Dear Mr. Hood:
Per your request for more information on 714X, we have more combined
experience that anyone in the United States, please review the
following, do not let the FDA attack on me throw you.
Dear Colleague:
The right of access to knowledge and treatments that are available
globally is a fundamental Constitutional issue affecting every American
today. In consideration of your time this is a brief letter of
introduction that urgently requests your attention and assistance.
The New England Journal of Medicine, May, 1986 and Lancet , May, 1996
published articles revealing that the so-called "war on cancer" has
failed. However, numerous effective and non-life threatening therapies
for cancer continue to be denied to the US Citizen. This is the most
insidious kind of tyranny.
My name is Charles Pixley. Since October of 1990 my company has been
revealing the extraordinary research of micro-biologist Gaston Naessens
and his camphor compound, trade name 714X, which qualifies as a
Homeopathic mixture. Although not a panacea, it causes the body to
reject cancer and other degenerative diseases.
Author Christopher Bird first wrote of M. Naessens' genius in The
Persecution and Trial of Gaston Naessens. That trial ended in 1989 in
acquittal of M. Naessens and approval of 714X through the Emergency Drug
Relief Act. The 1994 Canadian Investigational and Emergency Drug List
includes 714X for Anti-Cancer and Immune Related Disease Therapy.
By April of 1992 the FDA had allowed over 5,000 prescriptions into this
country and Writers and Research formalized the clinical application and
published the correct protocol in the book, "Do No Harm," thereby making
this treatment available through informed consent. The FDA responded by
illegally voiding its Personal Import Policy.
In 1994 the FDA raided the office of our Institutional Review Board
(IRB). In April of 1996 my company and I were tried, convicted and
sentenced, not on the grounds of efficacy or lack thereof, but for an
alleged conspiracy to impede an FDA investigation and for the
importation of an unapproved "new drug."
What Price Freedom?
Coincidentally, during my trial the 2nd and 9th Circuit Courts ruled
that Citizens have a Right to doctor assisted suicide. We maintain that
the obverse Right must also exist--the Right to choose ANY treatment
available worldwide to preserve your life without Government
interference.
It is our intent to take control of our lives and our Constitution. We
intend to win and have engaged Harvard Law Professor Alan M.
Dershowitz. Our current goal is to raise the remaining expenses and
fees; he will then undertake the responsibility for preparing and
arguing this fundamental Rights issue before the Second Circuit Court of
Appeals.
We are looking for individual and corporate angels who will sponsor
$100,000, $50,000, $25,000, $10,000, $5,000, $3,000, $1,000, $500, or
$300 dollar amounts. We have established the W.A.R. Defense Fund and
100% of your donations will go for litigation expenses.
'
We recognize that this is a limited discussion; please contact us if
you require further material. In anticipation of your thoughtful
response, thank you for your attention.
Sincerely,
Charles Pixley
4810 Saint Paul Boulevard
Rochester, NY 14617
716 266 4630
David and Goliath in the Twenty-first Century
by Caroline Grey Ganz
United States v. Charles Pixley, a case currently before the Federal
Court of Appeals for the Second Circuit, raises once again the
fundamental issue of the individual's right to gain access to any and
all forms of medical treatment available globally on the basis of
informed consent.
This is a profound issue as it raises serious questions regarding the
efficacy of orthodox medicine in dealing with chronic and degenerative
diseases, the accuracy and dependability of the methods used to
determine that efficacy and the right of the federal government to
enforce any orthodoxy in any field of human aspiration.
The courts are wrestling with the issue of the right to choose the time
and manner of one's death while those aspiring to live find every
conceivable impediment that bureaucracy can devise, from harassment, to
confiscation of property, to loss of parental rights, to prosecution,
put in their way in the name of public safety. In essence, the Federal
Government has enforced the blocking of potentially life-enhancing and
live-saving treatments while considering the legal ramifications of
suicide.
The following is a brief chronology of events leading up to the present
case and synopsis of the principles upholding the legal and medical
foundation upon which it stands.
Writers and Research, Inc. was originally formed by Charles Pixley in
1989 to express the knowledge of particular individuals whose work is of
benefit to the general public. One such man is bio-chemist Gaston
Naessens whose life-long research has produced a microscope capable of
viewing live blood at high magnification and resolution. This
instrument enabled him to identify a tiny entity in the blood,
pleomorphic in nature and virtually indestructible, which has the
properties of both energy and matter.
From his observations of the blood of many individuals suffering a
variety of diseases, M. Naessens formulated a camphor based medicinal,
known as 714X (trimethyl bicyclo nitr amino heptane-cl), which functions
to re-establish the activity of the immune system in the human body and
allows the natural regenerative processes to prevail. It is homeopathic
by nature and definition as the active ingredients are extremely dilute
and its activity is a stimulation of the body's innate systems of
defense rather than direct bio/chemical intervention.
