Chapter 1

THE WATERGATE SYNDROME

Examples of dishonesty and corruption in the field of drug research; a close look at the first major study which declared Laetrile) vitamin B-17) “of no value;” proof that the study was fraudulent; the FDA’s ruling against the use of Laetrile because it had not been tested; and the refusal then to allow anyone (except its opponents) to test it.

Early in 1974, the California medical board brought formal charges against Stewart  M. Jones, M.D., for using laetrile in the treatment of cancer patients.  It was learned later, however, that Dr. Julius Levine, one of the members of that board, himself had been using Laetrile in the treatment of his own cancer.  When Dr. Jones’ case came up for review, the political pressures were so great that Dr. Levine felt compelled to resign from his post rather than come out openly in support of Dr. Jones and his patients. [2]

This is happening in a land which boasts of freedom and whose symbol is the Statue of Liberty.  For the first time in our history, people are being forced to fell from our shores as medical emigrants seeking freedom-of choice and sovereignty over their own bodies.  Laetrile has been available in Australia, Brazil, Belgium, Costa Rica, England, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Mexico, Peru, the Philippines, Spain, Switzerland, Russia, Venezuela, and Vietnam-but it is not allowed in the “land of the free”

In spite of this, however, many doctors have defied the bureaucracy and have proved in ther own clinics that vitamin-deficiency concepts of cancer is valid. 

With billions of dollars spent each year in research, with additional billions taken in from the cancer-related sale of drugs, and with vote-hungry politicians promising ever-increasing government programs, we find that, today, there are more people making a living from cancer than dying from it.  If the riddle were to be solved be a simple vitamin, this gigantic commercial and political industry could be wiped out overnight.  The result is that the science of cancer therapy is not nearly as complicated as the politics of cancer therapy.

If there was any good that came from the Watergate scandals of the Seventies, it as the public awakening to the reality that government officials sometimes do not tell the truth.  And when caught in such “mendacities,” they invariably claim that they lied only to protect national security, public health, or some other equally noble objective.

This Watergate syndrome is not new.  Several years ago, an FDA agent who had testified in court against a Kansas City businessman admitted under cross-examination that he had lied under oath twenty-eight times.  When asked if he regretted what he had done, he replied: “No.  I don’t have any regrets.  I wouldn’t hesitate to tell a lie if it would help the American consumer.” [3]

The FDA is not squeamish over its tactics to “help the American consumer.”  When a businessman falls into disfavor with the bureaucracy, there are no holds barred, and the law is used, not as a reason for attack, but as a weapon of attack.  In  other words, the FDA does not take action because the law says it should.  It does so because it wants to, and then searches through the law 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 with vitamis and minerals and still call it sugar.  But the court ruled otherwise, pointing out:

The basic flaw in the government’s case is that it is seeking, under the guise of misbranding charges, to prohibit the sale of a food in the market place simply because it is not in sympathy with its use.

Usually there is much more going on in these cases than over-zealousness on the part of a few bureaucrats.  Pretending to protect the public is the favorite cover for hidden agendas.  Legislation claiming to protect the consumer usually is written by representatives of the very industries from which the consumer supposedly is to be protected.  Politicians who are grateful for the financial support of those industries are eager to put their names on the legislation and push for its enactment.  Once it becomes law, it serves 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.  In medicine, however, there is the added necessity to pretend that everything is being done scientifically.  Therefore, in addition to recruiting the aid of politicians, scientists also must be enlisted- a feat that is easily accomplished by the judicious allocation of funding for research.

