-Caveat Lector-
This is a reply to the article from another list. Posting this FYI
Does Clinton has ties to this company too?
This has to reference links in it.
Laura
AKA The Pied Piper
*********Forwarded**************
This comes as no great shock to me. Baxter is one of
the "Big 4" who were involved in a class action suit by
persons with hemophilia, who were KNOWINGLY exposed to
HIV before the word finally came down that the blood was
officially tainted. This company, like Monsanto and
numerous others, will not stop at murder to make money.
They literally do not care if people die using their
products, because it is considered an acceptable loss in
terms of dollars and cents (definitely not sense!). For
more info about Baxter's involvement with persons with
hemophilia, read the book "Cry Bloody Murder" by Elaine
DePrince, or see the movie "And the Band Played On." My
nephew has hemophilia, this is of great interest to me.
Thanks.
-----Original Message-----
From: Steve Wingate <[EMAIL PROTECTED]>
To: [EMAIL PROTECTED] <[EMAIL PROTECTED]>
Date: Monday, January 18, 1999 4:06 PM
Subject: [CTRL] FDA rules allowed fatal blood trials without consent,
officials say
-Caveat Lector-
FDA rules allowed fatal blood trials without consent,
officials say
Copyright � 1999 Nando Media
Copyright � 1999 Associated Press
CHICAGO (January 17, 1999 6:31 p.m. EST http://www.nandotimes.com) -
A company conducted an ill-fated blood substitute trial without the informed
consent of patients in the study - some of whom died, federal officials say.
Baxter International Inc. was able to test the substitute known as HemAssist
without consent because of a 1996 change in federal FDA regulations.
The changes broke a 50-year standard to get consent for nearly all
experiments on humans. They were designed to help research in
emergency medicine that could not happen if doctors took the time to get
consent.
But the problems with the HemAssist trial are prompting some medical
ethicists to question the rule change.
"People get involved in something to their detriment without any knowledge
of it," George Annas, a professor of health law at the Boston University
School of Public Health, told the Chicago Tribune. "We use people. What's
the justification for that?"
No other company has conducted a no-consent experiment under the rule,
FDA officials said.
Baxter officials halted their clinical trial of HemAssist last spring after
reviewing data on the first 100 trauma patients enrolled in the nationwide
study.
Of the 52 critically ill patients given the substitute, 24 died,
representing a
46.2 percent mortality rate. The Deerfield, Ill.-based company had
projected 42.6 percent mortality for critically ill patients seeking
emergency
treatment.
There has been an intense push to find a blood substitute because artificial
blood could ease the effects of whole-blood shortages.
Researchers say it lasts longer than conventional blood, eliminates the
time-consuming need to match blood types and wipes out the risk of
contamination with such viruses as HIV and hepatitis.
The principle of informed consent was first articulated following the
revelation that Nazi doctors performed hideous experiments during World
War II. It became even more important because of U.S. -backed syphilis
experiments on blacks in the South that went on for decades after a cure
for the disease were revealed.
The 1996 regulations require a level of community notification that is not
used in most scientific studies, including community meetings, news
releases and post-study follow-up.
Some say such notification cannot replace direct consent from patients or
their relatives.
"Public notification means nothing," said Dr. Arthur Caplan, director of the
Center for Bioethics at the University of Pennsylvania. "I know people are
enamored of it, but it means nothing."
No lawsuits have arisen from the blood substitute trial, Baxter officials
said.
"The regulations worked in this instance," company spokeswoman Mary
Thomas said Sunday. "We voluntarily stopped the trial early on at the first
sign of unexpected results to insure patient safety."
------------------------------------------------------------------------
Steve Wingate
California Director
SKYWATCH INTERNATIONAL
Today's Midi
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*************end reply************************
Laura
aka The Pied Piper
http://members.xoom.com/ThePiedPiper/Intro2.htm
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