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*May 26, 2007, 11:51PM*
Medical experiments to be done without patients' consent
Five-year project aims to improve car crash, cardiac, other
treatments
By ROB STEIN
Washington Post
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RESOURCES
NORTH AMERICA NET
The studies are being conducted by the Resuscitation
Outcomes Consortium, a
network that includes medical centers in Seattle, Portland,
San Diego,
Dallas, Birmingham, Pittsburgh, Milwaukee, Toronto and
Ottawa and around
Iowa and British Columbia.
WASHINGTON — The federal government is undertaking the most
ambitious set of
studies ever mounted under a controversial arrangement that
allows
researchers to conduct some kinds of medical experiments
without first
getting the patients' permission.
The $50 million, five-year project, which will involve more
than 20,000
patients in 11 sites in the United States and Canada, is
designed to improve
treatment after car accidents, shootings, cardiac arrest and
other
emergencies.
The three studies, organizers say, offer an unprecedented
opportunity to
find better ways to resuscitate people whose hearts suddenly
stop, to
stabilize patients who go into shock and to minimize damage
from head
injuries. Because such patients are usually unconscious at a
time when every
minute counts, it is often impossible to get consent from
them or their
families, the organizers say.
The project has been endorsed by many trauma experts and
some bioethicists,
but others question it. The harshest critics say the
research violates
fundamental ethical principles.
The organizers said the studies are going forward only after
an exhaustive
scientific and ethical review by the National Institutes of
Health, which
authorized the funding in 2004, and the Food and Drug
Administration, which
approved the first phase about a year ago and the second
phase six months
ago.
The first experiments, involving nearly 6,000 patients,
focus on people who
are in shock or have suffered head injuries from a car
crash, a fall or some
other trauma.
About 40,000 such patients show up at hospitals each year,
and the standard
practice is to give them saline infusions to stabilize their
blood pressure.
For the study, emergency medical workers are randomly
infusing some patients
with "hypertonic" solutions containing much higher
levels of sodium, with or
without a drug called dextran. Animal research and small
studies involving
people have indicated that hypertonic solutions could save
more lives and
minimize brain damage.
The next experiment, which will involve about 15,000
patients, is designed
to determine how best to revive those whose hearts suddenly
stop beating.
About 180,000 Americans suffer these sudden cardiac arrests
each year.
Emergency medical workers often shock these patients
immediately to try to
get their hearts started again. But some do a few minutes of
cardiopulmonary
resuscitation first. Researchers want to determine which
strategy works
better by randomly trying one or the other — both with and
without a special
valve attached to devices used to push air into the lungs
during CPR. That
study is expected to start next month.
"We will never know the best way to treat people unless
we do this research.
And the only way we can do this research, since the person
is unconscious,
is without consent," said Myron Weisfeldt of the Johns
Hopkins University
School of Medicine, who is overseeing the project.
"Even if there are family
members present, they know their loved one is dying. The
ambulance is there.
The sirens are going off. You can't possibly imagine gaining
a meaningful
informed consent from someone under those
circumstances."
Before starting the research at each site, researchers
complete a "community
consultation" process. Local organizers try to notify
the public about the
study and gauge the reaction through public meetings,
telephone surveys,
Internet postings and advertisements and through stories in
local media.
Anyone who objects can get a special bracelet to alert
medical workers that
they refuse to participate.
The project proceeds only after also being vetted by a set
of local
independent reviewers known as an institutional review
board. Another group
of independent advisers known as a data safety monitoring
board will
periodically review the study for any signs of problems.
Despite such oversight, some previous similar projects have
sparked intense
debate. Most recently, a study testing a blood substitute
called PolyHeme
was criticized for putting patients at risk without
consent.
In fact, concerns raised by the PolyHeme study and others
prompted the FDA
to launch a review of the entire program that permits
experiments to be done
without consent in emergency situations.
"The ethics and policy concern is how you balance the
streamlining of
research to get the best information to treat patients
against the moral
imperative to get consent," said Nancy M.P. King, a
bioethicist at Wake
Forest University School of Medicine. "The emergency
consent exception is
supposed to carve out a very narrow window. What's been
happening is that
narrow window seems to be expanding."
Some bioethicists say the new research is more ethical than
some of the
earlier studies in several ways, including that patients are
not being
denied highly effective therapies. Most patients who receive
the current
treatments do not survive.
"I understand why there might be concerns, but I think
ethically this is
permissible," said Arthur Derse, a bioethicist at the
Medical College of
Wisconsin, which refused to participate in the PolyHeme
study. "The
treatments we currently have are unsatisfactory."
But others say that the studies could be done by finding
patients or family
members who are in a position to provide consent, even
though that might
make such studies more difficult.
"This just seems like lazy investigators not wanting to
try to get informed
consent in situations where it is difficult to get it, so
they say it is
impossible," said George Annas, a Boston University
bioethicist. "I don't
think we should use people like this."
Annas was particularly disturbed that children as young as
15 might be
included in the research.
"Suppose a 15-year-old child is in the back of a car
that is in a terrible
accident," Annas said. "The EMTs arrive and say:
'We are doing an experiment
with two techniques. We think they are about equal. Is it
okay if we flip a
coin to see how we treat your son? Or would you rather we
just give him the
treatment we think is best?' Unless you think all parents
would have the
EMTs flip a coin, consent here is necessary."
Others are concerned patients may be getting experimental
therapies that
could turn out to be inferior to standard treatments.
"The most promising experimental medical interventions
have often been shown
to be less effective than standard treatment," said
Kenneth Kipnis, a
University of Hawaii bioethicist.
The "community consultation" process has also come
under fire.
"Community consultation is intended to be a
collaboration with the community
of potential subjects, not just letting them know what the
plan is," said
King, the Wake Forest bioethicist.
But Weisfeldt at Johns Hopkins said the critics would be
unhappy under any
circumstances.
"Some people object to the whole concept of doing any
study whatsoever
without permission," Weisfeldt said. "We try to
explain all the layers of
approval we've gone through and that this is the only way we
can do the kind
of research that could save many more lives in the
future."
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