This reality was revealed by former FDA Commissioner, James L. Goddard in a 1966 speech before the Pharmaceutical Manufacturers Association.  Expressing concern over dishonesty in the testing for new drugs, he said:

I have been shocked at the materials that come in.  In addition to the problem of quality, there is the problem of dishonesty in the investigational new drug usage.  I will admit there are grey areas in the IND [Investigation of New Drug] situation, but the conscious withholding of unfavorable animal clinical data is not a grey matter.  The deliberate choice of clinical investigators know to be more concerned about industry friendships than in developing good data is not a grey matter.[4]

Goddard’s successor at the FDA was Dr. Herbert Ley.  In 1969, he testified before a Senate committee and described several cases of blatant dishonesty in drug testing.  One case involved an assistant professor of medicine who had tested 24 drugs for 9 different companies.  Dr. Ley said:

Patients who died while on clinical trials were not reported to the sponsor…Dead people were listed as subjects of testing.  People reported as subjects of testing were not in the hospital at the time of tests.  Patient consent forms bore dates indicating they were signed after the subjects died. [5]

 Another case involved a commercial drug-testing firm that had worked on 82 drugs from 28 companies.  Dr Ley continued:

Patients who died, left the hospital, or dropped out of the study were replaced by other patients in the tests without notification in the records.  Forty-one patients reported as participating in studies keeping, supervision and observation of patients in general were grossly inadequate. [6]

As one would predict from the foregoing discussion of how contract labs can be used by sponsors to abrogate responsibility for quality research , contract labs were found to have a worse record of GLP [Good Laboratory Practices] violations that sponsor labs.  The worst record of all, however, was with university laboratories.  One must be extremely cautious about this finding since there were only five university laboratories in the study.  Nevertheless, it must undermine any automatic assumption that university researchers, with their supposed detachment from the profit motive, are unlikely to cut corners on research standards.[9]

Let’s bring this into focus on the issue of cancer.  Science can be used, not only to push drugs into the market that do not work, but also to hold back remedies that do-because these remedies represent potential competition to pharmaceutical industry which controls the drug-approving process.  The controversy that once surrounded Dr. Andrew Ivy’s anti-cancer drug known as Krebiozen is an example of  this phenomenon.

 During the course of Dr. Ivy’s trial, a letter was read into the court record written by a doctor from Indianapolis.  The doctor stated in 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’s laboratories  and had administered it, but that it had done absolutely no good.  When called to the witness stand, however, the doctor’s answers were vague and evasive.  Under the pressure of cross-examination, he finally broke down and admitted that he never had treated such a patient, never had ordered the biopsy in question, and never 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 FDA agents had written the letter and asked  him to sign it.  He did so because he wanted to help the agency put  an end to quackery. [12]

In September of 1963, the FDA released a report to the effect that Krebiozen was, for all practical purposes, the  same as creatine, a common substance that was found in every hamburger.  To prove this point, they produced a photographic overlay supposedly showing the spectograms of Krebiozen and creatine superimposed over each other.  These were published in Life magazine and other segments of the mass communications media as “unimpeachable proof” that Krebiozen was useless.

When Senator Paul Douglas saw the spectrograms, he was suspicious.  So he asked Dr. Scott Anderson, one of the nation’s foremost authorities on spectograms, to make his own study. Using standard techniques of analysis, Dr. Anderson identified twenty-nine differences between the two substances.  There were sixteen chemical and color differences.  The version released to the press by the FDA had been carefully moved off center until there was a maximum appearance of similarity, but when restored to the true axis, the two were as different as night and day.[13]

The tactics used against Laetrile are even more dishonest than those against Krebiozen.  Perhaps the most damaging of them has been a pseudo-scientific report released in 1953 by the Cancer Commission of the California Medical Association.  Published in the April issue of California Medicine, the report presented an impressive collection of charts and technical data indicating that exhaustive research had been carried out into every aspect of Laetrile.  Its molecular Composition had been analyzed, its chemical action studied, its effect on tumor-bearing rats observed, and its effectiveness on human cancer patients determined.  The stern conclusion of all the supposedly objective research was stated: “No satisfactory evidence has been produced to indicate any significant cytotoxic effect of Laetrile on the cancer cell.”

