Chapter Twenty-One
THE PROTECTION RACKET
Cartel agents in the FDA and other agencies of government; the CFR
as a control structure over U.S. foreign policy; scientific
ineptitude at the FDA; and the growth of FDA power. |
Cartel agents in the FDA and other agencies of government; the CFR
as a control structure over U.S. foreign policy; scientific
ineptitude at the FDA; and the growth of FDA power.
In 1970, Dr. Herbert Ley made a statement that, coming from a lesser
source, easily could be dismissed as the ranting of an uninformed
malcontent. Considering that Dr. Ley was a former Commissioner of
the Food and Drug Administration, however, his words cannot be
brushed aside so lightly. He said:
The thing that bugs me is that the people think the FDA is
protecting them. It isn't. What the FDA is doing and what the public
thinks it's doing are as different as night and day.(1)
1. San Francisco Chronicle, Ian. 2, 1970, as quoted in Autopsy on
The A.M.A., (Student Research Facility, Berkeley, 1970), p. 42.
What is the FDA doing? As will be shown by the material that
follows, the FDA is "doing" three things:
-
First, it is providing a means whereby key individuals on its
payroll are able to obtain power and wealth through granting special
favors to politically influential groups that are subject to its
regulations. This activity is similar to the "protection racket" of
organized crime: for a price, one can induce FDA administrators to
provide "protection" from the FDA itself.
-
Secondly, as a result of this political favoritism, the FDA has
become a primary factor in that formula whereby cartel-oriented
companies in the food-and-drug industry are able to use the police
powers of government to harass or destroy their competitors.
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And thirdly, the FDA occasionally does some genuine public good if
that does not interfere with serving the vested interest of its
first two activities.
To appreciate the extent of cartel influence within the FDA, let us
look briefly at the larger picture - at evidence of that same
influence in other agencies and at all levels of government.
Previously we outlined the degree to which the cartel succeeded in
placing its friends and agents into such areas of government as the
office of the Alien Property Custodian, the Attorney General's
office, the State Department, and the White House itself.
In
addition to the names previously mentioned, there are such
dignitaries as
-
Secretary of State Dean Rusk (former head of the
Rockefeller Foundation, as was John Foster Dulles)
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Secretary of the
Treasury Douglas Dillon (a member of the board of the Chase
Manhattan Bank)
-
Eugene Black, Director of the U.S. International
Bank for Reconstruction and Development (also Second Vice-President
and Director of Chase Manhattan)
-
John J. McCloy, President of the
UN World Bank (also Chairman of the Board of Chase Manhattan, and
trustee of the Rockefeller Foundation, and Chairman of the Executive
Committee for Squibb Pharmaceutical) (1)
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Senator Nelson Aldrich
(whose daughter married John D. Rockefeller, Jr., and whose son,
Winthrop, became Chairman of the Chase National Bank and also was
appointed as Ambassador to Great Britain)
-
President Richard Nixon
and Attorney General John Mitchell (Wall Street attorneys for
Warner-Lambert Pharmaceutical),
...and many others. The list of men who
are or were in key positions within the Rockefeller group reads like
a "Who's Who in Government."
1. McCloy had been Assistant Secretary of War from April 1941 to
November 1945. As High Commissioner in West Germany after the war,
he was instrumental in making Konrad Adenauer, his brother-in-law,
Chancellor of West Germany. He also was Chairman of the Board of the
Ford Foundation and chief
U.S. disarmament negotiator.
It is impossible to appraise the extent of Rockefeller influence
within the federal government without knowing a little bit about the
Council on Foreign Relations. The CFR has come to be called "the
hidden government of the United States," and as we shall see, that
is a fairly accurate description.
The CFR is semisecret in its operation. It shuns publicity, and
members are sworn not to disclose to the public the proceedings of
its conferences and briefings. It has a formal membership of
approximately three-thousand elite personalities.
In Harper's magazine for July, 1958, there was an article entitled
"School for Statesmen," written by CFR member Joseph
Kraft.
