When Tyranny Strikes from within: The FDA part 1


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Posted by for Willaim H. Moore, Jr., HomMD and attorney on June 03, 1997 at 13:10:36:

William H. Moore, Jr. Attorney at Law
910 East Victory Drive Savannah, Georgia, 31405
(912) 233-5858 - Telephone (912) 233-6984-Facsimile

March 22, 1995

Congressman Jack Kingston
1507 Longworth House Office Building
Washington, DC, 20510

Re: Food and Drug Administration

Dear Congressman Kingston:

When tyranny overtakes America and destroys freedom, it will not be an invasion of foreign troops,
it will be through our own government bureaucracy and that has been occurring with alarming frequency
lately - no Adhere more than in the FDA.

This has become a criminally, corrupt organization under the leadership of David Kessler, who
aspires to become America's first Medical Furhrer.

He has already put into place a Fedstapo of FDA Storm Troopers which should be dismantle
immediately and irrevocably by Congress which should, as a matter of fact, dismantle the entire agency
as a good idea which went badly wrong, and a mistake our Nation should never repeat.

Most of what the agency does could be done much better, at far less cost, by a private sector industry
organization much like the Underwriters Laboratory.

The FDA was created to make sure that Food, Drugs and Cosmetics were safe, pure and sanitary.

The agency, was small but efficient enough; what got wrong was the typical, indeed, irreversible lust
of bureaucrats to expand their jurisdiction and intermeddle into the lives of the citizenry and, by
1962, the agency inveigled a complacent Congress into passing the efficacy requirement for drugs which
has been, since its inception, the royal road to disaster for America.

Efficacy, has nothing to do with safety, purity and sanitation and, indeed, efficacy is and -I-
always will be a matter of viewpoint and opinion, unlike safety, purity and sanitation, which are
absolutes.

Under the guise of efficacy, the agency has forgotten its safety mandate, driven the cost of drugs and
devices to an incredible cost, destroyed the ability of American Device Manufacturers to compete in
international markets and, incredibly attempted to take over the control of medical practice, over which it
was never intended to have any jurisdiction. It has been shot through with corruption, inefficiency and
all the other evils of rampant bureaucracy.

At this time the FDA has approved several drugs which are unsafe, such as Prozac (Fluoxetine
Hydrochloride)1, and some common antihistamines 2 which accelerates cancer growth, and Tylenol
(Acetaminophen), and Advil, (Ibuprofin) 3 which cause end-stage kidney failure, and liver damage and
although these effects are well known, the FDA has taken no action. In the meanwhile, it has kept off the
market many safe drugs and devices while it dawdles its way through efficacy determinations and
expends gigantic sums of money harassing people who manufacture, sell or use vitamins, minerals and
herbs which are absolutely safe, or seizing large shipments of wholesome orange juice because
Obersturmbahnfuhrer von Kessler didn't like the label.

I and a large number of other Americans feel that the imposition of the efficacy requirement (21
USC 355(d)(5) in addition to the safety requirement (21 USC 355(d)(1), was a mistake and one A-which
should be rectified by the repeal of 21 USC SS 355 (d)(5) and the amendment of 21 USC SS 355 (d)(1)
to include much more expansive pre-marketing toxicity testing along the lines recommended in the United
State General Accounting Office Report (B- 235044-GAO PEMD 90 15 FDA Drug Review,
Postapproval Risks 1976-86), which found severe post-approval risks including heart failure, myocardial
infarction, anaphylaxis, respiratory depression and arrest, convulsions, seizures, kidney and liver failure,
severe blood disorders, birth defects and fetal toxicity and blindness to have occurred in more than 50%
of drugs approved by, FDA between 1976 and 1985.

The crux of the argument is that where a drug is safe and non-toxic, and a person suffering from
a disease wishes to use it, with full knowledge that its effectiveness has not been proven or even is
believed by many to be ineffective, the government's intrusion into the individual's choice of treatment is
grossly paternalistic and a denial of the individual's right to decide for him or her self.

