Who Wrote The American Cancer Society’s Denunciation of Hydrazine Sulfate?

After careful study of the literature and other available information, the American Cancer Society does not have evidence that Hydrazine Sulfate is of any objective benefit in the treatment of cancer in human beings.

Thus begins an article in the March/April 1976 issue of CA — A Cancer Journal for Clinicians. CA is the official publication of the American Cancer Society. The article appears under the familiar heading, “Unproven Methods of Cancer Management,” an ongoing series of disreputable proportion in which anonymous “authorities” claim to have carefully studied various cancer treatments and found them wanting. Frequently the unnamed authors commit serious sins of omission and commission, display poorly concealed malice, exhibit unscientific predilections and incomplete scholarship and resort to guilt-by-association, character assassination and outright lies. Over the years, these ex cathedra exponents of orthodoxy have succeeded in discrediting and virtually destroying a long list of researchers, many of whom appear to have labored honestly and selflessly in search of a cancer cure. All made the apparently unforgivable mistake of proposing methods of cancer management outside the mainstream of “proven” cancer orthodoxy (in which stream, incidentally, nearly 400,000 Americans afflicted with cancer will drown this year alone).

The ACS appears to have patterned its “anti-quack” force after the one previously commanded by Morris Fishbein, back in the days when M.F. was editor of the Journal of the American Medical Association. Fishbein, always identified as an M.D., was forever conducting “investigations” from his swivel chair at AMA headquarters in Chicago. And he was forever denouncing the “charlatans” and the “quacks” of the world for presuming to have found substances which might be more effective against cancer than anything thereto proposed by the AMA/ACS axis. More than once he was forced to retract his calumnies, but by then the damage had already been done. In the 40s and 50s, Fishbein carried on a running feud with Harry Hoxsey, the colorful “quack” who combined a “tonic” of natural substances with a rigorous diet to treat cancer. Fishbein called Hoxsey a fraud and swore that Hoxsey’s father (from whom the son obtained the formula for the “tonic”) had himself died of cancer. In the ensuing slander suit it was proved that the elder Hosxey died of a disease unrelated to cancer. Fishbein, under oath, was forced to admit that he’d never attended a patient a single day in his life, and doubt was cast over the validity of his M.D. degree. (A subsequent bit of litigation involving Hoxsey, by the way, ended with the court ruling that his tonic was indeed useful against some forms of cancer. The Hoxsey treatment is still available today in Mexico and, according to some of my sources, is probably rich in amygdalin or Laetrile.)

Today, those nostalgic for the hatchet-job journalism of Morris Fishbein are referred to CA’s “Unproven Methods” column. The same convolutions of fact appear there in abundance although, unlike Fishbein, the craven architects of these maledictions are careful to remain anonymous.

Consider the case of hydrazine sulfate, a substance whose anti-cancer properties have been elucidated by one Joseph Gold, M.D. Dr. Gold is an entirely orthodox sort of fellow whose credentials are all in order and who, over the years, has published the results of his research in many respected cancer journals (Oncology, Annals of the New York Academy of Sciences, Cancer Research, Journal of the National Cancer Institute and so forth). Whether he is ultimately proved right or wrong — and the verdict is far from in at this point — on the usefulness of hydrazine sulfate in the treatment of cancer, it can be said with certainty that his painstaking labors of a dozen or more years deserve better than the unprincipled assault which the ACS has seen fit to visit upon him.

An Unfamiliar Approach

By the ACS hydrazine sulfate is disparagingly described as nothing more than an “inexpensive chemical…commercially available for more than a century; during World War II, it was used in rocket fuel.”

To Dr. Gold, director of the Syracuse Cancer Research Institute in New York, hydrazine sulfate is an anti-cancer agent that is “doing everything it is supposed to do, and perhaps more. Hydrazine sulfate represents the first of a class of new agents designed to interrupt host participation in cancer” in a way none of the approved chemotherapies can do.

