Laetrile: The Goddamned-Contraband-Apricot Connection. It may not be the "magic bullet" but it scares the hell out of the American Cancer Society
Part I
"Laetrile is goddamned quackery." — Helene Brown, Project Director, Community Cancer Control, former Chairman of the Board, American Cancer Society of California, Today's Health, November, 1973.
"It is still my belief that amygdalin [Laetrile] cures metastases." — Dr. Kanematsu Sugiura, Sloan-Kettering Institute for Cancer Research, Medical World News, October 6, 1975.
"It would therefore seem that, due to the small fraction of significant increases in life spans among nontoxic tests and due to the lack of objective observed significant tumor regressions, amygdalin…is inactive against established subcutaneous Lewis lung tumor." — Report to the National Cancer Institute from the Southern Research Institute, December 3, 1973.
"My analyses and conclusions differ diametrically from those of the Southern Research Institute/National Cancer Institute report wherein it is concluded that amygdalin 'does not possess activity in the Lewis lung carcinoma system.'…. My analysis of the data is that it is overwhelmingly positive." — Dr. Dean Burk, while serving as Chief of the Cytochemistry Division of the National Cancer Institute, March 22, 1974, letter to Dr. Seymour Perry, Deputy Director, NCI Division of Cancer Treatment.
"The data provided by the McNaughton Foundation certainly indicate some [Laetrile] activity in animal tumor systems." — Dr. Carl Baker, former Director of the National Cancer Institute.
"I would certainly not turn off Laetrile if it had an iota of activity that we could pinpoint. Unfortunately, there's no activity at all." — Dr. Frank Rauscher, Jr., Director of the National Cancer Institute.
"Every study to date has not found any evidence of efficacy of Laetrile, and if there was one shred of evidence from animal or cell systems, I would issue an IND." — Dr. Alexander Schmidt, Commissioner of the Food and Drug Administration.
"It is of key importance that the first animal study yielding clear evidence of amygdalin's efficacy was done in 1968. The dogma of amygdalin as a 'quack' drug had been in full swing for 15 years by this time, and thus had reached a stage where it was unlikely to be unseated by mere experimental evidence." — Mark McCarty, The Triton Times, University of California, San Diego, November 24, 1975.
"It is not true that the Mafia play any part in the battle for the free and unhampered use of Laetrile…if they had it is most probable that Laetrile would have been cleared by the FDA years ago." — Andrew McNaughton, Chairman of the McNaughton Foundation.
Each year an estimated 20,000 Americans suffering from cancer go to clinics in Mexico to receive injections of a substance derived from apricot kernels. That substance is widely known as "Laetrile," the chemical name for which is amygdalin. Nearly all of those Americans are refugees from cancer orthodoxy, individuals for whom the American Cancer Society's "proven cures" and therapies (surgery, radiation, chemotherapy) proved worthless.1 Laetrile is aggressively decried as "quackery" by the American Cancer Society (ACS) and those who use or prescribe it are often subjected to harassment and even arrest by the Food and Drug Administration (FDA), the Internal Revenue Service and other federal agencies. Spokesmen of the ACS charge that those who promote Laetrile are on par with "murderers," soulless profiteers who exploit the desperate. Those who resort to Laetrile, the warning is oft-repeated, will surely die. (So, of course, will more than 350,000 Americans who "resort" each year to the orthodox therapies exclusively. But that fact receives little emphasis.)
The "bottom line," inevitably, is that the "promises" of the Laetrile advocates entice those who might be saved with "proven" methods into pinning all their hopes on this "worthless" substance. Dr. Victor Richards, in his book The Wayward Cell, Cancer (University of California Press, 1972), concedes that orthodox chemotherapy is largely ineffective in the control and cure of cancer; yet he discerns for it a use which can only be described as "political." For, "nevertheless," he writes, "chemotherapy serves an extremely valuable role in keeping patients oriented toward proper medical therapy and prevents the feeling of being abandoned by the physicians in patients with late or hopeless cancers. Judicious employment and screening of potentially useful drugs may also prevent the spread of cancer quackery." I can only conclude from this that Dr. Richards is saying, in effect, that "our orthodox lies" are better than "your unorthodox lies." Looked at in another way it is a declaration of orthodox quackery in the name of negating unorthodox quackery.
After a painstaking investigation of all major Laetrile studies I have had to conclude that the evidence now available in no way justifies application of the term "quackery" to Laetrile. On the basis of this investigation I have further concluded that the advocates of this substance promise remarkably little and, in fact, promise less than do the defenders of orthodox therapies (who repeatedly see lights at the end of the tunnel and discern "cures" where there are none), that all but about one percent of those who turn to Laetrile, far from being "enticed" or deflected from orthodox therapies, have already been declared "terminal" or "hopeless" by orthodox oncologists or have failed to receive any benefit from orthodox medicine.
Whether Laetrile is an efficacious agent in the control of cancer must, in some ways, be considered as of only secondary importance in an anfractuous controversy which perhaps, more than any other in the realm of cancer politics, casts serious doubt on the wisdom and integrity of those charged with one of the most pressing missions of our time — the conquest of cancer.
The Trouble With Krebs
Why does the cancer "establishment" (generally defined as an alliance of the ACS, FDA, National Cancer Institute, the American Medical Association and various drug companies) oppose even the clinical testing of Laetrile with such ferocity? The easy answer is to surmise that it fears that the substance just might be the "magic bullet" that will do in not only cancer but (as night follows day) the cancer establishment itself. Actually, there are few even among the most zealous of the pro-Laetrilists who ascribe to the substance any such desirable pctential, and while there are no doubt a few among the more strident anti-apricotists who discern in legal-Laetrile a definite threat to their disease-dependent livelihoods it is likely that the lockstep resistance of the establishment accrues more from intellectual strabismus and academic catabolism than from any rational, open-eyed concern about money.
In fairness to the establishment, it must be said that its dogmatic defects, perhaps generic in science, are potentiated beyond inheritance by the antagonistic surviving dogmas of the opposing camp. Which is to say that not all is black-and-white. "Part of the confusion and controversy we brought on ourselves," says Andrew McNaughton, the Laetrile champion who will be profiled in Part II, next Newsletter.
The "central dogma" of the pro-Laetrilists is the "trophoblastic" thesis of cancer, the roots of which were first advanced by the Scottish researcher, Dr. John Beard, professor of embryology at the University of Edinburgh. In a paper published in Lancet in 1902 Beard presented evidence which he said led him to the conclusion that cancer cells and the pre-embryonic trophoblast cells which invade the uterine lining and literally give the developing embryo a grip on life are virtually identical. If the trophoblast cells, which anchor the embryo to its mother, do not "switch off" at the right moment, Beard discovered, disaster would ensue. Runaway trophoblast, he believed, constituted the deadliest of all cancers, the chorionepitheliomas, which kill mother and fetus in record time. His research revealed that the fetal pancreas normally becomes operant at the beginning of the eighth week of gestation, releasing enzymes that "turn off" the trophoblast cells, preventiig them from overdoing their job.
Further research convinced Beard that trophoblast cells could arise from primitive undifferentiated germ cells, about 80 percent of which are confined to the gonads where, as they mature, they become the sperm and ova, and about 20 percent of which are dispersed, he said, through all parts of the body for reasons not well understood. Unless kept in check by the pancreatic enzymes, these cells, too, he hypothesized, could evolve into cancer. For a more detailed analysis of the Beardian theory, one which affirms some particulars of it and "corrects" others in light of more recent research, see "The Trophoblastic Theory of Cancer Revisited," by Charles Gurchot, Ph.D., in the journal Oncology 31: 310-333, 1975. Dr. Gurchot is a pharmacologist previously on the staff of the University of California Medical School. Though a Laetrile advocate, Dr. Gurchot's views are somewhat at variance with those of Ernst T. Krebs, Jr., the man widely described as the "discoverer of Vitamin B-17," also known as Laetrile.
Biochemist Krebs, following up on the work of his late father, Dr. Ernst T. Krebs, Sr. and Dr. Beard, ultimately found an "extrinsic'" factor that could, he said, defend against cancer when the intrinsic metabolic defenses of the body failed or were overwhelmed by any of a number of environmental assaults or nutritional deficiencies. The principal intrinsic factors were said to be the pancreatic enzymes trypsin and chymotripsin which purportedly have the power to neutralize trophoblast defenses which otherwise prevent white blood cells from attacking the malignant invaders. The theory went that the trophoblast cells, stimulated by estrogen, which is present in men as well as women, got out of control when the pancreatic enzymes were insufficient, due to age, heredity or a diet that demanded, for purposes of digestion, great quantities of those enzymes.