Approximately one half of Americans 4 now use unorthodox medical services routinely for all or
some part of their health care and many Americans have little faith in the Orthodox (Allopathic) approach
to chronic degenerative diseases such as Cancer. This loss of faith is based on the experience of the past
30 years as to the ineffectiveness, toxicity and high cost of FDA approved Chemotherapy and a now
fairly inexpensive demonstration that unorthodox cancer remedies not approved by FDA are frequently
effective, produce no side effects and have a far more reasonable cost.

The general belief, prevalent in 1962 that allopathic medical treatments were or soon would be
universally effective for the treatment of diseases has not stood the test of time, and now thirty-three
years later is tattered, torn and stained by the failure of Allopathic medicine to find acceptable treatments
for cancer, arthritis, diabetes, or many other chronic diseases as well as the unacceptable rate of long
term harm from the chronic ingestion of drugs approved by the FDA as well as the increasing failure of
antibiotics to control infections. The myth of allopathic infallibility has been shown to be precisely that -
a myth; nearly half of American citizens now look elsewhere for treatment of chronic diseases - to
nutritional, herbal, Oriental and Homeopathic practitioners to an extent undreampt of in 1962.


In Regulating the Prescribing of Human Drugs for Non Approved Uses Under the Food,
Drug, and Cosmetic Act, 5 “Harvard Journal on Legislation,” Vol. 15:4 page 708 and 709, Kessler
stated:

“ . . Regulating the uses for which drugs are prescribed is far different from
regulating the availability of new drugs. The regulation of uses would broaden the reach
of the FDA and would have an added effect on the clinical decisions reached by patient
and physician. Under such an expanded role, the FDA would regulate not only 127
drug manufacturers, but also 375,000 physicians" . . .

This is precisely what Kessler did and the FDA is doing.

Much of the cost of pharmaceuticals is directly attributable to the inordinately high cost of
compliance with the efficacy requirements of the 1962 amendments, some three to four hundred million
dollars per individual use approval by the FDA - which can amount to several billion dollars a year
passed on to consumers as well as two to three billion dollars in expenditures of tax funds for the activity
(this year (1995) the FDA is requesting an additional $850,000,000 to acquire a new building).

These are unnecessary expenses to accomplish governmental purposes which many of us view as
inimical to our best interests and to our personal freedoms and liberties as well.

I urge you to initiate, co-sponsor and support legislation to dismantle the rampant out-of- control
bureaucracy of the FDA and replace its functions with private sector voluntary testing like the
Underwriter's Laboratory and transfer the FDA's food inspection function to the Department of
Agriculture where it has always belonged.

In a recent article entitled Problems With the FDA,6 the author states:

“The FDA is charged with regulating products from 90,000 companies that
account for 25 cents of every dollar spent by the American consumer - - more than
$550 billion. Besides regulating the safety and efficacy of new drugs and safeguarding
the food supply, the FDA is responsible for a wide array of products affecting all areas
of modern life, from the nation's blood supply to vaccines, feed and drugs for animals,
cosmetics, medical devices, and microwave ovens.

“As this list of responsibilities suggests, the FDA represents a collection of
regulatory authorities thrown together over the years as the consequence of historical
accident, legislative fiat, and bureaucratic reorganization." . . .

This combined with the Commissioner's personal enforcement and allopathic medical philosophies
may be at the root of some of the problems.

The efficacy of pharmaceuticals as well as herbs, vitamins and mineral supplements and other
nutrients is best left to the consumer and the consumer's advisors of choice - physicians and other health
care practitioners.

If unwise decisions result and some money is wasted, the amount wasted cannot approach in
magnitude the present and future costs of the type of regulation we now have under the FDA as it
presently exists and operates and at least if Americans male an occasional unwise purchasing decision, it
is their decision, not that of an ever expanding bureaucracy.

Efficacy as usefulness of products is a factor in marketing and purchasing most products - if the
products result in consumer satisfaction, they will survive in the market - if they do not, they will
disappear from the market. The social costs of Big Brotherism, Lysenkoism and Bureaucratic
inefficiency should be considered as well as the fiscal costs.

The Safety and Efficacy Requirements

The Safety Requirement in FDA premarket approval of drugs is set forth in 21 USC Sec 355
(d)(1), and the Efficacy Requirement is set forth in 21 USC Sec. 355 (d)(5).

