CHAPTER ONE of WORLD WITHOUT CANCER, by G. EDWARD GRIFFIN

[Guest guest]

G. EDWARD GRIFFIN GRANTED HIS PERMISSION FOR THIS POST:

 

Chapter One

 

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.

 

This year 550,000 Americans will die from cancer. One out of

three of us will develop cancer in our lifetime. That is eighty-eight

million people in the United States alone.

The purpose of this study is to show that this great human

tragedy can be stopped now entirely on the basis of existing

scientific knowledge.

We will explore the theory that cancer, like scurvy or

pellagra, is a deficiency disease aggravated by the lack of an

essential food compounds in modern man's diet, and that its ultimate

control is to be found simply in restoring this substance to our

daily intake.

What you are about to read does not carry the approval of

organized medicine. The Food and Drug Administration, the American

Cancer Society, and the American Medical Association have labeled it

fraud and quackery. In fact, the FDA and other agencies of

government have used every means at their disposal to prevent this

story from being told. They have arrested citizens for holding

public meetings to tell others of their convictions on this subject.

They have confiscated films and books. They even have prosecuted

doctors who apply these theories in an 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, is this: " We're going to protect them even if some of them

don't want protection. "

Early in 1974, the California medical board brought formal

charges against Stewwart 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. Johes'

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. .

This is happening in a land whichboasts of freedom and whose

symbol is the Statue of Liberty. For the first time inour history,

people are being forced to fell from our shores as medical emigrants

seeking freedom-ofchoice and sovereignty over their own bodies.

Laetrile has baan available in Australia, Brazil, Belgium, Costa

Rica, England, Germany, Greece, India, Israel, Italy, Japan, Lebanon,

Mexico, Peru, the Philippinesm, 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 politicitans probmising ever-increasing

government programs, we find that, today, there are more people

making a living from cancer than dying fromit. If the riddle were to

be solved be a simple vitamin, this gigantic commercial and political

industry could be wiped out evernght. 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. "

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 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 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 gray areas in

the IND [investigation of New Drug] situation, but the conscious

withholding of unfavorable animal clinical data is not a gray

matter. The deliberate choice of clinical investigators know to be

more concerned about industry friendships than in developing good

data is not a gray matter.

 

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.

 

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.

 

Between 1977 and 1980, it was discovered that 62 doctors had

submitted clinical data to the FDA which was manipulated or

completely falsified. In one study conducted by the FDA itself, it

was discovered that one in every five doctors investigated- doctors

researching the effects of new drugs-had invented the data they

reported and pocketed the fees.

These are not unusual or isolated cases. John Braithwaite, a

criminologist at the Australian Institute of Criminology (and also

former Commissioner of Trade Practices in Austrailia), states: " The

problem is that most fraud in clinical trials is unlikely to even be

detected. Most cases which do come to public attention only do so

because of the extraordinary carelessness by the criminal physician. "

According to Dr. Judith Jones, former Director of the Division of

Drug Experience at the FDA, if a research facility obtains results

that do not demonstrate the safety or effectiveness of a drug, it is

not uncommon for the drug company to bury the report and continue

testing elsewhere until they find a facility that gives them the

results they want. Unfavorable reports are rarely published, and

clinicians are pressured 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,

which enables some doctors to collect over $1 million per year from

drug research-all the easier if the treatments are imaginary. Even

if the tests are not fabricated, there is still the effect of

subconscious bias. These doctors know that, if they don't produce

the results the drug companies are seeking, the likelihood of their

receiving future work is greatly diminished.

The commercially operated testing facilities should become corrupted

by money is not hard to imagine. But it is often assumed that

university laboratories are different, that they are immune to the

profits that flow from criminal science. The truth, however, is

that money speaks just as loudly on campus as it does elsewhere.

Referring to a survey conducted by the FDA, Dr. Braithwaite explains:

 

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.