The familiar chemotherapeutic agents that are largely failing us today all seek to inhibit the growth of the grossest manifestation of cancer — the lump, the bump, the tumor itself. Dr. Gold realized some time ago that there are two sides to every coin; if the tumor is growing and, in effect, gaining in energy, then the tumor host, the patient, must be losing energy and literally shrinking, which is indeed the case, as any who have witnessed the characteristic wasting or “cachexia” of advanced cancer know. Dr. Gold reasoned that the limited effectiveness of the cytotoxic (cell killing) chemotherapies might be substantially enhanced if teamed with an agent that could conserve the energy of the host and thus, at the same time, deprive the tumor of the energy it needs to grow. Apart from striking closer to the fundamental metabolic root of the problem, this novel approach had the theoretical advantage of possibly obviating the need for highly toxic substances which invariably inflict severe side effects.

In short, the Gold concept promised something new under the sun, where something new was desperately needed. And in hydrazine sulfate he said that he had found at least one substance (and he concedes perhaps not the ideal one) which can partially break the “vicious cycle” or “metabolic circuit” that drains the host of energy and feeds the tumor.

Unlike normal cells, cancer cells do not “breathe,” i.e., obtain energy through ordinary respiratory processes; instead, they “ferment,” getting energy in an inefficient and wasteful manner. The cancer cells feed on the glucose or sugar of the body and leave lactic acid behind as an end product. It happens that the liver is programmed very rigidly to take this lactic acid and, through a very high-energy-consuming process, convert it back into glucose. Normally the body would have occasion, except in a few specialized situations, to do this only in periods of emergency, as when food intake was interrupted for prolonged periods and there was no other source of energy to be had. But with cancer, which puts out lactic acid continuously, it must do it all the time. And what happens is that for every single unit of energy it produces in this fashion it burns up several others in the manufacture process. As the cancer grows and puts out more and more lactic acid, the body has to work harder and harder to convert the stuff into “food” for the cancer — with the consequence that, ultimately, the normally expendable resources of the body are used up and the unexpendable ones have to be thrown into the fire. Thus the muscles are literally consumed by cancer’s voracious and always growing appetite, and the result is cachexia and death. This whole process is known as gluconeogenesis, meaning the production of new glucose from lactic acid in the liver.

The idea, then, is to halt gluconeogenesis, and that is what Dr. Gold believes hydrazine sulfate does. And the process, he says, is blocked by hydrazine at a point in its complex cycle that only minimally affects normal energy processes. Hydrazine inhibits the action of an enzyme crucial to gluconeogenesis.

Dr. Gold published his first paper on this subject (“Proposed Treatment of Cancer by Inhibition of Gluconeogenesis”) in 1968 in the cancer journal Oncology (no. 22, pp. 185-207). Since then he has published several more describing results in both animal and clinical trials. Early tests showed complete inhibition of gluconeogenesis in test-tube studies using rats. Additional animal studies showed significant inhibition of cachexia in cancerous animals and marked inhibition of tumor growth, compared to controls. Data were also generated to show that hydrazine sulfate and some other compounds known to inhibit the target enzyme critical to gluconeogenesis were not directly cytotoxic. As hoped, however, Dr. Gold asserts, the combination of hydrazine with standard cytotoxic drugs yields benefits neither class of drug alone provides. Dr. Gold’s studies indicated that the new anti-cancer agent was effective against a wide variety of animal tumor systems, including Walker 256 carcino-sarcoma, B-16 melanoma, Murphy-Sturm lymphosarcoma and 1-1210 solid leukemia.

Sloan-Kettering Enters the Picture: “Hate at First Sight”

In 1973, even before Dr. Gold had completed his animal testing, clinician began trying hydrazine sulfate on terminal cancer patients under IND (investigational new drug dispensation) from the FDA. Some enthusiasts (though not Dr. Gold himself) began making sweeping public claims for the substance which demonstrably raised the hackles of both those cancer researchers who are properly cautious and those who are improperly jealous and/or fearful of anyone’s progress against cancer save for their own. Gold was unfairly held responsible in some quarters for statements made by others over whom he had no control.

