WORLD WITHOUT CANCER - 1stCHAPTER

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Original sender's name: jojo Original sender's address: eatyourseeds Permission granted by G.Edward Griffin to send this: Chapter One The Watergate SyndromeExamples of dishonesty and corruption in the field of drug research; aclose look at the first major study which declared Laetrile) vitaminB-17) "of no value;" proof that the study was fraudulent; theFDA's ruling against the use of Laetrile because it had not beentested; and the refusal then to allow anyone (except its opponents) totest it. This year 550,000 Americans will die from cancer. One out of three ofus will develop cancer in our lifetime. That is eighty-eight millionpeople in the United States alone. The purpose of this study is to show that this great human tragedy canbe stopped now entirely on the basis of existing scientific knowledge.We will explore the theory that cancer, like scurvy or pellagra, is adeficiency disease aggravated by the lack of an essential foodcompounds in modern man's diet, and that its ultimate control is tobe found simply in restoring this substance to our daily intake. What you are about to read does not carry the approval of organizedmedicine. The Food and Drug Administration, the American CancerSociety, and the American Medical Association have labeled it fraud andquackery. In fact, the FDA and other agencies of government have usedevery means at their disposal to prevent this story from being told.They have arrested citizens for holding public meetings to tell othersof their convictions on this subject. They have confiscated films andbooks. They even have prosecuted doctors who apply these theories inan effort to save the lives of their own patients. The attitude of Big Brother, expressed bluntly in 1971 by Grant Leake,Chief of the fraud section of California's food and drug bureau, isthis: "We're going to protect them even if some of them don'twant protection." Early in 1974, the California medical board brought formal chargesagainst Stewwart M. Jones, M.D., for using laetrile in the treatment ofcancer patients. It was learned later, however, that Dr. JuliusLevine, one of the members of that board, himself had been usingLaetrile in the treatment of his own cancer. When Dr. Johes' casecame up for review, the political pressures were so great that Dr.Levine felt compelled to resign from his post rather than come outopenly in support of Dr. Jones and his patients. . This is happening in a land whichboasts of freedom and whose symbol isthe Statue of Liberty. For the first time inour history, people arebeing forced to fell from our shores as medical emigrants seekingfreedom-ofchoice and sovereignty over their own bodies. Laetrile hasbaan available in Australia, Brazil, Belgium, Costa Rica, England,Germany, Greece, India, Israel, Italy, Japan, Lebanon, Mexico, Peru,the Philippinesm, Spain, Switzerland, Russia, Venezuela, andVietnam-but it is not allowed in the "land of the free"In spite of this, however, many doctors have defied the bureaucracyand have proved in ther own clinics that vitamin-deficiency concepts ofcancer is valid. With billions of dollars spent each year in research, with additionalbillions taken in from the cancer-related sale of drugs, and withvote-hungry politicitans probmising ever-increasing governmentprograms, we find that, today, there are more people making a livingfrom cancer than dying fromit. If the riddle were to be solved be asimple vitamin, this gigantic commercial and political industry couldbe wiped out evernght. The result is that the science of cancertherapy is not nearly as complicated as the politics of cancer therapy. If there was any good that came from the Watergate scandals of theSeventies, it as the public awakening to the reality that governmentofficials sometimes do not tell the truth. And when caught in such"mendacities," they invariably claim that they lied only to protectnational security, public health, or some other equally nobleobjective. This Watergate syndrome is not new. Several years ago, an FDA agentwho had testified in court against a Kansas City businessman admittedunder cross-examination that he had lied under oath twenty-eight times. When asked if he regretted what he had done, he replied: "No. Idon't have any regrets. I wouldn't hesitate to tell a lie if itwould help the American consumer." The FDA is not squeamish over its tactics to "help the Americanconsumer." When a businessman falls into disfavor with thebureaucracy, there are no holds barred, and the law is used, not as areason for attack, but as a weapon of attack. In other words, the FDAdoes not take action because the law says it should. It does sobecause it wants to, and then searches through the lawe for an excuse.In the celebrated case of U.S. vs Dextra Fortified Sugar, for example,the FDA had ruled that it was "misbranding" to fortify sugar withvitamis and minerals and still call it sugar. But the court ruledotherwise, pointing out: The basic flaw