Chapter One
The Watergate Syndrome
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 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.
.
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 their 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
lie d 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 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 vitamins
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 Australia), 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
medals 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
spectrograms, 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 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.
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, h e
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 MacDonald, 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 Garland-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 re
ported 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
twenty-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 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-mil lion 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
Veterans.
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 ha s 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, implying 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
McNaughton 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 October 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
letter 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
inadequate 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.
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.
