The Attack Dog:
The Role of The FDA
Racketeering in Medicine - The
Suppression of Alternatives
by James P. Carter, M.D., Dr. P.H.
"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".- Dr. Herbert
Ley, FormerFDA Commissioner, 1970.
The FDA was created at the beginning of the century by government, with
input from the AMA, to govern the safety of foods, drugs and cosmetics.
It had no legal power to test drugs for safety, however. The following
account of the history of the FDA's role has been taken from a talk
entitled "The Rise of the Cult of Pseudoscience," given by Dr.
Charles Harris, a pathologist, to the American College of Advancement in
Medicine a few years ago.
In 1927, the FDA became a separate agency required to test drugs for
safety. In 1959, Senator Estes Kefauver (D-Tenn.) launched an
investigation into the pharmaceutical industry which had already been
accused of gouging the public. In the midst of the investigation, the
thalidomide tragedy occurred. Some historians say this tragedy was
significant in that it slowed the development of new drugs, because of
the additional bureaucracy which resulted. (Actually, thalidomide
remains a useful drug in the treatment of leprosy; it also stimulates
the immune system. Instead of teaching doctors how to use thalidomide
properly, as it did in the case of the new acne drug Acutane, the FDA
prohibited the use of thalidomide altogether.) Also during this time,
unethical medical research was uncovered in New York City. Cancer cells
were being inoculated into nursing home patients to determine what would
happen to them, unbeknownst to the patients or their relatives.
These events caused opposition to human experimentation, which became
severely regulated. A stronger FDA emerged, which was required to
guarantee not only safety, but effectiveness as well. This meant that
human subjects had to be involved in order to accomplish this.
Otherwise, proof of efficacy would be impossible. The pharmaceutical
companies then began to offer medicines and monies to the universities
to conduct the necessary clinical trials to show efficacy. The academics
began to worship at the altar of clinical trials. The result,
tragically, was that the double-blind crossover study became the
"double-cross blindover study". . .the real cult of
Pseudo-science was born.
The new rules and regulations pushed by the FDA resulted in these
disadvantages:
Slower development and delivery of new drugs An intimidated
pharmaceutical industry (until they began to win friends and influence
people) Medical services that had been offered voluntarily in connection
with clinical trials now made mandatory, either executed or enforced by
the FDA Refusal to look at alternatives Sluggish response times; lost
new drug applications; bribery; indifference; promotion of generics
leading to a generic drug scandal, and a total lack of flexibility
THE AMA CAUGHT RED-HANDED COLLUDING WITH THE FDA
The government-sponsored chelation studies (covered in an earlier
chapter) at Walter Reed and Madigan Army Hospitals did not originate
from any burning desire for scientific inquiry on the part of the FDA,
academia or pharmaceutical corporations. What, then, motivated them to
help design and approve a controlled study to evaluate the safety,
effectiveness, and dose-response curve of EDTA in the treatment of
peripheral vascular disease?
The answer lies in the comments of Stuart Nightingale, Asst.
Commissioner for Health Affairs of the FDA, when he went on record at a
meeting of the House of Delegates of the AMA in Honolulu, Hawaii, seven
or eight years ago, telling AMA delegates, "We can't put these
chelation doctors out of business by ourselves. We have to work closely
with you, the AMA, and other groups, to put them out of business."
It happened that a leading chelation doctor, Garry Gordon, was in the
audience intending to plead the case for using chelation in the
treatment of arteriosclerosis and its complications. Dr. Gordon hoped to
convince the AMA to at least allow time for independent scientific
inquiry and to not ban the therapy outright. Dr. Gordon recorded Dr.
Nightingale's remarks and later shared them with Attorney Greg Seeley,
legal counsel for the chelation doctors' professional organization, AAMP,
now called ACAM. Mr. Seeley observed that the FDA should not be in the
business of putting doctors out of business for using an approved drug
for an unapproved purpose, which is common medical practice. The
attorney drafted a letter to the FDA protesting Dr. Nightingale's
remarks. He also requested an explanation as to why chelation doctors
should be "put out of business" for treating heart disease
when chelation is already sanctioned as a medical procedure to remove
heavy metal, usually lead poisoning. Attorney Seeley had the AMA over a
legal barrel.
