Tuskegee Syphilis StudyNearly 65 years after the U.S. Public Health Service Syphilis Study at Tuskegee began; President Clinton apologized for the U.S. government's role in the research study, which was carried out in Macon County, Alabama, from 1932 to 1972.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 U.S. Public Health Service Syphilis Study at Tuskegee and other studies, the federal 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 TUSKEGEE TIMELINEThe Study BeginsIn 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.  It was called the "Tuskegee Study of Untreated Syphilis in the Negro Male."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.  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, an Associated Press 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 BeginsThe 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 was filed on behalf of the study participants and their families. In 1974, a $10 million out-of-court settlement was reached. As part of the settlement, the U.S. government promised to give lifetime medical benefits and burial services to all living participants. The Tuskegee Health Benefit Program (THBP) was established to provide these services. In 1975, wives, widows and offspring were added to the program. In 1995, the program was expanded to include health as well as medical benefits. The Centers for Disease Control and Prevention was given responsibility for the program, where it remains today in the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. The last study participant died in January

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2004.  The last widow receiving THBP benefits died in January 2009.  There are 16 offspring currently receiving medical and health benefits

1895 Booker T. Washington at the Atlanta Cotton Exposition, outlines his dream for black economic development and gains support of northern philanthropists, including Julius Rosenwald (President of Sears, Roebuck and Company).1900 Tuskegee educational 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 decide to follow men left untreated due to lack of funds in order 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 Institute 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 with study and not to treat men.  Decision was made to follow the men until death.1940 Efforts made to hinder men from getting treatment ordered under the military draft effort.1945 Penicillin accepted as treatment of choice for syphilis.1947 USPHS establishes "Rapid Treatment Centers" to treat syphilis; men in study are not treated, but syphilis declines.1962 Beginning in 1947, 127 black medical students are rotated through unit doing the study.1968 Concern raised about ethics of study by Peter Buxtun and others.1969 CDC reaffirms need for study and gains local medical societies' support (AMA and NMA chapters officially support continuation of study).1972 First news articles condemn studies.1972 Study ends.1973 Congress holds hearings and a class-action lawsuit is filed on behalf of the study participants.1974 A $10 million out-of-court settlement is reached and the U.S. government promised to give lifetime medical benefits and burial services to all living participants.  The Tuskegee Health Benefit Program (THBP) was established to provide these services.1975 Wives, widows and offspring were added to the program.1995 The program was expanded to include health as well as medical benefits.1997 On May 16th President Clinton apologizes on behalf of the Nation.2001 President’s Council on Bioethics was established.2004 CDC funds 10 million dollar cooperative agreement to continue work at Tuskegee University National Center for Bioethics in Research and Health Care.2004 The last U.S. Public Health Service Syphilis Study at Tuskegee participant dies on January 16.2006 Tuskegee University holds formal opening of Bioethics Center.2009 The last widow receiving THBP benefits dies on January 27.

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THE EXPERIMENT

"Bad Blood:"A Case Study of the Tuskegee Syphilis Project

by A.W. Fourtner, C.R. Fourtner and C.F. HerreidUniversity at Buffalo, State University of New York

THE DISEASE

Syphilis is a venereal disease spread during sexual intercourse. It can also be passed from mother to child during pregnancy. It is caused by a corkscrew-shaped bacterium called a spirochete, Treponema pallidum. This microscopic organism resides in many organs of the body but causes sores or ulcers (called chancres) to appear on the skin of the penis, vagina, mouth, and occasionally in the rectum, or on the tongue, lips, or breast. During sex the bacteria leave the sores of one person and enter the moist membranes of their partner's penis. vagina, mouth, or rectum.

Once the spirochetes wiggle inside a victim, they begin to multiple at an amazing rate. (Some bacteria have a doubling rate of 30 minutes. You may want to consider how many bacteria you might have in 12 hours if one bacterium entered your body doubling at that rate.) The spirochetes then enter the lymph circulation, which carries them to nearby lymph glands that may swell in response to the infection.

This first stage of the disease (called primary syphilis) lasts only a few weeks and usually causes hard red sores or ulcers to develop on the genitals of the victim, who can then pass the disease on to someone else. During this primary stage, a blood test will not reveal the disease but the bacteria can be scraped from the sores. The sores soon heal and some people may recover entirely without treatment.

Secondary syphilis develops two to six weeks after the sores heal. Then flu-like symptoms appear with fever, headache, eye inflammation, malaise, and joint pain, along with a skin rash and mouth and genital sores. These symptoms are a clear sign that the spirochetes have traveled throughout the body by way of the lymph and blood systems, where they now can be readily detected by a blood test (e.g., the Wassermann test). Scalp hair may drop out to give a "moth-eaten" look to the head. This secondary stage ends in a few weeks as the sores heal.

Signs of the disease may never reappear even though the bacteria continue to live in the person. However, in about 25% of those originally infected, symptoms will flare up again in a late or tertiary stage syphilis.

Almost any organ can be attacked, such as the cardiovascular system, producing leaking heart valves and aneurysms--balloon-like bulges in the aorta that may burst, leading to instant death. Gummy or rubbery tumors filled with spirochetes and covered by a dried crust of pus may develop on the skin. The bones may deteriorate as in osteomyelitis or tuberculosis and may produce disfiguring facial mutilations as nasal and palate bones are eaten away. If the nervous system is infected, a stumbling foot-slapping gait may occur or, more severely, paralysis, senility, blindness, and insanity.