The conclusions of the California Report are sufficient for most physicians and researchers.   Not one in ten thousand has ever even seen Laetrile, much less used it.  Yet, they all know that Laetrile does now work because the California branch of the AMA Cancer Commission said so, and they have had no reason so question the reliability of those who did the work.

Reporter Tom Valentine interviewed many leading cancer specialists to determine what they thought about Laetrile.  Here he describes a typical 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 if the renowned little hospital, which deals only with cancer, actually tested Laetrile, Dr. Mirand said, “No, we didn’t feel it was necessary after others of good reputation had tested it and found had no effectiveness in the treatment of cancer.”   He referred, as all authorities do, to the California Report.[15]

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 quoted as saying that smoking is “a harmless pastime up to twenty-four cigarettes per day.”  And then he added: “One could modify an old slogan:  A pack a day keeps lung cancer away.”[17]

It is a curious fact that it was precisely at this time that cigarette manufacturers were beginning to experience a slump in sales because of public concern over lung cancer.  In fact, tobacco industry had already pledged the first ten-million dollars out of a total of eighteen million to the AMA for “research” into the question of smoking and health.

The effect of this veritable flood of money from a source with, shall we say, “a vested interest” in the outcome of the research, was incredible and did not speak well for the AMA.  The result was the conversion of a relatively simple, straight-forward project into a monstrous boondoggle of confusion and waste.

In the report of the AMA’s Committee for Research on Tobacco and Health, it says:

To date, approximately $14 million has been awarded [from the tobacco industry] to 203 individual research projects at 90 universities and institutions.  As a direct result of these grants, 450 reports have been published in scientific journals and periodicals.[18]

The report then listed the research projects and described their purposes.  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 in American and Swedish Twin Roosters.

Post – Maturity Syndrome in the Pregnant Rat After Nicotine Absorption 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 in Monkey 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 for Research on Tobacco and Health, one is able to count but five research projects that are primarily concerned with cancer.  One of those dealt with laboratory-testing procedures only, and another was an experiment to see if tobacco smoke could be used to cure cancer of the skin!  So only three of these projects really dealt with the area of major public concern.  Three out of two hundred and three is only about one-and-a-half percent – which tells us something about the AMA’s scientific integrity on  the subject of smoking and cancer.

With the expenditure of a mere eighteen-million dollars – which is small, indeed, compared to the tobacco industry’s advertising budges over the same period – it was possible to direct the AMA’s medical research away from the important question of cancer and into a hundred giddy questions that served only to confuse and delay the ultimate truth.

Dazzled by the meteor shower of thousand-dollar bills, the AMA, in its December 1959 issue of the American Medical Association Journal, published an editorial stating flatly that there was insufficient evidence “to warrant the assumption” that cigarette smoking was the principal factor in the increase of lung cancer.  Furthermore, through its gargantuan research program, the AMA was making it increasingly difficult to obtain that evidence.

Was there any connection between the eighteen-million dollars given to the AMA from the tobacco industry and the public pronouncements of MacDonald and Garland, two of its most prominent members in California?  Perhaps not, although it has been rumored that these gentlemen of science actually did receive $50,000 for their “testimonials.”[19]

Whether or not this is true is not important now.  What is important is the fact that their medical opinion, if it had been widely followed, clearly would have resulted in the suffering and death of untold additional millions.  Also important is the fact that these are the same “experts” whose medical opinion  has been widely quoted and followed in the question of Laetrile.

