8. The Tuskegee Syphilis Study:
The United States Public Health Service carried out this
clinical study on 400 poor, African-American men with syphilis from 1932 to
1972. During the study the men were given false and sometimes dangerous
treatments, and adequate treatment was intentionally withheld so the agency
could learn more about the disease. While the study was initially supposed to
last just six months, it continued for 40 years. Close to 200 of the men died
from syphilis or related complications by the end of the study.
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Tuskegee syphilis experiment [1]
The Tuskegee syphilis experiment was an
infamous clinical study conducted between 1932 and 1972
in Tuskegee, Alabama by the U.S. Public Health Service to
study the natural progression of untreated syphilis in rural black
men who thought they were receiving free health care from the U.S. government.
The Public Health Service, working with the Tuskegee
Institute, began the study in 1932. Investigators enrolled in the study a total
of 600 impoverished sharecroppers from Macon County, Alabama; 399 who
had previously contracted syphilis before the study began, and 201 without the
disease. For participating in the study, the men were given free medical care,
meals, and free burial insurance. They were never told they had syphilis, nor
were they ever treated for it. According to the Centers for Disease
Control, the men were told they were being treated for "bad blood", a
local term for various illnesses that include syphilis, anemia, and fatigue.
The 40-year study was controversial for reasons related
to ethical standards; primarily because researchers knowingly failed to
treat patients appropriately after the 1940s validation
of penicillin as an effective cure for the disease they were
studying. Revelation of study failures by a whistleblower led to
major changes in U.S. law and regulation on the protection of participants in
clinical studies. Now studies require informed consent (with
exceptions possible for U.S. Federal agencies which can be kept secret by
Executive Order), communication of diagnosis, and accurate reporting
of test results.
By 1947, penicillin had become the standard treatment
for syphilis. Choices available to the doctors involved in the study might have
included treating all syphilitic subjects and closing the study, or splitting
off a control group for testing with penicillin. Instead, the
Tuskegee scientists continued the study without treating any participants and
withholding penicillin and information about it from the patients. In addition,
scientists prevented participants from accessing syphilis treatment programs
available to others in the area.
The study continued, under numerous US Public Health Service
supervisors, until 1972, when a leak to the press eventually resulted in its
termination on November 16.
The victims of the study included numerous men who died of
syphilis, wives who contracted the disease, and children born
with congenital syphilis.
The Tuskegee Syphilis Study, cited as "arguably the
most infamous biomedical research study in U.S. history," led to the 1979
Belmont Report and the establishment of the Office for Human Research
Protections (OHRP). It also led to federal laws and regulations
requiring Institutional Review Boards for the protection of human
subjects in studies involving human subjects. The Office for Human Research
Protections (OHRP) manages this responsibility within the US Department of
Health and Human Services (HHS).
History
Study clinicians
“ For the most part, doctors and civil servants simply did
their jobs. Some merely followed orders, others worked for the glory of
science. ” — John Heller, Director of the Public Health Service's
Division of Venereal Diseases
The venereal disease section of the U.S.
Public Health Service (PHS) formed a study group in 1932 at its
national headquarters. Taliaferro Clark was credited with its origin. His
initial goal was to follow untreated syphilis in a group of black men for 6 to
9 months, and then follow up with a treatment phase. When he understood the
intention of other study members to use deceptive practices, Clark disagreed
with the plan to conduct an extended study.He retired the year after the study
began.
Representing the PHS, Clark had solicited the participation
of the Tuskegee Institute (a well-known historically black
college in Alabama, now known as Tuskegee University) and also the
inclusion of the Arkansas regional PHS office. Eugene Dibble, an African
American doctor, was head of the John Andrew Hospital at the Tuskegee
Institute. Oliver C. Wenger, a Caucasian, was director of the regional PHS
Venereal Disease Clinic in Hot Springs, Arkansas. He and his staff took a
lead in developing study procedures.