These two requirements are separate and distinct and have different purposes.

The Safety Requirement comes from the 1938 F. D. & C. Act and was enacted in response to an
incident in which Eli Lilly & Co. marketed a elixir of Sulfonamide, in a base composed of diethylene
glycol - now a commonly used antifreeze, which is extremely toxic. There had been no toxicity testing of
the substance which was selected by a chemist because it had a sweetish taste. In the aftermath of this
disaster, Congress enacted the 1938 Food, Drug Cosmetic Act Which first set forth the safety
requirement.

The Efficacy Requirement was enacted as a part of the 1962 Amendment to the 1938 Food,
Drug and Cosmetics Act, which was enacted as a consequence of the narrowly averted Thalidomide
Disaster and oddly enough, that was a pure safety issue and did not involve efficacy at all, but the
efficacy requirement was included as a part of an overall program to strengthen the enforcement structure
of the FDA with regard to drugs.

Much of the current problem between Commissioner Kessler and a large segment of the
American public arises from the inclusion in the 1962 Amendment to the Food, Drug and Cosmetic Act
of the so called "efficacy requirement" to the 1938 Act. The pertinent portion of that Amendment reads:

"21 USC Sec. 355 (d)

(d) If the secretary finds, after due notice to the applicant in accordance with subsection (c) of
this section and giving him an opportunity for a hearing, in accordance with said subsection, that . . . or
(5) evaluated on the basis of the information submitted to him as part of the application and any other
information before him With respect to such drug, there is a lack of substantial evidence that the drug

Will have the effect it purports or is represented to have under the conditions of use prescribed,
recommended, or suggested in the proposed labeling thereof: . . . he shall issue an order refusing to
approve the application.. . .

"Substantial evidence," as used in 21 U.S.C. Sec. 355(d) & (e) (1962), means: [E]vidence
consisting of adequate and well-controlled investigations, including clinical investigations, by experts
qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the
basis of which it could fairly and responsibly be concluded by such experts that the drug will have the
effect it purports or is represented to have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof."

Our complaint about safety testing and the FDA approval process is that there is not enough
safety testing, and that quite frequently unsafe drugs get through the approval process, i.e., Zomax,
Oraflex, etc.

Efficacy, like beauty, oftentimes lies in the eye of the beholder, and certainly is influenced by
the medical philosophy of the person who chooses a particular product for a particular purpose. There is
no universally acceptable yardstick by which the concept of efficacy can be equitably measured in our
country.

Our complaint is that the efficacy requirement has come vastly to overshadow the safety
requirement, and it is the efficacy requirement which slows the drug approval process and add an
incredible 2 to 3 hundred Million Dollars to the cost of approving each use for which an IND is
submitted. Safety testing, even more exhaustive safety testing than is now required could not cost more
than 5 % of this cost.

Since the 1962 Amendment the efficacy requirement has skewed the drug approval process and
has been the basis of widespread anti-competitive activity engaged in by the FDA and the Pharmaceutical
Advertising Council.

A prime example of lack of attention to safety and over emphasis on efficacy is to be seen in the
disastrous clinical trials of Fileuridine (FIAU) at NIH.

FIAU is a DNA chain terminator, akin to AZT, and is extremely toxic and lethal - it was being
tested as an oral dosage for use in treatment of chronic Hepatitis B. The compound was developed at
Memorial Sloan Kettering Institute and licensed to Oclassen Pharmaceuticals, which entered into an
agreement with Eli Lilly & Co. to develop the drug. The first three tests were sponsored by Oclassen, the
last by Lilly - and were done at the NIH.

Rep. Edolphus Towns (D. NY) at that time Chairman of the House Government Operations
Human Resources and Intragovernment Relations Subcommittee characterized the test thusly,: "This is
not science - it is lethal science fiction. . . let's face it, innocent people died and painfully, suffered as
a result of these misdeeds. It appears this whole tragedy could and should have been prevented.".

In all, ten patients died as a result of toxicity of the drug - five of those during the Phase II
Study conducted by NIH. This toxicity could have and should have been anticipated from the results of
the earlier tests, in which the five patients who died had also participated as subjects.

