Fifty
Years After the Nuremberg Medical Trial: What Have We Learned?
Written by Evelyne Shuster, Ph.D.,
to the Op-Ed Page of
The Philadelphia Inquirer,
Decemeber 5, 1996.
To the Op-Ed Editor:
Fifty years ago, on December 9, 1946, the trial of Nazi doctors
by the American Military Tribunal began at Nuremberg. In the docks,
the 23 defendants, all but three prominent physicians and noted
scientists, were charged with murder, torture and unspeakable medical
atrocities they committed on concentration camp inmates. These medical
crimes were extraordinary in their brutality. They consisted of
various types of gruesome experiments such as high-altitude, freezing,
seawater, malaria, sulfanilamide, bone, muscle and nerve regeneration,
sterilization poisons and incendiary bombs.
In the wake of the Nuremberg trials of war criminals, the so-called
“Big Trial,” Americans wanted to know how it was possible
for a country as civilized as Germany to have allowed such crimes
to happen. Most importantly, how could doctors who prided themselves
in belonging to the most trusted of all professions, have performed
such torturous and deadly human experiments? How did they justify
their actions as consistent with good science and good medicine?
What moved them to treat people as less than laboratory animals?
Sigmund Rascher described how, in a series of ghastly high-altitude
tests, one inmate at the Dachau concentration camp was locked in
a low-pressure chamber with an oxygen mask, raised in the chamber
to an atmospheric elevation of more than 47,000 feet when his mask
was removed and a parachute descent was simulated. Agonizing in
pain, the man asked his “doctor” whether he could breathe:
“One moment please, doctor...may I breathe? Is it alright
if I breathe?” The man took a breath and said,“Thank
you very much... Am I allowed to breathe? I am content with it.”
Is the Hippocratic view of doctors as beneficent healers so powerful
that even in the Dachau torture chamber, an individual would turn
to his “doctors” for advice and protection, reverting
to be "a patient" in care of trusted doctors who can do
no harm? The relevance of Hippocratic ethics to human experimentation
was central to the Doctors’ Trial. Three physicians dominated
the medical ethics debate at Nuremberg. They were Leo Alexander,
a Viennese-born neuro-psychiatrist and chief medical advisor to
the prosecution, Werner Leibbrand, a German psychiatrist and medical
historian, the prosecution witness, and Andrew C. Ivy, a noted American
scientist, and the only expert physician in medical ethics to testify
in rebuttal for the prosecution.
All condemned Nazi doctors for having violated what they took to
be the central principle of Hippocratic ethics, First Do No Harm.
These physicians could not imagine that Hippocratic doctors will
intentionally harm or injure their patient-subjects, and they argued
that adherence to Hippocratic ethics would protect subjects as it
protects patients. They stressed that Hippocratic ethics governs
the doctor-patient relationship in human experimentation as it does
in the ordinary therapeutic relationship. They emphasized scientific
probity, prior animal research, and the integrity of qualified scientists,
and agreed that consent of the research subject is essential, the
lack of which constituted prima facie evidence of ethical wrongdoing.
Chief Counsel, Telford Taylor, and his assistant prosecutor, James
McHaney, concurred. Alexander articulated six and Ivy articulated
three necessary conditions for the conduct of human experimentation
grounded on Hippocratic ethics, with the first condition being that
the human subject must volunteer.
The problem with extending Hippocratic ethics to cover research
is that nowhere in the Oath is the patient’s autonomy conceptualized.
In this tradition, the patient should want to be treated. But once
he agrees to treatment, he remains silent, dutifully obedient, morally
and practically obligated to trust his physician’s ability
and judgment and to cooperate with him in combating the disease.
In the beneficent context of the doctor-patient relationship, the
patient relinquishes his autonomy with confidence in his doctor
who will do no harm.
In research, however, this is not possible, because the primary
goal is to test an hypothesis. The physician-investigator must follow
the research protocol irrespective of what he believes to be in
the best interest of the patient-subject. In this context, not only
the subject’s right to consent, but also his right to terminate
the experiment once it had begun must be recognized in order to
protect the subject. By framing research ethics within Hippocratic
ethics, Alexander, Leibbrand and Ivy predictably failed to recognize
the right of the subject to terminate the experiment at liberty
and independently from the investigator. This omission is monumental
because without such a right the subject’s autonomy collapses
into what the physician- investigator thinks is best.Clinging to
Hippocratic ethics permitted both Alexander and Ivy to conflate
research with treatment, and thus to blur the vital distinction
between patients and subjects, experimentation and therapy, and
between investigators and physicians. The judges at Nuremberg, to
their credit, did not expand on the conceptual Hippocratic framework
to include research. Instead, they formulated a new set of research
principles centered on the subject, and explicitly affirmed the
rights of the subject both to consent and to terminate an experiment.
