MEDICAL EXPERIMENTS TO BE DONE WITHOUT PATIENT'S CONSENT

||||||||||||||||||||||||||||||||||||||||||||||||||||||||

ROB STEIN, WASHINGTON POST - 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. . .

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. . . 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. . .

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.

http://chron.com/disp/story.mpl/headline/nation/4839234.html

||||||||||||||||||||||||||||||||||||||||||||||||||||||||

ECHOES FROM THE PAST

GINA KOLATA, NY TIMES, 1996 - For the first time in a half century, new
Federal regulations allow investigators to enroll patients in some
medical research studies without their consent. The Food and Drug
Administration regulations, . . .  apply only in carefully circumscribed
situations. The patients must have a life-threatening condition, like a
severe head injury, and must be unable to say whether they want to be
part of a study. They would be selected only if it was not feasible to
obtain consent from a relative. Furthermore, the community in which the
research is done must be notified about the study, and the research
design must have been reviewed and approved by the Food and Drug
Administration.

Even the most ardent supporters of the new regulations say they
understand the seriousness of what they have done. They have repealed a
principle that dates back to the Nuremberg trials of Nazi doctors after
World War II, when American judges were agonizing over rules that might
prevent doctors from ever again using human subjects in horrendous
experiments. The judges wrote a code of ethics, the Nuremberg Code,
whose first principle was that no one should ever be forced to take part
in a medical experiment. "The voluntary consent of the human subject is
essential," they wrote. . .

"It's a fateful step," Jay Katz, an ethicist and lawyer at Yale
University, said in a telephone interview from Germany, where he was at
a conference marking the 50th anniversary of the Nuremberg doctors'
trials. "The first sentence of the first principle of the Nuremberg
Code," he said, stated that nothing should be done to human beings
without their consent. And now, he said, "here we are making
exceptions."

http://query.nytimes.com/gst/fullpage.html?sec=health&res=
9F01E4D61538F936A35752C1A960958260


US HOLOCAUST MUSEUM - During World War II, a number of German physicians
conducted painful and often deadly experiments on thousands of
concentration camp prisoners without their consent. Unethical medical
experimentation carried out during the Third Reich may be divided into
three categories. The first category consists of experiments aimed at
facilitating the survival of Axis military personnel. In Dachau,
physicians from the German air force and from the German Experimental
Institution for Aviation conducted high-altitude experiments, using a
low-pressure chamber, to determine the maximum altitude from which crews
of damaged aircraft could parachute to safety. Scientists there carried
out so-called freezing experiments using prisoners to find an effective
treatment for hypothermia. They also used prisoners to test various
methods of making seawater potable. 

The second category of experimentation aimed at developing and testing
pharmaceuticals and treatment methods for injuries and illnesses which
German military and occupation personnel encountered in the field. . .
The third category of medical experimentation sought to advance the
racial and ideological tenets of the Nazi worldview. The most infamous
were the experiments of Josef Mengele at Auschwitz. Mengele conducted
medical experiments on twins. He also directed serological experiments
on Roma (Gypsies), as did Werner Fischer at Sachsenhausen, in order to
determine how different "races" withstood various contagious diseases.
The research of August Hirt at Strasbourg University also intended to
establish "Jewish racial inferiority."
 
http://www.ushmm.org/wlc/article.php?lang=en&ModuleId=10005168

LANCET, 2005 - Patients the world over need adequate protection from
overreaching physicians who use patients to test experimental drugs and
procedures without their informed consent. Jacques Michel, a retired
director of Hadassah Hospital in Jerusalem who also heads the hospital
ethics committee, triggered an investigation of 39 hospitals by Israel's
State comptroller, the government watchdog.

The findings of non-consensual experiments conducted primarily on
children, the elderly and psychiatric patients, shocked Israelis. . .
The violations were found to be worst in geriatric, rehabilitation, and
psychiatric hospitals, where some children had their eardrums
deliberately pierced so that a drug could be applied. In another painful
procedure, a needle was used to draw urine from the bladder for testing
without health ministry approval.". . . "Anyone who performs a medical
experiment on someone who doesn't or is unable to give his informed
consent should be tried for physical assault."

A striking difference between this and similar research scandals at
major US

http://www.ahrp.org/infomail/05/07/26.php

WIKIPEDIA - The Tuskegee Study of Untreated Syphilis in the Negro Male.
. . became notorious because it was conducted without due care to its
subjects, and led to major changes in how patients are protected in
clinical studies. Individuals enrolled in the Tuskegee Syphilis Study
did not give informed consent and were not informed of their diagnosis;
instead they were told they had "bad blood" and could receive free
medical treatment, rides to the clinic, meals and burial insurance in
case of death in return for participating.

In 1932, when the study started, standard treatments for syphilis were
toxic, dangerous, and of questionable effectiveness. Part of the
original goal of the study was to determine if patients were better off
not being treated with these toxic remedies.

By 1947, penicillin had become the standard treatment for syphilis.
Prior to this discovery, syphilis frequently led to a chronic, painful
and fatal multisystem disease. Rather than treat all syphilitic subjects
with penicillin and close the study, or split off a control group for
testing penicillin; the Tuskegee scientists withheld penicillin and
information about penicillin, purely to continue to study how the
disease spreads and kills. Participants were also prevented from
accessing syphilis treatment programs that were available to other
people in the area. The study continued until 1972, when a leak to the
press resulted in its termination.

||||||||||||||||||||||||||||||||||||||||||||||||||||||||