The FDA reply did not mention the obvious illegality of Nightingale's
remarks, but suggested that a delegation from AAMP meet with FDA
officials to discuss controlled clinical studies. A working relationship
was established between Dr. Ross Gordon, brother of Dr. Garry Gordon,
and Dr. Lawrence Lepickey, chief of the cardio-renal division of the
FDA. Working together with his designates, Dr. Ross Gordon developed the
research protocol now being used to evaluate the efficacy of EDTA in the
treatment of peripheral vascular disease and to determine a
dose-response curve. The reader will recall the statement by Organized
Med's mouthpiece, Victor Herbert, in his Ontario address, "that the
most effective method" of getting rid of a therapy like chelation
therapy is by taking the practitioner to court and that the second way
to fight the problem is "by lobbying for anti-quack
legislation." He added, "In New York State we are putting them
out of business." This legal strategy has gotten out of hand. The
definition of a quack is too vague and generalized for the courts to be
involved in resolving questions and conflict in science. The legal
system should be used only to stop someone who is causing harm to the
public. The debate over the safety and effectiveness of chelation
therapy (after nearly 500,000 people have been treated) and the debate
over the safety or toxicity of evening primrose oil (after some eighteen
countries have generally recognized it as safe, safe enough in fact to
be added to infant formula in Japan) should not be argued in court.
The Walter Reed Army study will be much larger in scope than the study
that was conducted in Heidelberg, West Germany, by Dr. Gerhard Schettler
and the study conducted by Dr. Anthony Gotto and his associates at
Baylor University and Methodist Hospital in Houston, Texas, neither of
which has ever been published. The Danish study published in August,
1991, as we have seen, is patently flawed in that there was obvious
manipulation of the sample study. Dr. Efrain Olszewer and I published
our study in the April, 1990, issue of the Journal of the National
Medical Association.
Dr. Lepickey has also remarked that Dr. Gotto should not have conducted
his independent study without clearing it with him and others in the
Cardiorenal Division of the FDA. This is strange. Isn't respected,
competent Dr. Gotto, researcher and administrator, capable of doing his
own research?
When all of the studies have been completed, most likely a meta-
analysis will be performed. This type of analysis determines
mathematically what the weight or preponderance of the evidence shows,
an unnecessary hassle to determine what should have been obvious at
first glance. The investigations and expenditures are unavoidable in a
scientific and legal sense, however, as long as "liars can
figure" and as long as people like Victor Herbert can be paid by
Organized Med to haul practitioners into court on accusations of fraud,
pretending to argue valid science before naive and
scientifically-illiterate panels and judges.
THE GENERIC DRUG SCANDAL - THE TIP OF THE ICEBERG
The American Academy of Family Physicians warned in 1989 that generic
drugs may at times be inferior, even dangerous, especially for persons
with asthma, diabetes, or heart disease. Nevertheless, generic drugs are
now an annual $3 billion dollar industry.
The FDA branch chief for generic drugs, Mr. Gerald Chang, accepted
thousands of dollars in illegal pay-offs from generic drug companies,
whose applications he approved. He facilitated those who paid him off
and inhibited the others. Mylan Labs Pharmaceuticals became suspicious
because its drugs were not getting approved. The CEO for Mylan, Mr. Roy
McNight, hired a private detective who conducted a one-year
surveillance, which included going through Chang's garbage, to find
evidence of this government scandal. They found plenty! Companies had
submitted fake data and cheated, and there were pay-offs. The generic
company Vitarin sent in bogus data and submitted the original drug for
testing, claiming it was their generic version. The FDA system of
approving generic drugs was subverted by the very industry it was
supposed to regulate.
This scandal certainly raises questions about the safety and
effectiveness of generic drugs and how they are regulated. A generic
drug is usually a discount-version of the name-brand drug. The generic
supposedly uses the same active ingredient as the name-brand. However,
some companies substituted brand-name drugs for their own generic
brands, just to get FDA approval; then they proceeded to manufacture
poor quality and/or ineffective generic substitutes. One-third of all
drugs sold in the U.S. today are generic. The generics industry claims
to offer the same quality as brand-name drugs, at substantially lower
prices. Certainly there are ethical generic companies now under serious
question, but the challenge lies in determining who cheats and who
doesn't.