In any event, Memorial Sloan-Kettering Cancer Center in New York was asked to evaluate the substance and agreed to do so in “cooperation” with Dr. Gold. That cooperation, according to Dr. Gold and an insider at S-K who asks to remain anonymous, never developed. The S-K team, headed by Manuel Ochoa, Jr., ultimately published its negative results in the November/December 1975 Cancer Chemotherapy Reports (part 1, vol. 59, no. 6). The S-K study concludes:

Significant subjective improvements or objective anti-tumor responses were not observed in any of the 29 patients adequately treated with hydrazine sulfate. The clinical observations in this report fail to support a role for hydrazine sulfate as an anti-tumor agent. We conclude that its clinical utilization is not warranted at present and do not plan further trials.

The tone of all this may well have been determined as much by the apparent animus that characterized Dr. Ochoa’s “collaboration” with Dr. Gold as by anything that occurred in the laboratory. As my S-K source recalls it, there was an immediate clash of egos between Dr. Gold and Dr. Ochoa: “It was natural hate at first sight.” Things didn’t improve as time marched on.

On April 3, 1974, Dr. Gold addressed a letter to Dr. Ochoa in which he wrote:

In summary, failure to adhere to an agreed-upon protocol by under-dosing, failure to adhere to an agreed-upon protocol by over-dosing, failure to maintain objectivity in a new study by forming expressed opinions even before the study was two weeks old — weaken the results of any study, if not invalidate them completely.

In this letter, Dr. Gold calls Dr. Ochoa’s attention to the fact that four meetings had to be convened (with S-K chiefs Drs. Lewis Thomas and Robert Good in attendance) to explore the reasons why the agreed-upon protocols weren’t being followed. These meetings ended, Dr. Gold says, with Dr. Ochoa again agreeing to follow the prescribed protocols, only then to deviate from them again.

Early in the study, Dr. Gold asserted in his letter to Dr. Ochoa

You were quoted by the family of [a] patient, as saying that you had “no enthusiasm or interest in” using hydrazine sulfate and that hydrazine sulfate was “worthless” in cancer patients. The patient’s brother telephoned, expressing his concern.

During a “chance” visit to S-K, Dr. Gold said that he examined seven patients who were receiving hydrazine sulfate and that four of them were “beginning to show response…in that they were eating more, feeling more alett and stronger…this was substantiated in the progress notes and nurses’ notes.” Given this response, Dr. Gold says., the agreed-upon protocols called for a new dosage schedule which was not adhered to. Instead, another protocol, one “which quickly wiped out whatever good responses they were beginning to show,” was, Dr. Gold claims, instituted.

Later in his letter to Dr. Ochoa, Dr. Gold writes:

At a meeting held on September 12, 1973, between officials of the Syracuse Cancer Research Institute and Memorial Sloan-Kettering Cancer Center, it was agreed that this project (your study) was to be a jointeffort between our two Institutes. This joint effort was emphasized in an Associated Press dispatch [originating] from the Public Relations Office of Memorial Sloan-Kettering Cancer Center itself, and syndicated throughout the country on September 28, 1973. By “joint effort” was meant, simply, the sharing of information and data regarding any patient study undertaken. The mutual advantages of such an arrangement were immediately apparent to the officials of both of our Institutes.

But a joint effort was never undertaken. Once the study began, no person at Sloan-Kettering responsible for this study ever got in touch with me or any official of the Syracuse Cancer Research Institute, regarding any patient or any aspect of any treatment with hydrazine sulfate. No information was released. No data were volunteered. No questions were asked…. When I pointed this out to you…you stated that it was your intention never to make this a joint study. You cannot imagine how such a statement undercuts the goodwill and sincere efforts of both our Institutes….

Despite Dr. Gold’s outspoken criticism of the Ochoa/S-K study and his de facto disassociation with it, the S-K researcher wrote an article scheduled for publication in Cancer Chemotherapy Reports in which this statement boldly appeared: “The protocol for the trial of hydrazine sulfate was developed in cooperation with Dr. Gold based on the experience he has reported.” Other statements in the article stressed that negative results were obtained despite strict adherence to Dr. Gold’s protocols. One of the S-K researchers sent Dr. Gold a copy of the article prior to its publication.