This set of principles, known today as the Nuremberg
Code, is the most important document on human rights
protection in human experimentation. The Doctors’ Trial was
ultimately not about doctors and their Hippocratic medical ethics,
but rather about human rights protection in human experimentation.
Ivy and Alexander never fully appreciated the uniqueness of the
Code they helped to formulate even in light of the brutal concentration
camp experiments. Not surprisingly, after Nuremberg, physicians
have consistently tried to displace the Nuremberg Code with other
more flexible regulations grounded on Hippocratic ethics, such as
the Declarations
of Helsinki
[There have been several declarations between1964 and 2004—Editor).
To the extent that contemporary physicians continue to mirror the
beliefs of Alexander and Ivy, the rights of research subjects will
remain marginalized and physician-investigators will continue to
mischaracterize their research on subjects as treatment of patients.
The Nuremberg Code is the ideal standard in the conduct of research.
In commemorating the fiftieth anniversary [now sixtieth—Editor],
we turn to the future.We must reassert the importance of the Code,
including the actual (not formal) recognition of the rights of subjects
both to consent and to withdraw their participation in research.We
must insist that the right to consent should not be exercised at
the expense of the right to withdraw.
The current Food and Drug Administration regulation that allows
investigators to conduct emergency research on unconscious patients
without consent violates the rights of subjects to consent and to
withdraw. Once enrolled in a research study, these subjects have
no possibility to terminate participation in the experiment unless
the investigators deem it appropriate.
In order to protect the interests of subjects in this kind of research
without consent, it is necessary to appoint an independent physician
who is not part of the research team and who will be able to terminate
the experiment if the welfare of subjects is being compromised.
Physician-investigators themselves are simply incapable of doing
just that. On a global level, the Nuremberg Code should be adopted
in total as the international guidelines for the conduct of research.
One suggestion would be to form a global organization of physicians,
lawyers, ethicists and human rights advocates to monitor research
and to prevent the continued abuse and exploitation of subjects.
(ADDED June 1, 2007). A decade later, FDA is revisiting
its entire program that permits investigators to conduct research
without consent in emergency situation. Concerns are that FDA emergency
consent exception is intended for a few well defined emergency situations,
but has dangerously expanded to include many more, like testing
blood substitute, and resuscitation procedures.
—Evelyne Shuster, Ph.D.
—Philosopher and Medical Ethicist.
EDITOR’S NOTE: As we have just passed
the 60th anniversary of the Nuremberg Trials, we thought that this
still relevant essay should be read by our readers. Bringing things
up-to-date, Dr. Shuster has added a new paragraph at the end of
the original op-ed. The ongoing importance of the issue of experimentation
without consent is illuminated in a recent story in The Washington
Post. See “Critical Care Without Consent: Ethicists Disagree
On Experimenting During Crises,” by Rob Stein, Washington
Post Staff Writer,
Sunday, May 27, 2007; Page A01.
Comments
will be reviewed and
posted on a daily basis.
| JUNE
20 – 26, 2007:
Prof. Barbara Katz-Rothman:
“My main question
is in response to the final paragraph: why one would put a
physician in the role of patient/research-subject advocate?
Physicians have repeatedly demonstrated that they are not
suited to that job, which was of course the problem in the
first place. Here one would imagine that they would over-identify
with other physicians rather than the patient/subject. Physicians
systematically accept the logic of medical practice in ways
that no 'outsider' ever would, seeing procedures as 'minor'
that the ordinary person would regard as highly invasive,
etc. And so far, ethicists have not shown themselves to be
a hell of a lot better. So a “global organization of
physicians, lawyers, ethicists and human rights advocates”
would probably end up looking like so many ‘ethics’
committees do, an arrangement of mostly like-minded foxes
watching the hen house.”
Dr. Katz-Rothman, RLTE Editorial Associate and Professor
of Sociology, CUNY Graduate Center, is a widely recognized
specialist in Medical Sociology, Bioethics, Gender and the
Sociology of Knowledge.
Peter Jucovy, M.D.:
“While it is regrettably
true that many physicians are not suited to the role of being
an advocate for patients or research subjects— being
too entrenched, as Barbara says, in the closed and often closed-minded
“logic of medical practice”—I would reject
the idea that such a tendency is systematic or that it is
even close to universal among members of the profession. At
the personal level, there are all types of minds and moral
characters in the medical ranks. Perhaps only a minority of
doctors exhibit the requisite elements for genuine patient/
subject advocacy, but I can assure everyone that many physicians
who are qualified for this role do exist, and many are actually
engaged in this work as part of their everyday activities.