The need to make this therapy consistently and effectively available to
the many individuals asking for assistance inspired Charles Pixley to
form an Institutional Review Board, the vehicle designed by Congress to
make unapproved drugs available to the public in preliminary trials, and
in January of 1992, the Writers and Research Institutional Review Board
was created with Dietmar Schildwaechter, MD, Ph.D. of Washington, D.C.
as Chief Medical Investigator.
To comply with the law of informed consent and to insure the
understanding of the individual, the first pre-requisite in any
treatment process, Writers and Research published the protocol, "Do No
Harm" in April 1992 containing requisite and related information. This
book has since been banned as a result of the court's decision.
Writers and Research has based its activity with regard to 714X on
three fundamental principles that are supported by Constitutional,
statutory and International Law: the right to determine the means to
prolong life as alternative to choosing death, the Institutional Review
board Requirement of informed consent, the FDA personal import policy,
the homeopathic exclusion in the 1938 Food Drug and Cosmetic Act, the
Nuremberg Code and the Helsinki Accord.
In July of 1992 the FDA issued an import alert on 714X rescinding
illegally its own personal import policy regarding 714X after allowing
over 5,000 prescriptions for 714X to be filled unhindered.
In March of 1993 a field agent of the FDA spent two weeks in the office
of Writers and Research conducting an inspection and issued a report
that the IRB was deficient on two counts: the consent form was
improperly worded, there was no adequate means to track progression or
regression of disease in "the human subjects," and Writers and Research
was importing a substance from a foreign country.
Charles Pixley was summoned to Rockville, Maryland to defend the IRB
and did so, asking, as he had done in the past two encounters, the
assistance of the FDA and federal government in bringing this knowledge
to the American people. He was told not to import the medicine
directly, not to refer to his enterprise as an IRB and if he did not
comply he would "be forced into court and have no choice but to plead
guilty."
From that point all orders for 714X were sent directly from Canada to
individual patrons, references to the IRB were deleted from the protocol
and in other respects the project proceeded as before.
On July 12, 1994 the Offices of Writers and Research, Inc. were subject
to a search and seizure by six agents of the FDA, in which all patron
files, research materials, medical reports, business records, personal
financial records, rolodex, and computers were confiscated.
In August of 1994, Mr. Pixley and his attorney met with Philip Lee,
M.D., Assistant Secretary of Health, who oversees the NIH, the CDC, the
FDA and other Health related agencies, and presented a petition for
waiver for 714X from the Investigational New Drug requirement.
In October of 1995 an indictment was handed down against Charles Pixley
and Writers and Research, Inc. on one felony count of conspiracy to
defraud an agency of the government and eighteen misdemeanor counts of
introducing into interstate commerce a substance unapproved by the FDA.
The services of Attorney William Moore, Jr. were retained and the case
went to bench trial on April 10, 1996. The defense was based upon the
exclusion of homeopathic medicines from new drug requirements by the
1938 Food, Drug and Cosmetic Act.
Homoeopathy is the practice of Medicine, Osteopathy or Dentistry in
accordance with the Doctrines, Tenets and Standards of the Homeopathic
School of Medical Practice. The core doctrine of Homeopathy is similia
similibus curantur -- likes cure likes -- and is the theory that
diseases or illnesses create symptoms as a result of the body's efforts
to rid itself of the illness.
Homeopathy seeks to assist the body's own curative efforts by
administering substances, which when given to a healthy person, will
produce like or similar symptoms. The substances so administered are in
an extremely dilute form.
Homeopathic physicians do not diagnose diseases; rather they catalogue
the sufferer's symptoms and locate a medicine which would craft the same
or very similar symptoms. This process is known as "provings" or
"repertorization." Due to this repertorization, homeopathic medicines
go through a far more extensive "testing" for safety and efficacy than
do their chemical counterparts. All homeopathic medicines are safe,
causing no side effects whatsoever.
In 1844, the American Institute of Homeopathy formed a committee on
pharmacopoeia which published the Homeopathic Pharmacopoeia of the
United States (HPUS). Since that time, The Institute of Pharmacopoeia
Commission and Committee have published nine editions of the United
States Homeopathic Pharmacopoeia.
A prominent Homeopathic physician from New York, Dr. Royal Copeland,
who had been the New York State Commissioner of Health, fought many
battles to prevent the allopaths from destroying Homoeopathy in New
York. As a US. Senator he sponsored and drafted the Food, Drug &
Cosmetic Act (PL 653-675, 52 Statutes 1040-1059), passed by the 75th
Congress in June 1938.
In that Act Congress designated three official compendia of drugs: the
United States Pharmacoepia (USP), the Compendium of Allopathic Drugs,
the Homeopathic Pharmacopoeia of the United States (HPUS) as well as the
National Formulary (NF). They are the authoritative listing of drugs,
their contents and formulations, as well as the method of their
compounding or manufacture.
From the time of passage of the 1938 F.D.&C. Act until now it has been
the interpretation of the FDA of its enabling legislation that
Homeopathic drugs listed in the Homeopathic Pharmacopoeia and its
Supplements are not required by the Act to undergo safety and
effectiveness testing and may be marketed without prior FDA approval or
the elaborate and costly New Drug Application process.