in the government's case is that it is seeking, underthe guise of misbranding charges, to prohibit the sale of a food in themarket place simply because it is not in sympathy with its use. Usually there is much more going on in these cases thanover-zealousness on the part of a few bureaucrats. Pretending toprotect the public is the favorite cover for hidden agendas.Legislation claiming to protect the consumer usually is written byrepresentatives of the very industries from which the consumersupposedly is to be protected. Politicians who are grateful for thefinancial support of those industries are eager to put their names onthe legislation and push for its enactment. Once it becomes law, itserves merely to protect the sponsoring industries against competition. The consumer is the victim, not the beneficiary. This is just as true in the field of medicine as in any other. Inmedicine, however, there is the added necessity to pretend thateverything is being done scientifically. Therefore, in addition torecruiting the aid of politicians, scientists also must be enlisted- afeat that is easily accomplished by the judicious allocation of fundingfor research. This reality was revealed by former FDA Commissioner, James L. Goddardin a 1966 speech before the Pharmaceutical Manufacturers Association.Expressing concern over dishonesty in the testing for new drugs, hesaid: I have been shocked at the materials that come in. In addition to theproblem of quality, there is the problem of dishonesty in theinvestigational new drug usage. I will admit there are gray areas inthe IND [investigation of New Drug] situation, but the consciouswithholding of unfavorable animal clinical data is not a gray matter.The deliberate choice of clinical investigators know to be moreconcerned about industry friendships than in developing good data isnot a gray matter. Goddard's successor at the FDA was Dr. Herbert Ley. In 1969, hetestified before a Senate committee and described several cases ofblatant dishonesty in drug testing. One case involved an assistantprofessor of medicine who had tested 24 drugs for 9 differentcompanies. Dr. Ley said: Patients who died while on clinical trials were not reported to thesponsor...Dead people were listed as subjects of testing. Peoplereported as subjects of testing were not in the hospital at the time oftests. Patient consent forms bore dates indicating they were signedafter the subjects died. Another case involved a commercial drug-testing firm that had worked on82 drugs from 28 companies. Dr Ley continued: Patients who died, left the hospital, or dropped out of the study werereplaced by other patients in the tests without notification in therecords. Forty-one patients reported as participating in studieskeeping, supervision and observation of patients in general weregrossly inadequate. Between 1977 and 1980, it was discovered that 62 doctors had submittedclinical data to the FDA which was manipulated or completely falsified. In one study conducted by the FDA itself, it was discovered that onein every five doctors investigated- doctors researching the effects ofnew drugs-had invented the data they reported and pocketed the fees. These are not unusual or isolated cases. John Braithwaite, acriminologist at the Australian Institute of Criminology (and alsoformer Commissioner of Trade Practices in Austrailia), states: "Theproblem is that most fraud in clinical trials is unlikely to even bedetected. Most cases which do come to public attention only do sobecause of the extraordinary carelessness by the criminal physician." According to Dr. Judith Jones, former Director of the Division of DrugExperience at the FDA, if a research facility obtains results that donot demonstrate the safety or effectiveness of a drug, it is notuncommon for the drug company to bury the report and continue testingelsewhere until they find a facility that gives them the results theywant. Unfavorable reports are rarely published, and clinicians arepressured into keeping quiet about them. The incentive for clinical investigators to fabricate data is enormous. American drug companies pay as much as $1,000 per patient, whichenables some doctors to collect over $1 million per year from drugresearch-all the easier if the treatments are imaginary. Even if thetests are not fabricated, there is still the effect of subconsciousbias. These doctors know that, if they don't produce the resultsthe drug companies are seeking, the likelihood of their receivingfuture work is greatly diminished. The commercially operated testing facilities should become corrupted bymoney is not hard to imagine. But it is often assumed that universitylaboratories are different, that they are immune to the profits thatflow from criminal science. The truth, however, is that money speaksjust as loudly on campus as it does elsewhere. Referring to a surveyconducted by the FDA, Dr. Braithwaite explains: As one would predict from the foregoing discussion of how contract labscan be used by sponsors to abrogate