By 1950 Krebs claimed to have synthesized an analog of the chemical amygdalin, the structure and many of the properties of which had been known since the 1830s. (Amygdalin, which occurs naturally in a great many seeds, grasses and other plants, is one of a family of cyanide-containing substances collectively labelled "nitrilosides.") According to Krebs, the cyanide component of Laetrile is safely bound to other compounds (much the same way that deadly chlorine is rendered harmless when bound to sodium in common table salt); only in the presence of an "unlocking enzyme" called beta-glucosidase can the cyanide and another highly toxic substance called benzaldehyde be released from the Laetrile molecule. "Fortunately," writes G. Edward Griffin, in his pro-Laetrile book, World Without Cancer (American Media, Thousand Oaks, California, 1974)
the unlocking enzyme is not found to any dangerous degree anywhere in the body except at the cancer cell, where it always is present in great quantity…. the result is that vitamin B-17 is unlocked at the cancer cell, releases its poisons to the cancer cell and only to the cancer cell. There is another important enzyme called rhodanese, which we shall identify as the "protecting" enzyme. The reason is that it has the ability to neutralize cyanide by converting it instantly into by-products that actually are beneficial and essential to health. This enzyme is found in great quantities in every part of the body except the cancer cell which, consequently, is not protected.
The total theory of trophoblastic offense and cyanide/enzymatic defense is, undeniably, an elegant one. Unfortunately, the this-is-fact-not-theory attitude of Dr. Krebs and some of his interpreters gives his detractors and some open-minded individuals who might otherwise look into his theories the excuse to ignore or reject him out of hand. For, the fact is, much of the foregoing never has been conclusively proved.
In another book that also deals favorably, though more objectively, with Laetrile, Vitamin B-17: Forbidden Weapon Against Cancer (Arlington House, New Rochelle, N.Y., 1974), former editor-in-chief of the Berkeley Daily Gazette Michael Culbert writes:
It is essential to point out here that there is not a unanimity of opinion as to the precise action of Laetrile — or vitamin B-17, as it was later called. To this day, Dr. Charles Gurchot questions the exact series of events in the Laetrile reaction as described by Krebs and states that the cyanide action is "not proven." And Dr. Dean Burk, Laetrile's chief defender within the otherwise hostile National Cancer Institute, told me: "Both Dr. [Hans] Nieper and I have conceived of several mechanisms of action of amygdalin which have nothing to do with any action of cyanide." Part of officialdom's critique against Laetrile was based on the alleged failure of tests to duplicate the precise action described by Krebs.
Though frequently characterized as a "genius," even by some who obviously dislike him, Krebs (whose doctorates are honorary but who studied medicine and anatomy for three years at the well-known Hahnemann Medical College in Philadelphia and later biochemistry, bacteriology and graduate pharmacology at the University of Illinois, University of California and elsewhere) has made mistakes which some say have seriously compromised his cause. In a biochemically informed evaluation of the Laetrile controversy that combatants on both sides have praised as particularly insightful, University of California/San Diego medical student Mark McCarty has dissected some of those "mistakes." In a two-part article entitled "Burying Caesar: An Analysis of the Laetrile Problem" (Triton Times, UCSD, November 24 and November 26, 1975), McCarty makes these observations:
Krebs, upon introduction of his Laetrile in the 50s, claimed that he had synthesized a beta-glucur oniside analog of amygdalin…. Krebs postulated that such a molecule would release cyanide when cleaved by the enzyme beta-glucuronidase. It is well-known that cancerous tissues often contain levels of beta-glucuronidase many-fold higher than its tissue of origin. Krebs therefore proposed that Laetrile was releasing cyanide selectively at the site of the cancer due to cleavage by beta-glucuronidase. This claim was disproved by the demonstration that Krebs' Laetrile was in reality only amygdalin, which cannot be cleaved by beta-glucuronidase. Then Krebs made the convenient ad hoc proposal that amygdalin was first being converted to the glucuronide derivative in the liver [via a biochemical process McCarty finds faulty]…from which the processed molecule would be carried to the site of the cancer and release its cyanide due to beta-glucuronidase cleavage. To the best of my knowledge, no experimental evidence has been presented by Krebs or anyone else to substantiate this theory.
Krebs' latest version of amygdalin's mechanism runs as follows: cancer cells have unusually high concentrations of beta-glucosidase, and little or no rhodanese (the enzyme which detoxifies cyanide, producing thiocyanate). Thus, cyanide would selectively attain high cytotoxic levels in cancer tissues. Several experimental studies at Sloan-Kettering and elsewhere have failed to confirm this ad hoc generalization. While a few of the tissue slices studied at Sloan-Kettering did show this enzyme pattern, it is apparent this mechanism alone could not account for the range of therapeutic efficacy claimed by Laetrile proponents. As previously stated, in-vitro [test-tube] experiments have repeatedly shown the inability of cancer cells to release cyanide from amygdalin within a reasonable incubation time.
It is important to emphasize that when Krebs states these theories, he states them as fact, not theory. His continued dogmatic, ad hoc, unconfirmable and even disprovable assertions as the mechanisms of amygdalin's action have undoubtedly made it easier for scientists to believe that Krebs is a quack and that Laetrile is a hoax."
Why has Krebs made claims that couldn't be supported? "I think it comes down to having lucked out with the right answer before he — or anybody else — knew why it was the right answer," says one pro-Laetrilist who wouldn't be quoted by name.
McCarty buys that explanation at least to the extent that he, too, despite his sometimes scathing critique of the pro-Laetrilists and especially Krebs, finds something "right" in the answer. It is his view, ultimately, in fact, that there is more good evidence to suggest that Laetrile is effective against cancer than there is good evidence to suggest that it is not. McCarty goes to great lengths to show how some alternate biochemical explanations could account for amygdalin's efficacy. In the course of this he very persuasively d.emonstrates the errors and distortions of a widely circulated article by David M. Greenberg, Ph.D. called "The Vitamin Fraud in Cancer Quackery," published in The Western Journal of Medicine, April 1975 and handed out in large numbers by the American Cancer Society.
McCarty recounts that this article for some time dissuaded him from believing that a more likely alternative to the Krebs scenario for Laetrile efficacy might hold water. (Briefly, the alternative holds that the cyanide is cleaved in the intestine where the proper chemistry for such release exists; that, via this route, given the proper regimen, blood levels of cyanide could result that would be high enough to kill cancer but low enough not to make the patient ill. Those interested in the biochemical particulars are directed to McCarty's paper, obtainable either from me or McCarty himself.) When some possible errors in the Greenberg piece became apparent, McCarty decided to investigate the literature cited by Greenberg, the literature upon which Greenberg's conclusions presumably were based.
"I was more than a little surprised by what I found," he recalls. It seems Greenberg claimed that it was the "general conclusion" of the many researchers he cited that "effective doses [of cyanide] were too close to the lethal dose to be of practical use." In fact, says McCarty, only one of the researchers reached that conclusion and eventhen, in his view, it was unmerited. "Thus," McCarty concludes this part of his analysis, "it appears quite possible that amygdalin may work by producing serum cyanide, without a requirement for local release at the cancer site. The half-truths and deceptions contained in Greenberg's article are all too typical of the statements of zealots on both sides of the Laetrile question."
How to Find an Iota and/or a Shred
Drs. Rauscher and Schmidt have said that if they could find an "iota" or a "shred" of evidence to suggest that Laetrile works they would rally to its defense. But, alas, there is neither iota nor shred to be found, they have claimed. Jesse Steinfield, former Surgeon General and long-time foe of Laetrile, has similarly stated: "Laetrile has repeatedly been tested in animal tumor systems of the NCI. In no instance did Laetrile have activity in any animal tumor system. There is no basis for the use of Laetrile in man based on data derived from experiments in animals." Similarly, Dr. Charles Mortell of the Mayo Clinic has said: "Extensive animal tumor studies conducted independently at two outstanding cancer research centers, New York Memorial Sloan-Kettering and the Southern Research Institute, have shown this drug to be totally without evidence of anti-cancer activity."
Review, in addition, the quotes that appear at the beginning of this Newsletter. Note in all of these condemnations of Laetrile the uniformly unequivocal negation: "no activity at all," "every study to date," "in no instance," "totally without evidence," and so forth. Let us contrast these categorical negatives with the facts, as we review a series of amygdalin tests.
