A year after professor Susan M.
Reverby, a historian at Wellesley College in Massachusetts, uncovered a
heinous Guatemalan syphilis experiment conducted between 1946 and 1948,
on at least 5,500 under the auspices of the US Public Health Service, a
hearing was held this week about the findings of the President's
Bioethics Commission investigation.
The Commission confirms that despite knowledge that it was unethical,
US government medical scientists PURPOSELY infected "at least 1,300 who
were exposed to the sexually transmitted diseases syphilis, gonorrhea
and chancroid" to study the effects of penicillin. At least 83 subjects
died."
THE NEW YORK TIMES, 1947:
"They infected soldiers, prostitutes, prisoners and mental
patients. More than 5,500 people in all were part of the medical
experimentation. And the presidential
panel said government scientists knew they were violating ethical
rules."
The research "included infecting prisoners by bringing them prostitutes
who were either already carrying the diseases or were purposely infected
by the researchers. Doctors also poured bacteria onto wounds they had
opened with needles on prisoners’ penises, faces and arms. In some
cases, infectious material was injected into their spines, the
commission reported."
None of those who were drafted volunteered or consented to the
experiment.
One such victimized human being was 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.” Nonetheless, he
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."
“Actually cruel and inhuman conduct took place,” said Anita L. Allen,
a bioethicist at the University of Pennsylvania's law school. “These are
very grave human rights violations.”
Those subjected to these gruesome experiments "were poor, handicapped
or imprisoned Guatemalans. They were chosen because they were “available
and powerless.”
BBC reported on March 14, 2011 that the researchers bribed care
workers to let them infect their charges and prisoners were encouraged
to sleep with infected prostitutes.
Members of the President's Commission concluded that “These
researchers knew these were unethical experiments, and they conducted
them anyway,” said Raju Kucherlapati of Harvard Medical School, a
commission member. “That is what is reprehensible.”
Another panelist, John Arras, a bioethicist at the University of
Virginia, stated: “I really do believe that a very rigorous judgment of
moral blame can be lodged against some of these people.”
The primary investigator of a series of inhumane, government-sponsored,
syphilis experiments was John C. Cutler. He and his team of US
scientists conducted syphilis experiments on US prisoners at
Terre Haute, Indiana,
and at Sing Sing, New York; on poor African-American men with late-stage
syphilis at Tuskegee, denying them treatment until 1973; and they
deliberately infected mental patients and prisoners in Guatemala,
causing 83 deaths.
PubMed, the database for medical-scientific journal articles, lists
John C. Cutler as the author on 58 journal articles published between
1946 and 1995. He died without ever being held accountable, in 2003.
The study was carried out by US scientists between 1946 and 1948.
Researchers bribed care workers to let them infect their charges and
prisoners were encouraged to have sex with infected prostitutes.
The experiment is acknowledged to be
"much worse than Tuskegee."
On Oct 2010 the
US
Apologized to the current Guatemalan government and President Obama
oordered an
investigation , on Nov 2010.
Today, profit--not cure--reins supreme in
medical research. The major sponsors of current medical
experiments--which are referred to as "clinical trials"--are the
pharmaceutical companies whose singular goal is to obtain FDA approval
for marketing their products.Most new drugs are "me too" copy cats that
offer no improvement, but all too often result in serious harm.
Arthur Caplan. director of the Bioethics Center at
the University of Pennsylvania--a center whose dependency on
pharmaceutical industry funding is legendary--is hardly someone who is
objective. He tried to shield his benefactors by claiming: "I don't
think the pharmaceutical companies are running around giving people
diseases or operating in prisons or mental asylums."
To gain an objective, evidence-based perspective,
one must turn to evidence gathered by lawyers during litigation, by
independent, ethicists who are not industry's academic shills, such as
Carl Elliott:
Useless Studies, Real Harm, The New York Times, and
Making a
Killing--Marketing Exercises; and
investigative reports--such as, Vanity Fair:
Deadly Medicine: Foreign Clinical Trials, Bloomberg News:
Big
Pharma's Shameful Secret and
Montreal Clinical
Trial Subjects Exposed to Tuberculosis ;
PBS:
"Bitter Pill" Based on Bloomberg Pharma's Shameful Secret Report,
The Washington Post:
Pfizer
Faulted-1996 Clinical Trials In Nigeria: Unapproved Drug Tested On
Kids...
The weakness of the current regulatory system is
acknowledged by most independent analysts without financial ties to
industry. The trials lack independent review and oversight, and human
subjects continue to be mostly the poor and disenfranchised.
Furthermore, many experiments fail to meet valid ethical and scientific
justification.
New drugs brought to market are mostly "me too"
copy-cats that do NOT improve medical outcomes. Indeed, numerous drugs
have been pulled from the market after they killed or maimed patients.