responsibility for quality research, contract labs were found to have a worse record of GLP [GoodLaboratory Practices] violations that sponsor labs. The worst recordof all, however, was with university laboratories. One must beextremely cautious about this finding since there were only fiveuniversity laboratories in the study. Nevertheless, it must undermineany automatic assumption that university researchers, with theirsupposed detachment from the profit motive, are unlikely to cut cornerson research standards. The trail of corruption leads all the way to the FDA itself. A studyconducted by USA TODAY revealed that more than half of the expertshired to advise the government on the safety and effectiveness ofmedicine have financial relationships with the pharmaceutical companiesthat are affected by their advice. The report stated: These experts are hired to advise the Food and Drug Administration onwhich medicines should be approved for sale, what the warning labelsshould say and how studies of drugs should be designed. These expertsare supposed to be independent, but USA TODAY found that 54%of thetime, they have a direct financial interest in the drug or topic theare asked to evaluate. These conflicts include helping apharmaceutical company develop a medicine, then serving on an FDAadvisory committee that judges the drug. The conflicts typically include stock ownership, consulting fees, orresearch grants. Let's bring this into focus on the issue of cancer. Science can beused, not only to push drugs into the market that do not work, but alsoto hold back remedies that do-because these remedies representpotential competition to pharmaceutical industry which controls thedrug-approving process. The controversy that once surrounded Dr.Andrew Ivy's anti-cancer drug known as Krebiozen is an example ofthis phenomenon. Prior to crossing swords with the FDA in the early 1960's, Dr. Ivyhad been widely acknowledged as one of the nation's foremost medicalspecialists. As head of the University of Illinois the graduatedegrees of Doctor of Philosophy (Ph.D.) and Master of Science (M.S.).He was an American Representative at the Nuremberg trials after WorldWar II in Germany. The American representative at the Nuremberg trialsafter World War II in Germany. The American Medical Association hadawarded him bronze, silver, and gold medels in recognition of hisoutstanding work in the field of medicine. He had written over athousand articles published in scientific and medial journals. Infact, the FDA itself often had called upon him as an expert to offermedical testimony in court. But when he began to use an unorthodoxapproach to cancer therapy, overnight he was branded as a "quack." During the course of Dr. Ivy's trial, a letter was read into thecourt record written by a doctor from Indianapolis. The doctor statedin his letter that he was treating a patient who had multiple tumors,and that a biopsy of the tissue had shown these tumors to be cancerous. The doctor said that he had obtained Krebiozen from Dr.Ivy'slaboratories and had administered it, but that it had done absolutelyno good. When called to the witness stand, however, the doctor'sanswers were vague and evasive. Under the pressure ofcross-examination, he finally broke down and admitted that he never hadtreated such a patient, never had ordered the biopsy in question, andnever had used Krebiozen even once. The whole story had been a lie.Why did he give false testimony? His reply was that one of the FDAagents had written the letter and asked him to sign it. He did sobecause he wanted to help the agency put an end to quackery. In September of 1963, the FDA released a report to the effect thatKrebiozen was, for all practical purposes, the same as creatine, acommon substance that was found in every hamburger. To prove thispoint, they produced a photographic overlay supposedly showing thespectograms of Krebiozen and creatine superimposed over each other.These were published in Life magazine and other segments of the masscommunications media as "unimpeachable proof" that Krebiozen wasuseless. When Senator Paul Douglas saw the spectrograms, he was suspicious. Sohe asked Dr. Scott Anderson, one of the nation's foremost authoritieson spectograms, to make his own study. Using standard techniques ofanalysis, Dr. Anderson identified twenty-nine differences between thetwo substances. There were sixteen chemical and color differences.The version released to the press by the FDA had been carefully movedoff center until there was a maximum appearance of similarity, but whenrestored to the true axis, the two were as different as night and day. The tactics used against Laetrile are even more dishonest than thoseagains Krebiozen. Perhaps the most damaging of them has been apseudo-scientific report released in 1953 by the Cancer Commision ofthe California Medical Association. Published in the April issue ofCalifornia Medicine, the report presented an impressive collection ofcharts and technical data indicating thateshaustive