The upshot is that no one seriously analyzed the potential for toxicity, which was available but
not adequately analyzed or reported in a way that might have led to some understanding of the delayed
type of toxicity which killed these subjects.

Three of the four deaths in a previous study occurred in patients who had received the drug
previously and five of the patients who died in the NIH Study had been treated with a related compound
in a previous study. The FDA's analysis of potential toxicity was inadequate.

The determination of the wisdom of continuing the efficacy requirement and whether or not to
strengthen the pre-market approval process by requiring more stringent premarketing testing of toxicity is
peculiarly that of the Congress, and the courts have consistently refused to substitute their judgment for
that of Congress. In the last analysis, it is a political question to be determined by this Congress
reflecting the will of the people.

2. Cancer Therapies

At the time the efficacy requirement was enacted (1962) there was considerably more reason to
believe that allopathic treatments were beneficial than has proven to be the case since then.

In 1962, the efficacy requirement may have seemed a good idea to everyone, as that Was a
period of limitless faith in drug therapies, and particularly in cancer therapies in which chemotherapy had
just begun to be used. to treat cancer and everyone expected these drugs to solve the cancer treatment
problem in a few years.

In 1974, President Nixon signed a Bill to create the National Cancer Institute and to launch a
much publicized "war on cancer" which was expected to conquer the cancer treatment problems in a
decade. Two decades later, it is apparent to everyone that the "war on cancer" was another Viet Nam,
and we lost!

The death rate from cancer is much increased due to iatrogenic (drug-induced) diseases and
there are still no effective treatments for most cancers, as well as a significant downside to
chemotherapy’s so that patients who are treated with these drugs frequently die earlier than those who are
not treated at all.

In 1986, Dr. John Bailer 7 published his classic appraisal of the war on cancer, and [written
after the preparation of this article; a 10 year follow-up by Michael B. Spoorn, 8 in 1996 both are
chilling, both reveal the so-called “war on cancer is a total failure.”

Today, the number of people dying from cancer is exceeded only by the number of people who
make a handsome living, mostly at taxpayer's expense from costly and ineffective research on cancer, all
with continuing dismal results.

On the other hand, several essentially non-chemotherapeutic approaches to cancer therapy, none
of which have been approved by the FDA, have been developed and thousands of Americans go out of
the country to receive these cancer treatments usually with excellent results, oftentimes with complete
cures.

The FDA has waged unrelenting war on these so-called unorthodox cancer therapies; there was
an 11 year long struggle over Laetrile which took place in the Western District of Oklahoma, when the
U.S. District Court enjoined the FDA from interfering with patients' access to the drug for years. During
that time 26 states passed statutes legalizing the use of Laetrile on an intrastate basis.

The efficacy requirement has been the major weapon used by the FDA to deny approval of and
access to many very effective and safe unorthodox cancer remedies and it continues to be used for that
purpose.

Whether or not unorthodox cancer therapies should be permitted for those who wish access to
them is not a medical or scientific question, it is purely a political question, which must be decided by the
Congress and can be decided by the simple expedient of repealing the efficacy requirement.

The toxicity of FDA approved chemotherapeutic agents for the treatment of cancer is appalling.
The FDA claims that the benefits outweigh the risks, but the question remains - benefit to who - these
benefits a-re certainly not to patients who die from these treatments rather than their disease and if they
do survive these treatments, frequently develop new secondary cancers caused by the treatments. If
anyone benefits from these “treatments” it is Oncologists, hospitals and the pharmaceutical industry
which profits from their sales.

We have developed over the past 50 years, a large and, in many cases, government supported
oncology or cancer industry, which remains devoted to highly toxic and frequently ineffective radiation
and chemotherapy, both of which are therapeutic disasters which this cancer establishment will not
abandon.

In desperation, many Americans are turning to other approaches which are non-toxic and more
effective but the FDA is intent on suppressing these new approaches in an attempt to force Americans
with cancer to take a slow walk through the valley of the shadow, of death in the form of allopathic
therapy which usually leaves them in Worse condition than they began and exhausts their financial
resources as well as hastens their demise.

Meanwhile, safe and effective remedies, such as Dr. Lawrence Burton's Immune Augmentation
Therapy, Dr. Stanislaw Burzynski’ss anti neoplastins, and Gaston Naessens' 714X are selectively
attacked by the FDA.

