Life is all about choices …

Responsible Research Ethics and The Tuskegee Syphilis Study

Join me as we journey back to an age in America –w–where the field of Medicine comes into its own, and –O–O–O–Optimism, –P–P–P–Progress –S–S–S–Science sit on the Throne of GOD Welcome to my Virtual Time Machine

All Aboard to the 20 th Century!

Piaget describes stages of cognitive development First Test Tube Baby Born 1978 First Human Heart Transplant Year First successful Open Heart Surgery Penicillin sulfa drugs First Electrocardiogram 1903 Back to Tuskegee

Syphilis the AIDS of an earlier time Untreated, it can lead to –severe heart disease, –brain damage, –paralysis, and –death. The problem was, until 1907, no one could treat it.

Then Nobel Prize-winning microbiologist Paul Ehrlich discovered Salvarsan an arsenic-based compound. It was the first chemotherapy.

The 1920s was a progressive era in medicine Armed with confidence and the Scientific Method, U.S. Public Health Service officials were determined to control syphilis in their time. They set up free treatment clinics throughout the south, including Macon county, Alabama, home to the Tuskegee Institute.

While writing the final report, Dr. Taliaferro Clark, head of the PHS Venereal Disease Division conceived an idea to salvage the study … Macon county offered an unparalleled opportunity for the study of the effect of untreated syphilis in the Negro male. But in 1932, the funding for treatment ran out.

The Study of Untreated Syphilis in the Negro male (1932 – 1972) was only supposed to last a year … but then Dr. Raymond Vondelehr advocated continuing the study to get autopsies. Autopsies would confirm clinical observation and therefore greatly contribute to the studys scientific reliability.

Bringing them to Autopsy By the time the story finally hit the newspapers in 1972, the experiment had gone on for 40 years. During all this time, it was no secret to the wider medical community. Results of the study had been published in well known medical journals.

Yet no one ever questioned the study.

Bad Blood Macon county residents were very poor. They lived and died without medical care because they could not afford it. They didnt distinguish between syphilis and a host of other maladies which they termed bad blood.

Bad Blood They traveled great distances to get a little free medical care from the government doctors whom they trusted. The government doctors simply told them they had bad blood.

399 Participants never told they had syphilis. None were offered a cure. Even when penicillin became available in 1943, researchers intervened to keep subjects from getting penicillin so the study could continue.

100 men died from related complications. At least 40 wives were infected. 19 children contracted congenital syphilis at birth. A whole peoples trust was shattered. 28 men died of syphilis.

Nothing learned will prevent, find, or cure a single case.

When the story finally hit the newspapers in 1972 The ensuing investigation concluded –"Society can no longer afford –to leave the balancing –of individual rights –against scientific progress –to the scientific community."

The Tuskegee Syphilis Study - became a major factor in the writing of the 1979 Belmont Report which guides human subject research today in the U.S.

The 3 Basic Ethical Principles of the Belmont Report Respect for Persons Benefice Justice

Respect for Persons Definition: Individuals should be treated as autonomous agents Persons with diminished autonomy are entitled to protection Application: Voluntary Informed Consent Belmont Report

Benefice Definition: Do not harm Maximize possible benefits Minimize possible harms Application: Assessment of risks and benefits Belmont Report

Justice Definition: Who should receive the benefits of research? Who should bear its burdens? Application: Equitable Selection of Subjects Belmont Report

Even after exposure and public outcry brought the study to a halt in 1972 and even after settling an expensive lawsuit, the U.S. Government never formally admitted to any wrong-doing until 1997.

The 1997 Presidential Apology

Consider the following statement by Tuskegee Researcher John Heller about the 1946 Nuremberg Trials …

I, like most everybody else, was horrified at the things that were practiced upon these Jewish people, such as doing experiments while the patients were not only alive but doing such things as would cause their deaths. All these sorts of things were horrendous to me and I, like most everyone else, deplored them. Dr. John R. Heller, Researcher, Tuskegee Syphilis Study

The Tuskegee Study started in 1932 and continued for 40 years, well past the 1946 Nuremberg trials.

Why do you think nobody saw a connection between Nuremberg and the Tuskegee Syphilis Study?

More Questions to Consider Why should we be concerned about Human Subject Research? Do you think another Tuskegee could happen in the future? Can you envision yourself ever being faced with an ethical dilemma in Human Subjects research? What are some guidelines or resources you could turn to? and finally …

Piaget describes stages of cognitive development First Test Tube Baby Born 1978 First Human Heart Transplant Year First successful Open Heart Surgery Penicillin sulfa drugs First Electrocardiogram 1903 Back to the Future!

choices have consequences Now its your turn - how will YOU choose? Life is all about choices …

The author wishes to acknowledge the following resources used in creating this presentation on Responsible Research Ethics: James H. Jones, Bad Blood: The Tuskegee Syphilis Experiment, New York: The Free Press, 1993 (expanded ed.). DavidDavid at Frogstone for the image Femme used in backdrop.FrogstoneFemme The Faces of Tuskegee website at MSU.Faces of Tuskegee website