Boasting that membership in this obscure organization had
become the magic key that opens the door of appointments to high
government posts, Kraft explained that, even then, CFR membership
included:
... the President, the Secretary of State, the Chairman of the
Atomic Energy Commission, the Director of the Central Intelligence
Agency, the Board chairmen of three of the country's five largest
industrial corporations, two of the four richest insurance
companies, and two of the three biggest banks, plus the senior
partners of two of the three leading Wall Street law firms, the
publishers of the two biggest news magazines and of the country's
most influential newspaper, and the presidents of the Big Three in
both universities and foundations, as well as a score of other
college presidents and a scattering of top scientists and
journalists.
This list - impressive as it is - was soon to be dwarfed by the
avalanche of CFR members who have since moved into control of
literally all of the nation's power centers.
It now rules through
hidden control over such power centers as government, media,
education, and finance. To see that this is not an exaggeration,
take a moment and wade through the tedious list that follows.
In government, CFR members include:
Presidents Hoover, Eisenhower,
Nixon, Ford, Carter, Bush, and Clinton;(1) Secretaries of State
Stimson, Stettinius, Acheson, Dulles, Herter, Rusk, Rogers,
Kissinger, Vance, Muskie, Haig, and Schultz.
1. According to Dan Smoot's The Invisible Government, President
Kennedy also had been a member. The basis for this is a personal
letter from the president in which he claimed membership. I have not
seen that letter, however, and the CFR staff, in a letter to me
dated June 11, 1971, stated flatly: "the facts of the matter are
that President Kennedy was invited to join the Council but, insofar
as our records indicate, never accepted that invitation either
formally or informally through the payment of membership dues." In
view of this, I felt it was best to omit President Kennedy's name
from the list, which is impressive enough without it.
Since 1953, there have
been 21 presidents and Secretaries of State. Seventeen of them have
been members of the CFR. That's a ratio of 81%. This seems to be a
magic number. It is the same ratio that holds for all the rest of
the highest government positions in the land.
In other words, since
1953, more than 81% of the following posts have been in the hands of CFR members: Vice Presidents, Secretaries of Defense, Joint Chiefs
of Staff, CIA directors, National Security Council, Secretaries of
the Treasury, members of the President's Cabinet, Under-Secretaries,
Ambassadors to the UN and major countries, and presidential
advisors.
When it comes to the Federal Reserve System, virtually 100% of the
board members have been CFR since 1953 - which tells us something
about how important it is to these people to have control over our
monetary system.
By the end of President Clinton's first term of office, more than
166 CFR members were holding key government posts.
So much for government. Now let's look at the media.
CFR members
include top executives and journalists for the:
-
New York Times
-
New
York Post
-
Washington Post
-
Washington Times
-
Chicago Tribune
-
Los
Angeles Times
-
Boston Globe
-
Dallas Morning News
-
Parade
-
Forbes
-
Christian Science Monitor
-
National Review
-
Harper's
-
Look
-
Time
-
Life
-
Newsweek
-
U.S. News and World Report
-
Newsday
-
Business Week
-
Money
-
Fortune
-
Harvard Business Review
-
Wall Street Journal
-
Atlantic Monthly
-
Encyclopedia Britannica
-
ABC
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CBS
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CNN
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NBC
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MGM
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the Associated Press
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Hearst News Service
-
Reuters
-
the Motion
Picture Association of America,
...and scores of others.
Let us emphasize that CFR members do not merely work for these media
giants as subversive agents hiding within the working staffs, they
control them at the top. They are the owners and the key executives
who determine content and editorial policy. It is through these
channels of communication and entertainment that members of the CFR
have been able to manipulate America's perception of reality.
We have previously covered the role of the tax-exempt foundations in
furthering the objectives of the pharmaceutical cartel, so it should
not come as a surprise to learn that these foundations also are
dominated by members of the CFR. They include directors of the Ford
Foundation, Rockefeller Foundation, Carnegie Fund, Heritage
Foundation, Kettering Foundation and Sloan-Kettering Institute for
Cancer Research. These are the organizations which have provided CFR
funding.
For many years, David Rockefeller was the chairman and principle
benefactor of the CFR. Its continuing leadership consists of proven
and trusted lieutenants who are firmly within the Rockefeller
financial interlock.