research had beencarried out into every aspect of Laetrile. Its molecular Compositionhad been analyzed, its chemical action studied, its effect ontumor-bearing rats observed, and its effectiveness on human cancerpatients determined. The stern conclusion of all the supposedlyobjective research was stated: "No satisfactory evidence has beenproduced to indicate any significant cytotoxic effect of Laetrile onthe cancer cell." The conclusions of the California Report are sufficient for mostphysicians and researchers. Not one in ten thousand has ever evenseen Laetrile, much less used it. Yet, they all know that Laetriledoes now work because the California branch of the AMA CancerCommission said so, and they have had no reason so question thereliability of those who did the work. Reporter Tom Valentine interviewed many leading cancer specialists todetermine what they thought about Laetrile. Here he describes atypical reaction: Dr. Edwin Mirand of Roswell Memorial Hospital in Buffalo, N.Y. said:"We've looked into it and found it has no value." When asked ifthe renowned little hospital, which deals only with cancer, actuallytested Laetrile, Dr. Mirand said, "No, we didn't feel it wasnecessary after others of good reputation had tested it and found hadno effectiveness in the treatment of cancer." He referred, as allauthorities do, to the California Report. Others have run up against the same stone wall. Professionalresearcher, David Martin, reported this experience: The cancer expert in question, as I had anticipated, told me thatLaetrile was "sugar pills." Had he told me that he had usedLaetrile experimentally on X number of patients and found it completelyineffective, I might have been impressed. But when I asked him whetherhe had ever used it himself, he said that he had not. When I asked himwhether he had ever traveled abroad to study the experience withLaetrile therapy in Germany, Italy , Mexico, the Philippines, or othercountries, her replied that he had not. And when I asked him if he hadever made a first-hand study of the pros and cons of the subject, againhe conceded that he had not. He was simply repeating what he hadheard from others who, in turn , were probably repeating what they hadheard from others, going all the way back to the antiquated 1953 reportof the California Cancer Commission. It is important, therefore, to know something of the nature of theCalifornia Report and of the scientific integrity of those who draftedit. Although the report as published in California Medicine was unsigned,it was written by Dr. Ian MacDonaldm, Chairman of the Commission, andDr. Henty Garland, Secretary. Dr. MacDonald was a prominent cancersurgeon, and Dr. Garland was an internationally famous radiologist.Both were listed in Who's Who. There were even seven other prominent physicians on thecommission-including four more surgeons, another radiologist, and apathologist-but they played no major part in the preparation of thereport. Not one of these men-not even MacDonald or Garaland-had everused Laetrile in the first-hand experiments of their own. All they haddone was to make evaluations and summaries of the written records ofothers. Before examining those evaluations and summaries, let us first recallthat MacDonald and Garland were the two physicians who had madenational headlines claiming that there was no connection betweencigarette smoking and lung cancer. In an address before the PublicHealth Section of the Commonwealth Club of San Francisco on July 9,1964, Dr. Garland had said: A current widely held hypothesis is that cigarette smoking is causallyrelated to a vast number of different diseases, ranging from cancer tocoronary arteriosclerosis. After studying the question for severalyears, notably in its reported relationship to primary bronchialcancer, it is my considered opinion that the hypothesis is notproven.... Cigarettes in moderation are regarded by many as one of the bettertranquilizers.... It is likely that obesity is a greater hazard toAmerican health than cigarettes. Dr. MacDonald was even more emphatic. In an article in U.S. News & World Report, he was shown with a cigarette in his hand, and is quotedas saying that smoking is "a harmless pastime up to twnty-fourcigarettes per day." And then he added: "One could modify an oldslogan: A pack a day keeps lung cancer away." It is a curious fact that it was precisely at this time that cigareetmanufacturers were beginning to experience a slump in sales because ofpublic concern over lung cancer. In fact, tobacco industry had alreadypledged the first ten-million dollars out of a total of eighteenmillion to the AMA for "research" into the question of smoking andhealth. The effect of this veritable flood of money from a source with, shallwe say, "a vested interest" in the outcome of the research, wasincredible and did not speak well for the AMA. The result was theconversion of a relatively simple, straight-forward project into amonstrous boondoggle of confusion and waste.In the report of the AMA's