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The following letter was written November 11,
1985 in response to repeated feedback of negative and false
statements stemming from the Arthritis Foundation, the Better
Business Bureau and the below addressed office of the Food and
Drug Administration. Donors, arthritics, and physicians would
send The Rheumatoid Disease Foundation/The Arthritis Trust of
America copies of these scurrilous memos. On receipt of this
letter, Harold Davis -- or at least his office - - quit the
practice of forwarding the Arthritis Foundation lies and
half-truths. A letter to the Arthritis Foundation attorney,
thankfully, seemed to be effective in stopping the practice at
its source. Although many of the premises discussed herein are
now moot, the summary (1) demonstrates to some extent the nature
of the problem of introducing treatments contrary to large
pharmaceutical company interests, and (2) well handles the
problem often faced by physicians whose patients wish to try
metronidazole; i.e., there is no evidence that metronidazole is
or ever has been carcinogenic.
About the Philanthropic Section of the Better Business Bureau
& the Arthritis Foundation!
Harold Davis
Consumer Safety Officer
Office of Consumer and Professional Affairs
Center for Drugs and Biologics, HFN-17
Department of Health & Human Services
Public Health Service
Food and Drug Administration
Rockville, MD 20857
Dear Mr. Davis:
Please reference your October 10, 1985 letter with Arthritis
Foundation and Council of Better Business Bureau, Inc.
attachments, appended hereto, and written to J.M. Blount, Jr.
M.D. You say therein that you do not take a position on the
Rheumatoid Disease Foundation. If so then why -- in your second
to last paragraph of your letter -- do you quote unresearched
falsehoods and distortions from the Council of Better Business
Bureau, Inc.? And why do you append falsehoods and distortions
designed by the Arthritis Foundation and the Better Business
Bureau? Where did you get the idea that “Apparently, the foreign
studies did not bear out Dr. Wyburn-Mason’s contention that
clotrimazole was effective against arthritis?” According to our
information, both double-blind studies by P.J. Wojtulewski
(including follow-on unpublished studies) and open studies by
Roger Wyburn-Mason showed an extremely high success rate when
treating Rheumatoid Disease with clotrimazole. Indeed, the rate
was so high that this foundation, through the Department of
Rheumatology at Bowman Gray School of Medicine, is now funding
additional double-blind studies using clotrimazole. I would
greatly appreciate the source(s) of your incorrect information,
that clotrimazole was shown to be ineffective.
You also state that clotrimazole is a 1% cream for
dermatological use. Clotrimazole is not just a 1% cream used for
dermatological purposes, but also a vaginal tablet used widely
for a certain kind of yeast/fungus Candida albicans infection
(Page 1856,1985 PDR). In vitro, it has antibacterial, antiyeast/fungus,
anti-amoebic qualities. To constantly quote that it is a “just a
1% topical cream” merely repeats the distortions initially laid
down by the Arthritis Foundation (four years ago) to discredit
us; said distortions later followed by the Council of Better
Business Bureau, Inc. unethical behavior. As to whether or not
the drug is available for use in the United States -- which you
say it is not -- please refer to the Physicians’ Desk Reference
where you will learn that it is available for use as indicated.
[It is now available through compounding pharamacists in a form
designed for arthritis treatment. Ed.] The reason we are running
scientific studies with its use is to determine if it satisfies
FDA requirements for safety and effectiveness in our fight
against Rheumatoid Diseases. [See http://arthritistrust.org,
newsletters: Winter 1985 & June 1993. Ed.]
As to the Council of Better Business Bureaus, Inc. attachment:
All of their memos start by stating that The information
contained herein has been compiled from sources deemed to be
reliable and, while not guaranteed, is believed to be factual
and accurate. It is not intended to recommend or deprecate, and
is furnished to assist you in exercising your own judgment. A
worthy goal, but unfortunately the remainder of their memos go
on to distort in such a fashion that, through deprecation, and
half truth, they can adversely influence judgment. Referencing
their March 1985 report entitled “Quackery and Unproven
Remedies”: lets take up this question of the oft repeated
Arthritis Foundation’s title “Quackery and Unproven Remedies”.
The illogical presumption by organizations that seek to maintain
their power-base is that anything that is “unproven” is also
“quackery.” By that reasoning, every medical advance in history
has first been classified as quackery. Indeed, according to the
U.S. Office of Technology Assessment publication (1978),
“Assessing the Efficacy and Safety of Medical Technology,”
80-90% of all insurance-approved-medical-board-practices are
unproven. Look at the standard treatments used by practicing
rheumatologists, the very same professionals who advise both the
Arthritis Foundation and the National Institute of Arthritis,
Diabetes and Digestive and Kidney Diseases.