Wenger and his staff played a critical role in developing
early study protocols. Wenger continued to advise and assist the Tuskegee Study
when it turned into a long-term, no-treatment observational study.
Raymond A. Vonderlehr was appointed on-site director of
the research program and developed the policies that shaped the long-term
follow-up section of the project. For example, he decided to gain the
"consent" of the subjects for spinal taps (to look for
signs of neurosyphilis) by depicting the diagnostic test as a
"special free treatment". Vonderlehr retired as head of the venereal
disease section in 1943, shortly after penicillin had first been shown to be a
cure for syphilis.
Several African American health workers and
educators associated with Tuskegee Institute helped the PHS to carry
out its experimentation and played a critical role in its progression, though
the extent to which they were aware of methodology of the study is not clear in
all cases. Robert Russa Moton, the head of Tuskegee Institute at the time,
and Eugene Dibble, of the Tuskegee Medical Hospital, both lent their
endorsement and institutional resources to the government study. Nurse Eunice
Rivers, an African-American trained at Tuskegee Institute who worked at its
affiliated John Andrew Hospital, was recruited at the start of the study.
Vonderlehr was a strong advocate for Nurse Rivers'
participation, as she was the direct link to the community. During
the Great Depression of the 1930s, the Tuskegee Study began by
offering lower class African Americans, who often could not afford health care,
the chance to join "Miss Rivers' Lodge". Patients were to receive
free physical examinations at Tuskegee University, free rides to and from
the clinic, hot meals on examination days, and free treatment for minor
ailments.
Based on the available health care resources, Nurse Rivers
believed that the benefits of the study to the men outweighed the risks.
As the study became long term, Nurse Rivers became the chief
person with continuity. Unlike the changing state of national, regional and
on-site PHS administrators, doctors, and researchers, Rivers stayed at Tuskegee
University. She was the only study staff person to work with participants for
the full 40 years. By the 1950s, Nurse Rivers had become pivotal to the
study—her personal knowledge of the subjects enabled maintenance of long-term
follow up.
Historians found evidence that most of the African American
staff that assisted the Tuskegee Experiments were under the belief that they
were part of a medical experiment that gave them the opportunity to act in the
best interests of poor Black residents of Tuskegee.
In the study's later years, John R. Heller led the national
division.
By the late 1940s, doctors, hospitals and public
health centers throughout the country routinely treated diagnosed syphilis with
penicillin. In the period following World War II, the revelation of
the Holocaust and related Nazi medical abuses brought about
changes in international law. Western allies formulated the Nuremberg
Code to protect the rights of research subjects. No one appeared to have
reevaluated the protocols of the Tuskegee Study according to the new standards.
In 1972 the Tuskegee Study was brought to public
and national attention by a whistleblower, who gave information to
the Washington Star and the New York Times. Heller of PHS still
defended the ethics of the study, stating: "The men's status did
not warrant ethical debate. They were subjects, not patients; clinical
material, not sick people."
Raymond A. Vonderlehr(medical doctor)
John Heller (medical doctor)
Eugene Dibble (medical doctor)
Eunice Rivers (nurse)
Charles S. Johnson(sociologist)
Study details
Subject blood draw, c. 1953
A Norwegian study in 1928 had reported on
the pathologic manifestations of untreated syphilis in several
hundred white males. This study is known as a retrospective studysince
investigators pieced together information from the histories of patients who
had already contracted syphilis but remained untreated for some time.
Subjects talking with study coordinator, Nurse Eunice Rivers
The Tuskegee study group decided to build on the Oslo work
and perform aprospective study to complement it. In the earlier phases of
the study this was not inherently unethical since there was nothing the
investigators could do therapeutically at the time. Researchers could study the
natural progression of the disease as long as they did not harm their subjects.
They reasoned that the knowledge gained would benefit humankind; however, it
was determined afterward that the doctors did harm their subjects by depriving
them of appropriate treatment once it had been discovered. The study was
characterized as "the longest non-therapeutic experiment on human beings
in medical history."