The CFR is not the subject of this study, so let us cut it short.
Virtually all of the nation's largest universities and corporations
and banking houses and insurance companies are also run by members
of the CFR. And remember, the entire organization has only about
three-thousand members. The average person has never heard of the
CFR, yet it is the unseen government of the United States.(1)
The glue that binds members of the CFR together is the plan for
world government and the personal power they anticipate from that.
But making money is not far behind as a secondary motive, and it is
that motive that comes into play in cancer research. So let us
forget the CFR for now, skip over the issue of foreign policy, and
return to domestic policy.
In particular, let us take a close look
at how the pharmaceutical cartel has captured control over the FDA.
Let us begin by acknowledging the obvious. The FDA could not have
achieved the public confidence it now enjoys if it did not
accomplish some good. The FDA has nipped many a medical racket in
the bud and has clamped down on firms that had been guilty of
unsanitary processing, of selling putrid or contaminated food, and
of distributing adulterated or misbranded drugs. In these
accomplishments it deserves to be commended for its diligence. As we
shall see, however, this showcase aspect of the FDA record pales by
comparison to its other record of ineptitude and corruption.
In March of 1972, after repeated inquiries from concerned
Congressmen, the FDA made public its official cleanliness standards
as applied to the food processing industry. To everyone's horror it
was learned that the FDA allows approximately one rodent pellet per
pint of wheat, ten fly eggs per eight and a half ounce can of fruit
juice, and fifty insect fragments or two rodent hairs for three and
a half ounces of peanut butter.(2)
For years, the FDA defended the use of the hormone
Diethylstilbestrol (DES) as an artificial fattening agent for
cattle. Then, after the evidence became too overwhelming to ignore,
it was finally banned because even trace amounts of this substance
as residue in the meat was shown to be a possible factor in inducing
cancer in humans who consumed it.(3)
1. For an overview of this subject, including a list of members and
the positions they have held, see The New American (Conspiracy
Report), September 16,1996. Also Shadows of Power; The Council on
Foreign Relations and the American Decline by James Perloff,
(Appleton, WI: Western Islands, 1988). Also The Capitalist
Conspiracy, by G. Edward Griffin (American Media, Westlake Village,
CA, 1971)
2. Consumer Reports, March, 1973, p. 152.
3. DES is an artificial female sex hormone. The logic for the higher
incidence of cancer is implicit in the role played by estrogen in
the trophoblast thesis of cancer. Here is one more grain of evidence
added to the mountain.
However, the same week
that it banned DES from cattle to make sure that none would find its
way into human consumption, it gave its approval to the
"morning-after contraceptive" - a pill containing fifty milligrams of
the same drug to be taken daily for five days. As one cattleman
commented bitterly:
"It turns out that a woman would have to eat 262
tons of beef liver to get the same amount of DES as the FDA makes
legal for the next-morning medication."(1)
There are approximately 3,000 chemical additives currently being
used by the food industry for the purpose of flavoring, coloring,
preserving, and generally altering the characteristics of its
products. Most are safe in the quantities used, but many of these
chemicals pose a serious health hazard with prolonged use.(2)
As in
the case of DES, the evidence is strong that many of them are
harmful, particularly if consumed over a prolonged period of time.
The FDA response to this situation is interesting. Instead of
rushing into battle to "protect the people," as it has done in the
case of those "dangerous" health foods and vitamins, it warmly
embraces and defends the cartel food processors and chemical firms
that otherwise might be damaged by loss of markets.
The following statements, taken from official FDA "Fact Sheets,"
tell the story with no need for further comment:
In general, there is little difference between fresh and processed
foods. Modern processing methods retain most vitamin and mineral
values...
Nutrition Research has shown that a diet containing white bread made
with enriched flour has nearly the same value as one containing
whole grain bread...
Chemical fertilizers are not poisoning our soil. Modern fertilizers
are needed to produce enough food for our population...
When pesticides on food crops leave a residue, FDA and the
Environmental Protection Agency (EPA) make sure the amount will be
safe for consumers...(3)
Vitamins are specific chemical compounds, and the human body can use
them equally well whether they are synthesized by a chemist or by
nature.(4)
1. "On Science," by David Woodbury, Review of the News, June
13,1973, p. 27.