According to their peers, in Clinics in Rheumatic Diseases, (W.B.
Saunders, 1983), the use of gold shots is at best a marginal
scientific presumption, having failed double-blind standards,
but being accepted nonetheless -- and in any case is proved by
such studies to be ineffective after 30 months. In the case of
use of penicillamine, the same peer source states that there is
absolutely no scientific evidence for use of penicillamine. So
here we have a situation where the Council of Better Business
Bureaus, Inc. quotes those who -- by their own standards --
habitually use “quackery” and “unproven” treatments; those who
admittedly do not know how to treat Rheumatoid Disease, and who
nonetheless continue to take money from folks for such
non-treatment while at the same time persuading the sick not
seek alternative treatments.
Isn’t that the actual definition of a quack? One who cannot
cure, but who convinces the patient to periodically pay money
for a worthless treatment and to not seek help elsewhere? In
turn, you, Harold Davis of the Department of Health & Human
Services, swallowing the quacks pseudo-scientific propaganda,
and claiming not to take a stand, continue to pass along mis-information
that is, at best, most likely to keep folks from trying an
alternate treatment which might get them well, while encouraging
them to continue to take treatments which admittedly cannot get
them well. Rheumatoid Disease is a controversial subject. If you
and the Council of Better Business Bureau, Inc. are not
qualified in the philosophy of scientific method, and in the
treatment and cure of arthritis, then you have absolutely no
ethical right to promote one side over another -- which you are
doing despite your paragraph stating that you are not.
In our case, we raise funds to do scientific studies. We are
funding five different scientific studies at three prestigious
university centers: Bowman Gray School of Medicine, Medical
College of Virginia, and Vanderbilt University. We will shortly
be funding an additional study at University of Tennessee, Kno
xville We have an additional $2,000,000 worth of double-blind
studies lined up to do that should, by rights, be done by
pharmaceutical companies, the Arthritis Foundation, or the
Federal Government because of drug orphan status, or other
reasons So long as you continue to send out misinformation by
the likes of the Arthritis Foundation and the Council of Better
Business Bureau, Inc., you are helping big pharmaceutical
companies and big Foundations maintain their power status, and
certainly you are not helping the sick to get well, for reasons
already named.
In our case, we tell everyone exactly what medical treatment
protocol to use, whether they contribute to our research or not.
Either our treatment works, or it doesn’t. If it doesn’t, we
will most surely shrink -- instead, we are growing.
We recommend any one of eight different antiamoebics mostly
available at any drugstore in America. We do not have any
financial stake in any of those medicines. We recommend that
every patient go first to their family doctor. We do not get a
percentage from the family doctor. We have no secrets, we give
information away freely, we conduct proper scientific studies at
appropriate prestigious universities. So where is the fraud
implied by your letter and flyers from the Council of Better
Business Bureau, Inc., and their behind-the-scenes promoter, the
Arthritis Foundation? As to the so-called “Public Information
Memo” by the Arthritis Foundation 83-07, dated 8/24/83: I have
read this memo dozens of times since it was first promulgated by
the Arthritis Foundation. Like so many of their propaganda
pieces designed essentially to keep themselves in power at the
expense of the sick, this one is fraught with half-truths,
innuendos, and lies.
The treatment protocol referenced in paragraph two was not
developed by Dr. Wyburn-Mason, but rather by a committee set up
by over 200 physicians, as attached. It has been revised twice
since Roger Wyburn-Mason’s death. Roger Wyburn-Mason did
not claim to find protozoons in the joints of arthritics, but
rather showed that their thermotropic properties permitted their
collection by certain laboratory devices when various tissues
were minced and used. Roger Wyburn-Mason had an M.D. and a Ph.D.
in protozoology, yet even he was unconvinced for many years that
a form of limax amoeba, which he named Amoeba chromatosa, was
responsible for RD in those that are genetically susceptible.
The major work was performed in cooperation with what was then
the doyen of amoebolgists in England, Vice-Admiral Stamm. Flagyl
is not a drug just for certain bacterial infections: (See: First
United States Metronidazole Conference, Biomedical, Information
Corporation, 800 Second Avenue, New York, NY 10017,
Syndey M. Finegold, M.D., Editor, Feb.19-20,1982.). Like many
antiamoebics it has been shown to be antibacterial,
viral-static, and antiamoebic under certain conditions. The fact
is that metronidazole will not kill Acanthamoeba and Naegleria
in the test tube, but must rely on its two major metabolites in
vivo, according to research pharmacologists. The memo states
that “Protozoa have never been demonstrated by anyone else in
spite of careful search including electron microscopy.”
