Life is all about choices … Responsible Research Ethics and The Tuskegee Syphilis Study

Life is all about choices …

Responsible Research EthicsResponsible Research Ethicsandand

The Tuskegee Syphilis StudyThe Tuskegee Syphilis Study

Join me as we journey back to an age in America

– where the field of Medicine comes into its own, and

–OptimismOptimism, –ProgressProgress–ScienceScience

•sit on the Throne of GOD

Welcome to my Virtual Time Machine

All Aboard to the 20th Century!

1923 - 1952 Piaget

describes stages of

cognitive development

First T

est T

ube Bab

y Born

197

8

First Human Heart Transplant Year - 1967

First successful Open Heart Surgery - 1952 

Penicillin - 1940

sulfa drugs - 1932

First Electrocardiogram 1903

Back to TuskegeeBack 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 1920’s 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 study’s 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 didn’t 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 people’s 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 Principlesof 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 outcryEven 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 ApologyThe 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 Why do you think nobody saw a connection between Nuremberg connection between Nuremberg and the Tuskegee Syphilis and the Tuskegee Syphilis Study?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 …

1923 - 1952 Piaget

describes stages of

cognitive development

First T

est T

ube Bab

y Born

197

8

First Human Heart Transplant Year - 1967

First successful Open Heart Surgery - 1952 

Penicillin - 1940

sulfa drugs - 1932

First Electrocardiogram 1903

Back to the Future!

choices have consequences

Now it’s your turn - Now it’s your turn - how will YOU choosehow 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.).

David at Frogstone for the image Femme used in backdrop.

The Faces of Tuskegee website at MSU.