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Part of Study Testing Trauma Treatments Is Shut Down

When will an invasive
government mandates that place children in a
test prep curriculum for their entire
elementary education be shut down? Where's the
parental consent for this experimentation being
done on their children?

By Rob Stein

A key part of a controversial project that has
been testing experimental treatments on trauma
victims has been shut down after the
researchers discovered that one new therapy
offered no benefit and that patients receiving
it appeared to die more quickly.

The research has been subject to intense
ethical debates because the patients, who were
often unconscious or disoriented because of
their injuries, could not give consent to
participate.

More analysis will be needed to examine why
there were more deaths initially among the
patients receiving the experimental treatment,
a concentrated form of a salt solution that was
being tested in seriously injured patients who
were in shock from severe blood loss, federal
officials said yesterday.

But they stressed that there was no overall
longer-term increase in deaths among the
patients receiving that therapy and that the
study was halted primarily because it failed to
meet a higher standard required for
experimenting on patients without their
consent: providing a clear benefit over
standard care.

"There was high hope based on all the evidence
at the time we designed the study that this
would be beneficial," said George Sopko of the
National Heart, Lung and Blood Institute, which
sponsored the research. "But we found that
there was no chance it was going to be better,
so it would have been unethical to continue."

Critics, however, said the results illustrated
why such research is unethical and called for
the government to shut down two other large
studies that are part of the same project.

"They shouldn't be doing these kinds of
studies," said George J. Annas, a Boston
University bioethicist. "You shouldn't be doing
research on people without their consent.
People have a right not to have the government
invade their body."

The study was one of three being conducted as
part of a $50 million, five-year, federally
funded project, the most ambitious set of
studies ever mounted under a federal exemption
that allows researchers to conduct some kinds
of medical experiments without first getting
patients' informed consent.

The project was designed to study more than
20,000 patients in 10 sites in the United
States and Canada in the hopes of improving
treatment after car accidents, shootings,
cardiac arrest and other emergencies. Because
such patients are usually unconscious at a time
when every minute counts, it is often difficult
if not impossible to get consent from them or
their families.

"In these situations, where someone has
collapsed or is about to die, you are not going
to have a chance to ask for consent, because
minutes matter," Sopko said.

Although the project was endorsed by many
trauma experts and some bioethicists, others
have questioned it, noting that attempts to
test treatments such as blood substitutes under
the same exemption may have put patients at
risk.

The study that was halted was designed to
involve about 3,700 patients who were in shock
as a result of severe bleeding. Typically,
emergency medical workers infuse such patients
with a normal-strength saline solution in the
ambulance until they can get to the hospital to
receive blood transfusions. Some research,
however, has suggested that the highly
concentrated saline might be superior, either
by itself or combined with another substance
known as dextran.

The study was suspended on Aug. 25, after 846
patients had been enrolled, when an independent
panel monitoring the project found that after
an average of 28 days, there was no difference
in the death rates between those receiving
concentrated saline and those receiving normal
saline, which was the study's predetermined
measure of success. Moreover, more patients
receiving concentrated saline died on their way
to the hospital or in the emergency room,
officials said.

Sopko did not release additional details,
saying more analysis is needed. But he said the
lack of excess deaths after 28 days indicated
that the treatment, while not superior, had not
harmed patients.

"The key is you want to see whether the patient
leaves the hospital or is alive after 28 days,"
he said.

Annas, however, said the findings suggest the
therapy may have harmed study participants.

"So they're saying it doesn't matter when you
die -- it doesn't matter if you die today or in
28 days, that the last 28 days of life are not
important?" Annas said. "That's ridiculous. It
may turn out they killed people with this
experiment -- people who didn't even know they
were in it and died before they were even told
they were in an experiment."

Further analysis of data from about 545
patients in the shock study in February
prompted organizers to permanently end that
trial, Sopko said. Despite the disappointing
findings, Sopko said the study was worth
conducting.

"This is essentially what clinical trials are
for: to provide you with solid evidence for how
to practice the best medicine," Sopko said.
"That's the danger of small studies that seem
to produce spectacular results. If you don't
get them confirmed by big trials, you might get
false hope."

In August, officials also suspended a second
study designed to test the same approach on
about 2,100 patients with head injuries. But an
analysis of preliminary data from about 800
patients in that study found no reason to halt
that trial, and the study resumed in November
after emergency medical workers at the
participating centers received additional
training to make sure they did not include
shock patients in the study, Sopko said. The
third study, which is comparing different ways
of resuscitating patients who have suffered
sudden cardiac arrest, is also continuing in
more than 16,000 subjects.


— Rob Stein
Washington Post
2009-03-27


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