“People often do self-destructive things in an effort to really stick the knife in,” Dr. Gold says of that mailing. He was appalled at what he read in the report and, through his attorneys, demanded that all references about following his protocols, enjoying his cooperation and so forth be expunged from the article which was already set into page proofs. Changes would not be made unless there were serious errors. But the changes were made, demonstrating, Dr. Gold believes, twhat he was right in his objections and that the S-K team had made grievous misrepresentations. Had the piece run as originally constructed it is evident that Dr. Gold would have been made to appear to be presiding over his own funeral.

Even as amended, however, Dr. Gold disagreed with the conclusions of the S-K report. He has no reason to believe, for example, he says, that any of the S-K patients were adequately or properly treated with hydrazine sulfate. The S-K team apparently believed that treatment for less than a week was “inadequate,” while Dr. Gold insists that treatment for less than three weeks or even a month is inadequate, given the characteristics of hydrazine sulfate, the actions of which are slower to develop than those of the typical cytotoxic drug. Four of the S-K patients were treated for less than wo weeks and 12 were treated for “14 to 28 days.” Only 13 were treated for more than 28 days. But the S-K data is invalid, in any event, Dr. Gold believes, since the prescribed protocols were ignored.

The Russians Get Positive Results

While the S-K controversy was building, other studies of hydrazine sulfate were in progress. Dr. Gold was analyzing data from an IND study under the direction of Calbiochem, a La Jolla, CA, pharmaceutical firm. Calbiochem supplied the drug to clinicians across the country who had patients in terminal stages of cancer. These doctors filled out data sheets on observed responses to hydrazine and returned them to Calbiochem. From these reports Dr. Gold prepared a report that appeared in the October 1975 issue of Oncology. He noted in this report a very low incidence of side effects accompanying significant objective and subjective responses.

In a series of 84 various evaluable disseminated cancer patients treated with hydrazine sulfate…it was found that 70 percent of the cases improved subjectively and 17 percent improved objectively. Subjective responses included increased appetite with either weight gain or cessation of weight loss, increase in strength and improved performance status and decrease in pain. Objective responses included measurable tumor regression, disappearance of or decrease in neoplastic-associated disorders and long-term (over one year) “stabilized condition.” Of the overall 59 subjective improvements, 25 (42 percent) had no concurrent or prior (within three months) anti-cancer therapy of any type. Of the 14 objective improvements, seven (50 percent) had no concurrent or prior anti-cancer therapy. Of the remaining cases in which there was either concurrent or prior anti-cancer therapy, improvements occurred only after the addition of hydrazine sulfate to the treatment regimen. Duration of improvement was variable, from temporary to long-term and continuing. Side effects were mild, comprising for the most part low incidences of extremity paresthesias, nausea, pruritis and drowsiness; there was no indication of bone marrow depression.

Another investigator, Dr. William Regelson of the Medical College of Virginia, also had an IND for hydrazine research. His study, like the S-K study, failed to find any benefits from the drug. But, unlike S-K, neither did he find any evidence of toxicity. These two facts and an apparent mixup in shipping that Dr. Gold says has come to his attention, led Dr. Gold to speculate that the Virginia researcher might inadvertenly have given placebos to both the controls and the experimentals in his study. Everybody else, Dr. Gold observes, has recorded at least some activity, either positive or negative, but the Regelson study turned up virtually nothing.

The Regelson study, though completed for some time, has never been published. Interestingly, one S-K researcher told me that Dr. Regelson’s “early work with hydrazine was so negative that he decided not to go ahead with a planned double blind study.” Yet, at the time this claim was made Dr. Regelson’s double-blind study, the one in which Dr. Gold suspects both groups got placebos, was already finished. ¹ Dr. Gold says that Dr. Regelson went ahead with his double-blind study precisely because his early results were encouraging.