THE HEALTH PROGRAM

The cause of syphilis, the stages of the disease's development, and the complications that can result from untreated syphilis were all known to medical science in the early 1900s. In 1905, German scientists Hoffman and Schaudinn isolated the bacterium that causes syphilis. In 1907, the Wassermann blood test was developed, enabling physicians to diagnose the disease. Three years later, German scientist Paul Ehrlich created an arsenic compound called salvarsan to treat syphilis. Together with mercury, it was either injected or rubbed onto the skin and often produced serious and occasionally fatal reactions in patients. Treatment was painful and usually required more than a year to complete.

In 1908, Congress established the Division of Venereal Diseases in the United States Public Health Service. Within a year, 44 states had organized separate bureaus for venereal disease control. Unfortunately, free treatment clinics operated only in urban areas for many years. Data collected in a survey begun in 1926 of 25 communities across

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the United States indicated that the incidence of syphilis among patients under observation was "4.05 cases per 1,000 population, the rate for whites being 4 per 1,000, and that for Negroes 7.2 per 1,000."

In 1929, Dr. Hugh S. Cumming, the Surgeon General of the United States Public Health Service (PHS), asked the Julius Rosenwald Fund for financial support to study the control of venereal disease in the rural South. The Rosenwald Fund was a philanthropic organization that played a key role in promoting the welfare of African-Americans. The Fund agreed to help the PHS in developing health programs for southern African-Americans.

One of the Fund's major goals was to encourage their grantees to use black personnel whenever possible as a means to promote professional integration. Thus, the mission of the Fund seemed to fit well with the plans of the PHS. Macon County, Alabama, was selected as one of five syphilis-control demonstration programs in February 1930. The local Tuskegee Institute endorsed the program. The Institute and its John A. Andrew Memorial Hospital were staffed and administered entirely by African-American physicians and nurses: "The demonstrations would provide training for private physicians, white and colored, in the elements of venereal disease treatments and the more extensive distribution of antisyphilitic drugs and the promotion of wider use of state diagnostic laboratory facilities."

In 1930, Macon County had 27,000 residents, 82 percent of whom were African-Americans, most living in rural poverty in shacks with dirt floors, no plumbing, and poor sanitation. This was the target population, people who "had never in their lives been treated by a doctor." Public health officials arriving on the scene announced they had come to test people for "bad blood." The term included a host of maladies and later surveys suggest that few people connected that term with syphilis.

The syphilis control study in Macon County turned up the alarming news that 36 percent of the African-American population had syphilis. The medical director of the Rosenwald Fund was concerned about the racial connotations of the findings, saying "There is bound to be danger that the impression will be given that syphilis in the South is a Negro problem rather than one of both races." The PHS officer assured the Fund and the Tuskegee Institute that demonstrations would not be used to attack the images of black Americans. He argued that the high syphilis rates were not due to "inherent racial susceptibility" but could be explained by "differences in their respective social and economic status." However, the PHS failed to persuade the Fund that more work could break the cycle of poverty and disease in Macon County. So when the PHS officers suggested a larger scale extension of the work, the Rosenwald Fund trustees voted against the new project.

Building on what had been learned during the Rosenwald Fund demonstrations and the four other sites, the PHS covered the nation with the Wassermann tests. Both blacks and whites were reached with extensive testing, and in some areas mobile treatment clinics were available.

THE EXPERIMENT

As the PHS officers analyzed the data for the final Rosenwald Fund report in September of 1932, and realizing that funding for the project would be discontinued, the idea for a new study evolved into the Tuskegee Study of Untreated Syphilis in the Negro Male. The idea was to convert the original treatment program into a nontherapeutic human experiment aimed at compiling data on the progression of the disease on untreated African-American males.

There was precedence for such a study. One had been conducted in Oslo, Norway, at the turn of the century on a population of white males and females. An impressive amount of information had been gathered from these patients concerning the progression of the disease. However, questions of manifestation and progression of syphilis in individuals of African descent had not been studied. In light of the discovery that African natives had some rather unique diseases (for example, sick cell anemia--a disease of red blood cells), a study of a population of African males could reveal biological differences during the course of the disease. (Later, the argument that supported continuation of the study may even have been reinforced in the early 1950s when it was suggested that native Africans with the sickle cell trait were less susceptible to the ravages of malaria.)

In fact, Dr. Joseph Earle Moore of the Venereal Disease Clinic of the Johns Hopkins University School of Medicine stated when consulted, "Syphilis in the Negro is in many respects almost a different disease from syphilis in the white." The PHS doctors felt that this study would emphasize and delineate these differences. Moreover, whereas the Oslo study was retrospective (looking back at old cases), the Macon Study would be a better prospective study, following the progress of the disease through time.

It was estimated that of the 1,400 patients in Macon County admitted to treatment under the Rosenwald Fund, not one had received the full course of medication prescribed as standard therapy for syphilis. The PHS officials decided that these men could be considered untreated because they had not received enough treatment to cure them. In

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the county there was a well-equipped teaching hospital (the John A. Andrew Memorial Hospital at the Tuskegee Institute) that could be used for scientific purposes.