Congressman John Dingle's sub-committee conducted the investigation and
broke the story. In June, 1990, Marvin Seife, the former head of the
FDA's generic drug division, was the fifth FDA official to be indicted
by a federal grand jury on charges of perjury. This indictment resulted
from a two-year investigation of improprieties between FDA officials and
generic companies. Four of Seife's former employees at FDA have already
been convicted on corruption and racketeering charges. Five industry
executives, three companies and one consultant have been convicted of
similar charges. Some thirty generics were asked to re-submit
abbreviated New Drug Applications. Other evidence uncovered refusal of
the FDA to hear complaints coming in from generic companies who were
playing it straight and not getting their drugs approved.
The Division of Generic Drugs, in this instance, was guilty of criminal
misbehavior. Congressman Dingle stated he could not "vouch for the
safety of generics." Former FDA Commissioner Frank Young
re-organized the Generic Division, prior to leaving office, uncovering
more evidence of fraud, bribery, substitution, and false reporting.
Where does it end? Not with the Generic Drug Division. Read on, please.
ADVICE FROM THE PRESIDENTIAL ADVISORS PANEL, 1990
In August, 1990, a Presidential Advisory Panel reported to President
Bush at the White House that the federal government should speed up
approval of experimental AIDS and cancer drugs, by requiring less
evidence of effectiveness before they are put on the market. The
chairman of the nine-member advisory panel was Dr. Lewis Lasagna, Dean
of the School of the Graduate Biomedical Sciences at Tufts University.
Dr. Lasagna warned that thousands of lives are lost each year from
delays in approvals and marketing of AIDS and cancer drugs.
The report stated, "Desperately ill patients are prepared to accept
the greater risk inherent in the use of such medications. Faced with the
consequences of a lack of therapy for AIDS and cancer, an expanded
mechanism for early access to investigational drugs is morally,
ethically and scientifically justified." Dr. Lasagna and the panel
suggested that approval of a new drug could be postponed until after the
drug is on the market, provided two types of studies are done first. One
study measures the effectiveness of new drugs in comparison with those
which are already on the market; the second assesses whether or not a
given drug prolongs life. The panel recommended that the government
should not insist that a drug company demonstrate "prolongation of
life, if a drug can improve the quality of a patient's life."
"For cancer and AIDS patients, time is running out, and they are
understandably upset with delays in obtaining the pharmacotherapy which
represents their only hope," the panel noted. For these
life-threatening diseases, it added, the government should approve new
drugs at the earliest possible point in their development, and, in any
event, earlier than previous time frames.
At a subsequent news conference, Dr. Lasagna pointed out that the FDA
often demands more data than are required by either federal law or
scientific criteria for judging the value of new drugs.
It now takes twelve years and costs $231 million to research, test, and
get approval for a new drug, according to a Tufts University study which
was released in the spring of 1990. This report by the Center for the
Study of Drug Development noted that, even accounting for inflation,
this estimate is twice what the Center had found when it did a similar
study in 1979. The Tufts study was based on a random selection of
ninety-three drugs developed by twelve pharmaceutical firms and tested
on humans between 1970 and 1982. The cost figures were then adjusted for
inflation to 1987 dollars.
Both Congressman Waxman of California and Congressman Wyden of Oregon
were critical of the FDA in 1990. They described a steadily
deteriorating ability of the Agency to carry out its mission and
functions. During the previous decade, the Agency was underfunded and
understaffed; there was a lack of information and a lack of
independence. This set the stage for the generic drug scandal.
Congressman Wyden accused the agency of putting politics before science.
These criticisms are only the tip of the iceberg. Further congressional
scrutiny into the agency's association with drug companies is certainly
warranted from the evidence surfacing. Why do representatives from drug
companies make up more than 50% of some FDA drug-advisory boards? This
creates a bias in favor of prescription and over-the-counter (OTC)
medicines over natural remedies or herbal products.