Up until the 1970s, when cancer authorities assured an inquiring public that "we've tested Laetrile and found it worthless," most could cite but one "study" to back them up. This was the now antiquated but still frequently relied-upon report of the Cancer Commission of the California Medical Association ("The Treatment of Cancer with Laetriles") California Medicine 78 (4) April, 1953). This was republished in 1963, apparently to make it seem more timely. The wholly negative conclusions of this report have been shown to be unsupported by the raw data upon which said conclusions purport to be based.
The California Medical Association (CMA) evaluated the records of some 44 patients who received Laetrile therapy for cancer at a number of California hospitals. The review was irrefutably slapdash (Krebs had refused to cooperate with the CMA in a more controlled study since the CMA would not agree to let a Laetrile friend direct the study), inasmuch as these records, never intended for a study of any kind, were deficient in numerous respects. Patients were widely diverse, were treated with various therapies, including Laetrile, and the extent or even the reality of their disease poorly defined in many cases. They were given, by today's standards, nearly negligible doses of Laetrile. (In each case, Dr. Burk says, less Laetrile was given during the entire course of treatment than is given in a single injection today.) Yet the conclusion of the CMA, circulated without supporting data, was that Laetrile had now been thoroughly tested and that "no satisfactory evidence has been produced to indicate any significant cytotoxic effect of Laetrile on the cancer cell."
The authors of these conclusions state also that some six pathologists who examined tissues of Laetrile-treated patients were of the "unanimous opinion" that "in no instance could any recognizable effect of a chemotherapeutic agent be observed in the histology of these various neoplasms." This was a witting lie, for when the raw data was, perhaps unwittingly, affixed to a reissue of the report in 1963 there was evidence that some of these pathologists had reported on a number of possible, amygdalin-related chemotherapeutic effects, e.g. "…hemorrhagic necrosis of tumor is extensive….an interpretation of chemotherapeutic effect might be entertained…." (This evidence may be found in Appendix Three of "Report by Cancer Advisory Council on Treatment of Cancer with Beta-Cyanogenic Glucosides ['Laetrile’].")
More appalling than the misrepresentations was the snide dismissal in the 1953 study of evidence suggesting that Laetrile, even in those tiny doses, might well have been demonstrating a marked palliative effect in advanced cancer cases. Since all of the doctors surveyed commented on this effect, the authors of the 1953 study couldn't overlook it, entirely. "All of the physicians whose patients were reviewed," the report states, "spoke of increase in the sense of well-being and appetite, gain in weight and decrease in pain," after which the authors saw fit to add: "…as though these observations constituted evidence of definite therapeutic effect." Though the authors themselves had no direct experience with Laetrile or patients treated with it they decided that these palliative reports were subjective and implied that they might be due to some "temporary metabolic effect." Given the intense pain and wasting of advanced cancers, the effect would have to be quite potent to be observable in all cases and, whether temporary or otherwise, certainly deserved intensive followup. Yet the authors of the 1953 report made no such recommendations, instead seemed eager to discount the observations and forget about them. In the past 20 years, it should be noted, as hundreds of doctors around the world have taken up the use of Laetrile, the most consistently reported effect of the substance is one of palliation, often bordering on the profound, in the great majority of cancer cases, no matter how advanced; over and over again, from widely diverse sources, one hears that Laetrile produces palliation even where the most powerful narcotics fail. More on this in Part II.
The Moral of the Story is…Don't Smoke in Bed?
One would not do justice to the Laetrile controversy without digressing for a few moments in order to briefly profile the two authors of the 1953 report that was to condemn Laetrile to the American Cancer Society's "unproven" column (from which, once so classified, "not even Jesus could be reprieved," as one observer put it). Dr. Ian MacDonald, an internationally famous cancer surgeon, served as chairman of the Commission; Dr. Henry Garland, a famous radiologist, was its secretary. Together they authored the report. Both were often in the news in the 50s and 60s for reasons which, though unrelated to Laetrile, are relevant here as we try to assess the character of these men.
Both were tireless in their efforts to discredit the data which was beginning at that time to link tobacco with lung cancer. Dr. MacDonald, for example, may be found smiling from the pages of a national magazine, cigarette in hand, declaring that smoking may be a "harmless pastime up to 24 cigarettes per day." He added that "one could modify an old slogan: a pack a day keeps lung cancer away." (See "Here's Another View: Tobacco May Be 'Harmless,'" U.S. News & World Report, August 2, 1957.) Dr. Garland had similar views and broadcast them frequently, telling the assembled of the Commonwealth Club of San Francisco, for example (July 9, 1964), that his many years of "study" had failed to find any link between smoking and disease and that "cigarettes in moderation are regarded by many as one of the better tranquilizers." Both men were publicly accused of accepting $50,000 testimonial fees from the tobacco industry. Dr. Garland, who often proudly asserted that he had been a chainsmoker since childhood, died of lung cancer. Dr. MacDonald burned to death in bed as result of a fire reported to have been started by his own cigarette. End of digression.
Did Jesse Get the Last Laugh?
In the late 1960s, the nonprofit McNaughton Foundation undertook a massive research and data-gathering effort to assess the effectiveness of Laetrile (both in animals via controlled tests and in humans via the clinical, human experience which, by that time, was already extensive in Mexico) with the hope of winning for the substance an "IND" or "investigational new drug status" from the FDA; the IND would permit clinical trials to proceed for the first time in the U.S. Hundreds of thousands of dollars were expended in this effort, and the ultimate IND application filled more than 1,000 pages. Included in it were hundreds of human case histories attesting to both palliative and tumor-regressing benefits. Also included were the results of extensive animal tests conducted by the SCIND Laboratories in San Francisco. These tests demonstrated that rats treated with amygdalin survived better than 50 percent longer than untreated rats afflicted with the same cancer.
Looking at the SCIND data, Dr. Carl Baker, then director of NCI, stated: "The data provided by the McNaughton Foundation certainly indicates some activity in animal tumor systems." As in the case of the 1953 CMA study there was enough evidence here, surely, to qualify as a "shred" or an "iota."
Now one must understand that Laetrile, i.e., amygdalin, is a substance which abounds in nature and is non-patentable. It is in the public domain. No drug company, therefore, was or is interested in spending the large amounts of money (usually in the many millions) required to test and develop a new drug to the point where it will be approved by the FDA. Yet a nonprofit organization, whose director was convinced of the efficacy of the substance, undertook this expensive and thankless task, winning, in the process, the ACS’s unremitting hostility. Here's what happened:
After gathering all the data, the Foundation filed its application with the FDA on April 6, 1970. On April 27 the Foundation received a letter from the FDA dated April 20, issuing an official IND number and granting approval to begin clinical trials. Then on May 6 the Foundation received a letter dated April 28 citing "deficiencies" in the IND application which had purportedly been overlooked before. Those deficiencies, the FDA asserted, would have to be corrected within ten days of receipt of the letter. The demand for new information was extensive, the deadline short. Nonetheless, the Foundation had 50 pages of new data nearly complete when a telegram arrived from the FDA on May 12 — a mere six days after receipt of the letter demanding new information — stating that, due to failure to comply with the request, the IND was being denied. The Foundation, aghast, finished its corrections and mailed them, nonetheless, to the FDA on May 15 (within ten days of receipt of the letter), appealing for reconsideration. The FDA curtly declined.
The political nature of this sequence of events was further emphasized when, during Congressional hearings that dealt in passing with the Laetrile controversy, the FDA claimed that it had never issued an IND number to the substance in the first place and, therefore, that nothing had been withdrawn under highly unusual circumstances, as some had charged. No one bothered to look at the letter itself, which reads in part: "As sponsor of the clinical study proposed in this exemption, you are now free to obtain supplies of the investigational drug and to initiate studies." What had happened? Dr. Burk, longtime head of the NCI's Cytochemistry Division and, in fact, one of the founders of NCI, a man whose own experiments with Laetrile convinced him of its efficacy, knew at least what hadn't happened. A ranking colleague of his at FDA told him that, in his decades-long experience at FDA, never had so short a deadline been imposed on a request for so much new information. Many agreed that the McNaughton application was far superior to a great many others which had immediately won INDs.
There are two notions as to what did happen. One is that the FDA never intended to permit amygdalin to be tested clinically in this country. Granting an IND would badly embarrass those forces which had so long inveighed against the substance; their credibility — along with their ability to raise funds — would be badly damaged, according to this theory. Thus, by making it appear that the application was faulty and that the Foundation failed to correct the defects, the FDA and all those who had opposed Laetrile for so long could say that the other camp had been given its chance and blown it. The other idea was that the FDA initially proceeded in good faith, that it found the application worthy and thus issued an IND, giving the go-ahead for clincial testing. Then, McNaughton and others believe, Jesse Steinfield, then Surgeon General (the post has since been dissolved), got wind of the IND and, as the apotheosis of the forces which had for so long condemned Laetrile, demanded that the IND be recalled at all costs. Steinfield's hatred for the Laetrilists, McNaughton says, was appealed during the trial of a Laetrile-using M.D. Steinfield testified for the prosecution. The spectators "laughed at him," McNaughton recalls. Whatever the case, it seems clear that if the FDA's behavior was not calculatedly corrupt it was then at least utterly craven.