2. See Toxics A to Z, by Harte, Holdren, Schneider, and Shirley
(Berkeley: University of California Press, 1991).
3. The reader is reminded that the chemical fertilizer and pesticide
industries are, like the drug industry, subsidiaries of the larger
cartelized chemical and petroleum industries.
4. "Nutrition Nonsense - And Sense," FDA Fact Sheet dated July, 1971.
In November of 1971, the FDA issued another "Fact Sheet" on the
subject of "quackery."
It says:
The term "quackery" encompasses both
people and products... Broadly speaking, quackery is misinformation
about health.(1)
1. "Quackery," FDA Fact Sheet dated November, 1971.
If the preceding hogwash about DES and the glories of processed
foods, chemical fertilizers, pesticides, and synthetic vitamins is
not "misinformation about health," then there is nothing that could
be so labeled! The Oxford Universal Dictionary defines a quack as
"one who professes knowledge concerning subjects of which he is
ignorant." By either definition, FDA spokesmen are the biggest
quacks the world has ever seen.
There is an important distinction between a quack and a charlatan. A
quack may be presumed an honest man who truly thinks he is helping
his patients. A charlatan, on the other hand, is fully aware of the
inadequacy of both his knowledge and his treatment. A man,
therefore, can be a quack, or both a quack and a charlatan.
Unfortunately, there is a lot more than mere quackery within the
FDA.
In 1960, during the much publicized investigation of the drug
industry conducted by the Senate, it was revealed that many top FDA
officials had been receiving extra-curricular "incentives" from some
of the very companies they were supposed to regulate. For example,
Dr. Henry Welch, director of the FDA Antibiotic Division, had been
paid $287,000 in kick-backs (he called them "honorariums") that were
derived from a percentage of drug advertising secured for leading
medical journals.
His superiors were fully aware of this conflict of
interest but did nothing to terminate it. It was only after the fact
was made public and caused embarrassment to the administration that
Welch was asked to resign.
In 1940, an incident occurred that, if it been widely publicized,
perhaps would have shocked the nation into realizing that the FDA
was not protecting the people, but was protecting the cartelists
instead. It was at that time that Winthrop Chemical was under fire
for shipping 400,000 tablets labelled as "Sulfathiazole," which were
found later to contain five grains of Luminal each. One or two
grains of Luminal puts people to sleep.
Five grains puts some of
them to sleep permanently. These tablets are known to have killed
seventeen victims in various parts of the country.
Winthrop Chemical failed to notify the public immediately of the
fatally poisonous character of the pills. Instead, the company, with
the aid and approval of the A.M.A. Council on Pharmacy and Chemistry
of the American Medical Association, continued to push the sale of
the Sulfathiazole pills, thus increasing the number of fatalities.
The FDA was sympathetic toward Winthrop Chemical and extremely
helpful.
Exercising their bureaucratic powers, Dr. Klumpp, head of
the FDA drug division, and his superior, FDA Commissioner Campbell,
refrained from prosecuting for the deaths. They helped to hush up
the matter and merely revoked Winthrop's license to ship
Sulfathiazole for three months, after the market had been glutted
with the product. The suspension of shipment for three months was a
meaningless gesture. Commenting on this episode, Howard Ambruster
adds:
Dr. Klumpp, by this time, had moved onward and upward. He had
accepted a position awarded him by Dr. Fishbein and became Director
of the A.M.A. division on food and drugs and secretary of its
Council on Pharmacy and Chemistry (the same council that had
"accepted" Winthrop's Sulfathiazole and approved its advertising).
And Dr. Klumpp kept moving.
Not long thereafter, Edward S. Rogers,
chairman of the Board of Sterling Products, announced that Dr. Klumpp had been elected president of Winthrop.(1)
1. Ambruster, Treason's Peace, op. cit., p. 213.
Some years later, an antibiotic drug by the name of Chloramphenicol
was manufactured and distributed by Parke-Davis and Company. Shortly
after it was released, reports began to appear in the medical
literature to the effect that Chloramphenicol was responsible for
blood toxicity and leukopenia (reduction of the white blood cells),
and that it had caused several deaths from aplastic anemia.