The new Food and Drug Commissioner, David Kessler, has been given a
mandate to (1) develop food labeling guidelines and (2) increase the
Agency's scrutiny over medical devices. Although laudable, these
objectives have nothing to do with the change that is needed in the
agency's orientation - from working for the industry it is supposed to
regulate, to working objectively for medical advances in the best
interests of those who pay FDA salaries, the American taxpayer.
In addition, if the proposed new regulations for medical claims for
foods are any indication, then the Agency appears to be going backwards
in regard to their first mandate. They are proposing that only two foods
and/or nutrients be recognized as having a direct effect on the
occurrence of disease: (1) calcium (osteoporosis), and (2) dietary fat
(cardiovascular disease and cancer).
The first of these is probably not even a direct effect in terms of
treatment or prevention. The fact that they consider all of the other
relevant research on nutrition and health inadequate for making clinical
claims suggests that, as least as far as food labeling is concerned,
business is worse than usual. These decisions are obviously not based on
science. The pharmaceutical boys just don't want to open the door to
this kind of competition, and they are using their FDA lackeys to help
keep it shut. Only a public outcry and/or pressure from Congress and the
White House can turn this situation around.
The late comedian Lenny Bruce's takeoff on an American politician,
"I'm not a crook - elect me!" came to mind when Dr. Kessler
took over the FDA in November, 1990, and said, "I am not going to
protect crooks." Jack Anderson, in his commentary "High Noon
for the New Sheriff at the FDA," noted that this was something most
federal agency heads don't have to say when they take the job. Anderson
commented, "[when Kessler takes over] it should be something like
grabbing the helm of the Exxon Valdez after it hit the bottom."
Dr. Kessler's predecessor, Frank Young, had been forced to resign after
the generic drug scandal surfaced under his watch in 1989. The agency's
credibility was at an all-time low. It was accused of prematurely
approving life-support medical devices, and allegations also surfaced
that FDA agents were using insider information on drug approvals to play
the stock market.
Anderson's congressional sources provided this insider observation:
"There is a big concern on Capitol Hill that Kessler doesn't get
captured by any of the bad elements that linger on in the FDA."
They went on to say that he should let it be known "that there's a
new sheriff in town." His tolerance for the old way of doing
business at the FDA remains to be seen. No one should hold his breath,
however. This is probably bigger than what one man can do, no matter how
well-intentioned.
Racketeering in Medicine: The Suppression of Alternatives Copyright ©
1992, 1993 by James P. Carter, M.D., Dr. P.H. Published by Hampton Roads
Publishing Company, Inc.891 Norfolk Square, Norfolk, VA 23502. Tel.:
(804) 459-2453 Fax: (804) 455-8907. ISBN: 1- 878901-31-X
THE FEDERAL DRUG ADMINISTRATION
In the late 1950's Dr. Henry
Welch, head of the FDA's division of antibiotics was paid-off $287,000
from drug companies he was supposed to regulate.
In 1964 the FDA filed a lawsuit against Andrew Ivy, Vice President and
Professor of physiology at the University of Illinois. Ivy was the elite
of mainstream medicine in the US at the time with impeccable
credentials. The moment he advocated an alternative treatment,
Krebiozen, he was branded a quack overnight. Over 20,000 cancer
patients had allegedly benefited from Krebiozen. After 289 days at
trial, and admitted purjured testimony from one doctor, Ivy and three
co-defendants were acquitted of all 240 counts. Krebiozen was never
properly investigated.
FDA commissioner (in the 1960's) James Goddard persecuted a potentially
excllent drug, DMSO, a simple molecule which often brought pain relief.
Positive studies by scientists numbered in the 1000's but he did not
care. A drug company executive supposedly told the leading DMSO
researcher, from "The Healing of Cancer",
"I don't care if it is the major drug of our century-and we all
know it is-it isn't worth it to us."
Apparently it would have threatened too many other profitable drug
lines. A few years after leaving the FDA Goddard became Chairman of the
board of Ormont Drug and Chemical company.
In 1969 the US Congress study found that 37 of 49 top FDA officials
moved to high corporate positions in companies they were previously
supposedly regulating.