Committee for Research on Tobacco andHealth, it says: To date, approximately $14 million has been awarded [from the tobaccoindustry] to 203 individual research projects at 90 universities andinstitutions. As a direct result of these grants, 450 reports havebeen published in scientific journals and periodicals. The report then listed the research projects and described theirpurposes. Here are just a few: Nicotine Receptors in Identified Cells of the Snail Brain. The Effects of Nicotine on Behavior of Mice. Angina Pectoris and Bronchitis in Relation to Smoking - A Study inAmerican and Swedish Twin Roosters. Post - Maturity Syndrome in the Pregnant Rat After NicotineAbsorption During Pregnancy. Interactions of Nicotine, Caffeine and Alcohol in Squirrel Monkeys. The Effect of Smoking in Placental Oxygen Transfer in Gravid Ewes. Urinary Excretion, Tissue Distribution and Destruction of Nicotine inMonkey and Dog. Body Build and Mortality in 105,000 World War II Army Verterans. Upon going through the back reports of the AMA's Committee forResearch on Tobacco and Health, one is able to count but five researchprojects that are primarily concerned with cancer. One of those dealtwith laboratory-testing procedures only, and another was an experimentto see if tobacco smoke could be used to cure cancer of the skin! Soonly three of these projects really dealt with the area of major publicconcern. Three out of two hundred and three is only aboutone-and-a-half percent - which tells us something about the AMA'sscientific integrity on the subject of smoking and cancer.With the expenditure of a mere eighteen-million dollars - which issmall, indeed, compared to the tobacco industry's advertising budgesover the same period - it was possible to direct the AMA's medicalresearch away from the important question of cancer and into a hundredgiddy questions that served only to confuse and delay the ultimatetruth.Dazzled by the meteor shower of thousand-dollar bills, the AMA, in itsDecember 1959 issue of the American Medical Association Journal,published an editorial stating flatly that there was insufficientevidence "to warrant the assumption" that cigarette smoking was theprincipal factor in the increase of lung cancer. Furthermore, throughits gargantuan research program, the AMA was making it increasinglydifficult to obtain that evidence.Was there any connection between the eighteen-million dollars given tothe AMA from the tobacco industry and the public pronouncements ofMacDonald and Garland, two of its most prominent members in California? Perhaps not, although it has been rumored that these gentlemen ofscience actually did receive $50,000 for their "testimonials." Whether or not this is true is not important now. What is important isthe fact that their medical opinion, if it had been widely followed,clearly would have resulted in the suffering and death of untoldadditional millions. Also important is the fact that these are thesame "experts" whose medical opinion has been widely quoted andfollowed in the question of Laetrile. An interesting footnote to this subject is the fact that Dr. MacDonaldwas burned to death in bed a few years later in a fire started by hiscigarette. Dr. Garland, who had boasted of chain-smoking since earlychildhood and who claimed to be living proof that cigarettes areharmless, a few years later died of lung cancer. In 1963, ten years after publication of the original California Report,the California State Department of Health officially decreed that hefindings of the antiquated study were "true" and adopted them asits own. When it did so, however, it performed an unexpected favor forthe public because it published for the first time all the originalexperiments and studies upon which the report had been based and, indoing so, it made available the documentary evidence proving thatMacDonald and Garland had falsified their summary of those experiments.In the 1953 report, the authors published the conclusions of John W.Mehl, M.D., to the effect that cyanide could not be released fromLaetrile. As will be explained in a later chapter, the release ofcyanide at the cancer cell is part of the reason that Laetrile works. Therefore, imlpying that cyanide cannot be produced was a severe blowto the credibility of Laetrile theory. Dr. Mehl was quoted as saying:"These results are inconclusive, and will be extended, but they donot support the claims made for "Laetrile."With the publication of the original experiments ten years later,however, quite a different story emerged. Buried in a maze ofstatistics, tables, and charts can be found an item labeled "LaetrileReport Appendix 4." It is a laboratory report signed by G.Schroetenboer and W. Wolman. It states: After refluxing for three hours, the odor of hydrogen cyanide could bedetected... The hydrogen cyanide was distilled into sodium hydroxideand determined by the Prussian Blue technique. This report was dated January 14, 1953 - two months before Dr. Mehlclaimed that cyanide could not be released from