The man who was director of the FDA's Bureau of Medicine at that
time - and the man who could have ordered Parke-Davis to withdraw this
drug from the market - was Dr. Joseph F. Sadusk. Instead of clamping
down on Parke-Davis, however, Sadusk used his official position to
prevent the drug from being recalled, and even ruled against
requiring a precautionary label.
Finally, in 1969, after the drug had earned a substantial profit for
its producer, and after it had been replaced by a newer product,
Parke-Davis was allowed to get off the hook merely by sending a
letter to all physicians stating that chloramphenicol
was no longer the drug of choice for any of the infections it
originally had been designed to cure.
Soon afterward, Dr. Sadusk left the FDA, supposedly to work at his
alma mater, Johns Hopkins University. But, within the year, the
pay-off was complete: He became vice-president of Parke-Davis and
Company.
Dr. Sadusk's successor was Dr. Joseph M. Pisani who shortly resigned
to work for The Proprietary Association, the trade association that
represents the manufacturers of non-prescription drugs - a part of the
very industry Dr. Pisani had "regulated."
Dr. Pisani was replaced by Dr. Robert J. Robinson, whose stay was
even shorter than that of his predecessor. He became a top executive
at Hoffman-LaRoche, a leading manufacturer of prescription drugs.
Omar Garrison continues the list, in his splendidly researched book,
The Dictocrats:
-
Dr. Howard Cohn, former head of FDA's medical evaluation,
who made a profitable transition from the agency to Ciba Pharmaceutical Company;
-
Dr. Harold Anderson, chief of FDA's division of anti-infective
drugs, who terminated his government employment to take a
position with Winthrop Laboratories;
-
Morris Yakowitz, who felt that a job with Smith, Kline and
French Laboratories would offer greater personal rewards than his
post as head of case supervision for FDA; and
-
Allen E. Rayfield, former director of Regulatory Compliance,
who chucked his enforcement duties (including electronic spying) to
become a consultant to Richardson-Merrell, Inc.(1)
1. Garrison, The Dictocrats, op. cit., pp. 70, 71.
In 1964, under pressure from Congress, the FDA released a list of
its officials who, during the preceding years, had left the agency
for employment in industry. Out of the eight hundred and thirteen
names appearing on that list, eighty-three - better than ten
percent - had taken positions with companies they previously
regulated.
Many of these people, of course, were from the very top
FDA echelons of management - men who were charged with making
decisions and issuing directives. While these men were with the FDA,
they had access to information regarding the research and processes
of all companies. When they went to work for one of those companies,
therefore, there is no reason they couldn't have taken that
information with them which, obviously,
could put the firm that hired them at a tremendous advantage over
its competitors.
Here, again, we find the classic pattern of government bureaucratic
power being used, not for the protection of the people as is its
excuse for being, but for the aggrandizement of individuals holding
that power and for the elimination of honest competition in the
market place. The voters approve one extension of government power
after another always in the naive expectation that, somehow, they
will benefit.
But, in the end, they inevitably find themselves
merely supporting a larger bureaucracy through increased taxes,
paying higher prices for their consumer goods and losing one more
chunk of personal freedom.
There are almost no exceptions to this rule, as will be obvious if
one but reflects for a moment on the results of government entry
into such areas of economic activity as prices and wages, energy
conservation, environmental protection, health care and so on.
As the Frenchman, Frederic Bastiat, observed over a hundred years
ago, once government is allowed to expand beyond its prime role of
protecting the lives, liberty and property of its citizens; once it
invades the market place and attempts to redistribute the nation's
wealth or resources, inevitably it falls into the hands of those who
will use it for "legalized plunder." There is no better way to
describe the governments of the world today - and the government of
the United States is no exception.
The FDA was added to the ever-lengthening list of government
regulatory agencies in 1906, largely as a result of the crusading
efforts of a government chemist by the name of Harvey Washington
Wiley. Spurred on largely by the organized dairy industry which
wanted the government to pass laws which would hinder competition
from non-dairy substitutes, Wiley became nationally famous through
his books and speeches against "fraud and poison" in our food.