I have tried since 1983 to get someone to send me information on
where and when and by whom such studies were made. With the
information, we could undoubtedly save a great deal of research
funds when attempting on-going efforts to reproduce Roger Wyburn-Mason’s
work at major university centers. Since both the Council of
Better Business Bureau, Inc. and the Arthritis Foundation are so
terribly concerned about saving donor funds, why don’t they
answer this one question for us? Where is the reported research?
Surely the statement cannot be an outright fabrication? Or can
it?
It is stated that “Attempts in England to repeat the therapeutic
success with metronidazole were unsuccessful.”
This is a lie. There were no attempts made in England in
recorded scientific literature to use our protocol. There
was one study made by physicians who refused to use our
protocol, but rather used a dosage that our book stated in
advance will not work. (Harkness, J.A.L., et. al.”A Double-blind
Comparative Study of Metronidazole and Placebo in Rheumatoid
Arthritis,” Rheumatology and Rehabilitation, 21, 231-234, 1982).
Rather than a study of our claims, it appears almost as if
someone wanted to sink the claims. You say to someone, “Look. If
you use 2 grams a day, for two days in a row, skip for five
days, and repeat, in all six weeks, you will get such and such
an effect; and if you use anything lower, you will not,” and the
person goes ahead and uses 60% less then you advise, would you
call that an independent test of your hypothesis? After all, if
their low dosage of 800 mg/day would’ve worked, then use of
metronidazole in treatment of vaginal infections would have
brought about remission/cure in those RD patients who had both
arthritis and vaginal infection. We have so advised, many times.
It is not scientifically kosher to claim that a study proved
ineffectiveness when no such study has been made. As to our
tax-exempt basis, as questioned in paragraph three: we are
tax-exempt by IRS on exactly the same basis as is the Arthritis
Foundation and the Council of Better Business Bureau, Inc.
Rather than continue to mail out such a lie, as you have, why
don’t you call up IRS? As to the Board meeting in Mississippi: I
attended that meeting. Jack Blount, Jr., M.D. was not inhibited
from using the treatment, although the Arthritis
Foundation-backed state-attorney-general spent half his time
attempting to get such a decision. I have it all on tape, if you
care for the truth. Dr. Blount was restrained from giving out
free prescriptions to needy patients who he had not seen, and
who had been refused our treatment by their own physicians.
Since Dr. Blount is now retired from practice, why is this
paragraph still printed and passed about, other than, by
innuendo, to discredit our whole effort? As to memo number
81-26, dated 12/31/81: I have also seen this set of fabrications
by the Arthritis Foundation since its release. Metronidazole is
not carcinogenic. This is one of the most popular
discreditations, unrelated to fact. According to a Senator
Kennedy joint hearing before the subcommittee on labor and
public welfare and the subcommittee on administrative practice
and procedure of the committee on the Judiciary United States
Senate Ninety-Fourth Congress, July 10-11, 1975: Searle
representatives testified that some lab data had been misplaced
regarding control-group rats, and that carcinogenic symptoms had
been observed in the control group. The FDA, they said, had
required them to throw the carcinogenic count into the
non-control group. [See “First Session On Examination of the
Process of Drug Testing and FDA’s Role in the Regulation and
Conditions Under Which Such Testing is Carried Out,” Preclinical
and clinical testing by the Pharmaceutical Industry, 1975,
Published by the U.S. Government Printing Office, Washington,
D.C. 1975] Thus, the Physicians Desk Reference now contains the
statement that metronidazole may cause cancers in rats. This
error has never been corrected as a package insert, and probably
never will be. In an address by Wayne Martin of Fairhope,
Alabama, before the Seattle Chapter of the International
Association of Cancer Victims and Friends, he summarized the
results of a study of Flagyl (metronidazole) in the treatment of
cancer: In the Seattle area, the Group Health Cooperative of
Puget Sound has treated 12,280 patients with Flagyl mostly for
the parasitic disease trichomonoasis, which causes urogenital
distress. Of this group, only five patients developed cancer
over a 2-1/2 year period, whereas among the 123,620 non-Flagyl
users, 311 patients developed cancer over the same period of
time. On a percentage basis, 0.04% of the Flagyl patients
developed cancer, compared with 2.5% of the non-Flagyl users --
a score of better than 60 to 1 in favor of Flagyl users. When a
correction for age was factored in, the score was still 3-1 in
favor of Flagyl users (Journal of the American Medical
Association, May 14, 1982, pp. 2498-2499.)