The US health service Tuskegee study began as
a clinical trial of the incidence of syphilis in the Macon
County population. Initially, subjects were studied for six to eight
months and then treated with contemporary methods
including Salvarsan, mercurial ointments, and bismuth.
These methods were, at best, mildly effective. The disadvantage that these
treatments were all highly toxic was balanced by the fact that no other methods
were known. The Tuskegee Institute participated in the study, as its
representatives understood the intent was to benefit public health in the local
poor population.
The Tuskegee University-affiliated hospital effectively
loaned the PHS its medical facilities and other predominantly black
institutions and local black doctors participated as well. The Rosenwald
Fund, a major Chicago-based philanthropy devoted to black education and
community development in the South, provided financial support to pay for
the eventual treatment of the patients. Study researchers initially recruited
399 syphilitic Black men, and 201 healthy Black men as controls.
Table from U.S. Public Health Service summarising
participants in the study.
Continuing effects of the Stock Market Crash of
1929 and the beginning of the Great Depression led the Rosenwald
Fund to withdraw its offer of funding. Study directors issued a final report as
they thought this might mean the end of the study once funding to buy
medication for the treatment phase of the study was withdrawn.
Medical ethics considerations were limited from the
start and rapidly deteriorated. To ensure that the men would show up for the
possibly dangerous, painful, diagnostic, and non-therapeutic spinal taps,
the doctors sent the 400 patients a misleading letter titled "Last Chance
for Special Free Treatment". The study also required all participants to
undergo an autopsy after death in order to receive funeral benefits.
After penicillin was discovered as a cure, researchers continued to deny such
treatment to many study participants. Many patients were lied to and
given placebo treatments so researchers could observe the full,
long-term progression of the fatal disease.
Taking a blood sample as part of the Tuskegee Syphilis
Study.
The Tuskegee Study published its first clinical data in 1934
and issued their first major report in 1936. This was prior to the discovery of
penicillin as a safe and effective treatment for syphilis. The study was not
secret since reports and data sets were published to the medical community
throughout its duration.
During World War II, 250 of the subject men registered
for the draft. These men were consequently diagnosed as having syphilis at
military induction centers and ordered to obtain treatment for syphilis before
they could be taken into the armed services.
PHS researchers attempted to prevent them from getting
treatment, thus depriving them of chances for a cure. A PHS representative was
quoted at the time as saying: "So far, we are keeping the known positive
patients from getting treatment."
Despite this, 96% of the 90 original test subjects
reexamined in 1963 had received either arsenical or penicillin treatments from
another health provider.
By 1947 penicillin had become standard therapy for syphilis.
The US government sponsored several public health programs to form
"rapid treatment centers" to eradicate the disease. When campaigns to
eradicate venereal disease came to Macon County, study researchers prevented
their patients from participating.
By the end of the study in 1972, only 74 of the test
subjects were alive. Of the original 399 men, 28 had died of syphilis, 100 were
dead of related complications, 40 of their wives had been infected and 19 of
their children were born with congenital syphilis.
Non-consensual experiments in Guatemala
Main article: Syphilis experiments in Guatemala
In October 2010 it was revealed that in Guatemala,
Public Health Service doctors went even further. It was reported that from 1946
to 1948, American doctors deliberately infected prisoners, soldiers, and
patients in a mental hospital with syphilis and, in some cases, gonorrhea, with
the cooperation of some Guatemalan health ministries and officials. A total of
696 men and women were exposed to syphilis without the informed
consent of the subjects. When the subjects contracted the disease they
were given antibiotics though it is unclear if all infected parties
were cured.
Wellesley College's historian Susan
Reverby discovered records of the experiment while examining archives
of John Charles Cutler, a government researcher involved in the now
infamous Tuskegee study. In October 2010, the U.S. formally apologized to
Guatemala for conducting these experiments.
Study termination
Peter Buxtun, a PHSvenereal disease investigator,
the "whistleblower".