 

The trail of corruption leads all the way to the FDA itself. A study

conducted by USA TODAY revealed that more than half of the experts

hired to advise the government on the safety and effectiveness of

medicine have financial relationships with the pharmaceutical

companies that are affected by their advice. The report stated:

 

These experts are hired to advise the Food and Drug Administration on

which medicines should be approved for sale, what the warning labels

should say and how studies of drugs should be designed. These

experts are supposed to be independent, but USA TODAY found that 54%

of the time, they have a direct financial interest in the drug or

topic the are asked to evaluate. These conflicts include helping a

pharmaceutical company develop a medicine, then serving on an FDA

advisory committee that judges the drug.

The conflicts typically include stock ownership, consulting

fees, or research grants.

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.

Prior to crossing swords with the FDA in the early 1960's,

Dr. Ivy had been widely acknowledged as one of the nation's foremost

medical specialists. As head of the University of Illinois the

graduate degrees of Doctor of Philosophy (Ph.D.) and Master of

Science (M.S.). He was an American Representative at the Nuremberg

trials after World War II in Germany. The American representative at

the Nuremberg trials after World War II in Germany. The American

Medical Association had awarded him bronze, silver, and gold medels

in recognition of his outstanding work in the field of medicine. He

had written over a thousand articles published in scientific and

medial journals. In fact, the FDA itself often had called upon him

as an expert to offer medical testimony in court. But when he began

to use an unorthodox approach to cancer therapy, overnight he was

branded as a " quack. "

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.

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.

The tactics used against Laetrile are even more dishonest

than those agains Krebiozen. Perhaps the most damaging of them has

been a pseudo-scientific report released in 1953 by the Cancer

Commision 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

thateshaustive 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.

 

Others have run up against the same stone wall. Professional

researcher, David Martin, reported this experience:

 

The cancer expert in question, as I had anticipated, told me that

Laetrile was " sugar pills. " Had he told me that he had used Laetrile

experimentally on X number of patients and found it completely

ineffective, I might have been impressed. But when I asked him

whether he had ever used it himself, he said that he had not. When I

asked him whether he had ever traveled abroad to study the

experience with Laetrile therapy in Germany, Italy , Mexico, the

Philippines, or other countries, her replied that he had not. And

when I asked him if he had ever made a first-hand study of the pros

and cons of the subject, again he conceded that he had not. He was

simply repeating what he had heard from others who, in turn , were

probably repeating what they had heard from others, going all the way

back to the antiquated 1953 report of the California Cancer

Commission.

 

It is important, therefore, to know something of the nature of the

California Report and of the scientific integrity of those who

drafted it.

Although the report as published in California Medicine was unsigned,

it was written by Dr. Ian MacDonaldm, Chairman of the Commission, and

Dr. Henty Garland, Secretary. Dr. MacDonald was a prominent cancer

surgeon, and Dr. Garland was an internationally famous radiologist.

Both were listed in Who's Who.

There were even seven other prominent physicians on the commission-

including four more surgeons, another radiologist, and a pathologist-

but they played no major part in the preparation of the report. Not

one of these men-not even MacDonald or Garaland-had ever used

Laetrile in the first-hand experiments of their own. All they had

done was to make evaluations and summaries of the written records of

others.

Before examining those evaluations and summaries, let us first recall

that MacDonald and Garland were the two physicians who had made

national headlines claiming that there was no connection between

cigarette smoking and lung cancer. In an address before the Public

Health 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

causally related to a vast number of different diseases, ranging from

cancer to coronary arteriosclerosis. After studying the question for

several years, notably in its reported relationship to primary

bronchial cancer, it is my considered opinion that the hypothesis is

not proven….

Cigarettes in moderation are regarded by many as one of the

better tranquilizers…. It is likely that obesity is a greater hazard

to American 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

quoted as saying that smoking is " a harmless pastime up to twnty-four

cigarettes per day. " And then he added: " One could modify an old

slogan: A pack a day keeps lung cancer away. "

It is a curious fact that it was precisely at this time that

cigareet 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.

 

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. "

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.

 

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.

 

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. " 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. 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. " 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. 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.

 

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.

 

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.

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.