Over the next months in 1932, cooperation was insured from the Alabama State Board of Health, the Macon County Health Department, and the Tuskegee Institute. However, Dr. J.N. Baker, the state health officer, received one important concession in exchange for his approval. Everyone found to have syphilis would have to be treated. Although this would not cure them--the nine-month study was too short--it would keep them non-infectious. Dr. Baker also argued that local physicians be involved.

Dr. Raymond Vonderlehr was chosen for the field work that began in October 1932. Dr. Vonderlehr began his work in Alabama by spreading the word that a new syphilis control demonstration was beginning and that government doctors were giving free blood tests. Black people came to schoolhouses and churches for examination--most had never before seen a doctor. Several hundred men over 25 years old were identified as Wassermann-positive who had not been treated for "bad blood" and had been infected for over five years. Cardiovascular problems seemed particularly evident in this population in the early days, reaffirming that Negroes might be different in their response. But nervous system involvement was not evident.

As Dr. Vonderlehr approached the end of his few months of study, he suggested to his superior, Dr. Clark, that the work continue for five to 10 years because "many interesting facts could be learned regarding the course and complications of untreated syphilis." Dr. Clark retired a few months later and in June 1933 Dr. Vonderlehr was promoted to director of the Division of Venereal Diseases of the PHS.

This promotion began a bureaucratic pattern over the next four decades that saw the position of director go to a physician who had worked on the Tuskegee Study. Dr. Vonderlehr spent much of the summer of 1933 working out the study's logistics, which would enable the PHS to follow the men's health through their lifetime. This included gaining permission from the men and their families to perform an autopsy at the time of their death, thus providing the scientific community with a detailed microscopic description of the diseased organs.

Neither the syphilitics nor the controls (those men free of syphilis who were added to the project) were informed of the study's true objective. These men knew only that they were receiving treatment for "bad blood" and money for burial. Burial stipends began in 1935 funded by the Milbank Memorial Fund.

The skill of the African-American nurse, Eunice Rivers, and the cooperation of the local health providers (most of them white males), were essential in this project. They understood the project details and the fact that the patients' available medical care (other than valid treatment for syphilis) was far better than that for most African-Americans in Macon County. The local draft board agreed to exclude the men in the study from medical treatment when that became an issue during the early 1940s. State health officials also cooperated.

The study was not kept secret from the national medical community in general. Dr. Vonderlehr in 1933 contacted a large number of experts in the field of venereal disease and related medical complications. Most responded with support for the study. The American Heart Association asked for clarification of the scientific validity, then subsequently expressed great doubt and criticism concerning the tests and procedures. Dr. Vonderlehr remained convinced that the study was valid and would prove that syphilis affected African-Americans differently than those of European descent. As director of the PHS Venereal Disease Division, he controlled the funds necessary to conduct the study, as did his successors.

Key to the cooperation of the men in the Tuskegee Study was the African-American PHS nurse assigned to monitor them. She quickly gained their trust. She dealt with their problems. The physicians came to respect her ability to deal with the men. She not only attempted to keep the men in the study, many times she prevented them from receiving medical care from the PHS treatment clinics offering neoarsphenamine and bismuth (the treatment for syphilis) during the late 1930s and early 1940s. She never advocated treating the men. She knew these treatment drugs had side affects. As a nurse, she had been trained to follow doctor's orders. By the time penicillin became available for the treatment of syphilis, not treating these men had become a routine procedure, which she did not question. She truly felt that these men were better off because of the routine medical examinations, distribution of aspirin pink pills that relieved aches and pains, and personal nursing care. She never thought of the men as victims; she was aware of the Oslo study: "This is the way I saw it: that they were studying the Negro, just like they were studying the white man, see, making a comparison." She retired from active nursing in 1965, but assisted during the annual checkups until the experiment ended.

By 1943, when the Division of Venereal Diseases began treating syphilitic patients nationwide with penicillin, the men in the Tuskegee study were not considered patients. They were viewed as experimental subjects and were denied antibiotic treatment. The PHS officials insisted that the Study offered even more of an opportunity to study these men as a "control against which to project not only the results obtained with the rapid schedules of therapy for syphilis but also the costs involved in finding and placing under treatment the infected individuals." There is no

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evidence that the study had ever been discussed in the light of the Nuremberg Code, a set of ethical principles for human experimentation developed during the trials of Nazi physicians in the aftermath of World War II. Again, the study had become routine.

In 1951, Dr. Trygve Gjustland, then the current director of the Oslo Study, joined the Tuskegee group to review the experiment. He offered suggestions on updating records and reviewing criteria. No one questioned the issue of contamination (men with partial treatment) or ethics. In 1952, the study began to focus on the study of aging, as well as heart disease, because of the long-term data that had been accumulated on the men. It became clear that syphilis generally shortened the lifespan of its victims and that the tissue damage began while the young men were in the second stage of the disease (see tables in Appendix A).

In June 1965, Dr. Irwin J. Schatz became the first medical professional to object to the study. He suggested a need for PHS to reevaluate their moral judgments. The PHS did not respond to his letter. In November 1966 Peter Buxtin, a PHS venereal disease interviewer and investigator, expressed his moral concerns about the study. He continued to question the study within the PHS network.

