer and AIDS. After a series of positive tests
on lung cancer, a UCLA researcher reported surprisingly negative results
last year.
But an excellent article in the March Penthouse (a magazine that has long
done innovative articles on medical politics) by Emmy-winner Jeff Kamen reveals
that the Phase III trial of hydrazine at UCLA was not carried out according
to the instructions of the drug's developer, Joseph Gold, MD of Syracuse,
NY.
In particular, the chief UCLA investigator, Dr. Michael Kosty, is said to
have failed to instruct patients not to take barbiturates or alcohol while
participating in the hydrazine sulfate study. Yet for nearly two decades,
Gold has repeatedly warned that these two substances negate the effects of
hydrazine sulfate.
By not forbidding cancer patients from taking these substances, it was assured
that hydrazine would have no effect, compared to the control group.
In the earlier trials at UCLA–Harbor Hospital, hydrazine was positive,
but in that test alcohol and barbiturates were properly restricted.