Whatever the case, Dr. Regelson subsequently “lent” his IND to Dr. Harvey J. Lerner of the department of surgery at Pennsylvania Hospital in Philadelphia. Dr. Lerner then conducted a small study using outpatients. His brief, negative report on this experience was published in the government’s Cancer Treatment Reports, July, 1976. The article was published despite the fact that the individuaIs (Dr. Gold included) who “refereed” ‘the paper said it should not be published unless expanded to include all the data upon which the negative conclusions were presumably based. Yet the paper was published in its original, incomplete form. Apart from the very small number of evaluable patients studied in this report, Dr. Gold objects also to the fact that outpatients, “who could not be properly monitored” were used. Dr. Gold fears that these outpatients were, in some cases at least, using other drugs which might have reduced the efficacy of hydrazine — such as alcohol or barbiturates, both known to dampen hydrazine’s effects and both very commonly used.

But the most significant hydrazine studies (or at least the ones least likely to be tainted by American cancer politics) have been forthcoming from the Soviet Union’s highly regarded Petrov Research Institute of Oncology of the USSR Ministry of Health in Leningrad. Writing in Problems in Oncology (21: 45-52, 1975), the Russians describe success in using hydrazine sulfate against a number of animal tumor systems, as well as against a variety of human cancers. The drug was given to 48 “far-advanced” cancer patients in whom all other cancer therapies had failed to bring results. The addition of hydrazine sulfate produced, according to the researchers, a 35 percent objective and a 58 percent subjective response. And of a second study, they wrote:

In a series of 95 evaluable, late-staged cancer patients who had become refractory to all usual means of physical and chemical anti-cancer treatment, administration of hydrazine sulfate produced a 41 percent objective response and a 55 percent subjective response. Objective response included measurable tumor regression and stabilization of condition. Subjective response included improvement in general status and appetite, “vigor enhancement” and reduction in or disappearance of pain. Side effects were in general inappreciable, occurring in 30 percent of the patients but never interfering with continuation of the treatment program.

These Soviet results were summarized in the July 1976 issue of Cancer Treatment Reports, published in this country. I’ve seen both the original Soviet paper and the abbreviated version in CTP. I submit that the Soviet paper lost something in the editing. The positive results are still there but in muted and much-harder to discern form.

Enter the ACS: A Rush to Judgment

The Soviets are continuing their research, and the National Cancer Institute is said to be keeping a close watch on what happens in Leningrad. It may be that NCI is not exhibiting real bias (by de-emphasizing the Soviet report in Cancer Treatment Reports and by publishing alongside it Lerner’s negative poorly-controlled and much smaller study) but, rather, may simply be taking a very cautious stance vis-a-vis a cancer treatment that does not fall into the familiar chemotherapeutic niche.

One cannot be so charitable about the American Cancer Society’s outspoken opposition to hydrazine sulfate. In the March/April 1976 edition of CA, the ACS house organ that tries to masquerade as a scientific journal, there is, as noted at the beginning of this newsletter, the familiar “Unproven Methods” smear job on hydrazine sulfate. The article is wormy with error and bias.

The article begins, in italics:

After careful study of the literature and other available information, the American Cancer Society does not have evidence that Hydrazine Sulfate is of any objective benefit in the treatment of cancer in human beings. The following is a summary of information contained in the Society’s files, as of February, 1976.

The key words to pay heed to, initially, are “the literature and other available information,” which clearly implies all the literature plus other information not published, and “as of February 1976,” which clearly implies up-to-date reporting.

Trouble is: by February Dr. Gold had published his Calbiochem study of 84 evaluable patients, some of the results of which were quoted earlier, and the Soviets had published their first study with impressive case histories and positive results. Both studies revealed “objective” as well as “subjective” benefits. Neither report is mentioned in the CA article. Both articles fly full in the face of the ACS statement that there is no evidence in the literature (or elsewhere) “of any objective benefit” accruing from the use of hydrazine sulfate.

The ACS report, its claims to the contrary notwithstanding, was far from current as of February, 1976. It was, in fact, written eight months earlier. When pressed, a CA editor admitted this, claiming that this long lead time is required for materials that appear in the “Unproven Methods” column because they must first clear a committee (names of members of which have been requested and promised but never forthcoming), then be approved by the board of directors of the ACS, then pass muster with the ACS legal staff to head off libel and then and only then be published in CA.

