The Tuskegee Syphilis Experiment: A Critical Examination of a Breach in Ethics (President Bill Clinton with Tuskegee Survivors) URP Ethics Forum June 25, 2012 Lauren Cordeiro, Callie Clark, Matthew DeStefano, Kasey Devlin, Dominic DeBiasio, and Dr. Evanseck

(Untreated Stage Three Syphilis) Sexually Transmitted Disease (STD) Caused by the bacterium Treponema palladium Great imitator Three stages of syphilis: Primary: Development of sore(s) Secondary: Development of rash Tertiary: Damage of internal organs leading to death (Untreated Stage Three Syphilis) "Syphilis - CDC Fact Sheet." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 16 Sept. 2010. Web. 21 June 2012. http://www.cdc.gov/std/syphilis/stdfact-syphilis.htm.

"Tuskegee Study of Untreated Syphilis in the Negro Male” When? 1932 – 1972 Where? Macon County, Alabama Who? The US Public Health Service along with the Tuskegee Institute 600 African American men2 399 with syphilis (Experimental Group) 201 without syphilis (Control Group) 2. "About the USPHS Syphilis Study." Tuskegee University. Tuskegee University, n.d. Web. 20 June 2012. <http://www.tuskegee.edu/about_us/centers_of_excellence/bioethics_center/about_the_usphs_syphilis_study.aspx>.

Two parts to the experiment How? Two parts to the experiment Initially was 6-9 months with treatment following Modification added that eliminated treatment after 6-9 months and prolonged experiment for several years Participants were unaware of syphilis. Treatment was for “bad blood”. Incentives for treatment: Free medical examinations, rides to and from clinic, meals upon examination, treatment of minor ailments and free burial arrangements after death.

To, “record the natural history of syphilis in blacks.”2 Why? To, “record the natural history of syphilis in blacks.”2 “Dr. Clark planned to study empirically the long held notion that syphilis affected blacks differently than whites by comparing his findings to a study of untreated syphilis in white males in Oslo, Norway.”3 The Oslo Study: 1909-1928, “…reported the natural history of untreated syphilis in a group of white males.”4 (Dr. Clark, Head of PHS-VD) (Dr. Dibble, Head of Tuskegee Institute Hospital) 3. Jones, James H. Bad Blood: The Tuskegee Syphilis Experiment. New York: Free, 1981. 18. Southern Changes. The Journal of Southern Regional Council, 1978-2003. Web. 20 June 2012. <http://beck.library.emory.edu/southernchanges/article.php?id=sc04-6_011>. 4. Brody, H. "Faces of Tuskegee." MSU Center For Ethics and Humanities in the Life Sciences. N.p., n.d. Web. 23 June 2012. <https://www.msu.edu/course/hm/546/tuskegee.htm>.

Timeline5 1932: Experiment Begins 1936: Major paper on the experiment was published. Study is criticized due to not knowing if men are being treated. A decision was made to follow the men until death. 1940: Men in study are denied entry into military in order to prevent treatment for syphilis. 1945: Penicillin now accepted as treatment of choice for syphilis, but not given to men. 1947: “Rapid Treatment Centers” now available for those with syphilis, but men in study are declined treatment. 1972: First news articles condemn study and study is subsequently terminated. 5. "The Tuskegee Timeline." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 15 June 2011. Web. 21 June 2012. <http://www.cdc.gov/tuskegee/timeline.htm>.

Ethical Dilemmas Did not act for the benefit of others Instead of helping the sick patients, they made matters worse by not treating them Individuals participated in the study, only because they were influenced by an outside source Reasons for conducting the experiment were unjust Medical ethical principles

Did Not Act in the Best Interest of Others The men would die of the “natural” disease Syphilis anyway Deceived the men to gain their trust “It is my desire to keep the main purpose of work from the negroes…and keep their interest in treatment”6 (Vonderlehr) 6. Brandt, Allan M. "Racism and Research: The Case of the Tuskegee Syphilis Study." Hastings Center Magazine, (1978): 1-13. SciFinder. Web. 9 June 2012. -prevent/remove harm; improve the situation of others -goal of medicine is to promote welfare of patients -scientists/doctors have the knowledge/power to help/do good The men wouldn’t be treated anyway in their town No intentions of giving out treatments; subjects trusted USPHS

Harmful, not Helpful Patients were told they were receiving treatments When a treatment was discovered it was not distributed The act of not treating the patients was in itself a harmful treatment (Penicillin core structure, where “R” is a variable group; found to treat syphilis in 1945) -Ineffective treatments/ more important to do no harm than to do good -did not give them pencillin, refused to give them a treatment that was effective -studies showed that untreated syphilis poses dangers -USPHS actually sought to prevent treatments -free medical exams, burial insurance, treatment, food -men were given mercurial ointment and neoarphenamine (both ineffective drugs) 2. Giving treatment would violate the experiments original intent