"I Need One More Misleading Statistic and I Can Retire."2
In 1973, NCI contracted the Southern Research Institute (SRI) to carry out tests on amygdalin. These were destined to become some of the most controversial to date. In one series of SRI experiments an animal tumor system designated as leukemia L1210 was used and no efficacy was discovered. Nobody in the Laetrile camp disputed this negative finding. The McNaughton Foundation had tested Laetrile in this system some time earlier and found that it had no effect. SRI/ NCI knew this, so it is difficult to understand why they selected this system. In its other experiments, SRI used as its animal "testbed" mice afflicted with Lewis lung tumor, which is a tumor system noted for its resistance to almost all chemotherapies. In a report issued by SRI some months previous to its Laetrile experiments, it was stated: "the Lewis lung tumor is relatively insensitive to all the antimetabolites and most of the alkylating agents tested in our laboratories." Why Laetrile was tested against such an intransigent system remains a matter of speculation.
Nonetheless, Laetrile did show some effect against this stubborn tumor; the level of effectiveness was calculated by the SRI, however, to be less than "statistically significant" in terms of survival times. The blanket-negative conclusion that found its way to the press was that amygdalin was "inactive against established subcutaneous Lewis lung tumor." Dr. Burk, one of the first to see the SRI report, was outraged by this conclusion. With his broad grasp of statistics, he analyzed the data and in a 14-page letter to Dr. Seymour Perry, Deputy Director of the NCI's Division of Cancer Treatment, detailed, with full supporting figures, the "overwhelming" efficacy of Laetrile in Lewis lung carcinoma. Dr. Burk succeeded, to the satisfaction of a number of "outside" statisticians, in showing that his conclusions came closer to the truth than did those of SRI/NCI. Throughout his analysis, still available for all to see, Dr. Burk used the raw data SRI supplied. In the view of several statisticians, SRI had manipulated the data in an unconscionable fashion — to such an extent that Dr. Burk charged "corruption," emanating from higher administrative levels within NCI. When correctly analyzed, Dr. Burk said, the data revealed enough statistical significance to make Laetrile, particularly given this stubborn foe, look good, indeed.
One of the misleading things SRI did was to lump all of their experimental mice together in their final analysis — those that received what appeared to be optimum doses of Laetrile with those that received far too little and some others which received far too much. The groups of mice which received optimal doses (the same in each group) consistently showed significantly greater survival — but this evidence of efficacy at proper dose was washed out when all of the mice were lumped together. Dr. Burk charged "corruption" because he believes no statistician worthy of the name could knowingly make such an elementary error. Dr. Burk's analysis (which so far goes unrefuted) showed that far more of the groups of mice demonstrated statistically significant effects. But even, he said, if one accepted SRI's data one would still have to deal with two groups of mice in which SRI admitted to a statistically and biologically significant effect. In his letter to Dr. Perry, Dr. Burk stated:
How SRI and the NCI can logically discard, neglect or disregard the importance of the two "statistically and biologically" significant positive experiments (let alone the four "statistically" significant positive experiments they themselves report) out of a total of 71 in announcing their categorically negative conclusions is beyond my understanding and experience, even on a basis of what is known in the statistical trade as "simultaneous inference," or what Dr. [Saul A.] Schepartz [Associate Director for Drug Research and Development, NCI] in his covering letter referred to as "total experience." It is as though one were to examine the heavens every year for 75 years between the last two arrivals of Halley's Comet in 1835 and 1910, find no such comet in the intervening years 1836-1909, and then conclude from this last set of negative observations that Halley's Comet does not exist, eventhough in fact it had appeared twice ("3%" of 75 years). One simply cannot conclude from a large body of negative evidence that positive evidence, however occasional ("3%"), does not exist or is of no importance or of no interest — either astronomically or mouse-experimentally.
Using widely recognized methods of analysis which many regard as superior in this sort of experimentation, Dr. Burk, by conservative estimates, expanded the SRI-cited three percent "significance" to better than ten percent which, compared with anti-cancer substances on the market, gives amygdalin a superior rating, particularly in this tumor system. But even if one accepted the SRI figures one was surely supplied with evidence sufficient to be characterized as a "shred" or at least an "iota."
Among the statisticians who examined the Burk data and the SRI data was Dr. Michael Fox (Chairman of the Biomathematics Department of the City of Hope National Medical Center near Los Angeles and an Assistant Professor of Biomathematics at UCLA). By using analytical methods which he believes are superior to those employed by SRI he found some cases in which there was a statitiscally significant difference (between treated and control animals) which had not been noted by SRI. Dr. Fox said he knew nothing about Laetrile when he examined the data.
Another statistician, Harold Hornby, who is a research scientist with NASA and a Fellow of the Royal Statistical Society in London, was similarly unfamiliar with Laetrile when a colleague suggested he look at the SRI data. (That colleague was Douglas Alexander, also a NASA research scientist and previously assistant to Dr. C. Chester Stock in the management of experimental chemotherapy at Sloan-Kettering.) Hornby says that the SRI study is "badly designed from beginning to end." The Burk corrections, he adds, were entirely "in order." His own analysis convinced him that the chances of obtaining the effects of amygdalin efficacy evident in the SRI study by chance alone were one in many millions. "I'd guess that most statisticians would certainly agree with me on this. In fact, I would think it would take a captive statistician to come up with something like this SRI analysis in the first place. Remember Disraeli, who said: 'There are three kinds of lies: lies, damned lies and statistics.' It's also been said that statistics don't lie but that liars use statistics. You can 'prove' anything you want with statistics if you're willing to make certain false assumptions, as for example assuming that any dose of Laetrile must demonstrate some effectiveness in the control of cancer if Laetrile is to be considered effective or useful; therefore mice that are overdosed and underdosed are lumped together with mice given the proper dose and so on."
Dr. Burk and many others have criticized the basic design of many of the animal tests, stating that they are ill-equipped to discern the maximal efficacy of slow-acting agents. In the SRI tests, for example, mice were given Laetrile for only seven days. The advocates of Laetrile claim it is a far greater cancer preventive than cancer control, so that, Dr. Burk suggests, experiments should and could be designed to seek out a possible preventive effect — perhaps by administering Laetrile to animals for periods of time before inoculating them with cancer. And where it is being tested as a control or cure it should be given time to work to its fullest possible extent. It should be regarded, Dr. Burk points out, more like the slow, long-term acting agent L-dopa, which is used with some success in treating Parkinson's disease, than like the highly toxic orthodox chemotherapies which are more adequately tested by "quickie" experiments (inasmuch as they will either exhibit a fairly immediate poisoning effect on the cells or they won't). Certainly every effort should be made to determine optimal dose in any given tumor system before beginning any experiment upon which "definitive" conclusions will be based.
Optimal dose was sought in an experiment conducted by Dr. T. Metianu, Director of Research/Pharmacology-Toxicology, Pasteur Institute, Paris. His results showed that Laetrile was effective in mice injected with an adenocarcinoma — effective at levels of unquestionable statistical significance. And in Dresden, Dr. Paul G. Reitnauer, Chief Biochemist of the Institute Manfred von Ardenne, described an experiment ("Prolongation of Life in Tumor-Bearing Mice by Bitter Almonds," Arch. Geschwulstforsch 42 (4) pp. 135-37, 1974, East Germany) in which amygdalin-rich bitter almonds were ground up and added to the food of mice (strain 40 H) 15 days before they were inoculated with cancer (Ehrlich ascites) cells. An equal number of the same strain of mice received the same food but without the bitter almonds and were inoculated with cancer at the same time. The animals given the almonds survived considerably longer than the animals which served as controls. The difference was significant at a high level of statistical confidence. What are the German and French words for "shred" and "iota"?
Sloan-Kettering: The "Cover-up That Wasn't"3 That Probably Was
If Drs. Schmidt and Rauscher don't have access to the French and German scientific literature they certainly have better access than I to the internal archives of Sloan-Kettering Institute for Cancer Research, flagship of orthodoxy's anti-cancer armada. Sloan-Kettering has been experimenting with Lastrile for years, although there has never been so much as a preliminary report published by S-K on that effort. If the flagship hadn't sprung a leak in 1973 and then another in 1975, say the Laetrile advocates, the "outside" world might never have learned of S-K studies that showed an anti-cancer effect, using amygdalin, in certain animal tumor systems.