CA‘s executive editor, Dr. Sidney Arje, states: “Everything that is in that statement [on hydrazine sulfate], every statement that is made is backed up by some source, and so we provide our legal department with the source of that information and they check it over and everything in there has to be verified and, of course, they clear it.”

Fine.

Trouble is: what about the statement that this article is current as of February, 1976?

Dr. Arje: “That’s when it was published. At that point that was what we had.”

Yeah, but what about what you just said, Dr. Arje, about an eight-month lead time in which you are so terribly careful about avoiding libel, not making errors, etc.? How can you be current as of February, 1976 if the piece was written eight months earlier?

Dr. Arje: “That’s right. That was, uh, that’s an error. That’s an error. That’s right. You’re right about that.”

Trouble is: now that we have an admission that this article was not current as of February, 1976 and that in fact it was written in mid-1975 and not revised thereafter, how can one account for a footnote in the CA article that purports to base some of its damning information on an article published in the November 1975 issue of Cancer Chemotheragy Reports (now rechristened Cancer Treatment Reports)? This is the negative article authored by Dr. Ochoa et al. How could an ACS article, written and locked up in early summer of 1975 contain a reference to an article published in November of 1975?

Here’s how: ACS never saw the article in Cancer Chemotherapy Reports. The Society obtained an advance copy of the manuscript directly from Sloan-Kettering where one or more goody-two-shoes were apparently eager to cooperate. The Society was told that the article was scheduled for publication in the November issue of Reports. ACS then overlooked or chose to ignore the fact that such submissions are almost always subject to revision prior to actual publication. There were, as it turned out, serious misrepresentations in this article and, under threat of lawsuit, S-K and the editors of CTR were forced to make several changes.

But the ACS went blithely on its way using the original, erroneous manuscript, all of which demonstrates just how much care is taken during that eight-month lead time. It also suggests a thing or two about the competence and/or sincerity of the ACS legal department, not to mention the ethics of ACS editors.

And there are more troubles still. In addition to misquoting, in effect, from Cancer Chemotherapy Reports (in what I submit was a consciously calculated risk), the ACS also saw fit to distort and quote-out-of-context other sources, as well.

The CA article states that “Other investigators at the American Association for Cancer Research meeting expressed concern at being unable to obtain ‘hard data’ from Dr. Gold on the number of patients treated, the number showing objective tumor regression and the dosage schedule.” A Medical World News article is cited as the source of this information. I looked up that article and found that one (singular) investigator “expressed unhappiness at being unable to obtain ‘hard data’ from Dr. Gold on the number of patients he had treated, the number showing objective regression of tumor, and dosages and frequency.” The “unhappy” investigator was identified by MWN as Dr. Martin Apple, assistant profesor of pharmacology at the University of California, San Francisco. CA doesn’t quote the following from the same MWN article: “But he [Dr. Apple] still feels the scale has not yet tipped one way or the other.” Nor does CA include this quote from Dr. Apple: “I believe, theoretically, that a drug that interferes with gluconeogenesis of cancer cells could be an effective type of drug.”

There are plenty of other examples of manifest distortion, bias and unfairness in the CA article, of which the following are merely samples:

• The ACS claims that Dr. Gold is in full-time practice, implying that his cancer clinic is merely a hobby. Multiple sources verify that Dr. Gold has never been in full-time practice; he has devoted almost all of his time to research, which, as his many publications attest, is anything but a hobby.

• At no time was Dr. Gold given a chance to respond to the “charges” made against him in CA. “They never even lifted up the telephone to get my side; that’s how ‘careful’ they were,” he says.