Pioneering the pattern that was followed many years later by
Ralph
Nader, Wiley succeeded in drumming up tremendous support from both
the public and in Congress for government regulation and
"protection. " The result was the Pure Food and Drug Act of 1906
which created the FDA and gave it wide powers over the food and drug
industries. Wiley became its first director.
The first major revision of the Food and Drug Act came in
1938 as a result of a fatal blunder made by the chief chemist at the
S.E. Massengill Company of Tennessee. The previous year, one hundred
and seven people - mostly children - had died from ingesting an
anti-biotic substance known as "Elixir of Sulfanilamide."
The
chemist had tested the compound for appearance, flavor and
fragrance, but had not tested it for safety.
The attendant publicity resulted in public acceptance of increased
powers to the FDA requiring all drug manufacturers to test each new
compound for safety and to submit the results of those tests to the
agency for approval prior to marketing. The FDA also was empowered
to remove from the market any existing substance it believed to be
unsafe.
From a strictly theoretical point of view, the first part of this
law was beyond reproach, but the second part was a colossal mistake.
It is logical to require a food or drug manufacturer to take
reasonable steps to insure the safety of his product. It is also
logical to require him to place appropriate warnings on his product
labels where there is a possibility that its improper use could
result in harm.
But to give a government agency the power to
prohibit the marketing of a substance because it feels it is
unsafe - this was the crack in the dike that eventually destroyed the
barrier against the rushing flood waters of favoritism and
corruption. After all, most drugs could be removed from the shelves
on the truthful assertion that they are unsafe; and, as we have
seen, the process by which some are removed and others allowed to
remain is not always a scientific one.
As Science magazine reported: The FDA is not a happy place for
scientists to work... Several researchers showed the students [who
were gathering data on the FDA] atrocity logs in which they kept
detailed accounts of assaults on their scientific integrity... The
most common complaint was that the FDA "constantly interferes" with
medium and long-range research projects, at least partly from fear
that the results will embarrass the agency.
The students also
criticized the FDA for retaliating against scientists who disagree
with its position.(1)
1. "Nader's Raiders on the FDA: Science and Scientists "Misused"'
Science, April 17, 1970, pp. 349-352.
Granting the government the power to suppress products because of
allegedly being "unsafe" was bad enough. But it was nothing compared
to the fiasco that was enshrined into law as the Kefauver-Harris
amendments to the Food and Drug Act on
October 10, 1962.
Following in the wake of the publicity given to
the deformed babies born to European mothers who had taken the drug
thalidomide, the new law gave the FDA the power to eliminate any
drug product that it claimed was ineffective as well!
The thalidomide scare had no bearing on the new law. First of all,
thalidomide was not being used in the United States. And secondly,
the birth defects were not caused by a lack of the drug's
"effectiveness," but lack of adequate testing to determine "safety"
and long-range side effects.(1)
1. Thalidomide has since been shown to be highly effective in the
treatment of leprosy patients and has been credited with saving many
lives. But, because of government restrictions on its manufacture
and use, many leprosy patients are being denied the drug which, to
them, could mean the difference between life and death. See
"Thalidomide Combats Leprosy," (AP), Boston Globe, June 29, 1969, p.
50. Also, "Horror Drug Thalidomide Now Used to Save Lives of Leprosy
Patients," National Enquirer, Nov. 25, 1973, p. 50.
It is almost impossible to prove that any particular drug is
effective. What will work for one may not work for another. The test
of effectiveness often is a subjective evaluation on the part of the
user. Effectiveness can be determined only by the patient either
alone or with consultation with his physician. Putting such power
into the hands of political appointees with their almost unbroken
record of corruption throughout the years is madness.
And, as we
shall see in a following chapter, it is precisely this aspect of the
"protection racket" that has prevented Laetrile from being available
in the United States and, thus, has been responsible for the
needless suffering and death of millions.
