With “Short Takes” On:
- Spitball Fights Inside the FDA
- The Vitamin C Habit at High Government Levels
- Nicholas Von Hoffman’s Encouraging Words
- A Psychic Prediction of Israeli “Cancer Cure”
- Israeli Cancer Team Starting Laetrile Trials
- Calling Jimmy Carter
- Calling Fritz Mondale
- Hearing from Hubert Humphrey’s Press Secretary
- and Other Developments…
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.”
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.
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.
The chief of the Bureau of Drugs of the FDA spoke not long ago to government personnel about his experience at FDA. Here is some of what he said:
I want to describe to you the agency as I saw it from the standpoint of an outsider in 1967-1969, based to some extent on a relationship with FDA [he was then a consultant…. My intent is to be very candid and to be fairly personal because, as I read the record and transcripts of your previous discussions with people experienced in drug regulation, I do not think you have been told things like I am going to tell you. And I think that you should know them.
FDA was a most unusual place at the time Dr. Edwards became commissioner, and I want to remind you of that era and the chaos around it because we’re still trying to sort out some of the events today and we’re still trying to build an institution.
The history of the FDA from 1962 until 1969-70 was notably checkered. In that seven-year period there was a very sudden, rapid growth in the number of people at the agency…[and] within a five year period the whole place underwent two moves….
I’d also remind you that, in 1969, Dr. Edwards was the fourth FDA commissioner in a six-year period. The kinds of management style and the kinds of communications which go with a stable management were never really built….
Dr. Edwards inherited the Parklawn Building as a very unhappy institution. I saw that as a consultant…. You must picture [the Bureau of Drugs] in the Parklawn Building [in Rockville, Md.] at that time, full of unhappy people, many of whom lived in Virginia, feeling their lives were changed [they had previously worked closer to home in Crystal City, Va.]; no carpets in the building; the place half painted; walls being built….
There was an enormous documents room — I don’t know whether you believe it or not, but this was a place where people said fights went on in a literal sense. There was absenteeism; there was open drunkenness by several employees, which went on for months; there was intimidation internally, and there was a great deal of what I would call feudalism in bureaucracy.
I have been told this stemmed from the fact that Dr. Goddard had a managerial style that was really quite disastrous on internal communications. During his tenure, the management tended to break down…that combined with the moves and the reorganization left…management disastrously weakened by the late 1960s and nobody wanted to be manager.
I can tell you that in my first year at FDA — even actually longer than that, 1972, 1973 — going to certain kinds of meetings was an extraordinarily peculiar kind of exercise. People — I’m talking about division directors and their staffs — would engage in a kind of behavior that invited insubordination; people tittered in the corners, throwing spitballs. Now I’m describing physicians. People wouId slouch down in their chair and not respond to questions and moan and groan…. This was a kind of behavior I have not seen in any other institution from a grown man.
It seems like such a short while ago that “responsible” health officials were telling us, over and over again, how Americans, owing to “worthless” dosing with vitamins, “have the most expensive urine in the world,” the idea being that all those vitamins pass right through you without doing any good along the way. Now, Dr. Theodore Cooper, assistant secretary for health at HEW, has told Medical Tribune (page one interview, November 3, 1976) that “I personally take the water soluble [C and B] vitamins in fairly large doses.” And he added: “the work on Vitamin C would seem to indicate that it is safe and suggests that there may be interesting effects, especially with terminal malignancies and with viral infections.” Dr. Cooper does not say in the interview just how much C he uses each day but an acquaintance of his tells me that the assistant secretary takes 1,000 mg. (one gram) daily. Medical Tribune noted that “Dr. Cooper said that the personal views and habits of top health officials [and there were indications in the article that many other top officials are taking large doses of C and recommending them to their families] may sometimes differ from officially stated positions.” In an accompanying editorial the Tribune commended Dr. Cooper for “opening the windows to the fresh air of medical reality.” The editorial stated: “As so often in the past, Dr. Theodore Cooper, America’s top medical official…has directly and forthrightly broken new ground. Once again he has set a healthy precedent, this time not only in respect to medicine but also in regard to openness in government.”
Fine. I commend Dr. Cooper, too. But I’m not forgetting that he was far from “open” and honest with the American people when he promoted the swine flu vaccine which has been discussed several times in these pages. Perhaps Dr. Cooper was trying to make up for that deception when he spoke up about Vitamin C; for, among other things, he suggested that the vitamin might be useful in protecting against swine flu.