In the early 1970s, then-President Nixon received petitions signed by nearly 45,000 individuals demanding that clinical testing of Laetrile be initiated at once. (As will be discussed in Part II, there are, according to Medical World News and other reliable sources, perhaps 200,000 Americans now active in the Laetrile "movement," including, according to another report, at least 600 M.D.s who either openly or clandestinely use the substance in their practices.) The White House petitions were channeled to investment banker Benno C. Schmidt, Chairman of the President's Cancer Panel and, putatively, overlord of the War on Cancer (which, incidentally, some members of Congress predicted in the late 60s would be over this year if only the public would put up more money; the public did; the war rages on with little or no progress in sight). Schmidt, in turn, turned the whole business over to Sloan-Kettering, of which he was one of the board members.4
Testing began in 1972 using mice specially bred to develop spontaneous mammary tumors, as well as those which readily accept cancerous transplants. In October of 1973 someone at S-K leaked to the press the initial results of that testing. Between September 1972 and June 1973 Dr. Kanematsu Sugiura, internationally known, senior researcher at S-K had, according to the leaked report, "performed three sets of major experiments to determine the effects of amygdalin…upon mice with spontaneous mammary tumors (adenocarcinomas). The mice strain was CD8F1…. The results clearly show that amygdalin significantly inhibits the appearance of lung metastases in mice bearing spontaneous mammary tumors and increases significantly the inhibition of the growth of the primary tumors over the appearance of inhibition in the untreated animals." Those treated with Laetrile, Dr. Sugiura reported, had a 20 percent rate of metastases, while about 80 percent of the untreated controls developed metastases. Dr. Sugiura went on to describe, in the leaked S-K document, preliminary results with a group of Swiss Webster mice. He noted complete regression of tumors in a couple cases following Laetrile administration — something he had never seen in this system using any other chemotherapeutic agent.
Interviewed by Science in December 1973, S-K officials verified the authenticity of the leaked report. (At no time, it should be pointed out, has anyone at S-K, either on or off the record, suspected Dr. Sugiura himself of leaking the reports.) Thereafter they merely said research was continuing and declined further comment. S-K officials had clearly been embarrassed by the leak and, as Culliton intimated in her Science article, no doubt feared that scientists elsewhere "might presume they had all gone off the deep-end because they were studying Laetrile and other suspect cancer therapies." If anything, over the next couple years, S-K spokesmen seemed eager to convey their orthodoxy by implying that they weren't having much luck with Laetrile, after all.
Then, in the July 21, 1975 New York Times, science reporter Jane Brody wrote:
Actually, the first round of experiments done at Sloan-Kettering hinted that the drug, a derivative of apricot pits, might inhibit the spread of malignant tumors. But repetition of the experiments by other investigators there showed no such effect, said Sloan-Kettering scientists who attribute the first spurious results to the vagaries of experimental variation and unfamiliarity with the animals used. Dr. [Daniel] Martin [of the Department of Surgery Research at the Brooklyn-Queens Catholic Medical Center] said that if amygdalin had any effect at all, it should prevent the development of metastases (or spread of cancer) to the lungs, but it did not in his tests nor in the two most recent tests at Sloan-Kettering.5 Growth of the original tumors was not inhibited, and the treated animals did not look better or live longer."
In an article in Medical World News (August 11, 1975) S-K's "negative" results were amplified. The article states that "in mid-1973, the first series of experiments…showed that mice treated with amygdalin had a 20 percent rate of metastases as opposed to 80 percent for controls. Meanwhile, back at the lab those favorable results could never be reproduced….Dr. C. Chester Stock, Vice President of Sloan-Kettering Institute and Director of the Institute's Walker Laboratories, says, 'We have found amygdalin negative in all the animal systems we have tested."
Those who recalled the 1973 leak must have been surprised to hear Dr. Stock make that categorically negative statement. It was as if the experiments Dr. Sugiura conducted two years earlier didn't count. Then in late August, 1975, perhaps because of Dr. Stock's negative assessment, a new batch of documents, including handwritten laboratory notes, were leaked to a pro-Laetrile organization in California (the Committee for Freedom of Choice in Cancer Therapy in Los Altos) and thence to the press. The leaked documents consisted of several reports showing that Dr. Sugiura had conducted several more amygdalin tests between 1973 and 1975, all showing consistent anti-cancer effects. The documents were attached to an unsigned letter typed on official Memorial Sloan-Kettering Cancer Center stationery.
The letter stated: "Here are some of the results of Sloan-Kettering's continuing experiments with Laetrile. Due to political pressure these results are being suppressed. Please do your best to bring these important findings to the attention of the people. Krebs' theory is very promising, and Laetrile should be tested clinically to see if it really holds water."
Sloan-Kettering officials conceded that the documents were, genuine. In a series of experiments, reported on in papers dated August 3, 1973, March 1, 1974, March 5, 1974, May 31, 1974, September 30, 1974 and February 8, 1975, Dr. Sugiura reported results showing amygdalin efficacy at a level, in all cases, similar to that seen in his earlier series.
In the confusion that ensued (much of it never sorted out by the press), there was a great deal of quibbling over methods of evaluation and a great deal was made of the fact that the "leaker" had been "selective" in leaving out of the bundle of documents he shipped off to California the negative results that had been obtained when the effects of amygdalin had been subjected to Dr. Martin's animal system which, undeniably, does appear to offer a "finer" screen for the detection of metastases, though it can hardly be regarded as "fail-safe" or as a resolutely valid predictor of an agent’s behavior in man. But the leaker, were he present, might persuasively argue that there was no reason to leak the negative studies since S-K officials were happily "releasing" rather than leaking those to the press anyway, while saying nothing about Dr. Sugiura's positive results which, as a whole, constitute the bulk of S-K’s experience with this substance.
After reviewing the extensive new data leaked in August, Mark McCarty, who had been critical of both sides of the Laetrile controversy in his evaluation at the University of California Medical School in San Diego, said:
Only an idiot would sincerely attribute such a consistent string of results to "the vagaries of experimental variation." Nor could Sugiura possibly be guilty of "unfamiliarity with the animals used," inasmuch as he has devoted several decades of his life to tests of cancer chemotherapeutics in animal models. One must conclude that either amygdalin really does have efficacy in this system or that Sugiura is consciously or unconsciously biasing his results (painting metastases on mice?) The latter possibility seems very unlikely; Sugiura's work has been highly respected for decades, and he would have nothing to gain by backing amygdalin — he is in his eighties, hardly a man on the make. He is certainly aware that no merit is gained by producing unconfirmable results. What is perhaps more significant is that he has nothing to lose by bucking the system. One can only conclude that Sloan-Kettering spokesmen have "mis-spoken themselves," or that their previous statements are now "inoperative."
Stonewalling on the Hang-Out Road
Indeed, when I asked Dr. Stock how he could justify his assertion that "we have found amygdalin negative in all the animal systems we have tested" in light of the Sugiura data, he said: "I think when I said that I probably said all the transplantable animal tumor systems which was not as clear a picture." Did Medical World News (MWN) misquote Dr. Stock?
The October 6, 1975 issue of MWN contains an article called "Laetrile Testing: A Cover-Up That Wasn't." In it we are told that MWN Senior Writer David Leff learned in advance of the impending leak by the pro-Laetrile committee and invited S-K officials to respond to the cover-up accusations. Choosing, in Watergate parlance, to "go the hang-out road" rather than to "stonewall it," Dr. Stock, the article states, "arranged an unprecedented charts-on-the-table meeting between MWN and Dr. Sugiura flanked by colleagues who have repeated his Laetrile tests with negative results."
The problem with MWN's assessment of this as the "cover-up that wasn't" is that nowhere in this article is Dr. Stock asked to explain the blanket negative offered in his preceding encounter with MWN (just before the new leak). He is not asked if he "misspoke" himself; nor does MWN give any indication that it might have misquoted him. The main thrust of the article is that S-K is going out of its way to let-it-all-hang-out, when, in fact, had it not been for the leak (which, in turn, might not have occurred had Dr. Stock not been quoted earlier in MWN as finding amygdalin negative in all animal tumor systems tested), this "charts-on-the-table" meeting would never have taken place!
Worse, in discussing the experiments of those colleagues flanking Sugiura at that "hang-out" conference, MWN completely overlooked something of considerable potential importance. So did Jane Brody when she reported, as stated earlier, that in the "two most recent tests at Sloan-Kettering growth of the original tumors was not inhibited, and the treated animals did not look better or live longer."