• No positive information is included in the piece; those sources who have had both good things and bad things to say about hydrazine sulfate found only their negative comments reported in CA. Dr. Apple, just discussed, is but one example of this. CA reported that Tom Foley of Calbiochem was deluged with requests for hydrazine following some premature publicity about it by someone not involved in any of the research. “That was the roughest period I ever remember,” CA quotes Foley, citing MWN again as its source; “…we must have gotten calls from every patient and the families of every patient west of the Mississippi.” The impression is left that Calbiochem is sorry it ever got involved with so suspect a substance as hydrazine sulfate. CA didn’t bother to report the rest of Foley’s statement to MWN, which goes as follows: “This thing really bothers me, because if the drug proves to be of value, I don’t want it labeled another Laetrile.” Foley, in short, was far from having made up his mind. No matter; the ACS had obviously made up its mind.

CA eagerly reported on Regelson’s negative findings (despite the fact that they had never been published) but did not point out that Regelson is far from “turned off” on hydrazine and Dr. Gold’s gluconeogenesis theory. Reached by phone, Regelson did not hesitate to say: “Gold’s concepts are good. Not only that, he’s got animal data. I think he’s an honest man.” Regelson’s name, incidentally, was misspelled in the CA article, but then ACS only had eight months to check such things. Another researcher’s name was also misspelled.

• Interesting that the ACS could dig up Regelson’s small unpublished study and cite it in its CA report but couldn’t seem to locate the large Soviet study or any of Gold’s studies. In fact, ACS does not cite a single one of Dr. Gold’s numerous published papers. To do so, given the high caliber of the medical journals in which he has published his hydrazine results, would obviously belie the negative impression of the man that CA so assiduously seeks to portray. Thus the publication implies that Dr. Gold is spreading the word on hydrazine via “information sheets” and public speeches. It uses pejorative terms such as “promotion” to characterize the discussion of hydrazine sulfate. If a man has ever been libeled, it is Dr. Joe Gold.

After having reviewed all of these points, editor Arje of CA said: “I suppose you can criticize any article that’s gleaned from literature in the way that it’s presented, and if you want to make a case for it that’s fine. All I can say is that whatever we did we did with great consideration. I mean, it wasn’t a casual attempt. Most of the attitude toward the hydrazine problem was resolved in our minds with the Sloan-Kettering experience. I don’t want to argue with you on the phone about the details of this thing.”

But he continued: “First of all, I’m not that familiar with it and secondly I think you’ve made your point and we do recognize some deficiencies in the piece. You’re not the only one who pointed it out [a member of the New York Cancer Society also lodged a complaint], and we’re going to do something about it. I mean, what more can a reliable outfit do?”

Don’t tempt me. Asked if a correction would be made, Dr. Arje responded: “No, we wouldn’t do that. I don’t think we’d go to that length. I don’t see that we’re responsible for retracting.”

Then Dr. Arje asked: “Do you have a personal interest? I mean, are you working for Gold?” No. “Then why are you picking on us like this?”

And so the whole situation, error after error, distortion after distortion, was gone over again. This time, Dr. Arje said: “Yeah, maybe the statement should read ‘at this time it doesn’t appear to be….’” He let the sentence trail. “Yeah, I think we could soften up our position. I’m sympathetic with your criticism, and we’ll certainly consider it in the future. I think all the things you’ve pointed out are helpful. I just want to be sure you understand our…[didn’t finish the sentence] … the way it has worked, and there’s no reason why it can’t be improved.”

Arje then indicated that all distribution of reprints of the hydrazine sulfate story would be halted pending “revision” of the article. No promise was made as to when the revision would be made.

“Readers May Now Draw Their Own Conclusions.”

Has CA made good on its promise to rectify some of its errors, to “soften up,” as Dr. Arje put it? Take a look at the September/October 1976 issue of CA. The ACS has escalated its attack on hydrazine sulfate and, in so doing, has resorted to an outright, outrageous lie.