In February of 1969, the PHS called together a blue ribbon panel to discuss the Tuskegee study. The participants were all physicians, none of whom had training in medical ethics. In addiiton, none of them were of African descent. At no point during the discussions did anyone remind the panel of PHS's own guidelines on human experimentation (established in February 1966). According to records, the original study had been composed of 412 men with syphilis and 204 controls. In 1969, 56 syphilitic subjects and 36 controls were known to be living. A total of 373 men in both groups were known to be dead. The rest were unaccounted for. The age of the survivors ranged from 59 to 85, one claiming to be 102. The outcome of this meeting was that the study would continue. The doctors convinced themselves that the syphilis in the Tuskegee men was too far along to be effectively treated by penicillin and that the men might actually suffer severe complications from such therapy. Even the Macon County Medical Society, now made up of mostly African-American physicians, agreed to assist the PHS. Each was given a list of subjects,

In the late 1960s, PHS physician, Dr. James Lucas, stated in a memorandum that the Tuskegee study was "bad science" because it had been contaminated by treatment. PHS continued to put a positive spin on the experiment by noting that the study had been keeping laboratories supplied with blood samples for evaluating new blood tests for syphilis.

Peter Buxtin, who had left the PHS for law school, bothered by the study and the no-change attitude of the PHS, contacted the Associated Press. Jean Heller, the reporter assigned to the story, did extensive research into the Tuskegee experiment. When interviewed by her, the PHS officials provided her with much of her information. They were men who had nothing to hide. The story broke on July 25, 1972. The study immediately stopped.

APPENDIX A

The following are a variety of data sets compiled from later publications of the Tuskegee study.

Table 1. 1963 viability data of Tuskegee group

____ DEAD____ ____ALIVE____ ____UNKNOWN____n. % n. % n. %

Syphilitics 242 59 85 21 85 21

Controls 78 45 66 34 39 20

from: Rockwell, et al. (1964)

Table 2. Abnormal findings in 90 syphilitics and 65 controls

Abnormality ___Syphylitics____ ____Controls____n. % n. %

Electrocardiographic 41 46 21 32Cardiomegaly via X-ray 37 42 22 34Peripheral neuropathy 12 13 5 8Hypertension d. b .p. 38 43 29 45

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>90Cardiac murmurs 24 27 20 31

Urine 28 36 21 33

from: Rockwell, et al. (1964)

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Table 3. Aortic arch and myocardial abnormalities at autopsy

____Aortic arch____ ____Myocardial____n. % n. %

Syphilitics (140) 62 44 48 34

Controls (54) 8 15 20 37

X 2 P<0.005 X 2 P>0.25 not different

from: Caldwell et al. (1973)

http://ublib.buffalo.edu/libraries/projects/cases/blood.htm

Blowing the Whistle

The story finally broke in the Washington Star on July 25, 1972, in an article by Jean Heller of the Associated Press. Her source was Peter Buxtun, a former PHS venereal disease interviewer and one of the few whistle blowers over the years. The PHS, however, remained unrepentant, claiming the men had been “volunteers” and “were always happy to see the doctors,” and an Alabama state health officer who had been involved claimed “somebody is trying to make a mountain out of a molehill.”

Under the glare of publicity, the government ended their experiment, and for the first time provided the men with effective medical treatment for syphilis. Fred Gray, a lawyer who had previously defended Rosa Parks and Martin Luther King, filed a class action suit that provided a $10 million out-of-court settlement for the men and their families. Gray, however, named only whites and white organizations as defendants in the suit, portraying Tuskegee as a black and white case when it was in fact more complex than that—black doctors and institutions had been involved from beginning to end.

The PHS did not accept the media's comparison of Tuskegee with the appalling experiments performed by Nazi doctors on their Jewish victims during World War II. Yet in addition to the medical and racist parallels, the PHS offered the same morally bankrupt defense offered at the Nuremberg trials: they claimed they were just carrying out orders, mere cogs in the wheel of the PHS bureaucracy, exempt from personal responsibility.

The study's other justification—for the greater good of science—is equally spurious. Scientific protocol had been shoddy from the start. Since the men had in fact received some medication for syphilis in the beginning of the study, however inadequate, it thereby corrupted the outcome of a study of “untreated syphilis.”

The Legacy of Tuskegee

In 1990, a survey found that 10 percent of African Americans believed that the U.S. government created AIDS as a plot to exterminate blacks, and another 20 percent could not rule out the possibility that this might be true. As preposterous and paranoid as this may sound, at one time the Tuskegee experiment must have seemed equally farfetched.

Who could imagine the government, all the way up to the Surgeon General of the United States, deliberately allowing a group of its citizens to die from a terrible disease for the sake of an ill-conceived experiment? In light of this and many other shameful episodes in our history, African Americans' widespread mistrust of the government and white society in general should not be a surprise to anyone.

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The PHS did not accept the media's comparison of Tuskegee with the

experiments performed by Nazi doctors on Jewish victims during

World War II. Yet the PHS offered the same defense offered at the

Nuremberg trials — they were just carrying out orders.