Ironically, in July, the US government, under the Obama
Administration, issued
proposed regulatory changes (92 pp.)
that would (essentially) eviscerate the very regulatory legal
protections that were adopted in the wake of the revelations about the
unethical conduct of the Tuskegee syphilis experiment.
This week the President's Bioethics Commission urged the US to join
the rest of the civilized world, by ADDING compensation requirements for
the protection of human research subjects--either directly or through
mandatory insurance.
“The panel felt strongly that it was wrong and a mistake that the
United States was an outlier in not specifying any system for
compensation for research subjects other than, ‘You get a lawyer and
sue.’”
Below, ABC News:
Syphilis Experiments Shock, But So Do Third World Drug Trials
The New York Times:
Panel Hears
Grim Details of Venereal Disease Tests
The Washington Post:
Compensation system urged for research victims
Read more at:
U.S. apologizes for newly revealed syphilis experiments done in
Guatemala
BBC News:
US scientists 'knew Guatemala syphilis tests unethical'
Al Jazeera:
Panel condemns US syphilis study in
Guatemala
Vera Hassner Sharav
ABC News
Syphilis Experiments Shock, But So Do Third
World Drug Trials
By
SUSAN DONALDSON JAMES
A commission set up last year by President Barack Obama has
revealed that
83 Guatemalans died in U.S. government research that infected
hundreds of prisoners, prostitutes and mental patients with the
syphilis bacteria to study the drug penicillin -- a project that the
group called "a shameful piece of medical history."
"The report is good and I applaud the Obama administration for
giving it some sunshine," said Dr. Howard Markel, a pediatrician and
medical historian from the University of Michigan. "Internationally,
what we do as a human society is to make sure that these things
never happen again."
But medical ethicists say that even if today's research is not as
egregious as the Guatemala experiment, American companies are still
testing drugs on poor, sometimes unknowing populations in the
developing world.
Many, like Markel, note that experimenting with AIDS drugs in
Africa and other pharmaceutical trials in Third World countries,
"goes on every day."
"It's not good enough, in my opinion, to protect only people who
live in the developed world -- but all human beings," he said.
The U.S. Public Health Service and the Pan American Sanitary
Bureau worked with several Guatemalan government agencies from 1946
to 1948, exposing about 1,300 people to the sexually transmitted
diseases syphilis, gonorrhea or chancroid.
Getty Images
The Presidential Commission for the study of... View
Full Size
They infected soldiers, prostitutes, prisoners and mental
patients. More than 5,500 people in all were part of the medical
experimentation.
And the presidential panel said government scientists knew they
were violating ethical rules.
Scientists wanted to see if penicillin, which was a relatively
new drug, could prevent infections. The research was paid for with
U.S. tax dollars and culled no useful medical information.
This week the Obama commission revealed that only 700 of them
received treatment and 83 died by 1953. The commission could not
confirm whether the deaths were a direct cause of those infections.
In the 1940s, syphilis was a major health threat, causing
blindness, insanity and even death.
Many of the same researchers had carried out studies on prisoners
in Terre Haute, Indiana, but unlike the Guatemalan patients, the
Americans gave consent.
For years, the experiments were secret, until a medical
historian at Wellesley College in Massachusetts found the records
among the papers of Dr. John Cutler, who led the experiments. A
federal commission to learn more was set up last year.
According to Markel, ethical considerations in science began to
emerge after World War II, and further enlightenment followed after
the American civil rights movement.
"This was far too common a phenomenon until our recent history --
in the prison population and homes for the mentally retarded," he
said. "Part of the reason we did this research is we didn't think of
them as humans."
The discovery of the Holocaust and the murder of 6 million people
-- Jews, the disabled, homosexuals and gypsies, as well as bad
experimentation by Nazi doctors, opened the world's eyes.
The founding of the United Nations and the World Health
Organization also brought attention to human rights.
"Each new discovery and advance in social rights, we had to learn
the lesson over and over again," he said. "For a long time, blacks
were second or third class citizens."
Tuskegee Project Continued Until 1972
One government project that
infected black men in Tuskegee, Ala., continued up until 1972
when an Associated Press story on the project caused public outrage.
In 1932, the Public Health Service, working with the Tuskegee
Institute, began a study to record the natural history of syphilis
in hopes of justifying treatment programs for blacks.
The study initially involved 600 black men -- 399 with syphilis,
201 who did not have the disease. The study was conducted without
the benefit of patients' informed consent.
Like the Guatemalans under experimentation, they never
received any treatment to cure their illness.
"Some people ask if what went on in Guatemala could go on today,
and I say I don't think so," said
Arthur
Caplan, director of the Center for Bioethics at the University of
Pennsylvania. "I don't think the pharmaceutical companies are
running around giving people diseases or operating in prisons or
mental asylums."