The two S-K researchers who were selected to attempt replication of Dr. Sugiura's results were Dr. Franz Schmid and Dr. Elizabeth Stockert. Dr. Stockert said she got negative results. Dr. Schmid conducted two series of experiments. When I spoke with him he told me that, in contrast with other amygdalin experiments at S-K, he believed it would be most logical to let the experimental mice die naturally before examining them histologically (via microscopic tissue studies) for evidence of metastases in order to let the Laetrile have a fuller possible impact. Previously the animals had been "saerficed" when the researcher, subjectively, decided they were about to die anyway.
In Dr. Schmid's first test, started on April 22, 1975, the average life span of the 20 cancerous control mice who received no medication was 40 days. The 20 mice which were treated with amygdalin lived an average of 53 days. Dr. Schmid found that 70 percent of the Laetrile-treated animals had, at death, lung metastases. Some 58 percent of the controls had lung metastases. So the Laetrile-treated mice had more metastases but were still living longer. Indeed, in this experiment they lived 30 percent-longer.
In Dr. Schmid's second test the animals were again permitted to die naturally; this time, however, the dosage of Laetrile was sharply decreased in an effort to approximate the dosage that would be administered clinically to a human cancer patient. Again, the controls actually had fewer metastases, but the Laetrile-treated mice lived an average of 63 days compared to a 41-day average for controls. In other words, the Laetrile-treated mice lived about 55 percent longer than the controls.
Brody was simply wrong — either because she had been given misinformation or because she didn't ask the right questions. MWN knew the basic design of the Schmid experiments, yet apparently didn't see fit to inquire into the matter of survival times. And if my experience with S-K is typical I doubt very much that such information was volunteered by officials of the Institute.
What can one make of more metastases and longer survivals in the same animals? Dr. Schmid, when asked, said that this could be due to the Laetrile and that one would expect to find more metastases in animals that lived longer, since they would have a longer time to develop. The survival times were not emphasized, I was told, because the design of the test was to assess metastases. But, surely, to overlook a promising effect which arises, however serendipitously or incidentally, in the course of studying another effect can not be characterized as good science. This effect should have been isolated and followed-up-particularly since the anecdotal clinical evidence suggests that human cancer victims using Laetrile often survive in relative good health far beyond what the statistics say should be expected despite the presence and even continued spread of metastases. To the cancer victim, life — not metastases — is what it's all about.
In my first long conversation with Dr. Stock I asked three times whether survival rates had been taken into consideration in Laetrile testing. The first time I asked, Dr. Stock answered: "We do measure the size of the primary tumor but so far we have not seen any significant or consistent difference there." The second time I asked, he said: "If you're willing to take that [meaning the subjective feeling that the animals are about to die as justification for killing them] as a satisfactory endpoint in survival we haven't seen a significant difference."
"But," I asked, "you haven't actually let them go all the way to death?"
"No." [See Addendum, p. 24 of this Newsletter.]
When I interviewed Dr. Stock at a later date, after I had learned that there had been experiments that preceded my first conversation with Dr. Stock in which the animals had been permitted to "go all the way" and die naturally, I broached the subject again. Dr. Stock acknowledged no misstatement but said: "In the group of experiments about half of them show a longer life span and half of them show a shorter lifeepan." It soon became clear that he was including in this assessment the majority of studies in which the mice are sacrificed, though that was clearly not what I was asking about.
"I understand this [the Schmid experiments] was the first time," I said, "the animals had been allowed to go until they died naturally before tissue was examined…is that correct?
"We had one other experiment where this also happened," he answered.
"We're talking about three experiments in which animals were permitted to go ‘til natural death?"
"I haven't reviewed," he answered, "in which of these experiments they were permitted to go all that time."
"When I spoke to Dr. Schmid," I pointed out, "it was my impression that he felt that this should be done and this was the first time it had been done, with those two experiments in April and May."
"Yes. Well, we don't know if that's a significant increase or not."
"Well," I said, "by my calculations in the one the treateds lived 25 percent longer than the controls and in the other they lived better than 50 percent longer." (I later calculated the previously cited 30 percent and 55 percent advantages, so that in my conversation with Dr. Stock if I was "erring" at all it was on the side of caution.)
"Well," he responded, "I'm just getting a chance to have [an S-K statistician] look at this aspect of it next week."
I ask the reader to re-read this dialogue and draw his or her own conclusions.
Meanwhile, I had heard that a "cooperative" test had taken place, commencing in August 1975, to try to reconcile the different results or further accentuate those differences so that a "clearer" picture might emerge. Dr. Schmid was designated to work with Dr. Sugiura on a series of amygdalin experiments. Rumors I heard indicated that in this cooperative test the Laetrile-treated animals had fewer metastases. When I asked Dr. Stock about the test he said the difference between controls and treated animals was "not statistically significant." When I asked for the figures I was dumbfounded to learn that, depending upon which way one questionable mouse was "analyzed," either 73 percent of the controls and 44 percent of the Laetrile-treated animals had lung metastases or 80 percent of the controls and 44 percent of the treated animals had metastases. This was not statistically significant? (Dr. Schmid, in his conversation with me, called the difference "very marked.") When I pursued the point, Dr. Stock said that he was not a statistician. When I asked to speak with the statistician who had characterized this finding as not statistically significant I was told that might be possible at some future date.
In a later conversation, returning to this study, I,commented that I didn't see how it could be regarded as other than "statistically significant" given the figures which Drs. Stock and Schmid themselves cited. Dr. Stock then said that the study "might" indeed be significant by itself but when it was lumped with other studies, with all the data pooled, then it wasn't. I suggested that this was an irrational way of examining the study and that "negation-by-total-experience" was a discredited statistical construct. I also pointed out that it was hardly fair to characterize all the studies as negative, given the outcome of this cooperative test and Dr. Sugiura's long series of preceding positive results.
Dr. Stock said: "I say we have had negative results but I guess I should put it another way and say we haven't had consistently positive results and we don't feel we have something unless we do have."
Dr. Sugiura's last word on the subject: "Most of the time when other people repeat my experiments, they confirm them — especially in the chemotherapy of cancer. I don't remember ever doing experiments that were later not confirmed. It is still my belief that amygdalin cures metastases."
In fairness to Dr. Stock, I feel compelled to say that among orthodox researchers who have involved themselves with Laetrile he is one of the more reasonable. He says that he has been impressed by the widespread reports of palliation in human cancer patients treated with amygdalin and that clinical trials to evaluate that aspect of the substance might be in order. He adds that he sees no reasonable objection to letting people use Laetrile so long as they don't ignore the other therapies, where indicated. He says that he wishes someone would carefully summarize the clinical data that does exist. (As will be discussed in Part II, an effort is now underway to do just that in Mexico where many thousands have been treated with Laetrile.) Dr. Stock concedes, in contrast with Dr. Martin, that "something could be negative in animal experiments and still be active in man."6
"It's Only Natural"
Those are Dr. Stock's personal views; his official views, apparently, will be shaped by the "total, statistical picture," which he continues to characterize, when he is not challenged, as categorically negative. Time and again, as I discussed the Laetrile issue with individuals on both sides, Dr. Stock was described by those who knew him, either in so many words or in effect, as "a decent fellow who is under a lot of pressure." One eminent, orthodox cancer specialist at a "leading" university said, on a not-for-attribution basis:
"First of all, I'm not going to tell you that I've looked into Laetrile because I haven't. Up until recently I didn't know a damn thing about it except what the American Cancer Society told me and that may be a lot of crap. A couple of my brighter students seem to think there's something in it. Maybe someday I'll have a look. But as for what you're saying now, I do know that most of the fellows at Sloan-Kettering are a honorable lot, all things being relative.
"Now I don't know how well or how poorly they handled the situation but judging by these leaks and press reports they've obviously had some trouble. When an issue gets this polarized it's more a political thing. Benno [Schmidt] didn't do them [S-K] any favor. Actually he was too new to this to realize what a can of worms he was opening when he dumped this on them [S-K]. They're in the position now where they've got negative and positive results. And no.matter what they conclude they're going to be in trouble with somebody. Of course one side carries a lot more clout than the other, and there's going to be a natural tendency, maybe even subconcious, to weight those negative results rather heavily.
"Who wants to be in the position of telling those people who have been saying for years that there's nothing to this, the same people, incidentally, who are giving you funds, that maybe there is something to it? You're going to embarrass the hell out of a lot of powerful people. You just don't bite the hand that feeds you. It's only natural."