PRESIDENTIAL APOLOGYTHE WHITE HOUSE Office of the Press SecretaryFor Immediate Release May 16, 1997

REMARKS BY THE PRESIDENT IN APOLOGY FOR STUDY DONE IN TUSKEGEE

The East Room 2:26 P.M. EDT

THE PRESIDENT: Ladies and gentlemen, on Sunday, Mr. Shaw will celebrate his 95th birthday. (Applause.) I would like to recognize the other survivors who are here today and their families: Mr. Charlie Pollard is here. (Applause.) Mr. Carter Howard. (Applause.) Mr. Fred Simmons. (Applause.) Mr. Simmons just took his first airplane ride, and he reckons he's about 110 years old, so I think it's time for him to take a chance or two. (Laughter.) I'm glad he did.  And Mr. Frederick Moss, thank you, sir. (Applause.)

I would also like to ask three family representatives who are here -- Sam Doner is represented by his daughter, Gwendolyn Cox. Thank you, Gwendolyn. (Applause.) Ernest Hendon, who is watching in Tuskegee, is represented by his brother, North Hendon. Thank you, sir, for being here. (Applause.) And George Key is represented by his grandson, Christopher Monroe. Thank you, Chris. (Applause.)

I also acknowledge the families, community leaders, teachers and students watching today by satellite from Tuskegee.  The White House is the people's house; we are glad to have all of you here today. I thank Dr. David Satcher for his role in this.  I thank Congresswoman Waters and Congressman Hilliard, Congressman Stokes, the entire Congressional Black Caucus.  Dr. Satcher, members of the Cabinet who are here, Secretary Herman, Secretary Slater, members of the Cabinet who are here, Secretary Herman, Secretary Slater.  A great friend of freedom, Fred Gray, thank you for fighting this long battle all these long years.

The eight men who are survivors of the syphilis study at Tuskegee are a living link to a time not so very long ago that many Americans would prefer not to remember, but we dare not forget.  It was a time when our nation failed to live up to its ideals, when our nation broke the trust with our people that is the very foundation of our democracy.  It is not only in remembering that shameful past that we can make amends and repair our nation, but it is in remembering that past that we can build a better present and a better future.  And without remembering it, we cannot make amends and we cannot go forward.

So today America does remember the hundreds of men used in research without their knowledge and consent.  We remember them and their family members.  Men who were poor and African American, without resources and with few alternatives, they believed they had found hope when they were offered free medical care by the United States Public Health Service.  They were betrayed.

Medical people are supposed to help when we need care, but even once a cure was discovered, they were denied help, and they were lied to by their government.  Our government is supposed to protect the rights of its citizens; their rights were trampled upon. Forty years, hundreds of men betrayed, along with their wives and children, along with the community in Macon County, Alabama, the City of Tuskegee, the fine university there, and the larger African American community.

The United States government did something that was wrong -- deeply, profoundly, morally wrong.  It was an outrage to our commitment to integrity and equality for all our citizens.

To the survivors, to the wives and family members, the children and the grandchildren, I say what you know: No power on Earth can give you back the lives lost, the pain suffered, the years of internal torment and anguish.  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. (Applause.)

The American people are sorry -- for the loss, for the years of hurt.  You did nothing wrong, but you were grievously wronged.  I apologize and I am sorry that this apology has been so long in coming. (Applause.)

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To Macon County, to Tuskegee, to the doctors who have been wrongly associated with the events there, you have our apology, as well.  To our African American citizens, I am sorry that your federal government orchestrated a study so clearly racist.  That can never be allowed to happen again.  It is against everything our country stands for and what we must stand against is what it was.

So let us resolve to hold forever in our hearts and minds the memory of a time not long ago in Macon County, Alabama, so that we can always see how adrift we can become when the rights of any citizens are neglected, ignored and betrayed.  And let us resolve here and now to move forward together.

The legacy of the study at Tuskegee has reached far and deep, in ways that hurt our progress and divide our nation.  We cannot be one America when a whole segment of our nation has no trust in America.  An apology is the first step, and we take it with a commitment to rebuild that broken trust. We can begin by making sure there is never again another episode like this one.  We need to do more to ensure that medical research practices are sound and ethical, and that researchers work more closely with communities.

Today I would like to announce several steps to help us achieve these goals.  First, we will help to build that lasting memorial at Tuskegee. (Applause.) The school founded by Booker T. Washington, distinguished by the renowned scientist George Washington Carver and so many others who advanced the health and well-being of African Americans and all Americans, is a fitting site.  The Department of Health and Human Services will award a planning grant so the school can pursue establishing a center for bioethics in research and health care.  The center will serve as a museum of the study and support efforts to address its legacy and strengthen bioethics training.

Second, we commit to increase our community involvement so that we may begin restoring lost trust.  The study at Tuskegee served to sow distrust of our medical institutions, especially where research is involved.  Since the study was halted, abuses have been checked by making informed consent and local review mandatory in federally-funded and mandated research.

Still, 25 years later, many medical studies have little African American participation and African American organ donors are few.  This impedes efforts to conduct promising research and to provide the best health care to all our people, including African Americans.  So today, I'm directing the Secretary of Health and Human Services, Donna Shalala, to issue a report in 180 days about how we can best involve communities, especially minority communities, in research and health care.  You must -- every American group must be involved in medical research in ways that are positive.  We have put the curse behind us; now we must bring the benefits to all Americans. (Applause.)