But today, drug companies hoping to speed up their Phase 3
clinical trials and get Food and Drug Administration (FDA) approval
go to developing countries to find an abundance of poor patients
will to try new drugs.
"Giving people a fatal disease is the worst thing you can do,"
according to Caplan, who said ethical questions are also raised when
"we give poor people medicine for a disease they might have, and
leave and sell [the drugs] in the U.S."
Remembering an 'Ace' Tuskegee Airman Watch Video
He said there are also no internationally enforceable standards
for such research. "The world doesn't have any rules," said Caplan.
About a decade ago when the human genome was being mapped,
companies were excited about exploring new drug options, and private
funding expanded.
"We began to see big money come from pharma, intended to sell in
the developing world but trying it out in poor nations because it
could be done cheaply and faster. They face less vigorous regulatory
oversight," he said.
The key to protection is informed consent. If a patient is in a
placebo group and not getting the drug, they need to know that, he
said.
"If they have no education and they are bedazzled to see a doctor
for the first time, they may not be listening," said Caplan.
"Informed consent at its best is dubious in poor countries."
Existing treatment that works on a disease should never be held
back, he said. "If you come to test a diabetes drug among poor
people in India and given them a placebo and not insulin, you are
exploiting them, especially if you are going to sell the drug only
in Europe and Canada and they get to use it for a while and then you
leave."
Drugs should also be made available once the study concludes,
according to Caplan.
"And if the country is so corrupt the drugs get stolen on the
black market, we should commit building a water treatment plant or a
clinic or make a road," he said.
And those who don't think about where their drugs are tested
should think twice, he said.
"It's the same phenomenon: 'I can get really cheap clothes made
by sweat shop in labor in China. I am not asking how it's made, I
just like the low price,'" said Caplan. "The stance we take toward
the poor is they matter less."
Prisoners, like those infected with syphilis in Guatemala are
often poorly education and "easily coerced," said Caplan.
Meanwhile, Guatemala's Vice President Rafael Espada said his
government would make a formal apology to his people because local
doctors had also been involved in the U.S.-funded program.
President Obama has also apologized to Guatemalan President
Alvaro Colom. A final report is due in December.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
August 30, 2011
THE NEW YORK TIMES
Panel Hears Grim Details of
Venereal Disease Tests
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.
From 1946 to 1948, American taxpayers, through the Public Health
Service, paid for
syphilis-infected Guatemalan prostitutes to have sex with
prisoners. When some of the men failed to become infected through
sex, the bacteria were poured into scrapes made on the penises or
faces, or even injected by spinal puncture.
About 5,500 Guatemalans were enrolled, about 1,300 of whom were
deliberately infected with syphilis,
gonorrhea or
chancroid. At least 83 died, but it was not clear if the
experiments killed them. About 700 were treated with
antibiotics, records showed; it was not clear if some were never
treated.
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.” Nonetheless, he
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 was
left paralyzed for two months by
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.
The panel’s hearings also brought to light that a local doctor
had invited the American researchers, and that Guatemalan military
and health officials had initially approved the work. In 1947, an
international conference on venereal diseases — based on the
experiments — was held in Guatemala City, according to Dr. Rafael
Espada, the vice president of Guatemala, in remarks quoted by the
Guatemalan news media.
Dr. Espada, a physician, is leading his country’s inquiry into
the matter and is expected to deliver his report in October. On
Monday, he told Guatemalan reporters that five survivors, all in
their 80s, had been found and would receive medical tests.
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.
Also, one commission member added, “Regardless what you think of
the ethical issues, it was just bad science.” The results were
never published in medical journals, note-keeping was “haphazard at
best” and routine protocols were not done.
The Guatemala experiments
came to light only last year when a medical historian found
descriptive notes in the archives of the University of Pittsburgh.
The historian, Susan M. Reverby of Wellesley College, was
researching the infamous Tuskegee study, in which Alabama
sharecroppers infected with syphilis were left untreated from 1932
to 1972. Dr. Cutler oversaw the Tuskegee study after his Guatemala
work finished; he was also an acting dean at the University of
Pittsburgh in the 1960s.
Dr. Cutler sent his Guatemala reports to only one supervisor, but
Dr. Gutmann said they went up the chain to Surgeon General Thomas
Parran Jr., a favorite of President Franklin D. Roosevelt. According
to
a government biography, Dr. Parran was famous for his long
campaign against syphilis, which was then a major public health
problem but could not even be mentioned on the radio.
In 1943, Dr. Cutler’s team had tried to infect 241 inmates of a
federal prison in Terre Haute, Ind., with gonorrhea. But that time
they adhered to ethical protocols, using only volunteers, explaining
the risks and offering cash or help getting reduced sentences in
return for participating.
