http://www.cdc.gov/nchstp/od/tuskegee/time.htm
The Tuskegee Syphilis Study, carried out in Macon County, Alabama, from 1932
to 1972, is an example of medical research gone wrong. The United States Public
Health Service, in trying to learn more about syphilis and justify treatment
programs for blacks, withheld adequate treatment from a group of poor black men
who had the disease, causing needless pain and suffering for the men and their
loved ones.
In the wake of the Tuskegee Study and other studies, government took a closer
look at research involving human subjects and made changes to prevent the moral
breaches that occurred in Tuskegee from happening again.
The Study Begins
In 1932, the Public Health Service, working with the Tuskegee Institute, began
a study in Macon County, Alabama, to record the natural history of syphilis in
hopes of justifying treatment programs for blacks. It was called the
"Tuskegee Study of Untreated Syphilis in the Negro Male".
The study involved 600 black men—399 with syphilis and 201 who did not have
the disease. Researchers told the men they were being treated for "bad
blood," a local term used to describe several ailments, including
syphilis, anemia, and fatigue. In truth, they did not receive the proper
treatment needed to cure their illness. In exchange for taking part in the
study, the men received free medical exams, free meals, and burial insurance.
Although originally projected to last 6 months, the study actually went on for
40 years.
What Went Wrong?
In July 1972, a front-page New York Times story about the Tuskegee Study caused
a public outcry that led the Assistant Secretary for Health and Scientific
Affairs to appoint an Ad Hoc Advisory Panel to review the study. The panel had
nine members from the fields of medicine, law, religion, labor, education,
health administration, and public affairs.
The panel found that the men had agreed freely to be examined and treated.
However, there was no evidence that researchers had informed them of the study
or its real purpose. In fact, the men had been misled and had not been given
all the facts required to provide informed consent.
The men were never given adequate treatment for their disease. Even when
penicillin became the drug of choice for syphilis in 1947, researchers did not
offer it to the subjects. The advisory panel found nothing to show that
subjects were ever given the choice of quitting the study, even when this new,
highly effective treatment became widely used.
The Study Ends and Reparation Begins
The advisory panel concluded that the Tuskegee Study was "ethically
unjustified"—the knowledge gained was sparse when compared with the
risks the study posed for its subjects. In October 1972, the panel advised
stopping the study at once. A month later, the Assistant Secretary for Health
and Scientific Affairs announced the end of the Tuskegee Study.
In the summer of 1973, a class-action lawsuit filed by the National Association
for the Advancement of Colored People (NAACP) ended in a settlement that gave
more than $9 million to the study participants. As part of the settlement, the
U.S. government promised to give free medical and burial services to all living
participants. The Tuskegee Health Benefit Program was established to provide
these services. It also gave health services for wives, widows, and children
who had been infected because of the study. The Centers for Disease Control and
Prevention was given responsibility for the program, where it remains today in
the National Center for HIV,
STD, and TB Prevention.
Timeline
1895 Booker T. Washington at the Atlanta Cotton
Exposition, outlines his dream for Black economic development and gains support
of northerner philanthropist including Julius Rosenwald (founder of Sears).
1900 Tuskegee experiment gains widespread support. Rosenwald Fund
provides monies to develop schools, factories, businesses, and agriculture.
1915 Booker T. Washington Dies, Robert Motin continues work.
1926 Health is seen as inhibiting development and major health
initiative is started. Syphilis is seen as major health problem. Prevalence of
35 percent observed in reproductive age population.
1929 Aggressive treatment approach initiated with Mercury and Bismuth.
Cure rate is less than 30 percent, treatment requires months and side effects
are toxic, sometimes fatal.
1929 “Wall Street Crash” Economic Depression begins.
1931 Rosenwald Fund cuts support to development projects Clark and
Vondelehr decides to follow men left untreated due to lack of funds to show
need for treatment program.
1932 Follow-up effort organized into study of 399 men with syphilis and
201 without. The men would be given periodic physical assessments and told they
were being treated. Motin agrees to support study if “ Tuskegee gets its full
share of the credit” and Black professionals are involved (Dr. Dibble and
Nurse Rivers are assigned to study).
1934 First papers suggest health effects of untreated syphilis.
1936 Major paper published... Study criticized because it is not known
if men are being treated. Local physicians asked to assist and asked not to
treat men. It was also decided to follow the men until death.
1940 Efforts made to hinder men from getting treatment by military draft
effort.
1945 Penicillin accepted as treatment of choice for syphilis.
1947 US PHS establishes “Rapid Treatment Centers” to treat Syphilis,
men in study not treated, but syphilis declines.
1962 Since 1947, 127 Black medical students are rotated through unit
doing the study.
1968 Concern raised about ethics of study by Peter Bauxum and others.
1969 CDC reaffirms need for study and gains local medical societies
support (AMA and NMA chapters officially support continuation of study).
1970 First news articles condemns studies.
1971 Congress holds hearings and law suit initiated.
1972 Study ends and participants compensated with cash and continued
medical treatment.
1997 May 16th President Clinton Apologizes on behalf of the Nation.
Aftershocks
How Tuskegee Changed Research Practices
After the Tuskegee Study, the government changed its research
practices to prevent a repeat of the mistakes made in Tuskegee.
In 1974, the National Research Act was signed into law, creating the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research. The group identified basic principles of research conduct and
suggested ways to ensure those principles were followed.
In addition to the panel’s recommendations, regulations were passed in 1974
that required researchers to get voluntary informed consent from all persons
taking part in studies done or funded by the Department of Health, Education,
and Welfare (DHEW). They also required that all DHEW-supported studies using
human subjects be reviewed by Institutional Review Boards, which read study
protocols and decide whether they meet ethical standards.
The rules and policies for human subjects research have been reviewed and
revised many times since they were first approved. From 1980–1983, the
President’s Commission for the Study of Ethical Problems in Medicine and
Biomedical and Behavioral Research looked at federal rules for doing research
on human subjects to see how well those rules were being followed. An Ethics
Advisory Board was formed in the late 1970s to review ethical issues of
biomedical research. In 1991, federal departments and agencies (16 total)
adopted the Federal Policy for the Protection of Human Subjects.
Efforts to promote the highest ethical standards in research are still going on
today. In October 1995, President Bill Clinton created a National Bioethics
Advisory Commission, funded and led by the Department of Health and Human
Services. The commission is reviewing current regulations, policies, and
procedures to ensure all possible safeguards are in place to protect research
volunteers.