All of these have been shown repeatedly to be effective for a great number of people and
absolutely non-toxic their primary failing being that they do not conform to allopathic theories about
cancer and are condemned by the FDA despite their impressive records of success and the thousands of
cures they have advanced.

While it is not the task of Congress to weigh the relative benefits of various approaches to
cancer and decide which if any is best, it is the task of Congress to ensure that Americans are able to
make their own choices and decisions about such matters without bureaucratic interference.

This can be accomplished by the repeal of the Efficacy Requirement, thus determining that such
matters are not appropriate subjects for government control and should be left up to the people to decide
for themselves. This would be one of the most popular Acts this Congress could enact and one which
would restore much faith in the political process.

I have no quarrel with the highly toxic chemotherapy’s being available to those who wish
to be treated with them - my quarrel is with the government trying to make these the only treatments
available. I don't think the government has any business in deciding what treatments should be available
and not available based on some government officials appraisal of how effective he or she imagines these
to be and I particularly object to this being done at the taxpayers expense.

The repeal of the Efficacy Requirement would not in any way interfere with continuing access to
orthodox (allopathic) cancer treatments by those who wish to use them, but it would make unorthodox
therapies available to those who do not choose to use the orthodox therapies, and make them available for
use by their own physicians at home, so they would not be required to travel to Europe, or Mexico to
obtain these treatments. Indeed, the repeal of the FDA Efficacy Requirement, may well engender new
and more productive research initiatives in cancer research and benefit both the health and economy
of America.

Additionally, the manner in which Commissioner Kessler approached and the FDA intends to
approach the regulation of drugs has already come closer to Lysenkoism than is tolerable in a free
country.

3. Other Disease Treatments

Generally speaking, most pharmaceuticals, particularly those synthesized from petrochemicals
are toxic and their safety for human ingestion needs constant monitoring.

Vitamins, trace minerals, amino acids, herbs, herbal extracts, and homeotherapeutic medications
are not toxic in appropriate dosages and do not require the level of surveillance necessary for synthetic
chemicals, although any substance can be toxic if consumed to excess.

The human race has survived the use of nutrients and herbal medications for thousands of years
without any real outbreaks of mass toxic reactions due to these, while the first century of the use of
synthetic pharmaceuticals has produced a number of mass toxic deaths and illnesses, attributable to the
use of these substances as drugs.

The FDA's surveillance of toxicity, however, is in inverse ratio to the risks involved.

Nutrients and herbal products receive extremely vigorous, indeed oftentimes ludicrous
surveillance, while highly toxic petrochemical drugs receive inadequate surveillance by the FDA.

Largely due to the efficacy requirement it costs a minimum of 321 Million Dollars and takes
about 12 years for a new drug to achieve approval by the FDA. This cost is passed on to consumers of
the products, adding several Billion Dollars a year to consumer expenditures for drugs.

Due to its pre-occupation with the unnecessary efficacy requirement, the FDA's safety
determinations have deteriorated to the extent that over 50% of the drugs approved produce serious and
oftentimes fatal toxicity after approval by means not covered in pre-approval testing.

Some classic examples are Chloramphenicol which produces thousands of fatal blood dyscrasia's
(aplastic anemia), MER 29, a compound for lowering cholesterol which produced cataracts in thousands
of patients, Zomax a "safe" analgesic which killed thousands of patients after FDA approval, Birth
Control Pills caused Strokes and DES which caused cancer in the daughters of patients.

Many people who still resort to allopathic medical care do so because some one else pays for
their care and will only pay for allopathic care - most people who can afford to pay for their own care get
it from non-allopathic practitioners, either here or out of the country.

Commissioner Kessler is trained as a physician and his particular medical philosophy is that of
Allopathic Medicine, one of the five major medical philosophies which have existed in American
Medicine for the past two hundred years.

The philosophic orientation of Allopathic Medicine is diametrically opposed to that of the other
four major medical philosophies and Kessler and others in the FDA are incorrect in their attempt to
establish their medical philosophy, Allopathic medicine, as the only true or orthodox philosophy in
medicine.

