The Tuskegee Syphilis Experiment An Ethical Breach in the Name of Science Caela Long, Marissa McGovern, Zack Marsh, Christopher Merrill, and Christina Monnie

Background of the Study

What is Syphilis? Sexually Transmitted Disease Symptoms include (but not limited to): Sores Rashes Brain Damage/Death Three Stages of Syphilis (examined in this study): Primary: single sore lasting 3-6 weeks Secondary: skin rashes and more sores Latent: no sores, dormant form of the disease - Late/Tertiary: deadly form, attacks central nervous system other vital organs such as the heart and liver

Syphilis and Study Timeline 1926: 35% prevalence of syphilis in African Americans 1931: Rosenwald Fund discontinues funding 1973: Congress holds hearings and lawsuit on behalf of participants 2004: Last participant dies 1905: Bacterium causing syphilis isolated 1945: Penicillin accepted as treatment of choice 1900 2013 1907: Blood test for syphilis developed 1974: Participants receive $10 million settlement 1932: PHS follow up studies commenced. Interns/nurses from Tuskegee Institute get involved. 1929: mercury and bismuth treatment <30% effective 1972: First news articles condemn studies. Study ends.

Origins of the Study The initial goal was to understand and examine the prevalence of syphilis in Macon County, Alabama among African American males. Funded by the Julius Rosenwald Fund. Cut funding in 1931 due to the racial associations of the results. 35% of African American males in Macon County had syphilis. U.S. Public Health Service (PHS) conducted follow up studies led by: Tuskegee Institute  provided resources and interns (for training) Dr. Taliaferro Clark  formulation of study Dr. Raymond Vonderlehr  selected the participants The “modified” goal was to study untreated syphilis in African Americans compared to Europeans. Started in 1932.

The Tuskegee Syphilis Experiment The study included: 399 infected African American men 201 uninfected African American men These men were promised: Free medical care/treatment Free burial The duration of the study was from 1932-1972.

How did the PHS prolong this study for 40 years? They thought the patients wouldn’t seek medical help anyways Since the patients were still suspicious of hospitals Rationalized the racial aspects of the experiment: Poor They did not treat the control group who got syphilis The patients thought they were being treated The promises of free medical care/treatment and free burial Ignored criticism from papers Public was never informed CDC, AMA, and NMA all supported its continuation in 1969

The Main Reason for the Successful Prolongation The PHS prevented the patients in the study from being treated Kept local doctors from providing treatment Informed Alabama Health Department to not treat the patients Informed the government/military not to treat the drafted patients of the study

The Termination of the Study The Whistleblower Peter Buxtun PHS Venereal Disease Investigator Questioned the morality and ethics of the experiment The PHS decided to still let the project go until completion Buxtun went to the press in the early 1970s In 1972 it was finally brought to the public’s attention Jean Heller of the Associated Press was published in the New York Times The study ended quietly and suddenly

Ethical Concerns

Evidence of Ethical Violations Never informed that they were part of a medical study Patients were being treated for “bad blood” Treatment was withheld from the patients

What caused the breach in ethics? Early treatments using heavy metals (mercury) were not administered to the patient. The medical staff tracked the patients assuring that patients were not administered treatment. Penicillin treatments were never given to the patients. Paid for their Burials  enticement The patients and their families were never told the bodies would be autopsied.

Ethical or Not? Syphilis in African American males is different than syphilis in white males and needed to be further studied Early treatment for the disease was dangerous Many of the men were too sick for Penicillin treatment to be effective

Outcomes

Outcomes: Patients At least 28 of the 399 affected men died from advanced syphilis Some wives and children of those in the study contracted the disease because the men weren’t treated National Association for the Advancement of Colored People (NAACP) filed a class-action lawsuit Won $10 million to be divided among the participants of the study Those still alive, wives, widows, and children got free health care

Outcomes: Society National Research Act Law created to protect human subjects in research Passed in 1974 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created as a result. The Belmont Report summarized the basic ethical issues that needed to be followed when doing research

Outcomes: Formal Apology President Clinton apologized to those involved and had a ceremony for them in 1997. "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.” -President Clinton

Cost to Society African Americans not trusting in the public health system or the government In a survey given to African Americans by Oregon State 16% believe that AIDS was created by the government to control the black population and 15% believe it is a form of genocide African Americans have less confidence that efforts are trying to be made to control AIDS and other health problems in their communities

Overview/ Recommendations

Overview Reported 28 men died directly: Indirect Implications 100 more died of related complications 40 wives reported having some form of syphilis 19 children were born with congenital syphilis Indirect Implications Who knows?

Who is Culpable? What Could’ve Prevented This? Directly: PHS Doctors Clark and Vonderlehr Indirectly: Tuskegee Institute Interns/Nurses  Afraid? Eunice Rivers  Government and Outside Doctors trying to administer Penicillin Why didn’t anyone speak up? Didn’t it cross their mind?

Preventing A New Tuskegee Experiment Difficult to Imagine Clinical Trials Placebo vs. Treatment Long Studies  Obsession Recommendations: Arm Yourself with Knowledge Institutional Review Boards  protect from outside distractions First line of defense  present before every study Ask questions Look into treatments used Be active in the studies “See Something, Say Something” Pressure  Superiors

Piecing It All Together Relevance Beneficiaries Present and Future Clinical Studies Students Professions with Science Backgrounds Especially Researchers

References Brandt, Allan M. “Racism and Research: The Case of the Tuskegee Syphilis Study.” The Hastings Center Report , Vol. 8, No. 6 (Dec., 1978), pp. 21-29 Brunner, Borgna. “The Tuskegee Syphilis Experiment.” 2005. Retrieved June 07, 2013. "Case Study 3: The Tuskegee Syphilis Study" Online Ethics Center for Engineering 7/20/2006 National Academy of Engineering Accessed: Thursday, June 13, 2013 <www.onlineethics.org/Education/precollege/scienceclass/sectone/chapt4/cs3.aspx> Chadwick, A. (Performer) (2002). Remembering tuskegee [Web series episode]. In Morning Edition. Washington DC: National Public Radio. Retrieved June 06, 2013, from http://www.npr.org/programs/morning/features/2002/jul/tuskegee/ Manuel-Logan, R. (2012, July 26). Black Urban Legends, Black Conspiracy Theories HIV AIDS | Breaking News for Black America. Breaking News for Black America | News One. Retrieved June 06, 2013, from http://newsone.com/2026978/black-urban-legends-hiv-aids/ “Research & Economic Development.” History of Research Ethics. Web. 13 June 2013. www.ors.umkc.edu “The Tuskegee Timeline." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 15 June 2011. Web. 13 June 2013 Images Acquired using www.google/images