The process whereby the Homeopathic Pharmacopoeia Commission and
Committee arrive at HPUS listings is perhaps comparable to the process
whereby the American Law Institute (A.L.I.) arrives at its Restatements
of the Law and Model Codes. In the case of the A.L.I., Judges,
professors and prominent lawyers exhaustively consider and debate the
decision of the Courts, the Common Law and similar material before
making a statement or restatement of the law in an area or field of
law.
These statements are published and thereafter cited by the Courts and
considered authoritative statements or perhaps a consensus of legal
principles by the legal community. A very similar process is involved
in the preparation of the Homeopathic Pharmacopoeia and its
supplements. In the areas of drug or medical regulations by the FDA,
the holdings and comments of the Homeopathic Formulary Commission and
Committee are accorded much the same deference as are the Restatements
of Law are published by the A.L.I. review by Courts and Counsel in legal
practice.
The Homeopathic Pharmacopoeia Commission and Committee carefully
consider all available information, the Provings, the Repertories and
the Literature of Homeopathic Medicine as well as the clinical
experience of the members of the Commission and Committee are all
considered and debated exhaustively before a decision is reached.
The methods used to test the safety and efficacy of drugs used in the
practice of Allopathic Medicine are inappropriate with regard to
Homeopathic Medications as the quantities of drug substance involved in
Homeopathic Medications are minuscule and in most instances would have
no discernible pharmacological effect as do allopathic drugs.
Very few modern pharmacologists are trained to appraise the Homeopathic
effects of drugs. Indeed it is no surprise that pharmacologists trained
in the Allopathic doctrines do not have the knowledge or interest to
accept or study the principles and premises of Homeopathic medicine.
In 1938 when the Act was passed and in 1962 when it was amended, the
medical establishment was of the opinion that Homoeopathy was "a dying
Art and science," that only a few hundred Homeopathic physicians were in
practice and when they retired, Homeopathic medicine would hopefully
become a footnote in medical history.
Since that time, there has been a very pronounced revival of interest
in Homeopathy on the part of many physicians as well as the public.
Today it is estimated that some five thousand American physicians and
other
health care practitioners such as Chiropractors, Naturopaths and
Oriental Medical Practitioners [acupuncturists] regularly employ
Homoeopathy in their practice and the public now purchases large
quantities of over the counter Homeopathic medicines.
In 1994 the New England Journal of Medicine, the premier Allopathic
medical journal, estimated that some 40% of Americans now get some or
all of their primary medical care from practitioners who utilize
Homoeopathy, acupuncture, herbs and manipulation and spend some $19
billion dollars for such care annually. Far from being a dying art and
science Homeopathy and Homeo-therapeutics are a large and growing part
of health care in the United States as they were before the 1910 merger
attempt.
At the trial of Charles Pixley, Harris Coulter, Ph.D., medical
historian and editor of the Eighth Edition of the Homeopathic
Pharmacopoeia of the United States, testified that after examining the
report of the Organic Branch, National Forensic Cancer Center, he is of
the opinion that 714X is a combination of Homeopathic drugs listed in
the Homeopathic Pharmacopoeia of the United States and, to the extent
that they are all so listed, 714X is not a new drug, but a combination
of Homeopathic medicines, all of which are generally considered safe and
effective as Homeopathic drugs or medications by experts who are
qualified by experience and training to make such evaluations.
On April 19 a verdict of guilty on all counts was handed down. A
report and request for support were sent to all patrons, colleagues and
friends of Charles Pixley and Writers and Research, and on July 7, the
day of sentencing, Judge Telesca held up a handful of 50 odd letters
sent on behalf of the defendants, along with ten or so for the
government. He was visibly impressed by the voice of the public and
stated that he had spent a great deal of time and thought on his
decision and order.
Coincidentally, during the trial the 2nd and 9th Circuit Courts of
Appeal ruled that American Citizens have a Right to doctor assisted
suicide. In his defense, Charles Pixley maintain that the obverse Right
must also exist--the Right to choose any treatment available worldwide
to preserve life without Government interference.
The intent is to win and Harvard Law Professor Alan M. Dershowitz has
agreed to act as consultant. The current goal is to raise the remaining
expenses and fees; he will then take responsibility for preparing and
arguing this fundamental Rights issue before the Second Circuit Court of
Appeals.
The Constitution of the United States is at stake. The fundamental
issues raised here exceed national boundaries and affect the life and
well-being of countless individuals worldwide.
Caroline Grey Ganz is co-author of "Do No Harm," has served as a Board
Member of the above referenced Institutional Review Board since its
inception in 1992 and is an invaluable editor for Writers and Research,
Inc. Caroline resides at 31 Harrison Terrace, Rochester, New York,
14617, 716 544 0524, with her husband Frank, sons Gerald and William and
daughter Aileen.
