Re: 1999 UHMS Ethics Task Force report :
(Exchange between Dr Evelyn Chan from the UHMS and Mr. David Freels from the ''HBOTForMedicaid'' discussion list.)Dr Chan :
>I'd like to be able to help further, but really cannot, as my memory
>is really unable to come up with anything else. I do not remember
>the details to be able to respond to your questions. I do recall,
>however, that the draft was presented in 1999 (as you state) in
>Boston and that although the final report was published in 2001, the
>editor actually had a delay of about 2 years between the time I
>submitted the final report and the date of publication. I don't
>know what the delay was and I actually assumed that the report would
>never be published. So, I forgot about that report until the editor
>later (like, 2 years later) sent me a copy of the article in press
>to proof-read and correct. At that point, I only corrected the
>grammar. So, I haven't looked at those documents in something like
>7 years or so. ECDavid Freels :
Dr Chan,
I encourage you to try harder to remember the sequence of events
relating to the how and why parts of the 1999 UHMS Ethics Task Force
Report were deleted from what became Ethical Dilemmas in Hyperbaric
Medicine.I'll come a little closer to the point of my correspondence. I think
the UHMS leadership used you to create something of an ethical
buffer, to take the heat off themselves for clearly unethical medical
practices on the part of the UHMS.Further, because your name is at the top of the authors list of both
the 1999 UHMS Ethics Task Force Report and Ethical Dilemmas in
Hyperbaric Medicine, it's possible that your credibility as a medical
ethicist could be compromised due to your involvement with the UHMS.
I'm trying to clearly understand the process by which the 1999 UHMS
Ethics Task Force Report became Ethical Dilemmas in Hyperbaric
Medicine--within the context of just what contributions and
noncontributions were made by all the people involved with the Ethics
Task Force.The deletions to your 1999 Report directly contradict the commonly
held interpretations of the 2001 "Collet study" [Lancet. 2001 Feb
24;357(9256):582-6.], billed at it's publication as the first
randomized, double-blind, controlled study of HBOT for cerebral palsy
children. The AHRQ reference you cited in your reply further
documents this widely-held misinterpretation.In fact, it was this same AHRQ report that Georgia Medicaid cited in
their 2005 denial of our 1999 request for HBOT reimbursement for our
12-year old cerebral-palsied son. Jimmy first received HBOT when he
was five years old. Before/after functional brain imaging confirmed
the improvements. We first asked for Medicaid HBOT reimbursement in
1999 but were denied three times. We eventually had a hearing in 2000
before an Administrative Law Judge (ALJ), where we lost. We appealed
and won. The state then appealed to the Georgia State Court of
Appeals. In 2002, we won again, and the case was remanded back to
Georgia Medicaid for a decision. Three years later they finally made
their decision, but we were denied again. This time Georgia Medicaid
cited the same AHRQ report you sent in reply and also reference in
your CV
(http://www.uth.tmc.edu/schools/med/imed/general/Chan%20CV-0805.pdf#search=%22%2\
2Evelyn.C.Chan%40uth.tmc.edu%22%22).On June 15, 2006 we had another hearing before the same ALJ from
2000. Our expert witnesses included Dr Paul Harch, radiologist, and
Dr. Pierre Marois (Dr. Marois was the original PI until the Canadian
government forced him to step down and replaced him with Jean-Paul
Collet.). On August 9, 2006 the same ALJ that ruled against us in
2000 found Hyperbaric Oxygen Therapy "necessary to correct or
ameliorate" our son's brain-injury.However, thousands and thousands of brain-injured children have been
denied access to HBOT due to the misinterpretation of the Collet
study, as per the example of the AHRQ report. While about ten states
have changed their Medicaid reimbursement policy; nonetheless,
thousands remain untreated. I know because I'm moderator of a
1300-member Yahoo group specifically created to help parents use the
Medicaid law to help their children. See
http://groups.yahoo.com/group/medicaidforhbot/The Collet study had two treatment groups: one group received ambient
air at 1.3 ATA; the second group received 100% oxygen at 1.75 ATA.
Both groups experienced significant improvements.In September, 2000, six months prior to publication of Collet, lead
author Jean-Paul Collet was an invited guest speaker before the
annual meeting of the American Academy of Cerebral Palsy and
Developmental Medicine (AACPDM) in Toronto, Canada where he claimed
improvements in the 1.3 group were due to a placebo effect and/or a
participation effect.According to information in your 1999 report, the 1.3 ATA group
clearly received therapy--which would explain why the children
experienced such significant improvements. Which meant it wasn't
placebo or participation effect, it was therapy.The 1999 information deleted from the published 2001 article also
explains why it's actually scientifically, physically, and ethically
impossible to conduct a randomized, double-blind, placebo-controlled
study of Hyperbaric Oxygen Therapy for cerebral palsy children. This
scientific fact could better help pediatric neurologists understand
just how HBOT works. Instead, what now exists is rancorous confusion.The Collet study has been widely misinterpreted, and has led to the
denial of HBOT for thousands of brain-injured children. If every
member of the UHMS Ethics Task Force saw your 1999 report, then they
knew 18 months before its publication what really happened in the
Collet study.When finally published, 15 members of the UHMS Ethics Task Force said
nothing to clarify the confusion surrounding the Collet study--to the
detriment of thousands of brain-injured children.Perhaps even worse--from an ethical standpoint--at the conclusion of
the Collet trial, the raw data was never reviewed by the
investigators involved. Instead PI Collet gathered a "scientific
advisory committee" to actually decide the meaning of the results of
the study. Only one member of Collet's "scientific advisory
committee" had any experience with Hyperbaric Oxygen Therapy. He is
Dr. Wayne Evans, MD.Dr. Wayne Evans, MD also served on your UHMS Ethics Task Force.