Perhaps it should be mentioned for the record that most of the
employees of the FDA are honest and conscientious citizens who are
not participants in fraud, corruption, or favoritism. Most of them,
however, are at the lower echelons and have no voice in the policies
of the agency they serve. But the higher one climbs within the
structure, the greater become the temptations, and the very highest
positions of all are reserved for those who have demonstrated their
talents, not in the field of science where truth is king, but in the
field of politics where truth, often as not, is chained in the
deepest dungeon as a dangerous enemy to the throne.
The result of concentrated government power, however, is
almost as deadly when wielded by honest men as it is in the
hands of those who are dishonest. This point was brought home
quite convincingly by Lynn Kinsky and Robert Poole in an analysis
prepared by them for Reason magazine.
Discussing the impossibility
of determining drug "effectiveness vs. ineffectiveness" for
populations as a whole, they wrote:
The uppermost concern of the bureaucratic mind is rules and
procedures expressed in countless official forms and paperwork. The
inference, in the FDA's case, is that if the bureaucrat does not
know how to ensure that a drug is "effective," the next best thing
is to require such a mountain of paperwork that the bureaucrat is
"covered" at every possible turn.
As a result, since the FDA began
requiring "effectiveness" documentation, the length of time it takes
to get a New Drug Application processed has tripled. Preparing the
monumental paperwork adds millions of dollars to a drug firm's
research budget - which has the effect of discouraging smaller
(perhaps more innovative) firms from even attempting to get new
drugs approved.(1)
1. "The Impact of FDA Regulations on Drug Research in America
Today," by Lynn Kinsky and Robert Poole, Reason, Vol. 2, No. 9,
reprint, pp. 9,10.
It bears repeating that the FDA could not long maintain public
confidence if it did not occasionally go after a few genuine
villains.
Most of these culprits, however, are small-time operators.
The industrial giants often are guilty of the same offenses, but the
FDA extends to them an unofficial favored status. One of the reasons
for this double standard is that the larger companies have the
financial resources to challenge the FDA's actions in the courts, a
procedure that often reveals the shabbiness of the agency's work,
thus damaging its public image. Since the FDA is especially
interested in the favorable publicity resulting from its efforts to
"protect the people," it quite naturally prefers to pick on the
little guy who cannot afford to fight back.
In 1962, for example, the FDA, in cooperation with state health
officials, seized a supply of safflower oil capsules in a small
Detroit store on the basis that they were being used to promote the
book, Calories Don't Count, by Herman Taller, M.D. It is widely
accepted today that, indeed, in a dietary program, calories do not
count for many people nearly as much as do the carbohydrates.
But,
in 1962, the FDA had declared that this book should not be read by
the American people, and especially that safflower oil capsules
could not be sold in any way that connected them with the theme of
the book. This, in their great wisdom, was declared as false
labeling.
Following standard procedure, the FDA tipped off the local news
media that a seizure was about to take place and, as a result, when
the officials arrived on the scene, members of the press were on
hand to fully document and photograph the great raid. Needless to
say, the public was both impressed and grateful to learn that their
FDA was on the job "protecting" them from such unscrupulous
merchants of fraud.
The main point, however, is that the city's largest department store
also had been displaying the books and capsules. But, prior to the
raid on the smaller store, the FDA had called the officials of the
larger store, advised them of the pending seizure, and suggested
that they could avoid embarrassing publicity if they would merely
remove the offending merchandise quietly and voluntarily.
The agency
had correctly reasoned that it could accomplish its goal better by
picking on the little guy and avoiding a confrontation with a firm
that had the resources to fight back.
Sometimes the failure to treat the big operators with the same
harshness as the small is due, not to the fact that they are large,
but because they are "in." They are part of the cartel
establishment. For example, during the 1970 hearings before the
House Subcommittee on Intergovernmental Relations, it was revealed
that a small journal was forced by the FDA to publish a retraction
of certain statements contained in an advertisement for an oral
contraceptive. But the large and prestigious New England Journal of
Medicine which carried the same ad was not required to publish any
retraction at all.