Furthermore, on a theoretical plane, I would argue that patient
advocacy is foremost among the complete physician's professional
responsibilities. I'd even equate it with the core of entire
role of being a physician. In my own conception of medicine,
it is the physician who bridges the patient's world of living
life with the possibility—and ultimate certainty! —of
becoming ill, and the medical scientist's world of deciphering
the pathological events that can undermine human life and
then finding ways to reverse or mollify the effects of those
events on behalf of the patient. In that role, the primary
calling of the physician is to listen to and interpret the
story of another person's illness, examine the person for
physical clues to augment and refine an ongoing interpretation
of the that story, piece together the best scientific model
to explain the story medically (that is, make a “diagnosis”),
and then refashion the medical explanation into one that the
particular patient can use to made informed decisions about
what to do next. A good physician will articulate the available
treatment choices in neutral, explanatory language, and then—only
then and only if the patient wants to hear one—make
a recommendation to the patient from the set of choices. I
would say this job is the essence of being an advocate, and
most doctors recognize this and try to do it right. Many stumble
along the way, particularly at the step where translation
of medical logic and language into lay person logic and language
should occur, but I believe that most doctors do a fair job
of it. Doctors are even learning how not to be subtly coercive
about patient's decisions.The last 25 years has seen major
progress with the advent of living wills, hospice, respite
care, and so on—all instruments and arrangements designed
to give informed choice back to the people who are ill and
to their families. However, the key is that all this be done
in a way where the decisions are made in a medically informed
context (even if medical people do not agree with the actual
decision in the end). It is the job of the doctor to inform,
explain, and advise.That is patient advocacy.
“Let me get back to Barbara's main objection to Evelyne's
final suggestion about a having independent physicians monitor
human research being conducted by other physician investigators,
and even an international board that includes physicians along
with ethicists, human rights advocates and lawyers. I agree
with Evelyne both theoretically—along the lines of my
conceptual view given above—and pragmatically. Physicians
are—and I say this in recognition that it is both a
strength and a serious flaw—very jealous of their status
as professionals. One given in a profession is that while
in other non-professional walks of life, there are employers
and employees, supervisors and the supervised, in professions,
individual workers are on their own, even as they work in
teams (yes, doctors do often fail as team members). Professions
are self-regulating. (One contemporary problem is that non-physician
administrators and regulators control so much activity in
HMOs, hospitals, and other health care organizations. This
has led to enforced bad decision-making in situations where
physicians acting with true independence would do a hell of
a lot better.) So ask the question, which oversight body would
likely be more effective in policing the activities of physician
researchers: the one which includes physician experts or the
one which excludes doctors? The oversight committee which
lacks physician membership immediately loses credibility and
has no chance of being effective. That is a matter of simple
political strategy. But more fundamentally, the committee
would do a far better job if it were well represented by physicians
whose scientific knowledge and practice expertise enabled
them to identify, understand, and explain potential risks
to subjects that others could not see. As the chairman of
an institutional review board, I know this for a fact: just
as a lay person can spot potential problems to which a physician
may be blind, a knowledgeable medical specialist brings a
critical dimension to an oversight committee simply by knowing
biomedical details that others do not.”
Dr. Jucovy is head of the human research subjects protection
program at the Philadelphia Veterans Affairs Medical Center.
Evelyne Shuster responds:
"I appreciate both comments by Barbara and Peter. Barbara
may be right about physicians who may not be sensitive about
patient/ subjects' rights, and may only defend their interests
in research and "getting things done." It is also
true that many ethicists ignore the meaning of human rights
and what it takes to promote and protect them in research.
Ethicists in general have been pathetically focused on narrow
medical ethics issues like living wills that do not work,
and the ever recurrent right of patients to refuse treatment.
Debates on these specific medical ethics issues are necessary,
but they are not sufficient. I would agree with Barbara that
the last thing we need is another committee that resembles
our current institutional ethics committees!.
"I would agree almost entirely with Peter, but would
add that this committee should include members of the community
(at least 50%) from which research subjects are drawn. No
one profession should dominate the committee's deliberation,
and to have only one community representative should not be
acceptable.”
|
|
Karl
Brandt, the lead defendant in the medical trial.
Wolfram
Sievers, Executive Secretary of the 
Administration
Dr. Waldemar Hoven, chief doctor at Buechenwald, testifies in his
own defense. 
During
the Medical Trial (Case #1 of the Subsequent