The Physicians Desk Reference also states that since 1967 there
has never been a reported case of human arcinogenicity or
mutagenicity through the use of metronidazole. Why didn’t the
Arthritis Foundation report this fact, too? The answer: they
wish to propagandize through lies and half-truths, not inform
and educate. According to The First Metronidazole Conference,
metronidazole is world-widely used, often in dosages much higher
than our recommendations, and often in hospital settings where
it is frequently used intravenously in very high dosages. As to
Searle’s letter attached by Robert L. Alberti, M.D., Director of
Communications at Searle: Isn’t it obvious that Searle is bound
by the legal implications of anything they state in a letter?
They cannot legally make any other claim than they made, without
bringing on themselves costly reprisals by governmental agencies
-- no matter the value or non-value of metronidazole.
The Arthritis Foundation knows this. So why, then, do they rely
on statements made by Searle company spokesmen that can not be
legally constructed any other way? What does the Arthritis
Foundation think they are proving, if not simply to distort and
falsify data to control people’s minds? I might also add that
Searle’s patent has run out on metronidazole -- so why should
Searle want to promote a medicine that might compete with their
very lucrative line of anti-inflammatories that treat only
symptoms and keep folks sick, and paying and paying?
The Arthritis Foundation has seen studies, presented to them by
several physicians. Indeed, back in 1978 the Arthritis
Foundation was made aware of Roger Wyburn-Mason’s massive 479
page publication detailing a lifetime of work in identifying the
causation of Rheumatoid Disease. This work - presented to the
Arthritis Foundation - was not from a fly-by-night quack, but
rather a very brilliant research physician. Consider his
background: He received the very highest grades obtainable in
every degree taken. He was in on the original clinical trials of
sulfa drugs. He specialized in nerve diseases, and has two nerve
diseases named after him. He became the very first to identify a
viral cause of cancer. He wrote several very definitive books:
Trophic Nerves, Reticulo-Endothelial System, A New Protozoon,
and so on. He received an honorary degree and also earned a
Ph.D. in protozoology. Does this sound like a man set to decieve
the world?
Medical doctors, at best, receive about four hours of study in
protozoology. They are the last people in the world to tell you
about protozoons. Protozoologists, on the other hand, understand
the implications of Roger Wyburn-Mason’s work quite clearly, as
the attached bibliography of protozoal literature clearly shows.
Indeed, Kofoid and Swezy, two University of California
Protozoologists, in 1922 first reported the same phenomenon as
Roger Wyburn-Mason, and published same in the University of
California Publications in Zoology, to be ignored by physicians
thereafter.
As to the Arthritis Foundation’s memo 83-10 dated 12/23/83: They
are finally beginning to catch up to facts, having finally
corrected two out of hundreds of lies and distortions. Still
they do have the unmitigated gall to suggest that after they
rejected all information from Roger Wyburn-Mason and other
physicians since 1978, that they should sit in judgment as to
whether or not our treatment is valid and whether or not our
cost ratios are appropriate. Know that the Arthritis Foundation
is supported in heavy part by the pharmaceutical industry. They
do not need to go through costly direct-mail routes to raise
their funds. They spend gigantic amounts on large, expensive
buildings and staff salaries. All their ratios are juggled
(probably in collusion with the Better Business Bureau’s
so-called standards) so that they can glibly make a statement
that brings into question our cost-ratios.
Now as to the Philanthropic Advisory Service of the Council of
Better Business Bureaus, Inc. report dated September 1984: I
want to make one major comment about their report: They state
that our accountant stated that we cannot control the money
prior to reaching a CPA-bonded mail-opening point, where the
money is recorded by a CPA. They point to this statement as an
implication that we must be doing something not quite kosher. In
July 18, 1984, (prior to the date of the BBB memo) in a last
letter to this organization, I explained that the U.S. Post
Office controls all the mailed letters until it reaches the CPA.
According to their statement, above, we should then control the
U.S. Post Office. The CPA refers to the fact that it is
impractical to audit the 1-1/2% to 2% return that comes to our
bonded CPA from our half million per-month mailings. Why is it
impractical? Because to sample-audit tens of thousands of
monthly returns through the U.S. Post Office would require
expenditure of funds far greater than we receive, and
additionally would require some rather sophisticated cooperation
with the U.S. Post Office.
