Excerpts :
http://blogs.nature.com/news/2011/08/commission_condemns_guatamalan_1.html
Researchers knowingly violated ethical boundaries when they
intentionally infected Guatamalan prisoners, mental health
patients, and prostitutes with sexually transmitted diseases in a
1940s research project, a presidential commission concluded
yesterday.
When the harrowing experiments came to light (see 'A shocking
discovery'), President Barack Obama charged the President’s
Commission for the Study of Bioethical Issues with investigating
the matter. After picking through 125,000 pages of historical
documents, the committee determined that the experiments were
unethical even by the prevailing norms of the era, and that those
who conducted the research actively sought to keep experiments out
of the public eye.
It was also no accident that the research was performed in
Guatemala, argued Amy Gutmann, chairwoman of the commission and
president of the University of Pennsylvania. “Some of the people
who were involved in this experiment explicitly said, ‘We could not
do this in our own country’,” she said. “It was a foreign
population that was seen as ethnically, racially, nationally
different.”
“The only way you could continue doing this is to think of what
you were working on as material as opposed to human subjects,”
Gutmann added.
The work was also in clear opposition to ethical standards of
the time, argued Nelson Michael, director of the US Military HIV
Research Program. “I’m not aware of any standards that would have
said, ‘it’s ok to go offshore to do this kind of research’,” he
said. “They did it because they found a doorway that they found
darkened and they went through it.”
Sexually transmitted diseases, including gonorrhea and syphilis,
were among the biggest threats to public health at the time. It was
estimated that 20% of the people living in psychiatric institutions
were there because of the neurological effects of advanced
syphilis. The researchers in the Guatemalan study, which included
John Cutler, an architect of the Tuskegee syphilis experiments,
were looking for a way to prevent the spread of such diseases. But
despite that sense of urgency, the studies carried out in Guatemala
were poorly designed, poorly executed, and entirely unethical, the
commission concluded.
All told, the commission found that more than 5,000 people were
enrolled in either or both of the programme’s two research arms:
one in which prisoners, the mentally ill, and prostitutes were
intentionally infected via injections with syphilis and gonorrhea,
and another in which blood and spinal fluid was tested for
background levels of the infectious agents. The latter studies were
also conducted in young Guatemalan orphans. All of the experiments
were performed without consent of the subjects.
The commission found evidence of at least 83 deaths, but could
not determine to what extent the deaths were likely to be related
to the experiments.
The committee is still writing up its conclusions, and plans to
submit a report on the historical study to Obama in September. It
will also prepare a second report – following a probe into the
adequacy of current policies to protect human research subjects –
by the end of the year.
John Arras, a philosopher at the University of Virginia, said
that he initially struggled with the decision over whether the
researchers deserved blame for the ethical transgression. But the
details of the experiments wiped away any doubt, he added.
Arras then detailed the stomach-churning case of Berta, a
patient in a psychiatric ward who was deliberately injected with
syphilis and not given treatment until three months after her
infection. Soon after, Cutler wrote that Berta seemed about to die
from the syphilis they infected her with. That same day, he
inserted gonorrheal pus from another patient into both of her eyes,
her urethra, and her rectum. He also re-injected her with more
syphilis. Several days later, her eyes were filled with pus from
the gonorrhea and she was bleeding from her urethra.
“I would submit that this kind of case cannot be waved away by
even the most acute awareness of fluctuation in medical ethics
standards of the time,” Arras said.
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http://www.nytimes.com/2011/08/31/world/americas/31syphilis.html
Gruesome details of American-run venereal disease experiments on
Guatemalan prisoners, soldiers and mental patients in the years
after World War II were revealed this week during hearings before a
White House bioethics panel investigating the study’s sordid
history.
About 5,500 Guatemalans were enrolled, about 1,300 of whom were
deliberately infected with syphilis, gonorrhea or chancroid. The
stated aim of the study was to see if penicillin could prevent
infection after exposure. But the study’s leaders changed
explanations several times.
“This was a very dark chapter in the history of medical research
sponsored by the U.S. government,” Amy Gutmann, the chairwoman of
the bioethics panel and the president of the University of
Pennsylvania, said in an interview.
President Obama apologized to President Álvaro Colom of
Guatemala for the experiments last year, after they were
discovered.
Since then, the panel, the Presidential Commission for the Study
of Bioethical Issues, has studied 125,000 pages of documents and
has sent investigators to Guatemala. While the panel will not make
its final report until next month, details emerged in hearings on
Monday and Tuesday.
The most offensive case, said John Arras, a bioethicist at the
University of Virginia and a panelist, was that of a mental patient
named Berta.
She was first deliberately infected with syphilis and, months
later, given penicillin. After that, Dr. John C. Cutler of the
Public Health Service, who led the experiments, described her as so
unwell that she “appeared she was going to die.” He then inserted
pus from a male gonorrhea victim into her eyes, urethra and rectum.
Four days later, infected in both eyes and bleeding from the
urethra, she died.
“I really do believe that a very rigorous judgment of moral
blame can be lodged against some of these people,” Dr. Arras
said.
Also, several epileptic women at a Guatemalan home for the
insane, were injected with syphilis below the base of their skull.
One woman became completely paralyzed for two months by syphilitic
meningitis.
Dr. Cutler said he was testing a theory that the injections
could cure epilepsy.
Poor, handicapped or imprisoned Guatemalans were chosen because
they were “available and powerless,” said Anita L. Allen, a
bioethicist at the University of Pennsylvania’s law school and a
panelist.
Dr. Cutler’s team took pains to keep its activities hidden from
what one of the researchers described as “goody organizations that
might raise a lot of smoke.”
Members of the bioethics commission recalled Nazi experiments on
Jews and said that Dr. Cutler, who died in 2003, must have known
from the Nuremberg doctors’ trials under way by 1946 that his work
was unethical.
Also, according to Dr. Gutmann, Dr. Cutler had read a brief
article in The New York Times on April 27, 1947, about other
syphilis researchers — one of them from his own agency — doing
tests like his on rabbits. The article stated that it was
“ethically impossible” for scientists to “shoot living syphilis
germs into human bodies.” His response, Dr. Gutmann said, was to
order stricter secrecy about his work.
