GENTECH archive


blood trials done without consent

Monday January 18 1:58 AM ET 
Blood Trials Done Without Consent
CHICAGO (AP) - Twenty-four critically ill patients died after being given a
blood substitute without their informed consent, according to federal
Baxter International Inc. (NYSE:BAX - news) was able to test the substitute
known as HemAssist without consent because of a 1996 change in U.S. Food and
Drug Administration regulations. 
The change, which broke with a 50-year standard that required informed consent
for nearly all experiments on humans, was designed to facilitate research in
emergency medicine that could not happen if doctors were forced to take the
time to get patient consent. 
Baxter officials halted their clinical trial of HemAssist last spring after
reviewing data on the first 100 trauma patients enrolled in the nationwide
Of the 52 critically ill patients given the substitute, 24 died,
representing a
46.2 percent mortality rate. The suburban Deerfield, Ill.-based company had
projected 42.6 percent mortality for critically ill patients seeking emergency
The push to find a blood substitute has been intense 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. 
No company other than Baxter has conducted a no-consent experiment under the
rule, according to FDA officials. 
The new 1996 regulations require a level of community notification that is
higher than most scientific studies, including community meetings, press
releases and post-study follow-up. 
Yet it's unlikely that any of the patients who wound up being transfused with
the blood substitute in emergency rooms had been reached by the public
notification, the Chicago Tribune reported Sunday. 
Some say such notification cannot replace direct consent from patients or
``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.'' 
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 Tribune. ``We use people. What's the justification
for that?'' 
A Baxter spokeswoman told the Tribune that no lawsuits have arisen from the
blood substitute trial. 
``The regulations worked in this instance,'' Mary Thomas said Sunday. ``We
voluntarily stopped the trial early on at the first sign of unexpected results
to insure patient safety.'' 
Thomas says Baxter is in favor of obtaining patient consent whenever possible.
Yet company officials also believe it is important to advance lifesaving
medical therapy for patients - something impossible to do without the revised
FDA regulations, Thomas said.