Dr. Nelson L. Michael, an
AIDS researcher at the Walter Reed Army Institute of Research
and a panelist, speculated that the research was rushed and badly
done because it had started under intense pressure to help the war
effort. Curing troops’ venereal diseases was a major goal of
military medicine.
The panelists generally agreed that the ethical review boards now
mandated by the American government, universities, foundations and
medical journals would prevent similar abuses today by anyone
spending taxpayer or foundation money.
Pharmaceutical and medical device companies also do research in
poor countries and still need watching, panel members said. But
large companies say publicly that they adhere to ethical principles.
“The problem in 1946,” Dr. Gutmann said, “was that ethical rules
were treated as obstacles to overcome, not as fundamental bedrock of
human dignity. That can still apply today. That’s why our panel is
doing our report.”
Panel members endorsed the idea of creating compensation funds
for subjects who are harmed in the future, or requiring researchers
to buy insurance for that purpose. Some countries require these
steps; the United States does not.
Elisabeth Malkin contributed reporting.
~~~~~~~~~~~~~~~~~~~~~
THE WASHINGTON POST
Compensation system urged for
research victims
By
Rob Stein, Published: August 30
The United States should create a system to compensate people who
are harmed by participating in scientific research, a panel of
federal advisers recommended Tuesday.
Many other countries require sponsors of studies and researchers
to carry insurance for research-related injuries or have other ways
to compensate volunteers who are harmed, making the United States an
“outlier,” the subcommittee of the
Presidential Commission for the
Study of Bioethical Issues concluded.
“The panel felt strongly that it was wrong and a mistake that the
United States was an outlier in not specifying any system for
compensation for research subjects other than, ‘You get a lawyer and
sue,’” said Amy Gutmann of the University of Pennsylvania, who
chairs the commission and served on the subcommittee.
The recommendation came on the second day of a two-day public
hearing to air the results of a commission probe into medical
experiments that the U.S. government researchers conducted in
Guatemala in the 1940s.
The recently uncovered studies involved more than 5,500 men,
women and children who were unwittingly drafted into tests involving
the venereal diseases syphilis, gonorrhea and chancroid. The tests
included deliberately — sometimes grotesquely — attempting to infect
subjects without their permission or knowledge.
On Monday, the commission
revealed that the researchers had obtained consent first before
conducting earlier, similar experiments on inmates in Terre Haute,
Ind., and hid what they were doing in Guatemala. This, the
commission found, clearly showed that the doctors knew their conduct
was unethical.
In the government-sponsored studies conducted in Guatemala
between 1946 and 1948, doctors tried to infect prisoners, soldiers
and mental patients by giving them prostitutes who were carrying the
diseases or were infected by the researchers. The researchers also
scraped sensitive parts of subjects’ anatomy to expose wounds to
disease-causing bacteria, poured infectious pus into subjects’ eyes,
and injected some victims’ spines.
On Tuesday, the 13-member commission discussed the 48-page report
outlining the findings
of a 14-member international subcommittee investigating whether
current rules adequately protect people in medical studies from
physical harm or unethical treatment internationally.
The experts in bioethics and biomedical research from India,
Uganda, China, Russia, Brazil, Argentina, Belgium Guatemala, Egypt
and the United States met in London, Washington and Philadelphia and
made five broad recommendations.
“The United States should implement a system to compensate
research subjects for research related injuries,” said Christine
Grady of the National Institutes of Health, who helped present the
findings of the subcommittee. “Many countries around the world and
some U.S. research institutions have actually moved forward and
developed compensation systems.”
One “promising model” for a compensation system could be the U.S.
National Vaccine Injury Compensation Program, a no-fault alternative
to traditional lawsuits that compensates people injured by vaccines,
the panel said.
India and Brazil have bioethics committees that “ensure that
research sponsors pay compensation to participants injured in
research,” the panel wrote. The University of Washington uses a
“self-insured no-fault” system.
President Obama ordered the probe when the experiments were
made public in October along with an unusual public apology by
his secretaries of state and health and human services.
After filing a report in September, the commission will meet
again in November to come up with ways to bolster protections for
research subjects internationally and in the United States. It will
issue a final report in December. The Guatemalan government is
conducting its own investigation, but has twice postponed briefing
the commission.
Wellesley College historian Susan M. Reverby uncovered the
disturbing experiments while reading papers from John C. Cutler, a
doctor with the federal government’s Public Health Service. Cutler
participated in the Tuskegee experiment, in which hundreds of
African American men with syphilis in Alabama were left untreated to
study the disease between 1932 and 1972. Cutler died in 2003.
In the Guatemala case, about 700 of the subjects were treated,
but it remains unclear whether their care was adequate. About 83 of
the subjects died, but investigators have been unable to determine
whether any deaths were caused by the studies.
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