Much of their "enforcement activity" is aimed in this direction, which is a blatant perversion of
the enforcement machinery of the FDA which from its inception was not to have any regulatory function
with regard to the practice of medicine, a function reserved to the several states with their police power
and the 10th Amendment.


These intentions are contrary to the intent of Congress in enacting both the 1938 Act and the
1962 Amendments and are a stated intention on the part of Commissioner Kessler to attempt to extend the
jurisdiction of the FDA to include control over the practice of medicine, which is a matter within the
constitutional jurisdiction of the States and not that of the Federal Government through the right and duty
of the Congress to control interstate commerce.

A significant number of people no longer repose their trust in Allopathic medicine and the
exclusive use of highly toxic synthetic pharmaceuticals for the treatment of and prevention of diseases,
and in their day to day activities regarding their health frequently and increasingly, look to other
philosophies and systems of health care.

Those who wish to continue to use allopathic health care are free to do so; the changes suggested
here have no impact on the allopathic health care system other than opening it up to competition by other
systems without government interference.

Commissioner Kessler, being trained as an allopathic physician frequently misuses the FDA's
regulatory authority to attack non-allopathic practitioners in an effort to force millions of Americans
to utilize Allopathic care - this is not a legitimate use of the authority which Congress gave the FDA in
1962; indeed, from its inception, the Food, Drug and Cosmetics Act was held not to have any jurisdiction
over the practice of medicine.

Commissioner Kessler's intentions in this regard are to be found in his own writings. In The
Basis of The FDA's Decision on Breast Implants 9, “New England Journal of Medicine,” 26:1713-1715
(1992), Commissioner Kessler stated:

". . . If members of our society were empowered to make their own decisions
about the entire range of products for which the FDA has responsibility, however, then
the whole rationale for the agency would cease to exist." . . .

The regulation of the purity, safety and distribution of foods, food stuffs, and nutritional
supplements, including herbs, should not be a concern of the FDA or of any agency resulting from a
restructuring of the FDA.

4. Discriminatory Activity By FDA

The FDA has relentlessly misused its regulatory authority to discriminate against non-
allopathic health care providers and health food stores. The following is a partial list of Gestapo-
type raids conducted by FDA agents to suppress Homeopathic Clinics (licensed by State law),
Acupuncture Clinics, (licensed by State laws), nutritionally-oriented physicians, and physicians whose
practices are not in accordance with Allopathic philosophy:

CARDIOVASCULAR DISEASES: Hundreds of Physicians who perform life saving Chelation Therapy,
the unblocking of arteries with EDTA, and without dangerous surgery.

STROKE PREVENTION AND REHABILITATION: The persecution of David Steenblock, MD, Lake
Forrest, CA, 1995, for using Hyperbaric Oxidative Therapies, to restore stroke victims.


FIRTY YEARS OF PERSECUTION OF SUCCESSFUL PHYSICIANS and or
THEIR NON-ALLOPATHIC CANCER AND AIDS THERAPIES

Early twentieth century attack and imprisionment of Dr. Royal Rife, destruction of his
microscope and burning of his books. Rife found a way to destroy all disease microbes with a specialized
sound wave generator.

Persecution of Max Gerson's, MD, and defemation of his famous diet therapy, max saved
hundreds if not thousands of terminal cancer patients prior to WWII, hsi daughter carries on his work
today in Santa Barbara, CA.

Persecution of Jossef Issels, MD in the mid 1960’s of San Diego, for his pioneering of methods
to non-allopathic eliminate cancer.

Persecution of Dr. Andrew Ivey, pillar of the Allopathic community and President of the AMA
and panelist of the Nuremberg Trial who introduced the Homeotherapeutic, cure for cancer, Krebiozen
upon returning from Germany.

Persecution of Dr. Ernst Krebs, for his discoveries and blocking access to Laetrile.

Persecution of James Privitera, MD, of Santa Monica, for treating cancer patients with
laetrille, hydrazine sulfate and other non toxic non allopathic therapy.

Persecution of Syracuse University, Joseph Gold, MD and blocking introduction of Hydrazine
Sulfate as a remedy to relieve starvation caused by cancer therapy, now


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