False Advertising to Patients No informed consent “These negroes are very ignorant and easily influenced by things that would be of minor significance in a more intelligent group”6 (Clark) Did not want participants to know they would be autopsied (Spinal tap) 6. Brandt, Allan M. "Racism and Research: The Case of the Tuskegee Syphilis Study." Hastings Center Magazine, (1978): 1-13. SciFinder. Web. 9 June 2012. -deceit -no informed consent Submitting voluntarily (under false pretenses!) is not informed consent 1. wasn’t a voluntary submission because they believed they were getting treatment- were being controlled by outside influences 1.Told they were ill and promised free care, promise of treatment gained their cooperation -devalues credibility of experiment because they were lied to

Letter to participants: “Some time ago you were given a thorough examination and since that time we hope you have gotten a great deal of for bad blood. You will now be given your last chance to get a second examination. This examination is a very special examination and after it is finished you will be given a special treatment if it is believed you are in a condition to stand it. REMEMBER THIS IS YOUR LAST CHANCE FOR SPECIAL TREATMENT. BE SURE TO MEET THE NURSE”6 6. Brandt, Allan M. "Racism and Research: The Case of the Tuskegee Syphilis Study." Hastings Center Magazine, (1978): 1-13. SciFinder. Web. 9 June 2012.

Unjust Practices Experiment exhibited a racist nature “Syphilis in the negro is in many respects almost a different disease form syphilis in the white”6 (Dr. Moore) In 1972 the remaining survivors were treated, as well as their family members after the news of the experiment was leaked by a whistleblower… Peter Buxtun: A former employee of the United States Public Health Service who leaked information on the experiment to journalist Jean Heller of the Washington Star in 1972.7 6. Brandt, Allan M. "Racism and Research: The Case of the Tuskegee Syphilis Study." Hastings Center Magazine, (1978): 1-13. SciFinder. Web. 9 June 2012. 7. "Protection from Harm: The Tuskeegee Syphilis Study." Tuskeegee Syphilis Study. Dartmouth University, n.d. Web. 22 June 2012. <http://www.dartmouth.edu/~thabif/newfiles/tuskee.html>. Historical context (1932) 1. Dr. Moore stressed the importance of treating syphilis in the late stages After the emergence of Darwinism people believed the African American race would go extinct (evolutionary scheme) 1. Nature of blacks, sex, and disease/ medicine cannot change evolution 1. Mass treatment among the rural blacks

Costs to Society Mistrust in the medical system and government. A 2002-2003 survey by Oregon State University and Rand Corp.8 8. Fears, Darryl. "Study: Many Blacks Cite AIDS Conspiracy." Washingtonpost.com. Washington Post, 25 Jan. 2005. Web. 20 June 2012. <Study: Many Blacks Cite AIDS Conspiracy>.

Mitigating Circumstances Dr. John Heller, Director of Public Health Service’s Division of Venereal Diseases, stated “The men's status did not warrant ethical debate. They were subjects, not patients; clinical material, not sick people.”9 (Dr. Heller, Assistant of On-Site Medical Operations) 9. Stocks, J.T. "Research Ethics: The Tuskegee Syphilis Study." MSU's Center for Ethics and Humanities in the Life Sciences, n.d. Web. 21 June 2012. <https://www.msu.edu/user/sw/ethics/tuskg.html>.

Consequences 1974 - National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1980-1983 - President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research 1995 - National Bioethics Advisory Commission 2001 - President's Council on Bioethics

Outcomes or Sanctions President Clinton held a ceremony in honor of the study participants 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, and I am sorry ... To our African American citizens, I am sorry that your federal government orchestrated a study so clearly racist.“ ~Bill Clinton10 Five of the Eight surviving participants attended. 10. "Remarks by the President in apology for study done in Tuskegee". Office of the Press Secretary, The White House. 1997-05-16. http://clinton4.nara.gov/textonly/New/Remarks/Fri/19970516-898.html. Retrieved 2009-09-06.

Outcomes for People Involved11 Subjects – For many death In 1972, 74 of the participants were alive. There were 40 wives infected and then 19 children were born with congenital syphilis. The NAACP filed a class action lawsuit in which the U.S. government paid $9 million and agreed to provide medical treatment to surviving participants and their families infected by the disease. On January 4, 2004 the last Tuskegee participate died. On January 27, 2009 the last widow receiving THBP benefits died. 11. "Tuskegee Study - Timeline". NCHHSTP. CDC. 2008-06-25. http://www.cdc.gov/tuskegee/timeline.htm. Retrieved 2008-12-04.

6 Critical Unethical Issues 1) Violation of constitutional rights of the participants. 2) Governments behavior with their knowledge of syphilis. 3) PHS led the participants to believe that they were being properly treated. 4) PHS failed to obtain the participants’ written consents to be a part of the study. 5) Racially motivated and discriminated against African Americans. 6) No rules and regulations governing the experiment.

What Actions Should have been taken ? Patients needed more information about their condition and treatment. Standard treatment should have been controlled. Treatment should have been initiated after cure was found.

Preventing History from Reoccurring Educating future generations. New laws as a result of the unethical study. Educating patients about their rights will permit and authorize them to necessitate nothing less than the best medical care possible from healthcare professionals. Emphasis on ethical behavior training.

Relevance Today Regret leads to determination to prevent future wrongs. Positive symbol for all Americans by signifying the importance of acknowledging past wrongs, reconstructing trust, and practicing ethical research. Ethical behavior is now an important component of scientific research.