An interesting footnote to this subject is the fact that Dr. MacDonald was burned to death in bed a few years later in a fire started by his cigarette.  Dr. Garland, who had boasted of chain-smoking since early childhood and who claimed to be living proof that cigarettes are harmless, 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 he findings of the antiquated study were “true” and adopted them as its own.  When it did so, however, it performed an unexpected favor for the public because it published for the first time all the original experiments and studies upon which the report had been based and, in doing so, it made available the documentary evidence proving that MacDonald 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 from Laetrile.  As will be explained in a later chapter, the release of cyanide at the cancer cell is part of the reason that Laetrile works.  Therefore, imlpying that cyanide cannot be produced was a severe blow to the credibility of Laetrile theory.  Dr. Mehl was quoted as saying:  “These results are inconclusive, and will be extended, but they do not 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 of statistics, tables, and charts can be found an item labeled “Laetrile Report 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 be detected…  The hydrogen cyanide was distilled into sodium hydroxide and determined by the Prussian Blue technique.[20]

            This report was dated January 14, 1953 – two months before Dr. Mehl claimed that cyanide could not be released from Laetrile.  It is significant, therefore, that MacDonald and Garland completely ignored the positive report while giving prominence to the negative one.

            Since that time, the release of cyanide from Laetrile has been confirmed by the AMA’s chemical lab, by the cytochemistry section of the National Cancer Institute, and even by the California Department of Public 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 microscopic examinations of tumors from patients who had been treated with Laetrile showed absolutely no indication of favorable chemical effect.  Ten years later, however, this assertion was shown to be a bald-faced lie.  Appendix Three contains the findings of two pathologists who stated in plain English that they did observe anti-tumor effects which, indeed, could have been caused by the Laetrile.  In a statement dated December 15, 1952, for example, John W. Budd, M.D., reported: “Case 1M…. Hemorrhagic necrosis of tumor is extensive….  An interpretation of chemotherapeutic 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 cells affected show coagulation necrosis and pyknosis….

            M-3….  There appears to be more degeneration in the tumor cells in the lymph node.  I would consider this as a possible result of chemical agent….

            Two cases….  Showed moderated changes … which might be considered as chemotherapeutic toxic cellular changes.[21]

            Nothing could be more plain than that.  Nevertheless, MacDonald and Garland stated flatly in the California Report:  “No evidence of cytotoxic changes was observed by any of the consultants.” [22]  That statement, of course, was a lie of gigantic proportions.

            Even if the findings of these researchers had not been falsely summarized by MacDonald and Garland, the 1953 California Report still would have been totally useless as a scientific verdict against Laetrile because the strength of the doses used on cancer patients was too 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 cautiously administered only fifty to one-hundred milligrams at a time.  Gaining confidence with experience, these levels gradually were raised until, by 1974, Laetrile was being used intravenously at levels of six to nine thousand milligrams daily.  Generally, it takes an accumulation of fifty to seventy thousand milligrams over a period of about a week or ten days before the patient can report tangible indications of improvement.  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 the maximum accumulative dose was only two thousand milligrams spread over twelve injections.  Five patients received only two infections, and five received only one.

It is not surprising, therefore, that the California experiments failed to produce conclusive evidence Laetrile was effective against cancer.  As Dr. Krebs observed at the time,  “There is nothing quite so easy to accomplish as failure.”

In spite of all the incredible distortions of fat and the perversions of scientific truth, Drs. MacDonald and Garland were forced to admit on page three of their California Report:

All of the physicians whose patients were reviewed spoke of increase in the sense of well-being and appetite, gain in weight, and decrease in pain…

Then, attempting to belittle these important results, they added:

…as though these observations constituted evidence of definite therapeutic effect.

That statement, alone, should have disqualified the California Report, for these observations are, indeed, among the very things which indicate to a physician whether or not his drug therapy is effective.[23]   Most doctors would be ecstatically happy if they could cause their cancer patients to experience an increase in a sense of well-being and appetite, a gain in weight, and especially a decrease in pain.

In the 1970’s, there was little chance that Laetrile would be given a chance to be tested except by its opponents.  Every time proponents attempted to obtain permission to do so, they were turned down cold.  On April 6, 1970, for example, the McNaughton Foundation, under the sponsorship of Andrew McNaughtonm submitted an application to the FDA for permission to engage in what is called IND  (Investigation of New Drug) Phase One studies.  Permission was granted on April 27.  Then, in  the words of one reporter, “All hell broke loose.”[24]  The FDA apparently received a phone call from an irate and politically influential figure who passed the word:  “Stop the tests!”