When asked about this discrepancy, FDA
Commissioner Charles Edwards replied that the larger magazine
"didn't really mean to offend."(1)
1. "Who Blocks Testing of Anti-Cancer Agent?," Alameda Times Star
(Calif.), Aug. 3, 1970.
This is not to say, of course, that the FDA never tackles a larger
firm, for occasionally it does. But, when it does, you can be sure
that the cards are stacked against the defendant.
Regardless of
one's financial resources, unless he is part of the international finpol interlock, he cannot hope to match the unlimited resources of
the federal government.
Private citizens must hire attorneys. The
government has buildings full of attorneys on the tax payroll just
waiting to justify their salaries. It matters not in the least to
the FDA how long the litigation drags on, because the delays,
postponements, and continuations actually are part of its strategy
to bankrupt the defendant with astronomical legal expenses.
In the court proceedings against Dr. Andrew Ivy, for example, the
trial lasted for almost ten months. Testimony of 288 witnesses
filled 11,900 pages of transcript - enough to make a stack seven feet
high. It is estimated that the FDA spent between three and five
million dollars of the taxpayers' money. There is no way that the
average citizen can hope to match that kind of legal offensive.
On top of this financial handicap, the defendant must face the fact
that there are few judges or juries who will have the courage to
decide a case against the FDA, whose attorneys are adept at planting
in their minds that if they should do so, and if they are wrong,
they will be personally responsible for thousands of deaths.
Under
this kind of intimidation, a judge or jury is almost always inclined
to conclude that they will leave the scientific questions up to the
scientific experts (the FDA!), and that they will concern themselves
strictly with the questions of law.
However, even in those cases where the court's verdict is favorable
to the defendant, he often must face the wrath of FDA officials who
then make it a point to harass him and, hopefully, to initiate
additional law suits.
Commenting on this aspect of the protection racket, Omar Garrison
writes:
During the course of a legal battle which appeared to be going
against the government, a ranking FDA official told the defense
attorney:
"If this case plays out, we will just work up another
lawsuit, you know."
It was not an idle threat. There is documented evidence to show
that, in case after case, a respondent exonerated by the court has
emerged from the ordeal (often exhausted and bankrupt) only to be
faced with a second or even third indictment...
The dictocrats seem
to reason that sooner or later a defendant will exhaust his
financial resources and lose the will to defend himself when he
realizes that he is pitted against the limitless potential of the
national government.(1)
1. Garrison, op. cit., pp. 153, 156.
The limitless potential of the national government includes a lot
more than a battery of tax supported lawyers. Once an individual has
incurred the wrath of the FDA, he can expect to find himself the
target of harassment from other agencies of the government as well.
Probably first at his door will be the man
from IRS to scrutinize his tax records with a determination to find
something wrong.
If the defendant sells a product, the Federal Trade
Commission will take a highly personal interest in his operations.
If he has programs on radio or television, the stations that carry
his message will be contacted by the Federal Communications
Commission and reminded that such programming is not in the public
interest.
The man from OSHA (Occupational Safety and Health
Administration surely will want to examine his facilities for
possible (inevitable) violations of obscure safety and health codes.
The Fair Employment Practices Commission may suddenly discover
unacceptable employment or hiring practices. If he is a physician,
he can look forward to closer attention from PSRO (Professional
Standards Review Organization) to evaluate his judgment in the care
of his patients.
As a last result, he may even find himself the
object of Post Office action resulting in the denial of such a basic
business necessity as the delivery of mail. And superimposed upon
all these actions there has been the constant and conscious effort
of the FDA to secure maximum exposure in the mass media for the dual
purpose of perpetuating its own image of "protecting the people"
while at the same time destroying the reputations and businesses of
those it has singled out for attack.
The advance notice to the press
corps of a planned raid or arrest thus becomes an essential part of
the FDA's strategy. Even if the defendant eventually is exonerated
in court, he will be viewed by the general public as criminally
suspect because of the lingering impact of the dramatic news stories
and pictures of his arrest.
The economic damage done to the
defendant as a result of this carefully contrived publicity often is
far greater than any fine or penalty that could be imposed in court.
Lest this sweeping indictment sound too harsh or exaggerated, let us
turn our attention next to specific examples and actual cases.
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