On Friday, April 19, Charles Pixley, founder of a company called Writers
& Research, Inc. of Rochester, NY, was convicted of one felony count of
conspiring to defraud the Food and Drug Administration (FDA) by impeding
an investigation, and 18 misdemeanor counts of introducing the Canadian
health product 714X, developed by Canadian inventor Gaston Naessens, into
interstate commerce.
Mr. Pixley has been released on his own recognizance, pending sentencing
by Judge Michael A. Telesca on July 2. Mr. Pixley has also been hit with
a "gag order": the judge instructed him that he can no longer discuss,
sell, or promote 714X. This includes a compendium on the agent entitled
"Do No Harm," which serves as a kind of informed consent brochure for
the product.
Mr. Pixley has declared his innocence and will appeal both the decision
and the order. In fact, according to a press release from Writers & Research,
Inc., "he continues to provide services, particularly with the Enzyme
Therapy program, a specially designed powerful metabolic supplement program
designed by experience and research dating back to the 1930s."
The penalty for the crimes of which he has been accused could amount
to many years in a federal penitentiary. Pixley, 47, was defended by Attorney
William H. Moore, Jr., of Savannah, GA. For the last several years Mr.
Pixley has been battling with the FDA over his arrangement to have the
unconventional cancer remedy 714X shipped to patients in the United States.
Pixley¹s major defense strategy was his claim that 714X is in fact an
old homeopathic remedy called "Camphora 4X."
Testifying in support of this proposition was Harris Coulter, PhD, editor
of the semi-ofÞcial Homeopathic Pharmacopoeia of the United States (HPUS),
author of the four-volume Divided Legacy, and widely regarded as one of
the world¹s leading authorities on the history of homeopathy.
Pixley¹s side worked up an elaborate argument that since 714X contains
a highly diluted form of a camphorous product, as well as diluted salts,
it was in effect Camphora 4X. If true, this would "grandfather" the agent.
In other words, as an agent that predated the formation of the FDA in
1906, it has to be allowed into commerce.
Homeopathic drugs listed in the HPUS and its various supplements can
be marketed without FDA approval, mainly due to the extensive 'provings'
(tests) that are done prior to their inclusion in that book. The inÞnitesimal
dosages lead to a feeling of security about their safety.
However, the judge rejected this line of argument, and claimed that
if this product was indeed homeopathic Camphora 4X, then it was mislabelled.
But relabeling is not likely to happen any time soon. As a phone call
to Mr. Naessens¹s International Academy of Somatidian Orthobiology (IASO)
quickly revealed, Naessens categorically rejects the idea that his invention
is in fact even a homeopathic preparation, much less Camphora 4X. According
to IASO, it is a unique product.
The government¹s claim that Mr. Pixley was involved in a "conspiracy"
to impede the FDA does seem absurd on the face of it. In fact, the opposite
seems the case. Few people in the Þeld of alternative medicine have been
as persistent in his dealings with the FDA as Mr. Pixley. He testiÞed
at Congressional hearings, set up his own Institutional Review Board (IRB),
communicated repeatedly with the FDA, and in every way made himself a
highly visible target.
Pixley claims that the conspiracy was on the other foot. He says that
at one 1993 meeting a Government witness threatened him by saying, "If
you do not Þle a New Drug Application you will be brought to trial and
you will have no choice but to plead guilty."
Thinking that there had to be some legal way to redress his grievances,
Mr. Pixley actually arranged a meeting with Philip R. Lee, MD, US Assistant
Secretary of Health. (Pixley and Lee happen to have a mutual friend, Alden
Bryant of Berkeley, CA.) At this 8/4/94 get- together, Pixley claims that
Lee verbally granted him a waiver to bypass FDA¹s arduous New Drug Application
process. He never got this in writing, but he claims that a requested
waiver goes into effect if it is not explicitly denied in writing. A government
rebuttal witness appeared at the trial with a letter from Lee casting
aspersions on that meeting (Pixley claims this rebuttal letter was "fabricated.")
Mr. Pixley sometimes uses apocalyptic imagery in his defense. His enemies,
he says, practice "Passive Genocide," while he is helping "those who chose
to avoid the 'Death Camp' mentality of the allopathic system...." Our
birthright, he says,"is to live blissfully and not to live in a state
of constant compromise with suffering."....