Collet's "scientific advisory committee" met in January, 2000 to
interpret the results of the Collet study--right at six months after
you presented in Boston the 1999 UHMS Ethics Task Force Report.A few questions that really need answering:
1. Prior to the November, 2001 publication of Ethical Dilemmas in
Hyperbaric Medicine, did you know UHMS Ethics Task Force member Wayne
Evans also served on Collet's "scientific advisory committee" where
he interpreted the results of the Collet study?2. Was it a conflict of interest for Dr Evans to be a member of the
UHMS Ethics Task Force at the same time he was also a member of
Collet's "scientific advisory committee?"3. Was it ethical or unethical for Dr Evans to be a member of the
UHMS Ethics Task Force at the same time he was also a member of
Collet's "scientific advisory committee?"4. As primary author of both the 1999 UHMS Ethics Task Force Report
and Ethical Dilemmas in Hyperbaric Medicine, was it ethical or
unethical for you Dr. Chan to not disclose in either the 1999 Report
or the final 2001 article that Dr Evans was a member of both the UHMS
Ethics Task Force at the same time he was also a member of Collet's
"scientific advisory committee?"5. Was it ethical or unethical for all 15 members of the UHMS Ethics
Task Force to remain silent when the Collet study was published and
not publicly disclose contents of the 1999 report first presented at
the 1999 Boston meeting?This email is also "cc:'d" to the top decision makers of Georgia
Medicaid and also their legal representation because we have been in
a 7-year legal fight to help our son make the most of his mind, his
body, and his life. I am frankly tired of the legal fights, and I
want the ultimate decision makers to know what is actually going on.I hope these details have helped jog your memory as to the sequence
of events that led to the deletion of information present in the 1999
UHMS Ethics Task Force Report that was excluded from what became
Ethical Dilemmas in Hyperbaric Medicine.So you won't have to go back and dig through yesterday's email, I
want to again ask you the three questions from yesterday:Dr Chan, by your own admission, you were the primary author of both
the 1999 UHMS Ethics Task Force Report and Ethical Dilemmas in
Hyperbaric Medicine.In comparing the two documents, it's apparent that a number of key
words/key paragraphs that were part of the 1999 UHMS Ethics Task
Force Report were not included in the final published paper, Ethical
Dilemmas in Hyperbaric Medicine. Some of these key words/key
paragraphs include the following:1. "cerebral palsy"
2. "No specific criteria exist within the Society [UHMS] regarding
the type and number of studies necessary to qualify a new indication
for acceptance."3. "the laws of physics set limits on the use of pressurized air as a
control. This has been evident in all research trials--for approved,
as well as for off-label conditions. Because air is a mixed gas
containing nitrogen and oxygen, when it is pressurized, the oxygen
content increases with increasing pressure, making air an inadequate
gas mix for a control population."4. "However, if the concentration of oxygen in a control gas mix is
kept at "sea level" equivalent, then additional nitrogen is absorbed
under pressure. Patients in such control groups are consequently at
risk for decompression sickness when the chamber is decompressed.
This can lead to permanent neurological damage. To prevent this,
depending on the treatment pressure under investigation, such
'control' patients may need oxygen during decompression, in effect
hyperbaric oxygen therapy"5. "patients in a control group can receive a 'sham treatment' where
the chamber is not really compressed. But it is technically difficult
to keep physicians, and impossible to keep technicians, blinded for a
series of sham treatments day after day."6. "in the case of decompression sickness, thousands of favorable
responses to early therapy with HBOT established it as the primary
treatment,"Question #1: Since you Dr Chan were the primary author, why were
these key phrases and sentences not included in the final published
version?Question #2: Of the Task Force members listed below, who among them
disagreed with Dr Chan's inclusion of the phrases/sentences listed as
1-6 above?Wayne Evans, MD
Caroline Fife, MD
William Fife, Phd
Eric Kindwall, MD
Carol Noel King
Valerie Larson-Lour, RN
Bill Maxfield, MD
Lee B. Palmer, BSM, CHT
Trish Planck
Ralph Potkin, MD
Ron Sechrist
Keith VanMeter, MD
Lindell K. Weaver, MDQuestion #3: If there was disagreement about phrases 1-6 above, as
primary author Dr Chan, what was your process of deleting these
phrases/sentences from the final article? i.e., Was there a vote
taken where the majority of Task Force members asked you to delete
key phrases/sentences or could a single member "black-ball" the
inclusion of a key phrase/sentence? Please explain.Thanks for your help.
David Freels
2948 Windfield Circle
Tucker, GA 30084-6714http://health.groups.yahoo.com/group/medicaidforhbot
.