We cannot control funds mailed because the U.S. Post Office has
charge of the mail until it is delivered. See what I mean?
Catch 22 used in the worst way!
Deliberate distortion of truth in order to place us in the worst
light. The Philanthropic Advisory Service of the Council of
Better Business Bureaus, Inc. is neither an objective advisory
service, nor Better, nor even a business. They are an IRS
tax-exempt, charitable foundation that operates on exactly the
same basis as do we; and they have no more legal and/or ethical
right to judge us, then we have to judge them -- or said another
way: we have as much right to judge them, as they do us -- and
you should enclose this letter to those who query, along with
theirs, if you continue to insist on sending out theirs.
The Council of Better Business Bureaus, Inc. holds itself out to
be a watch dog to prevent abuses by charitable organizations and
as an authority to which the general public may turn to know
whether it is wise or foolish to give to this or that worthy
cause. It is not a governmental agency, and has no legal
authority to require anyone to report to it. Yet, through a
combination of pressure and publicity it persuades a great many
charitable organizations to provide it with data and to seek its
blessing.
We do not supply the Better Business Bureau, Inc. with data
because at the very first it became clear that it fails to act
with objectivity or fairness or to meet its own published
standards for charitable and philanthropic organizations. We are
also concerned about the nature of the reports that the BBB
publishes about charitable organizations. They are usually
filled with factual errors, distortion by omission, innuendo by
choice of words and positioning of sentences, and general bias
in tone. BBB sprinkles its reports with opinionated value
judgments -- sometimes blatantly and sometimes subtly. BBB is
not an authority on Rheumatoid Disease, and therefore is not in
a scientific position to evaluate whether or not this
organization is correct. Indeed, the history of most medical
advances in the field of medicine are fought against this very
authoritarian, non-informed resistance: Semmelweis, Koch, Sister
Kenney, Pasteur, Ehrlich, Roentgen, Lister, Jenner, Harvey, and
Ross, to name a few. So far as we are concerned, and from what
we have seen in our office, the BBB sits in bed with the large
foundations, and uses every unethical tactic to stifle small
organizations.
The standards that are promulgated by the BBB are designed to
assist those whose major income is non-direct mail.
The BBB preaches that responsible organizations should supply it
with information. Until it learns something more about
responsible behavior itself, they do not deserve the honor.
Their assertion on one point only -- that of our presumed lack
of control during U.S. Post Office distribution -- so violates
the ethical standards required by the American Institute of
Certified Public Accountants and universally adhered to by
responsible professionals in the fields of accounting and
financial analysis, that we do not intend to comply with their
unsolicitated requests until such time as we are assured that
their standards and their behavior is cleaned up. The ethical
standards of the American Institute of Certified Public
Accountants prohibit the publication of selected portions of
financial statements, and for very good reason -- it is easy to
create any desired impression simply by including or excluding
particular data. No reputable accounting firm engages in such
practices, which appear to be routine for the BBB.
The question legitimately arises as to whether the BBB performs
any service of value to the public at all. Organizations,
such as ours, must file detailed reports with the Federal
Government and also with charity regulating agencies in most
states. The reports are available in their entirety from either
source. How, then, does the BBB serve a public interest by
demanding that we spend additional time and money answering
their questions based on data already supplied to appropriate
governmental agencies? All governmental agencies operate within
a framework of administrative hearings, court and law. Against
the BBB we have no such recourse, indeed, at best (which is
worse) they set up a slander and/or libel campaign that is not
subjected to the safe-guards of Federally guaranteed due-process
rights. Their constituents are not, for the most part, those
with Rheumatoid Disease seeking alternate ways to wellness, but
rather that of big-business and big-foundations seeking subtle
ways and means for controlling the almighty buck for their own
power and profit.
BBB remains free to distort and misuse any information that we
might supply -- as already demonstrated -- and at best our
response would be to engage in a very costly court battle, where
our contributors would not be the winners.
We send out a great deal of information, mostly free. If you
have any further questions about our literature, or goals,
and/or our research projects, please call or write. I will be
most happy to supply you with whatever you require, so that you
do not need to rely on destructive hearsay and gossip from
either the Arthritis Foundation or the so-called Better Business
Bureau.
Cordially,
Perry A. Chapdelaine, Sr
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