ADDENDUM: On p. 20 of this Newsletter I neglected to add that after Dr. Stock answered "no" to my question: "But you haven't actually let them go all the way to death?" the following additional exchange took place. I asked Dr. Stock if S-K would contemplate experiments in which animals would be permitted to die naturally. He answered: "Well, we haven't seen anything to encourage us to believe because [sic] we have been sacrificing these animals when they are quite ill; we haven't seen anything to indicate that is likely to show up." This statement was made, of course, after Dr. Schmid's experiments were completed, experiments in which longer survival times were observed.
"Laetrile: The Goddgmned-Contraband-Apricot-Connection" continues in my next Newsletter.
Short Takes/Coming Attractions/Not-For-Attribution
Apricots for the First Lady?
One United States Senator, one United States Congressperson and several highly placed cancer researchers all say they've heard that Betty Ford has been taking Laetrile. Andrew McNaughton, who keeps a close ear to the Laetrile underground, says the rumor is…"probably false…the substance to the rumor, which is very small, is that when Betty Ford was in Mexico City attending a convention a Mexican Department of Health federal plane came to Tijuana, picked up a supply of Laetrile and returned it to Mexico City. This had never happened before or since; it was unusual, but there's absolutely no evidence that it was for Betty Ford." McNaughton says that he knows some members of Congress and several overseas VIPs who have used Laetrile but knows nothing about Betty Ford. One of my elected informants still insists the rumor is true and says, "Andy is just being gallant."
Watson Sees the Light?
James Watson, the Nobel Prize winner who has been an outspoken critic of the National Cancer Plan and establishment claims that there's "light at the end of the tunnel," appears abruptly to have seen the light himself. His recent public assessments of the War on Cancer have been almost as rosy as those of the American Cancer Society. One acquaintance of Watson's says bluntly "He gets his funding the same place everybody else does. It was only a matter of time." Another claims: "Benno Schmidt was overheard saying to a colleague, 'I had a long talk with Jim, and he realizes now that he went much too far with some of those criticisms. I don't think we'll be hearing any more of that.'"
Dan Greenberg Takes It All Back?
Daniel S. Greenberg, Washington-based science writer and author of The Politics of Pure Science, wrote an article for Columbia Journalism Review (January/February 1975) taking the cancer establishment to task for grossly exaggerating our "progress" in the cancer war. The article, the substance of which ran also in The Washington Post, created considerable controversy and numerous unsuccessful attempts at rebuttal. Now Helene Brown, former president and chairman of the board of the ACS in California and presently project director of Community Cancer Control in Los Angeles and roving ambassadress of anti-quackery, has reportedly claimed that Greenberg has recanted many of his criticisms. That's what Ms. Brown told medical students when she spoke at Hahnemann Medical College earlier this year. In response to a question from the audience about the Greenberg article, Ms. Brown said that Greenberg had used phoney statistics. Two of the students approached Ms. Brown after her speech and pointed out to her that Greenberg's statistics came straight from the NCI's End Results in Cancer. Ms. Brown, the students say, then claimed that "we talked to Greenberg" in San Francisco and he took back most of what he said. Greenberg says he's never heard of Ms. Brown, much less met her, that he met with no one on this issue and took nothing back. Ms. Brown, it should be emphasized, is one of the American Cancer Society's principal national spokespersons.
Saffiotti Quits — A Backward Glance
In a book called Keeping Healthy in a Polluted World (Harper & Row, 1974, Penguin Books, 1975), author Harald J. Taub recounts some highly promising cancer research utilizing Vitamin A. This enterprising work was undertaken by Dr. Umberto Saffiotti. After the description of the work there appears this unintentionally melancholy paragraph: "After this work was done, Dr. Saffiotti was appointed to an important post at the National Cancer Institute and is now working there, in Bethesda, Maryland. Although there is little doubt he is pursuing his studies of vitamin A as a cancer preventive, no public information about his work has been issued since he moved to Bethesda." Almost ten years ago. At the end of April, 1976, Dr. Saffioti announced that he was resigning as head of the NCI's division that investigates and tries to identify cancer-causing agents so that they can be banned or preventive measures taken against them. He resigned in protest over lack of support for and mismanagement of the program from higher up the NCI chain-of-command. Vitamin A and its possible role in preventing/controlling cancer will be discussed in a future Newsletter.
If Rauscher Quits There'll Be Little Cause to Cheer
Rauscher to resign as head of NCI? That's the rumor. "He'll be gone by next year, perhaps by the end of this summer," says one Washington insider. Salary — presently in excess of $40,000 — is said to be one of the problems. "He's been offered more than twice that in industry," says my source. "But there's more to it than that. Congressional hearings into NCI operations are getting underway and may last some time. There may be a lot of heat. Also, there are two or three groups looking into mammography [a X-ray screening technique for early detection of breast cancer]. Rauscher has been overenthusiastic, some feel, pushing mammography much too hard. There may be more bad news in that area." As reported in the preceding Newsletters one of Rauscher's own men, Dr. John C. Bailar, has already warned, in The Annals of Internal Medicine, that mammography may ultimately cause as much cancer as it "prevents," taking as many lives as it saves. Latest to sound the alarm was Dr. Marvin Zelen; speaking at the Cancer Symposium in Brussels recently, Dr. Zelen said mammographic screening of the general population is not worth the risk. Who would replace Rauscher? The smart money is on Dr. Vincent T. DeVita, Jr., presently director of NCI's Division of Cancer Treatment. DeVita’s critics say he is even further out of touch with cancer realities than Rauscher and would be even less likely to encourage a shift in emphasis from cure to prevention. DeVita is a chemotherapy man with a "rah-rah" attitude about nearly every new drug therapy that comes along.
Surgeons Vote to "Ignore" Breast Cancer Book
Rose Kushner's Breast Cancer: A Personal History and Investigative Report (Harcourt, Brace, Jovanovich, 1975) has been officially ignored by the American College of Surgeons. They recently took a vote not to recognize the book, an action which might excite mirth were the subject not so deadly. The surgeons don't like the book because it states the facts about surgery, observing that, as the World Health Organization has recently confirmed, survival rates for cancer of the breast have not improved significantly in the last 50 years despite an awful lot of cutting. Fewer than 50 percent of all women who get breast cancer survive more than five years; about 90,000 women in this country are diagnosed as having the disease each year. Meanwhile, the radiotherapists are doing even worse than the surgeons. According to the government's National Surgical Adjuvant Breast Project, "The survival rate of patients receiving [post-surgical] radiation was slightly less than that observed in the controls" who received only surgery. Dr. Thomas Dao, breast cancer specialist at Roswell Park Memorial Cancer Institute, conducted a study and found that 89 percent of the women who received radiation after breast surgery later developed cancers metastasized at other sites, while only 48 percent of those who received surgery alone developed the distant metastases. These are the "proven" therapies.
Nobel Prize Winners Say Virus Not Central to Cancer
When Drs. Howard Temin, David Baltimore and Renato Dulbacco won Nobel Prizes last year for "discoveries concerning the interaction between tumor viruses and the genetic material of the cell," one might have expected to find them already or shortly pursuing human cancer viruses, real or imaginary. In fact, all three are on record as stating that viruses are not likely to have much to do with human cancers. Dr. Temin has stated, "with a high degree of certainty, that most human cancers are not caused by viruses." More attention should be paid to environmental factors, he says. Dr. Baltimore has suggested that substances in diet should be closely examined. Is NCI paying heed? Not hardly. Some $60 million is being spent in pursuit of the cancer virus that our best minds say doesn't exist. A couple million, less than one percent of the total NCI budget, is going into nutritional research — or may be going into nutritional research. A list of such things will be requested and, if forthcoming, published. It's not likely to be long.