Third, we commit to strengthen researchers' training in bioethics.  We are constantly working on making breakthroughs in protecting the health of our people and in vanquishing diseases.  But all our people must be assured that their rights and dignity will be respected as new drugs, treatments and therapies are tested and used.  So I am directing Secretary Shalala to work in partnership with higher education to prepare training materials for medical researchers.  They will be available in a year.  They will help researchers build on core ethical principles of respect for individuals, justice and informed consent, and advise them on how to use these principles effectively in diverse populations.

Fourth, to increase and broaden our understanding of ethical issues and clinical research, we commit to providing postgraduate fellowships to train bioethicists especially among African Americans and other minority groups.  HHS will offer these fellowships beginning in September of 1998 to promising students enrolled in bioethics graduate programs.

And, finally, by executive order I am also today extending the charter of the National Bioethics Advisory Commission to October of 1999.  The need for this commission is clear. We must be able to call on the thoughtful, collective wisdom of experts and community representatives to find ways to further strengthen our protections for subjects in human research.

We face a challenge in our time.  Science and technology are rapidly changing our lives with the promise of making us much healthier, much more productive and more prosperous.  But with these changes we must work harder to see that as we advance we don't leave behind our conscience.  No ground is gained and, indeed, much is lost if we lose our moral bearings in the name of progress.

The people who ran the study at Tuskegee diminished the stature of man by abandoning the most basic ethical precepts.  They forgot their pledge to heal and repair.  They had the power to heal the survivors and all the others and they did not.  Today, all we can do is apologize.  But you have the power, for only you -- Mr. Shaw, the others who are here, the family members who are with us in Tuskegee -- only you have the power to forgive.  Your presence here shows us that you have chosen a better path than your government did so long ago. You have not withheld the power to forgive.  I hope today and tomorrow every American will remember your lesson and live by it.

Thank you, and God bless you. (Applause.)

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RESEARCH IMPLICATIONS How Tuskegee Changed Research PracticesAfter 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's task was to review current regulations, policies, and procedures to ensure all possible safeguards are in place to protect research volunteers.  It was succeeded by the President's Council on Bioethics, which was established in 2001.

MORAL ISSUES ABOUT TUSKEGEE SYPHILIS STUDY Respect for Persons

This principle incorporates the convictions that individual research subjects should be treated as autonomous agents, and that persons with diminished autonomy (such as prisoners or inmates of mental institutions) are entitled to protection.

BeneficenceResearch involving human subjects should do no intentional harm, while maximizing possible benefits and minimizing possible harms, both to the individuals involved and to society at large.

JusticeAttention needs to be paid to the equitable distribution within human society of benefits and burdens of research involving human subjects. In particular, those participants chosen for such research should not be inequitably selected from groups unlikely to benefit from the work.

The Belmont report has greatly influenced the codes and regulations regarding human subjects’ research that have been established in the United States by federal and many state governments, universities, professional organizations and by private research institutions, as well as similar codes and regulations elsewhere in the world.

Issues

Significant questions of ethics and values raised by this case

An explicit requirement of the Tuskegee study was that the subjects not receive available treatment for a debilitating disease, a clear violation of normal medical practice. Would any study involving human subjects that violated normal medical practice necessarily be unethical?

The Tuskegee victims were not informed -- in fact they were deliberately misinformed -- about the nature of the study in which they were participants. A basic guideline for human subject research, specified in both the Nuremberg Code and the Belmont Report is the requirement of informed consent. What would have constituted informed consent in the case of the Tuskegee Study? If such informed consent had been obtained from the subjects, would this remove all questions about whether the Study was ethical?

In what sense were the premises and the practices of the Tuskegee study racist? An important question to explore when examining accusations of human rights violations or of prejudicial behavior is whether the standards being applied are those of the time the action took place, and if not, whether this should affect

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any judgement about the ethics of the situation. (Conforming to official social standards does not necessarily imply that you are behaving in an ethical manner. Most people would consider the medical experiments of the Nazi Doctors to be unethical even though they conformed to the principles spelled out in the Nazi ideology imposed on Germany by the Third Reich.)

Eunice Rivers, the African-American nurse who played a vital role by befriending the Tuskegee Study participants and assuring their cooperation has justified her support for the project in terms of the fact that the attention that she and the other medical staff gave to the men was more than a non-enrolled, poor, Macon County resident was likely to receive. If you had been in her place, do you think you would have come to the same conclusion with regard to the ethical choices available to you.

Ordinarily, one would not think of the media as the proper instrument for enforcing public morality. They had that role here, but should they have?

The political reaction to the Tuskegee revelations was largely responsible for establishing the committee that wrote the Belmont report, which set guidelines for experimentation on human subjects. These guidelines have been the basis for regulations, usually enforced by human subjects research panels, at most public and private institutions that conduct such research. Is this likely to assure that all future research on human subjects will be conducted in a manner that raises no ethical concerns?

The Belmont Report proposes three criteria for the evaluation of human subjects research, respect for persons, beneficence and justice, as described above in the introductory section. In what ways does the Tuskegee Study fail to conform to each of these criteria.

In experiments on infants, it is obviously impossible to obtain the informed consent of the subject. This is also true in experiments on senile individuals. Does this mean that ethical considerations preclude using such subjects in any experiment?

