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Subject:
From:
David Freels <[log in to unmask]>
Reply To:
St. John's University Cerebral Palsy List
Date:
Sat, 1 Dec 2001 09:21:05 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (44 lines)
The report of that committee--The Ethics Task Force--has never been made
public. Until now. It's an attachment to this email as a pdf file. If
you're not accepting attachments, you can download it at
http://groups.yahoo.com/group/medicaidforhbot/files/UHMS_Has_No_Ethics.PDF

Numerous aspects of this report are troubling. Specifically:

(1) Why has this document not been made public?

(2) The UHMS says it's nearly impossible to perform a double-blind
controlled study for Hyperbaric Oxygen Therapy on brain-injured children.
From the last paragraph on page 3:

"In particular, investigators confront difficulties designing and
conducting blinded, randomized controlled clinical trials.  They are nearly
impossible to conduct.

Research difficulties center upon the issues of creating conditions for a
control, blinding, randomization and patient consent.  Of these, setting up
control conditions ranks as one of the most difficult because the gas 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.
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, albeit for a
limited period of time.  Alternatively, 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."

With this detailed explanation of the impossibility to produce, create, and
perform a double-blind controlled study of HBOT for cp children, why did
the UHMS remain silent when Collet claimed his study in the Lancet was a
double-blind controlled study?

They didn't even post a position statement on their web page.

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