In 1970, former FDA commissioner Dr. Herbert Ley 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 is doing
are as different as night and day."
A 1975 GAO study found 150 FDA officials owned stock in the companies
they were supposed to regulate. In 1975, an independent government
evaluation found massive conflicts of interest among the FDA's top
personnel.
According to a Tuft's University study released in 1990, it now takes 12
years and costs 231 million dollars to research, test and obtain
approval for a new drug. Along with the requisite mountain of paperwork.
As is typical with all government bureaucrats, they demand copious
amounts of paperwork to protect themselves if their decision is proven
wrong. Meanwhile important drugs are held up for years or are never
investigated due to the enormous cost and time involved.
The FDA's generic drug scandal hit the news in 1989. Some companies were
obtaining fast approvals for their drugs from the FDA while others were
delayed for years. The CEO of one company hired a private detective to
investigate why some companies received approvals and his was not.
They found that several FDA reviewers were accepting bribes from some
drug companies to speed their drugs through the process and derail those
submitted by competing companies. Eventually 42 persons and ten
companies were found guilty of criminal acts.
A battle being fought now epitomizes how far the FDA will go in order to
protect the drug companies profits. For over eleven months Jim and Donna
Navarro have fought the FDA for the right to give their five year old
son, Thomas, an alternative treatment. Thomas suffers with
Medulloblastoma, a type of malignant brain cancer. After surgery,
chemotherapy was recommended. Jim and Donna asked what the side-effects
were;
...Fluid on the middle ear, hearing loss, memory loss, hyperthyroidism,
spinal growth deficit..." the list went on. Worse, permanent
retardation. Jim and Donna researched their sons cancer for thousands of
hours. They found Dr. Burzynski?s treatment (antineoplastons) in
Houston, that has had some very good success with this type of brain
cancer, with minimal short term side effects.
The FDA refuses to allow Burzysnki to treat Thomas until he has
undergone chemotherapy and radiation treatment first. Jim and Donna
pleaded with the FDA commissioner Jane Henney, her superior Donna
Shalala and several politicians, all to no avail. The FDA would rather
see Thomas Navarro dead than taking the medicine of his parents choice.
The FDA's motives are explicitly clear. Prominent FDA officials protect
the pharmaceutical companies profit margins and are later rewarded with
lucrative positions within those same companies. As Burzysnki says;
"The past commissioner of the FDA-now he is an official of one of
the large pharmaceutical companies, with a salary of 2 million a
year."
The Cancer Racket
THE FEDERAL DRUG ADMINISTRATION
Recently the FDA is trying to
police the Internet and close down any alternative treatment websites.
According to William Falloon the FDA wanted to set-up a rapid response
team to identify, investigate and prosecute websites. As Falloon says,
the FDA is seeking to establish an army of cyberspace storm troopers to
enable it to shut down large numbers of websites quickly.They wanted to
spend a million dollars a year on artificial intelligence computer
robots that would scan the internet for phrases such as "prevents
cancer" and "prescription drug" so the FDA could swiftly
gather the infomration needed to prosecute.
This would be hilarious if it didn't pose such a serious threat to our
freedom of choice, freedom of speech and freedom of the Internet. I
don't need the "nanny State" micromanaging my life and telling
me, oh-so-kindly, that they know what's best. That is statism, if you
like it, emmigrate to Beijing.
This is what you get when you allow corrupt, out-of-control government
bureacracies to have unlimited power to do whatever they want. The FDA
is staffed with unprincipled tyrants who wield far more power than they
should ever have. The FDA's history is one of serving the career goals
and political interests of key officials. They know where their bread is
buttered, and that is enforcing the agenda of man-made patentable drugs.
In 1970 Dr. Charles Edwards, commissioner of the FDA said,
"(It is) not our (FDA) policy to jeopardize the financial interests
of the pharmaceutical companies."
That's right Charles, the FDA protects the drug companies monopoly by
sytematically suppressing any and all natural or unprofitable
alternatives. Thirty years later, nothing has changed.
Truth
Seeker Co., Inc. (ISSN 0041-3712) © 1996
http://www.mindfully.org/Food/Food-Last-Forever-3.htm