Laetrile. It issignificant, therefore, that MacDonald and Garland completely ignoredthe positive report while giving prominence to the negative one.Since that time, the release of cyanide from Laetrile has beenconfirmed by the AMA's chemical lab, by the cytochemistry section ofthe National Cancer Institute, and even by the California Department ofPublic Health that then officially pronounced the original report to be"true" and adopted it as its own. Another claim made by Drs. MacDonald and Garland was that microscopicexaminations of tumors from patients who had been treated with Laetrileshowed absolutely no indication of favorable chemical effect. Tenyears later, however, this assertion was shown to be a bald-faced lie.Appendix Three contains the findings of two pathologists who stated inplain English that they did observe anti-tumor effects which, indeed,could have been caused by the Laetrile. In a statement dated December15, 1952, for example, John W. Budd, M.D., reported: "Case 1M....Hemorrhagic necrosis of tumor is extensive.... An interpretation ofchemotherapeutic effect might be entertained." Also an autopsy report by J.L. Zundell, dated September 10, 1952,discusses two clear cases of observed anti-tumor effect. It states: M-1.... This might represent a chemical effect since the cellsaffected show coagulation necrosis and pyknosis....M-3.... There appears to be more degeneration in the tumor cells inthe lymph node. I would consider this as a possible result of chemicalagent....Two cases.... Showed moderated changes ... which might be consideredas chemotherapeutic toxic cellular changes. Nothing could be more plain than that. Nevertheless, MacDonald andGarland stated flatly in the California Report: "No evidence ofcytotoxic changes was observed by any of the consultants." Thatstatement, of course, was a lie of gigantic proportions. Even if the findings of these researchers had not been falselysummarized by MacDonald and Garland, the 1953 California Report stillwould have been totally useless as a scientific verdict againstLaetrile because the strength of the doses used on cancer patients wastoo weak to prove anything. In fact, it was about one-fiftieth (1/50)of what generally is used to obtain optimum results. In the earlier days of Laetrile research, clinicians cautiouslyadministered only fifty to one-hundred milligrams at a time. Gainingconfidence with experience, these levels gradually were raised until,by 1974, Laetrile was being used intravenously at levels of six to ninethousand milligrams daily. Generally, it takes an accumulation offifty to seventy thousand milligrams over a period of about a week orten days before the patient can report tangible indications ofimprovement. But in the experiments used for the California Report,the typical dose given was only about fifty milligrams per infection.The maximum single dose was less than two hundred milligrams, and themaximum accumulative dose was only two thousand milligrams spread overtwelve injections. Five patients received only two infections, andfive received only one. It is not surprising, therefore, that the California experimentsfailed to produce conclusive evidence Laetrile was effective againstcancer. As Dr. Krebs observed at the time, "There is nothing quiteso easy to accomplish as failure." In spite of all the incredible distortions of fat and the perversionsof scientific truth, Drs. MacDonald and Garland were forced to admit onpage three of their California Report: All of the physicians whose patients were reviewed spoke of increase inthe sense of well-being and appetite, gain in weight, and decrease inpain... Then, attempting to belittle these important results, they added: ...as though these observations constituted evidence of definitetherapeutic effect. That statement, alone, should have disqualified the California Report,for these observations are, indeed, among the very things whichindicate to a physician whether or not his drug therapy is effective. Most doctors would be ecstatically happy if they could cause theircancer patients to experience an increase in a sense of well-being andappetite, a gain in weight, and especially a decrease in pain.In the 1970's, there was little chance that Laetrile would be givena chance to be tested except by its opponents. Every time proponentsattempted to obtain permission to do so, they were turned down cold.On April 6, 1970, for example, the McNaughton Foundation, under thesponsorship of Andrew McNaughtonm submitted an application to the FDAfor permission to engage in what is called IND (Investigation of NewDrug) Phase One studies. Permission was granted on April 27. Then, in the words of one reporter, "All hell broke loose." The FDAapparently received a phone call from an irate and politicallyinfluential figure who passed the word: "Stop the tests!" The next day, April 28, the FDA sent another letter to the Foundationadvising that, upon reviewing the records, certain "deficiencies"had been found in the IND application, and