Linus Pauling, the Nobel Laureate, has been turned down four times by the government when he has sought funds to continue his very promising work with Vitamin C in terminal cancer patients. Dr. Pauling and his collaborator, the Scottish clinician, Dr. Ewan Cameron, have just published their latest results in the Proceedings of the National Academy of Sciences (October, 1976). Here is their summary of the report:
The results of a clinical trial are presented in which 100 terminal cancer patients were given supplemental ascorbate [Vitamin C] as part of their routine management. Their progress is compared to that of 1,000 similar patients treated identically, but who received no supplemental ascorbate. The mean survival time is more than 4.2 times as great for the ascorbate subjects (more than 210 days) as for the controls (50 days). Analysis of the survival-time curves indicates that deaths occur for about 90 percent of the ascorbate-treated patients at one-third the rate for the controls and that the other 10 percent have a much greater survival time, averaging more than 20 times that for the controls. The results clearly indicate that this simple and safe form of medication is of definite value in the treatment of patients with advanced cancer.
The patients received what many consider to be a scant 10 grams a day for ten days via intravenous infusion and then the same amount orally thereafter.
Recently, Dr. Paul Chretien, chief of tumor immunology at NCI, reported that his preliminary research indicates that Vitamin C does, as Pauling has long maintained, stimulate the body’s immune response system. Dr. Chretien says that these findings lend support to Pauling and Cameron and he believes that Vitamin C might prove even more effective if given to cancer patients in earlier stages of their disease.
Yet, as indicated, Dr. Pauling is still having to go begging in order to scrape enough funds together to keep his research afloat. The taxpayers of this country are now giving almost a billion a year in an effort, so far largely misguided, to find a cancer cure. It’s a national disgrace that not a penny of that money is going to Dr. Pauling, one of the most innovative researchers of the century.
Philanthropists, large and small, please note: your checks will be welcome at the Linus Pauling Institute of Science and Medicine, 2700 Sand Hill Road, Menlo Park, CA 94025. It’s tax deductible. It’s money well spent.
In a two-parter on the battle over a cancer cure, Washington Post columnist Nicholas Von Hoffman related various aspects of the Laetrile controversy and then wrote:
These tidbits and the rest of the American cancer establishment’s bad-will effort not to investigate this substance have been assembled by David M. Rorvik. Rorvik is a freelance writer who is able to do this valuable work thanks to a journalism fellowship from the Alicia Patterson Foundation. The foundation is mentioned here because journalism has been as craven and irrational on this topic as the cancer mavins. Exposing politicians and/or their girl friends is cheap shot, no-risk journalism of the dingy award-winning variety. It takes guts for a writer to question the authority figures of medicine.
I’m grateful to NVH for those encouraging words and so, I’m sure, is the Patterson Foundation, eventhough its views are not necessarily my views — and vice-versa.
Miami psychic Micki Dahne was quoted, prior to last February, as saying that a massive earthquake would hit Guatemala in February, 1976. Such a quake did, in fact, strike on February 4, killing 22,000 persons. Now Ms. Dahne, according to America’s favorite newspaper, The National Enquirer (November 23), is predicting a quake of another sort.
There will be a massive shakeup of federally funded cancer research programs. The President [Carter] will streamline the programs so that funds are used to far greater advantage…. He’ll also enlist the aid of medical people outside of cancer research, opening new approaches in the battle against the disease.
Carter will send medical emissaries to other countries, including Japan and Russia — to learn of their latest advances against cancer. Finally, one of his emissaries will stumble across a team of doctors in Israel who are on the verge of a breakthrough — but are stalled by a lack of cash. They’ll be invited to America, where Carter will fund their research.
And in September of 1977, the Israeli team will rock the medical world with news that they’ve found a cure for cancer. Their treatment will be a new approach involving natural substances instead of drugs.
Hmmm. The HEW official who called my attention to this interesting item suggested that perhaps Ms. Dahne, her accuracy in predicting the Guatemalan earthquake notwithstanding, has been reading my newsletters. (See next item.)
Readers of DMR-4 will recall that I have reported that two distinguished Israeli medical doctors have undertaken an investigation of Laetrile, the controversial anti-cancer substance derived from apricot kernels and other natural sources. Both doctors were skeptical about Laetrile when, at the request of Israeli officials, they made their first pilgrimage to Mexico where thousands of patients have received the substance. Dr. Myron M. Issahary, prominent surgeon long affiliated with the famous Tel Hashomer Hospital and now chief surgeon of Israeli Aircraft Industries, said that when he arrived in New York (enroute to Mexico) he chanced upon a Time magazine article (the distortions of which are picked over in DMR-4) so unfavorable to Laetrile that he almost turned around and went home then and there. After several weeks in Mexico, where he had the opportunity to work with Laetrile first-hand, however, he described the Time article as “a felony.”
Since their first visit to Mexico last July, the two doctors have filed two internal reports with Israeli officials at the Ministry of Health and elsewhere. In their first report they stated:
In all our discussion with the medical staffs in Tijuana, no claim was ever made that Laetrile is a cure for cancer. It was said that it might more properly be called a control for cancer. In the short time that we were allotted we observed and confirmed the following: Laetrile acts as an analgesic; it gives the patient a sense of well being;…Laetrile is an appetite enhancer; the patient gains weight; it acts as a deodorant in decaying cancer masses (fetor).
