Paula Bickle is not a physician.
My understanding is that she has a doctorate in nutrition.
Paula Bickle claims to have conducted FDA monitored clinical trials of
DMPS, and boasts that she achieved “allowability” status for DMPS by means
of these trials. She claims to be
an expert in the use of DMPS.
She spoke to physicians at an
ACAM (American College for the Advancement of Medicine) conference in Dallas,
Texas in May of 2000. (The
full text of this lecture can be obtained on audio tape from Professional Audio
Recording in LaVerne, California.) In
that lecture, Dr. Bickle makes several claims with which I take issue.
A.
DMPSBACKFIRE website
In reference to this website,
Dr. Bickle states, “I have investigated every single one of those patient
reports on that website … I have gone back and investigated the cases and
found them to either be done over in Europe, specifically in Finland, or who
were treated by a physician who was not following the protocol, did absolutely
no laboratory, and overdosed the patients, or who were using a very impure form
of DMPS.”
Let me state categorically, that
Dr. Bickle has NOT investigated the patient reports on this website.
In order to do that, she would have had to have contacted me to learn the
names of the patients, the names of their doctors, and how to reach them.
Dr. Bickle has never contacted me. It
is disturbing when a researcher makes such disingenuous claims.
It is even more disturbing to think that health care practitioners may
rely on such assertions in prescribing health care for their patients.
B.
Ray’s Report
The one
backfire that Dr. Bickle speaks to specifically is that of “Ray Sool (sic)”.
She is speaking of Ray Saarela, who has been outspoken about the dangers
of DMPS for several years. (See
Ray’s Report.) Dr. Bickle claims
that Ray backfired from 500mg of Unithiol.
(Unithiol is the Russian predecessor of DMPS.
Dr. Bickle further claims that Unithiol is dangerous because it is
preserved with thimerasol and formaldehyde.)
Her facts about Ray’s experience are incorrect.
Ray backfired from 300mg of DMPS, not 500mg of Unithiol.
C.
Stevens-Johnson Syndrome
Dr.
Bickle states that a medical condition attributed to DMPS “was mistaken for
Stevens-Johnson Syndrome which never happened – I investigated it. It was
actually a mercury rash.”
There is only one report in the
literature today of a DMPS-induced case of Stevens-Johnson Syndrome.
It is from researcher Julian Chisholm, PhD.
He documented this in J Toxicol Clin Toxicol, 1992, 30:4, 493-504.
After hearing Dr. Bickle’s claim, I called Dr. Chisholm.
He told me that he had never heard of Dr. Bickle, nor had he ever been
contacted by her or by anyone on her behalf.
He told me that he has no reason to believe that what he observed was
merely a “mercury rash”, and called such a notion “nonsense”.
No competent researcher could mistake Stevens-Johnson Syndrome for a
mercury rash. In addition, we now
know from the reports from Canadian toxicologists, that DMPS can indeed induce
Stevens-Johnson Syndrome, and did so in 2 out of 33 patients treated with oral
DMPS. (See Q’s
Report.)
D.
DMSA
Dr. Bickle told her audience that DMSA is unsafe
because it crosses the blood brain barrier.
Several chemists have told me (and Dr. Klinghardt even agrees) that it
does not. I have to wonder if her
advocacy of DMPS rather than DMSA is based on sound medical practice, or financial
interests. An announcement appeared
last year in Alternative Medicine Magazine that Dr. Bickle had started her own
company to sell and distribute DMPS.
E. Her concerns for safety
Paula Bickle further states
“There were no adverse effects in the entirety of my Phase III protocol.
Underline: no adverse
effects in the entirety of the Phase III as long as the doctors ran the
protocol.” She later
claimed that “safety is on my brain” and “I’m paranoid for safety every
time we give DMPS”.
“M” was one of Dr.
Bickle’s patients at Cascade. (See
“M’s Report”.) His experience
and the following documents on this page speak to Dr. Bickle’s concerns for
patient safety.
1.
FDA Inspection Report
This is a public document
obtainable from the FDA. It speaks
for itself.
2.
FDA Warning Letter to Heyltex
Heyl, a pharmaceutical company from Berlin, is the manufacturer of DMPS.
Their subsidiary, Heyltex, is located in Dallas, Texas.
My understanding is that they originally sponsored Paula Bickle’s
“clinical trials”, but later withdrew.