demanding extensiveadditional data within ten days. Curiously, the letter was notdelivered to the McNaughton Foundation until May 6, nine days after itsupposedly had been written, and it is suspected that the letter mayactually have been written much later but back-dated so as to make itimpossible to comply with the already ridiculous ten day deadline. OnMay 12, six days after receipt of the "deficiency letter,"McNaughton received a telegram from the FDA advising him that theapproval for the Investigation of New Drug had been revoked.Nevertheless, hoping the FDA would reinstate its IND approval uponreceipt of the additional data, McNaughton proceeded with the paperworkand, on May 15, just nine days after receipt of the FDA's initialorder, sent off to Washington everything that had been requested. Bynow, however, the FDA was firm. Laetrile would not be tested. A former high official of the FDA told Dr. Dean Burk of the NationalCancer Institute that he could not recall in over thirty years ofservice any instance in which just ten short days were demanded for afifty page reply to alleged deficiencies. And, on Octover 1, 1970,there was nothing in the FDA procedural manual requiring terminationnotices after allowing only ten days for compliance. Clearly, theentire action was contrived in response to political pressures as anexcuse to stop the testing of Laetrile. One of the reasons given for revoking approval for IND was thatLaetrile might be toxic.The FDA said solemnly: Although it is often stated in the IND that amygdalin is non-toxic,data to demonstrate this lack of toxicity are absent... It isconsidered to be dangerous to base the starting dose for a chronic (6 +weeks) study in man on a single dose study in mice. It is alsodangerous to initiate human studies while the nature of the toxicityhas not been elucidated in large animal species. This is an incredible statement. First of all, as will be illustratedin a leter chapter, the non-toxicity of amygdalin (Laetrile) has been wwell-known, fully accepted, and non-controversial fact for a hundredyears. Second, the case histories submitted as part of the INDapplication were further proof of Laetrile's safety. And third, thevery question of toxicity is absurd inasmuch as all of the drugsapproved by the FDA and currently used in orthodox cancer therapy areextremely toxic. To deny the testing of Laetrile on the grounds thatit might be toxic is the height of sophistry. Another reason given by the FDA for refusing to permit the testing ofLaetrile was that the doctors who had used it did not keep sufficientlydetailed clinical records. This, too, was a lame excuse, because PhaseOne studies do not require clinical records. In righteous indignation, the courageous Dr. Burk of the NationalCancer Institute wrote to Elliot Richardson, then Secretary of HEW(which administered the FDA), and said: The granting of FDA permission for Phase One studies of IND has noabsolute or invariable requirements for any clinical studies at all,although the sponsor is requested to supply any type of indication thathe may posses, which the McNaughton Foundation has complied with to thelimit of current feasibility. Dr. Contreras [of Mexico] and Dr. Nieper[of Germany] have been primarily preoccupied, quite justifiably, withtreating cancer patients with Laetrile and related adjunctivetherapies, and not with carrying out a clinical evolution of Laetrilein the precise and complete schedule of FDA protocols. For you toindicate that their records are inadequatre for such a purpose isclearly a red herring, since there is no such IND Phase One requirementinvolved, nor corresponding claim made. But the "fix" was on. Laetrile would not be approved for testing,regardless of the facts. On September 1, 1971, the FDA announced thatthe Ad Hoc Committee of Consultants for Review and Evaluation ofLaetrile had found "no acceptable evidence of therapeutic effect tojustify clinical trials." And then it announced that, because oftheir findings, Laetrile could no longer be promoted, sold, or eventested in the United States. The California Report has remained as one of the primary authoritiescited by cancer "experts" ad nauseum and as the basis of legalrestraints against Laetrile. The cancer industry has also refused theadvocates of Laetrile a chance to conduct their own clinical trials onthe basis of such flimsy excuses that they would be laughable if theconsequences were not so serious. All of this is the product of bias,not objectivity. The reports and pronouncements are calculated todeceive, not to clarify. It is fiat, not science.Why is this happening? We shall deal with that part of the storynext. --~--~---------~--~----~------------~-------~--~----~You received this message because you are d to the Google Groups "MedicalConspiracies" group.To post to this group, send email to MedicalConspiracies (AT) googl (DOT) comFor more options, visit this group at http://groups.google.comMedicalConspiracies-~----------~----~----~----~------~----~------~--~---