UNIVERSAL DECLARATION OF HUMAN RIGHTS

PREAMBLE

Whereas recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the world,

Whereas disregard and contempt for human rights have resulted in barbarous acts which have outraged the conscience of mankind, and the advent of a world in which human beings shall enjoy freedom of speech and belief and freedom from fear and want has been proclaimed as the highest aspiration of the common people,

Whereas it is essential, if man is not to be compelled to have recourse, as a last resort, to rebellion against tyranny and oppression, that human rights should be protected by the rule of law,

Whereas it is essential to promote the development of friendly relations between nations,

Whereas the peoples of the United Nations have in the Charter reaffirmed their faith in fundamental human rights, in the dignity and worth of the human person and in the equal rights of men and women and have determined to promote social progress and better standards of life in larger freedom,

Whereas Member States have pledged themselves to achieve, in co-operation with the United Nations, the promotion of universal respect for and observance of human rights and fundamental freedoms,

Whereas a common understanding of these rights and freedoms is of the greatest importance for the full realization of this pledge,

Now, Therefore THE GENERAL ASSEMBLY proclaims THIS UNIVERSAL DECLARATION OF HUMAN RIGHTS as a common standard of achievement for all peoples and all nations, to the end that every individual and every organ of society, keeping this Declaration constantly in mind, shall strive by teaching and education to promote respect for these rights and freedoms and by progressive measures, national and international, to secure their universal and effective recognition and observance, both among the peoples of Member States themselves and among the peoples of territories under their jurisdiction.

Article 1. All human beings are born free and equal in dignity and rights.They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood.

Article 2. Everyone is entitled to all the rights and freedoms set forth in this Declaration, without distinction of any kind, such as race, colour, sex, language, religion, political or

other opinion, national or social origin, property, birth or other status. Furthermore, no distinction shall be made on the basis of the political, jurisdictional or international status of the country or territory to which a person belongs, whether it be independent, trust, non-self-governing or under any other limitation of sovereignty.

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Article 3. Everyone has the right to life, liberty and security of person.

Article 4. No one shall be held in slavery or servitude; slavery and the slave trade shall be prohibited in all their forms.

Article 5. No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment.

Article 6. Everyone has the right to recognition everywhere as a person before the law.

Article 7. All are equal before the law and are entitled without any discrimination to equal protection of the law. All are entitled to equal protection against any discrimination in violation of this Declaration and against any incitement to such discrimination.

Article 8. Everyone has the right to an effective remedy by the competent national tribunals for acts violating the fundamental rights granted him by the constitution or by law.

Article 9. No one shall be subjected to arbitrary arrest, detention or exile.

Article 10. Everyone is entitled in full equality to a fair and public hearing by an independent and impartial tribunal, in the determination of his rights and obligations and of any criminal charge against him.

Article 11.(1) Everyone charged with a penal offence has the right to be presumed innocent until proved guilty according to law in a public trial at which he has had all the guarantees necessary for his defense. (2) No one shall be held guilty of any penal offence on account of any act or omission which did not constitute a penal offence, under national or international law, at the time when it was committed. Nor shall a heavier penalty be imposed than the one that was applicable at the time the penal offence was committed.

Article 12. No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour and reputation. Everyone has the right to the protection of the law against such interference or attacks.

Article 13. (1) Everyone has the right to freedom of movement and residence within the borders of each state. (2) Everyone has the right to leave any country, including his own, and to return to his country.

Article 14. (1) Everyone has the right to seek and to enjoy in other countries asylum from persecution. (2) This right may not be invoked in the case of prosecutions genuinely arising from non-political crimes or from acts contrary to the purposes and principles of the United Nations.

Article 15. (1) Everyone has the right to a nationality. (2) No one shall be arbitrarily deprived of his nationality nor denied the right to change his nationality.

Article 16.(1) Men and women of full age, without any limitation due to race, nationality or religion, have the right to marry and to found a family. They are entitled to equal rights as to marriage, during marriage and at its dissolution. (2) Marriage shall be entered into only with the free and full consent of the intending spouses. (3) The family is the natural and fundamental group unit of society and is entitled to protection by society and the State.

Article 17. (1) Everyone has the right to own property alone as well as in association with others. (2) No one shall be arbitrarily deprived of his property.

Article 18. Everyone has the right to freedom of thought, conscience and religion; this right includes freedom to change his religion or belief, and freedom, either alone or in community with others and in public or private, to manifest his religion or belief in teaching, practice, worship and observance.

Article 19. Everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers.

Article 20. (1) Everyone has the right to freedom of peaceful assembly and association. (2) No one may be compelled to belong to an association.

Article 21. (1) Everyone has the right to take part in the government of his country, directly or through freely chosen representatives. (2) Everyone has the right of equal access to public service in his country. (3) The will of the people shall be the basis of the authority of government; this will shall be expressed in periodic and genuine elections which shall be by universal and equal suffrage and shall be held by secret vote or by equivalent free voting procedures.

Article 22. Everyone, as a member of society, has the right to social security and is entitled to realization, through national effort and international co-operation and in accordance with the organization and resources of each State, of the economic, social and cultural rights indispensable for his dignity and the free development of his personality.

