Sunday, May 27, 2007

Wrong, and Dumb

From the Washington Post:
May 26, 2007, 11:51PMMedical experiments to be done without patients'
consentFive-year project aims to improve car crash, cardiac, other
treatments
By ROB STEINWashington Post
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."
I have long suspected that the whole purpose of the discipline of "bioethics" is to rationalize a Yes to whatever scientists can conceive.

On my driver's license is a little printed sticker. It came with my license. There's a blank for the sticker on the laminated card. I choose to be an organ donor, so I put the little sticker in the little blank. I gave my consent in advance. If I change my mind, I remove the sticker.

That's how you get your consent. But that would probably be too difficult for the researchers. For their convenience, thousands of Americans will be unwitting guinea pigs in mortal experiments.

That's wrong. And by presuming that federal regulatory permission somehow voids state medical malpractice and civil liability laws, it is also breathtakingly stupid.

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