The report also states:
During a visit of Dr. Issahary…to the Sloan-Kettering Cancer Institute in New York, he met with Dr. L. Old, vice-president of the Institute. In his discussions, Dr. Old said the following:
1) Laetrile is not toxic and can be given subcutaneously up to 5 g. per k/w per day [five grams per kilo of body weight per day].
2) There is no contra-indication in giving Laetrile in addition to orthodox therapy.
3) It would be advantageous to investigate the mode of Laetrile treatments in Tijuana. Moreover, Dr. Old stated he would appreciate being kept informed on our Laetrile reports and activities.
The Israeli report then suggests a rationale for using much higher dosages of Laetrile than have previously been used and proposes a course of action for the Israelis to follow, including:
- animal experiments in which Laetrile is administered both before and after the induction of cancerous growths;
- tagging Laetrile with radioactive material in order to trace its course through the body and thereby gain a better understanding of how it may work (using such techniques, Mexican researchers claim to have found that Laetrile crosses the blood-brain barrier, something most drugs cannot do, and thus might be useful against brain tumors; this needs confirmation);
- experimenting with Laetrile in conjunction with other therapies including hyperthermy (artificial elevation of body temperature) which has been reported to potentiate the substance considerably;
- clinical studies in which the experimentals receive Laetrile in conjunction with orthodox treatments while the controls receive only orthodox treatment;
- experiments to establish optimal doses and chemotherapeutic combinations.
“Laetrile,” the first Israeli report concludes, “has promise in it…it deserves a thorough investigation.”
Now a second report, this one authored by Dr. David Rubin surgeon at Beilinson Hospital and cancer researcher at Hadassah Hospital in Jerusalem, has been issued. Dr. Rubin states:
Specific plans are now being made for a clinical study of Laetrile in the treatment of cancers of the breast in patients with advanced malignancies at the Hadassah Hospital in Jerusalem together with a number of biological research programs, which will be detailed at a later date.
The proposed clinical breast cancer studies with Laetrile will involve three separate groups of patients: two groups will be required for the double blind studies and one group will be an open study encompassing not only Laetrile but also all those components presently under study at Clinica Cydel and the other Laetrile clinics. In this approach, Laetrile is not regarded as a “magic bullet” but rather as the central factor in a therapeutic procedure which includes components such as proper nutrition, the use of enzymes, vitamins and minerals in the correct physiological balance, mega-doses of the acerbates [Vitamin C; the Israeli doctors recently conferred with Pauling on his cancer findings], enhancement of the immune system, adequate rest and exercise and…consideration of the mind-body relationship of each individual patient.
In short, the Israelis propose to implement what Andrew McNaughton, profiled in DMR-4, has long advocated: “the holistic approach to cancer management,” with Laetrile but one of several vital components. McNaughton expects the Israeli results to outstrip the Mexican results since some of the Tijuana clinicians are indifferent to some of the dietary and nutritional therapies.
If so, and if you’ve read the foregoing items, why wait months or a year to have one of your still unnamed medical emissaries “stumble across a team of doctors in Israel who are on the verge of a breakthrough”‘? I’ll be happy to introduce you to these gentlemen — he drop of a peanut. And, for that matter, when my fellowship with the Patterson Foundation runs out at the end of February I’ll be glad to take a microscopic piece of that billion in public funding that goes into our losing war on cancer and go to work for you and the taxpayers providing well-documented leads on a dozen or more extremely promising anti-cancer treatments/substances which have been tragically ignored by our medical establishment. A journalist, well versed in the politics of cancer, I submit, might be a lot more objective than a lot of M.D.s and might not make a bad candidate for one of your “emissaries” against cancer, should such materialize. I could suggest a number of other good candidates, too. You can reach me through the Patterson Foundation. I’ll be by my phone. Waiting. But not holding my breath.
Oh, well. Even if Jimmy doesn’t call, I hope to Christ (and I mean that quite reverently) that at least the first part of Ms. Dahne’s prediction comes true. If any one part of our government needs urgent reorganizing it’s our national cancer program (see DMR-1). The cynics are all saying a president, no matter how determined, can’t crack the cancer bureaucracy. I don’t believe it. With just a few key replacements the whole program could be turned around. And I believe Carter has some inkling of what’s wrong with the program right now. The most encouraging line I heard, in all those millions of words of pre-election rhetoric, issued from Mr. Carter in the closing moments of the final debate when Carter suddenly observed that, depsite all the money that’s been spent so far, our cancer rate is among the highest in the world and escalating at a murderous rate.