In commentary on the July issue of Cancer Treatment Reports, CA associate editor John L. Ziegler (at least they got somebody to sign this) claims:

The July issue contains two important reports on the lack of clinical effect of hydrazine sulfate. This compound received considerable publicity in the lay press prior to confirmation of clinical utility. Lerner and Regelson report no clinical effects in 25 evaluable cancer patients, and Gershanovich et al (Petrov Research Institute of Oncology, Leningrad, USSR) report a minimal objective effect (greater than 50 percent tumor regression) in two of 95 evaluable patients. Over half of their patients reported mood improvement, accompanied in some by dizziness, insomnia or general excitement. Previously, Ochoa et al…also reported lack of anti-tumor activity of hydrazine sulfate in 29 evaluable patients, and significant neurotoxicity was encountered in half of the patients. Thus, the weight of clinical evidence has failed to confirm the early enthusiastic reports by Gold…. While a controversy on this topic may continue, readers may now draw their own conclusions based on the published data.

Good grief.

To characterize the Soviet study as one demonstrating “lack of clinical effect of hydrazine sulfate” constitutes a malicious lie. The only other explanation is criminal idiocy, and I’m ruling out that possibility since Mr. Ziegler, though no wordsmith, is apparently capable of putting one letter after another to form (vaguely) comprehensible sentences and thus also is, presumably, capable of tying his shoes.

Note that in “weighing” the evidence, the ACS again ignores the 84 evaluable patients of the positive Gold/Calbiochem data and the 48 “far advanced” cancer patients of the first Soviet study. Then the ACS proceeds to re-write the second Soviet study to its own liking. The second Soviet study, the one involving 95 evaluable patients, must now be examined once again. First of all, note that the Soviets characterize these patients as “late-staged cancer patients who had become refractory to all usual means of physical and chemical anti-cancer treatment.” And I am quoting here from the paper that was summarized in Cancer Treatment Reports.

Here is what ACS left out of its latest attack on hydrazine sulfate:

• First of all, the Russians reported that three, not two, of these far advanced patients using hydrazine enjoyed greater than 50 percent tumor regression.

• Three additional patients in whom all other therapies had failed to bring improvement experienced a 25-50 percent tumor regression.

• An additional 13 patients, also previously “refractory,” saw their tumors regress up to 25 percent. In short, 19 of 95 evaluable patients (a very significant 20 percent of the patients) made gains against their cancers, after everything else had failed them.

• And 20 additional patients (21 percent of the total) had “stabilized” conditions. Their cancers did not advance once hydrazine sulfate was administered.

• Finally, according to the Soviets, 54 percent of the patients derived “subjective” benefits from hydrazine sulfate. This is the benefit that the ACS slights with the characterization of “mood improvement.” (And then not satisfied to damn with faint praise, the CA article quickly adds that this mood improvement comes accompanied by “dizziness, insomnia or general excitement.” That the ACS would even see fit to mention such benign side actions, given the well-documented, horrific side effects of the “proven” cytotoxic drugs, including the one in which the ACS owns half the rights [5-FU], is further indication of its malice.) But, most important is what the ACS fails to tell us about those subjective effects, for they are far from being limited to mere mood improvement. Here’s what the Soviets say about these subjective benefits in the CTR summary of their work:

They included reduction of fever, tendency toward normalization of the laboratory findings, reduction or disappearance of hemoptysis [expectoration of blood], and diminished respiratory deficiency. The subjective action was usually expressed as an appreciable improvement of general status and appetite, disappearance or reduction of severe weakness characteristic of the pretreatment period and, most importantly, reduction or complete elimination of pain (allowing in some cases rejection of narcotics).

And, so, dear readers, the ACS is right: it is time for each of us to draw his or her own conclusions. Dr. Regelson, who certainly can’t be counted an enthusiastic friend of hydrazine, says that the ACS has been “cavalier” in its treatment of the substance. Pat McGrady Sr., the long-time, former science editor of the ACS refers to the “unproven methods” columns as “scurrilous analysis that ought to be beneath the dignity of ACS, NCI and other participants.”

I’m tempted to conclude that the ACS is as corrupt, incorrigible, unprincipled and self-serving an organization as ever I hope to encounter, that, at its very roots, it’s malignant.

But I won’t say that.

No, rather let me cautiously conclude that:

After careful study of the literature and other available information, I do not find evidence that the American Cancer Society is of any objective benefit in the treatment of cancer in human beings.