The next day, April 28, the FDA sent another letter to the Foundation advising that, upon reviewing the records, certain “deficiencies” had been found in the IND application, and demanding extensive additional data within ten days.  Curiously, the letter was not delivered to the McNaughton Foundation until May 6, nine days after it supposedly had been written, and it is suspected that the letter may actually have been written much later but back-dated so as to make it impossible to comply with the already ridiculous ten day deadline.  On May 12, six days after receipt of the “deficiency letter,” McNaughton received a telegram from the FDA advising him that the approval for the Investigation of New Drug had been revoked.

Nevertheless, hoping the FDA would reinstate its IND approval upon receipt of the additional data, McNaughton proceeded with the paperwork and, on May 15, just nine days after receipt of the FDA’s initial order, sent off to Washington everything that had been requested.  By now, however, the FDA was firm.  Laetrile would not be tested.

A former high official of the FDA told Dr. Dean Burk of the National Cancer Institute that he could not recall in over thirty years of service any instance in which just ten short days were demanded for a fifty page reply to alleged deficiencies.  And, on Octover 1, 1970, there was nothing in the FDA procedural manual requiring termination notices after allowing only ten days for compliance.[25]  Clearly, the entire action was contrived in response to political pressures as an excuse to stop the testing of Laetrile.

One of the reasons given for revoking approval for IND was that Laetrile 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 is considered 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 also dangerous to initiate human studies while the nature of the toxicity has not been elucidated in large animal species.[26]

This is an incredible statement.  First of all, as will be illustrated in a leter chapter, the non-toxicity of amygdalin (Laetrile) has been w well-known, fully accepted, and non-controversial fact for a hundred years.  Second, the case histories submitted as part of the IND application were further proof of Laetrile’s safety.  And third, the very question of toxicity is absurd inasmuch as all of the drugs approved by the FDA and currently used in orthodox cancer therapy are extremely toxic.  To deny the testing of Laetrile on the grounds that it might be toxic is the height of sophistry.

Another reason given by the FDA for refusing to permit the testing of Laetrile was that the doctors who had used it did not keep sufficiently detailed clinical records.  This, too, was a lame excuse, because Phase One studies do not require clinical records.

In righteous indignation, the courageous Dr. Burk of the National Cancer 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 no absolute or invariable requirements for any clinical studies at all, although the sponsor is requested to supply any type of indication that he may posses, which the McNaughton Foundation has complied with to the limit of current feasibility.  Dr. Contreras [of Mexico] and Dr. Nieper [of Germany] have been primarily preoccupied, quite justifiably, with treating cancer patients with Laetrile and related adjunctive therapies, and not with carrying out a clinical evolution of Laetrile in the precise and complete schedule of FDA protocols.  For you to indicate that their records are inadequatre for such a purpose is clearly a red herring, since there is no such IND Phase One requirement involved, nor corresponding claim made.[25]

But the “fix” was on.  Laetrile would not be approved for testing, regardless of the facts.  On September 1, 1971, the FDA  announced that the Ad Hoc Committee of Consultants for Review and Evaluation of Laetrile had found “no acceptable evidence of therapeutic effect to justify clinical trials.”  And then it announced that, because of their findings, Laetrile could no longer be promoted, sold, or even tested in the United States.[27]

The California Report has remained as one of the primary authorities cited by cancer “experts” ad nauseum and as the basis of legal restraints against Laetrile.  The cancer industry has also refused the advocates of Laetrile a chance to conduct their own clinical trials on the basis of such flimsy excuses that they would be laughable if the consequences were not so serious.  All of this is the product of bias, not objectivity.  The reports and pronouncements are calculated to deceive, not to clarify.  It is fiat, not science.

Why is this happening?  We shall deal with that part of the story next.