Article 23. (1) Everyone has the right to work, to free choice of employment, to just and favourable conditions of work and to protection against unemployment. (2) Everyone, without any discrimination, has the right to equal pay for equal work. (3) Everyone who works has the right to just and favourable remuneration ensuring for himself and his family an existence worthy of human dignity, and supplemented, if necessary, by other means of social protection. (4) Everyone has the right to form and to join trade unions for the protection of his interests.

Article 24. Everyone has the right to rest and leisure, including reasonable limitation of working hours and periodic holidays with pay.

Article 25. (1) Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care

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and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control. (2) Motherhood and childhood are entitled to special care and assistance. All children, whether born in or out of wedlock, shall enjoy the same social protection.

Article 26. (1) Everyone has the right to education. Education shall be free, at least in the elementary and fundamental stages. Elementary education shall be compulsory. Technical and professional education shall be made generally available and higher education shall be equally accessible to all on the basis of merit. (2) Education shall be directed to the full development of the human personality and to the strengthening of respect for human rights and fundamental freedoms. It shall promote understanding, tolerance and friendship among all nations, racial or religious groups, and shall further the activities of the United Nations for the maintenance of peace. (3) Parents have a prior right to choose the kind of education that shall be given to their children.

Article 27. (1) Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits. (2) Everyone has the right to the protection of the moral and

material interests resulting from any scientific, literary or artistic production of which he is the author.

Article 28. Everyone is entitled to a social and international order in which the rights and freedoms set forth in this Declaration can be fully realized.

Article 29. (1) Everyone has duties to the community in which alone the free and full development of his personality is possible. (2) In the exercise of his rights and freedoms, everyone shall be subject only to such limitations as are determined by law solely for the purpose of securing due recognition and respect for the rights and freedoms of others and of meeting the just requirements of morality, public order and the general welfare in a democratic society. (3) These rights and freedoms may in no case be exercised contrary to the purposes and principles of the United Nations.

Article 30. Nothing in this Declaration may be interpreted as implying for any State, group or person any right to engage in any activity or to perform any act aimed at the destruction of any of the rights and freedoms set forth herein.

 

Analysis

Articles 3, 7, 8 & 25 were fully violated in this study. Article 3 states that Everyone has the right to life, liberty and security of person by which attributing syphilis virus to this group of persons would most likely deprive them from giving them the right to live. It puts the person’s life at stake for the sake of research purposes. Article 7 states that All are equal before the law and are entitled without any discrimination to equal protection of the law. All are entitled to equal protection against any discrimination in violation of this Declaration and against any incitement to such discrimination. People in this research were racially discriminated for no white person were incorporated in this study. The selection of the subjects did not undergo the most equal treatment that they should be conducting, Article 8 states that everyone has the right to an effective remedy by the competent national tribunals for acts violating the fundamental rights granted him by the constitution or by law. This article further reinitiates the idea that since there were violation of human right by the administration of the virus within the subjects and as well as no proper remedy was given to the clients. Article 25 laments the idea that Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control. By participating in this research, the standard of living adequate for health was deprived to the persons chosen to participate in this study.

LEGAL ISSUES

1. The U.S. government violated the constitutional rights of the participants…2. The government knew the participants had syphilis and failed to treat them.3. The Public Health Service failed to fully disclose to the participants that they had syphilis, that they were

participating in the study, and that treatment was available for syphilis.4. The Public Health Service led the participants to believe that they were being properly treated for

whatever diseases they had, when in fact, they were not being meaningfully treated.5. The Public Health Service failed to obtain the participants’ written consents to be a part of the study.6. The Study was racially motivated and discriminated against African Americans in that no whites were

selected to participate in the Study…7. There were no rules and regulations governing the Study.

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A class lawsuit was filed in the idea of violation of human rights in this study. A class action or a representative action is a form of lawsuit in which a large group of people collectively bring a claim to court and/or in which a class of defendants is being sued The participants in this study used this lawsuit since it dealt in a large group of people. The individuality of the persons who participated in this study were most likely expounded in the idea that if several lawsuits were filed, it would place a sluggish manner of providing justice to the persons who participated in this study.

JURISPRUDENTIAL DOCTRINES1. Bonus Pater familias

(good father of a family)“whereby the employer ultimately becomes liable on his own negligence”.

This means that the employer is liable upon a finding that he has been negligent in the selection of his employees (culpa in eligiendo) o in the supervision of his employee (culpa in vigilando).

ANALYSIS

The researchers served as the father of the family in this study. Hence, the idea that he was the proponent of this study, the responsibility is incorporated by which he is liable to the presumptions that conducting this study would most likely provide the avenue of the worst repercussions. The researchers in this study did not become liable to the repercussions on the subjects. However, in this case if the researchers were proven ineffective to provide responsibilities to their subjects, the responsibility should be passed to the government. The subjects were under the sovereignty of the country and with that, it most likely contributes to the idea that they should provide the due process in the provision of justice to the research subjects.

2. Doctrine of negligent conductUnder this doctrine, the nurse is liable for damages or injuries to the patient as a result of negligent performance or non-performance of the nurse's obligation in the hospital. Breach of contract

ANALYSIS

Since the researchers failed to provide the remedy for their subjects that opened the avenue for mortalities in the research scenario, there is a breach in the contact that they have provided. This doctrine stated that the researchers are liable for damages or injuries that the research subjects have obtained. It concludes the idea that whatever law suit that were given to them, answers and actions should be provided by the one who is liable.

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