The following is a disciplinary letter from the FDA to Heyltex
3.
Oregon Board of Medical Examiners
The Oregon Board of Medical Examiners has disciplined Paula Bickle for
practicing medicine without a license. This
determination was made based upon the affidavits of four physicians, a nurse and
a physician’s assistant, all of whom worked with Dr. Bickle at the Cascade
Health Group in Portland. (These
are public documents, and can be obtained from the Multnomah County authorities
in Salem.) She was later disciplined a second time for violating the conditions
of the first decree.
While all of the affidavits are
disturbing, one in particular is notable. It
is from an individual who is a Physician’s Technician and Registered Medical
Assistant. This is a portion of her
statement:
“Paula secured the position
of Principal Investigator for the study and I was contracted to the drug
manufacturer, Heyltex as the Safety Monitor. …
In July of 1997, I was in Portland and for the first time had the
opportunity to observe how Paula Bickle conducted business at Cascade Health
Group. Over a 5 day period I
observed practices that were totally unacceptable and that were rejected by her
medical director at that time.
As a result of my observations,
my personal and professional ethics drew me to the conclusion that this study
could not go forward with Paula Bickle as Principal Investigator.
My primary responsibility as Monitor is to insure that the protocol is
followed and that patient safety and good clinical practices are adhered to and
followed to the letter and to report infractions when patient safety is
disregarded. My report to Heyltex
on Paula’s practices and her direct disregard of the protocol and patient
safety led to her being dismissed as the Principal Investigator of this project.
Through my association with the Bickles it became increasingly clear that
they would take a little truth and wrap it around a lot of untruths while making
everything sound believable. This
became crystal clear to me during the week I spent in the clinic and questioned
various practices and attempted to verify information that I had been previously
given. I believe a large part of
their motivation is financial in nature with little regard to true quality
medical care for individuals or research.
Also of great concern to me is
that she is not just impacting patient safety in the Portland community.
She conducts training seminars for physicians, dentists and
paraprofessionals from all over the U.S. and foreign countries.
Some of what she teaches and at least one medical treatment included in
the training (at the seminars I attended) to professionals is inaccurate and has
the potential for harming the patients of these doctors.
This would probably never be traced back to her.
She is using reputable professional organizations to gain access to these
professionals – that is why they believe she is credible – just like I did
in the beginning.”
Warren Levin, M.D., was listed as one of the physicians participating in
Paula Bickle’s clinical trials. He
is also an advocate of the use of DMPS for chronic mercury poisoning.
Dr. Levin spoke at a conference I attended.
He was advocating the use of DMPS. During
the question and answer period, I took the microphone and told Dr. Levin and the
audience of my devastating experience with DMPS. He stated to me, and the audience, that he had never heard of
such a reaction to DMPS.
Some months later, a patient provided me with a copy of a letter Dr.
Levin had written on his behalf several years earlier.
This patient had become permanently disabled from a single injection of
DMPS, and Dr. Levin had written a letter in support of his request for
disability benefits. (Dr. Levin was
not the physician who had treated this patient with DMPS.)
In that letter, Dr. Levin spoke to the terrible adverse effects suffered
by this patient, and with regard to them, coined the term “backfire”.
It is my understanding that the clinical trials of DMPS never got off the
ground. Yet Dr. Levin has
information on the internet which would imply otherwise.
He claims that there is an “approved investigational protocol
underway”. He further claims that
the protocol has “IRB approval”. But in order for there to be IRB (Institutional Review Board)
oversight or “approval”, there has to be a study or a clinical trial going
on. Dr. Levin also says that this
investigation involves the study of 2500 patients over five years, each
patient’s case involving “extensive documentation”. In reality, no such study exists.
A January 2001 addendum to
his web page states:
“I am delighted to report that the FDA, based largely on the results of
the above study, has approved DMPS for use as a treatment for the removal of
mercury! It can currently be
obtained from compounding pharmacists for use by any physician!!”
This statement is untrue. The
FDA has NOT approved DMPS. And
“the above study” is a fiction. It
may be true that physicians can obtain DMPS from compounding pharmacies, but
that does not mean that pharmacies are compounding this drug legally, or that
physicians are using it legally. They
are not.
Dr. Levin’s internet information is both inaccurate and misleading.
I have serious concerns that patients may rely on this information in
making decisions about the use of this drug.