Group of Tuskegee Experiment test subjects
Charlie Pollard, survivor
Herman Shaw, survivor
In 1966 Peter Buxtun, a PHS venereal-disease
investigator in San Francisco, sent a letter to the national director of the
Division of Venereal Diseases to express his concerns about
the ethics and morality of the extended Tuskegee Study.
The Center for Disease Control (CDC), which by then controlled the
study, reaffirmed the need to continue the study until completion; i.e., until
all subjects had died and been autopsied. To bolster its position, the CDC
sought, and gained support for the continuation of the study, from local
chapters of the National Medical Association (representing
African-American physicians) and the American Medical
Association (AMA).
In 1968 William Carter Jenkins, an African-American
statistician in the PHS, part of the Department of Health, Education,
and Welfare (HEW), founded and edited The Drum, a newsletter devoted
to ending racial discrimination in HEW. The cabinet-level department
included the CDC. In The Drum, Jenkins called for an end to the Tuskegee
Study. He did not succeed; it is not clear who read his work.
Buxtun finally went to the press in the early 1970s. The
story broke first in the Washington Star on July 25, 1972. It became
front-page news in the New York Times the following day.
Senator Edward Kennedy called Congressional hearings, at which Buxtun
and HEW officials testified.
As a result of public outcry the CDC and PHS appointed
an ad hoc advisory panel to review the study. It determined the study
was medically unjustified and ordered its termination. As part of the
settlement of a class action lawsuit subsequently filed by
the NAACP, the U.S. government paid $9 million (unadjusted for inflation)
and agreed to provide free medical treatment to surviving participants and to
surviving family members infected as a consequence of the study.
Aftermath
In 1974 Congress passed the National Research
Act and created a commission to study and write regulations
governing studies involving human participants. On May 16, 1997,
President Bill Clinton formally apologized and held a ceremony for
the Tuskegee study participants: "What was done cannot be undone. But we
can end the silence. We can stop turning our heads away. We can look at you in
the eye and finally say on behalf of the American people, what the United States
government did was shameful, and I am sorry ... To our African American
citizens, I am sorry that your federal government orchestrated a study so
clearly racist." Five of the eight remaining study survivors attended the
White House ceremony.
The Tuskegee Syphilis Study significantly damaged the trust
of the black community toward public health efforts in the United States. As a
result, many distrust the medical community and are reluctant to participate in
programs such as organ donation. The study may also have contributed to
the reluctance of many poor black people to seek routine preventive care.
However, recent studies have challenged the degree to which knowledge of the
Tuskegee experiments have kept black Americans from participating in medical
research.
Distrust of the government because of the study contributed
to persistent rumors in the black community that the government was responsible
for the HIV/AIDS crisis by introducing the virus to the black community.
Ethical implications
This section requires expansion. (March 2010)
Depression-era U.S. poster advocating early syphilis
treatment. Although treatments were available, participants in the study did
not receive them.
After penicillin was found to be an effective
treatment for syphilis, the study continued for another 25 years without
treating those suffering from the disease. After the study and its consequences
became front-page news, it was ended in a day. The aftershocks of this study,
and other human experiments in the United States, led to the establishment
of the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research and the National Research Act. The
latter requires the establishment of institutional review boards
(IRBs) at institutions receiving federal support (such as grants,
cooperative agreements, or contracts).
In popular culture
David Feldshuh wrote a stage play in 1992
based on the history of the Tuskegee study, titled Miss Evers' Boys. It
was a runner-up for the 1992 Pulitzer Prize in drama. In 1997 it
was adapted for an HBO made-for-TV movie. The HBO adaptation was
nominated for eleven Emmy Awards, and won in four categories.
See also
Shiloh Missionary Baptist Church
Human experimentation in the United States
Eugenics in the United States
Guatemala syphilis experiment
Human subject research
World Medical Association
International Conference on Harmonisation for Registration
of Pharmaceuticals
Declaration of Geneva
Declaration of Helsinki
Operation Whitecoat
Nazi human experimentation
Project_4.1
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