The Harper's Cancer Special
The June 1976 issue of Harper's contains several short pieces on diverse aspects of cancer research, including this writer's "Defense of Unorthodoxy." Though there are good, honest pieces in the Harper's mix, there are a few that can only be classified deplorable. Perhaps the worst is Dr. Joseph R. Bertino's shamefully optimistic assessment of cancer chemotherapies ("50 Ways to Quell a Tumor"). Dr. Bertino, an "American Cancer Society Professor of Medicine and Pharmacology," devotes his opening paragraphs to a tired repetition of now thoroughly discredited ACS propaganda that simply does not, as has been demonstrated.several times, stand the statistical light of day. He claims that one-in-three patients who get cancer are cured today, as compared with one-in-five 25 years ago, that one-in-two would be cured "by surgeryand radiation therapy" if their cancers were detected early enough. I challenge Dr. Bertino to present data that will support these claims. I submit that he cannot even come close — but if he proves me wrong I will publish his data end do everything in my power to see that these data get the widest possible circulation. A piece by Dr. Samuel Hellman (another "American Cancer Society Professor") makes similarly unsupportable claims for radiation therapy. I'd like very much to see his data, too. Then there's Dr. Michael Shimkin's attack on the "quacks," and my defense of some of them, in the course of which, incidentally, I correct a number of inaccuracies in the Shimkin piece. My article is followed by a box which contains the ACS's latest "thinking" on "proponents of unproven methods of cancer management." It checklists "common features" of such individuals and is truly an insidious piece of neo-McCarthyism designed to enable ACS to tar anybody who disagrees with ACS as either something amounting to a "quack" or the "dupe" of "quacks." The last item in their checklist reads: "Their [the quacks'] chief supporters tend to be prominent statesmen, actors, writers, lawyers, even members of state or national legislatures — persons not trained or experienced in the natural history of cancer, the care of patients with cancer, or in scientific methodology." Isn't it odd how the supporters of "quacks" are apparently almost all intelligent, informed people — people whose number is growing to the extent that ACS now feels it must protect the ignorant and uninformed against them?
Who Has an Axe to Grind?
Since my first Newsletter ("Losing the War on Cancer: The Awful Numbers Revisited"), circulated, I've heard, secondhand, that a number of individuals at NCI and ACS have claimed that I "have an axe to grind." None of them will say what it is. I'd be delighted to hear from them directly. I have no vested interests of any kind in any field of cancer research, nor do I have friends or relatives who do. I have no financial interest in (nor am I a member of any group promoting) "unorthodox" approaches to cancer. I do not enjoy the unpopularity that ensues from emphasizing unpleasant truths which so many of my critics seem to want to sweep under the rug. A man who identified himself as Joseph Clark and purporting to be with the American Cancer Society called the Alicia Patterson Foundation director to complain bitterly about my first Newsletter. He charged that I had made "not one effort to check sources" and that I hadn't (sin of sins!) even bothered to probe the ACS's "unproven remedies department." This gentlemen lies when he says I made no effort to check sources. As for the "unproven" remedies, I have in my possession most of the ACS's declarations on same. The Patterson Foundation director asked Clark to put his criticisms in writing; he refused. I can only conclude that he has nothing substantive to object to. If he believes he does — if anyone does — I invite one and all to write me care of the Foundation. All criticisms will be given a thorough appraisal and if I can be shown to be wrong on any issue a correction will be forthcoming in the succeeding Newsletter. The same invitation is explicitly extended to the gentleman at NCI who has been so vocal, behind the scenes, in objecting to my first Newsletter.
END NOTES
1. Undeniably, orthodox therapies occasionally extend the lives of cancer victims and even save a relative few; however, as documented in my preceding Newsletter - "Losing the War on Cancer: The Awful Numbers Revisited" - cancer survival rates have improved, overall, by only one or two percent since the 1950s, proving that orthodox therapies, despite the millions spent on their development, have had negligible impact. In some categories of cancer, survival rates have actually diminished since the advent of certain "proven" therapies, indicating in the view of some researchers that treatment may sometimes actually do more harm than good. Almost all of the approved therapies can and frequently do have very serious side effects which significantly diminish the quality of remaining life of the cancer victim.
2. Darrell Huff, author of How to Lie with Statistics, Pellican Books, 1973.
3. See "Laetrile Testing: A Cover-Up That Wasn't," Medical World News, October 6, 1975.
4. Schmidt became interested in Laetrile, he says, because of the hundreds of letters he received pertaining to the substance. In an interview conducted by Barbara Culliton ("Sloan-Kettering: The Trials of an Apricot Pit," Science, December 7, 1973) he said: "When I answer these people and tell them that Laetrile has no effect, I would like to be able to do so with some conviction." So he made inquiries at NCI, and "People there told him," writes Culliton, "they had looked into the matter long since and found no basis for any claims that Laetrile is good for fighting cancer. The American Cancer Society...concurs. Schmidt asked a couple of leading cancer scientists what they knew about Laetrile. They, too, told him it has no value. But when he asked for evidence, he recalls, 'I couldn't get anybody to show me his work.'" Today, on the basis of "negative" S-K and SRI/NCI reports, Schmidt is said to believe that Laetrile has been fairly tried and found wanting.
5. Dr. Martin is out-of-step with his scientific peers when he insists that, in order to be effective, a chemotherapeutic agent must have some effect on metastases. The need for less simple-minded criteria in judging the efficacy of anti-cancer agents was emphasized recently in the distinguished British medical journal Lancet. A team of Oxford researchers observed that "in diseases where cure is unlikely and prolonged survival the exception, one should not assess success or failure of a treatment regimen only by survival-rate, nor by reduction in tumor volume alone. The intention of the treatment is to improve the quality of life of the patient, and any increase in survival should be considered as an extra gain rather than the prime intention. The quality of life achieved is difficult to assess, but may be judged to some extent by
1. the success or failure of the palliation of symptoms,
2. the incidence of troublesome side effects,
3. the overall limitations imposed by the disease on the patient's level of activity."
By a great many independent accounts, Laetrile scores very high in all three of these dimensions. Additionally, many clinicians using Laetrile report enhanced survival even in the presence of metastases. Primary tumor regression is seldom seen and metastases may merely stabilize or even continue to spread; yet those treated with Laetrile, numerous reports indicate, experience relief from pain, renewed vigor, good appetite, enhanced mobility and life spans far beyond that predicted for them by doctors using orthodox therapies. More on this in Part Il. Dr. Martin appears to be out of step in some other respects as well. On the basis of Laetrile evincing no efficacy in an animal-testing system he devised, Dr. Martin has stated (Medical World News, October 6, 1975): "I flatfootedly and categorically tell you that Laetrile is without activity against spontaneous tumors in mice - period." If this omniscience is unworthy of a serious research scientist, consider the even greater arrogance and thoughtlessness of Dr. Martin's next statement, as reported in Medical World News: Dr. Martin "sternly denounced the idea of doing human trials on the substance as 'a criminal abuse of hopes,' since this would deflect 'the dedicated efforts of a great many clinicians"' and their patients from using the "proven" therapies. Dr. Martin appears to be extrapolating from mouse to man with a measure of (implied) certitude which can only be regarded as irresponsible. Researchers at Sloan-Kettering, with whom Dr. Martin has worked closely, have surveyed a number of clinicians around the world who have used Laetrile in thousands of human patients; should not their nearly unanimous testimony that Laetrile prolongs the lives and eases the pains of cancer victims stand a tad taller than the limited-to-metastases testimony of his highly specialized dumb four-footed animals? As for the "fear" that if Laetrile is granted an IND, clinicians will be "deflected" from "proven" therapies, Dr. Martin has to know this is nonsense. INDs are being granted all the time; clinicians are not notorious for abandoning the tried-and-true for the new, even after the new has been conclusively demonstrated to be better.
6. Dr. Stock's view in this respect is hardly unique. Virtually dozens of studies and individual cancer researchers have reached the same conclusion, e.g.: "The convenience of these [animal] tumors as research tools tends to obscure the need for cancer research in man." (J. Holland and C. Heidelberger, Roswell Park Memorial Cancer Institute and the University of Wisconsin, Cancer Research, volume 20, p. 975); "The value of [animal] tumor inhibition per se, as a measure of [chemotherapeutic] effectiveness is limited.... thus, a screening system or evaluation program limited to measurement of local tumor growth [in animals] may miss compounds which produce therapeutic effects without extensive inhibition of tumor growth." (A. Goldin, J. Vendittit, N. Mantel, all of NCI, Cancer Research, volume 21, p. 1346); "It seems most unlikely from results obtained during the last decade that any single drug evaluation system...can be expected to predict the potential of all classes of drugs against all of the many classes of human cancer." (F. Schabel et al, Southern Research Institute, Cancer Research , volume 21, p. 235); "It would be really too much to ask that any one, or a few, types of cancers in animals would have the same responses as the hundred-odd different types of cancer in man." (M. B. Shimkin, M.D., U.S.P.H.S. Publication No. 1162, p. 136); An analysis concludes that after two decades the animal screening system at NCI is largely a failure in providing clues to human cancer. (Science, volume 1 (70), p. 305, 1970); "There are obviously tremendous differences between metabolisms of human and mouse [tumor] cells." (from "A Critical Evaluation of Cancer Chemotherapy," Cancer Research, volume 29, pp. 2262-69.)
Received in New York on May 27, 1976
©1976 David M. Rorvik
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.
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