A doctor friend of mine tells me that he spoke briefly with Mondale just before the election. My newsletters, the doctor says, were mentioned, along with the need to investigate some of the “unorthodox” approaches ‘to cancer treatment. According to the doctor, Mondale suggested a meeting after Inauguration. I certainly hope that meeting occurs. I believe we have some very solid material to present the vice-president-elect.
Well, at least Hubert can hear me. His press secretary, Ms. Betty South, writes:
Dear Mr. Rorvik:
I received today a copy of your newsletter of September 7 which states that Senator Humphrey may be using Laetrile in connection with the treatment he has been receiving for a cancerous bladder condition. Would you please advise your readers that this information is incorrect. He has never received Laetrile.
In DMR-4 I wrote: “HHH has also been said to be using Laetrile. It doesn’t seem unlikely on the basis of what I’ve heard, but the circumstantial evidence isn’t quite as strong as in the case of Betty Ford.” I then went on to commend the Senator for asking the FDA to conduct new hearings on Laetrile “in light of,” in his words, “continued favorable comment on its effectiveness by users.”
I herewith accept the denial that has been forthcoming from Ms. South — that Humphrey has not used Laetrile. I wish he would use it since I’m convinced (though I started out as a skeptic) that it is very useful against many different forms of cancer and needn’t be used to the exclusion of other therapies. Again, I commend Senator Humphrey for having the courage to speak out in favor of giving Laetrile a fair trial in this country.
Apart from the encouraging news from Israel, there are other good tidings for the Laetrilites:
- Canada, I’m told, has sanely and humanely begun letting cancer victims bring Laetrile into that country for their own use; Australia is implementing a similar policy, joining more than 20 other countries where Laetrile may now be used without harassment.
- The U.S. government appealed the validity of federal judge Luther Bohanon’s court orders allowing cancer patients, who petitioned him, to import Laetrile into the U.S. The government has lost its appeal. Pun incidental.
- Benjamin H. Ershoff and Emory W. Thurston of the Institute for Nutritional Studies in Los Angeles have reported administering apricot kernels (prime source of Laetrile and another substance called absisic acid, to be discussed in a future newsletter) to rats of the Sprague-Dawley strain, some of which were also exposed to well-established carcinogens. Variables were carefully controlled. The researchers concluded:
Present findings indicate that ground apricot kernel when incorporated at a 10 percent level in a natural food stock ration did not counteract the growth retardation occurring in immature male rats administered the carcinogenic agents 2-acetylaminogluorene or N-nitrosodiethylamine, nor did it reduce either the incidence or severity of hepatomoas induced by these carcinogenic agents in rats. Ground apricot kernels, however, did result in a marked increase in average length of survival of the rats administered the nitrosamine. Inasmuch as nitrosamines are potent carcinogenic agents which are present in a number of commonly ingested foods [such as bacon and various processed meats] and can be formed from amines, nitrites and other nitrosamine precursors in such foods or from [gases] which are released into the atmosphere by a number of industrial plants and from motor vehicle exhaust, the finding that ground apricot kernel will prolong the survival of rats administered N-nitrododiethylamine is potentially of considerable significance. The dosage of N-nitrosodiethylamine employed in the present experiment is many times greater than the amount of nitrosamines to which man is likely to be exposed. If ground apricot kernel is capable of prolonging life in animals exposed to a massive dose of N-nitrosodiethylamine, it is not unlikely that it will be even more protective when tested over a more prolonged period in animals administered smaller doses.
Further studies, they conclude, are obviously indicated.
At this point I have, either in the mill or planned, newsletters on the fluoridation/cancer controversy, the work of Dr. Virginia Livingstone (her autogenous vaccines, cryptocides and absisic acid research), nutrition and cancer, the work of Manfred von Ardenne in East Germany (perhaps the man closest to having a “cure” for solid tumors) and the effects of light and other electromagnetic radiations on cancer. I don’t know whether I will be able to squeeze all of this in (and already I’ve had to eliminate from my list a number of very promising projects) before my fellowship expires, but I’m hopeful. And, in coming “Short Talkes,” I’ll be examining the happy failure of the swine-flu vaccination program (for which I will take a small amount of credit) and the latest on the perils of mammography, with Helene Brown’s unique and fascinating defense of this risky business. Finally, I hope to take another look at the cancer statistics — to revisit those “awful numbers” once again.
1. The same S-K source also claimed Calbiochem had “gotten out of hydrazine research because there was nothing to it.” A spokesman for Calbiochem, however, says it was because hydrazine is in the public domain and thus unpatentable. “We saw absolutely no place to go with it.”
Received in New York on November 29, 1976
David M. Rorvik, a freelance writer, is an Alicia Patterson Foundation award winner. He is studying the politics of cancer research in the United States and elsewhere. This article may be published with credit to Mr. Rorvik as a Fellow of the Alicia Patterson Foundation. The views expressed by the author in this newsletter are not necessarily the views of the Foundation.