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Articles from The Cancer Chronicles
From The Cancer Chronicles #4
©Spring, 1990 by Ralph W. Moss, Ph.D.
"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.
NEW FACTS REVEALED ON HYDRAZINE TRIAL
From The Cancer Chronicles #15
© April 1993 by Ralph W. Moss, Ph.D.
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.
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