Tuskegee Syphilis Study

Jacqulyne Taylor

Concorida University

Health Policy and Management

MPH 525

Dr. Joseph Costa DHSc., PA-C

June 22, 2014

Table of contents

Chapter Page

Introduction………………………………………………………………………………..3

Background………………………………………………………………………………..3

PHS Involvement……………………………………………………………………….....4

Consent…………………………………………………………..………………………..6

Informed Consent……………………………………………………...... 6

Beneficence………………………………………………...……………………………...7

Individual Autonomy……………………………….…………………………………....7

Summary……………………………………………………..…………………………...8

Summary…………………………………………………………………………………8

Review……………………………………………………………………………………9

References

Chapter 1

Introduction

Background

The Tuskegee Syphilis Experimentwas a notorious study conducted by the United States Public Health Service (PHS) from 1932-1972.The experiment exploited the poor and perpetrated racism. The area chosen for the base of the study was in Macon County, Alabama. They sought out to find poor and illiterate black male volunteers offering incentives such as occasional free meals and transportation to the medical center. The study acquired 399 syphilis positive patients and 201 negative patients for the control group. The volunteers were told they had a serious disease called “bad blood”. The participant’s had a substantial expectation that there would be a therapeutic intervention involved in this study. This experiment had no real therapeutic objective or ethical guidelines. One of the main interests of the study was the data collected from the men postmortem. Another aim of the study was to help further research on developing a reliable test for syphilis ("Syphilis Study," 2014).

Throughout the experiment the participants were given occasional physicals that included painful tests and no therapeutic treatments.One of painful tests that was performed on the patients was the spinal tap. To entice the men to show up for this unpleasant procedure the physicians involved in the study sent out a letter that was full of empty promises and stating thatthis was the “Last Chance for Special Free Treatment”. By adding this phrase the hope was to frighten the men into showing up.Throughout the study the participants had been made to believe they were receiving treatment for their conditionbut the sad truth is the majority of men did not. A few men weregiven the treatment of bismuth, and mercury which was given in such small amounts it wasjust for public relations.As time moved on all syphilis treatments werereplaced with “pink medicine” which was just aspirin.In the 1940’s penicillin was found to be the standard treatment for curing syphilis but was never offered to the participants. The lies and deceit continued even to the point that when WWII started PHS made sure the men were not drafted for the war because the Army would have had to treat and cure thisdisease(James, 1981). The experiment finally ended in 1972 due to an exposure by a national media journalist.

PHS involvement

In 1928, the director of medical service for the Julius Rosenwald Fund approached officials in PHS to discuss ways to improve health disparities of black men especially in the south. At the time, the PHS was finishing a study on the frequency of syphilis among blacks in the U.S concentrating in the south. The PHS and the Rosenwald fund worked together to create a program to help treat this underserved population. Due to the high infection rate in Macon County the study looked to concentrate there. Unfortunately this program lost its funding due to the war and was at risk of closing. At the same time, there was a debate occurring among health professionals regarding the biological differences in disease response among different races. Dr. Taliaferro Clark a PHS physician saw an opportunity with the black men in Macon County and suggested the PHS take over the Rosenwald program and changes its focus. Here is a great account of events including PHS involvement courtesy of the Center for Disease Control:
“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.

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.

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 Study ends.” ("The Tuskegee Timeline," 12/2013, para. 8)

Chapter 2

Consent

Informed consent

Informed consent is the process when the patient’s personal physician provides comprehensive pertinent information on the upcoming procedure. This information must be given to a competent patient allowing them the choice to accept or decline the procedure. If the patient is not competent then a legally appointed guardian can stand in place of the patient during the consent meeting. Informed consent was the product of many lawsuits in the early 20th century pertaining to the right of clearly knowing all the information before the procedure occurs. One of the early court proceedings was about women who had a complete ova-hysterectomy while under anesthesia without her knowing beforehand or giving her permission. The judge claimed the doctor had the right to perform the surgery if he saw fit because she never gave him any written limitations before the surgery. This case continued on to the Supermen Court and they ruled in favor of the patient claiming that due to American’s rights it would prohibit a physician to perform any procedure without the permission of the patient. There were several ruling like this in the favor of the patient but it took until the 1950’s to secure the right as a patient to be informed (Millenson, 2012). Informed consent can be tricky so it is important all the information is in lay person’s language and all inclusive of details. In the medical world there is one situation where a person does not have to give informed consent that is in an emergency situation. During an emergency situation if the patient is unable to communicate and their life is in danger informed consent now becomes implied consent. This law is assuming that if the

patient was conscious they would want medical care in an emergency. This law is in effect only when the patient is unconscious and there is no written documentation such as a Do Not Resuscitate order. If the medical staff is made aware of any type of legal written document stating the patient’s wishes, they must follow that document instead of proceeding with implied consent (Consent, n.d.).

Beneficence

Beneficence is the action that is performed for the benefit of another person. Beneficence actions are positive actions that are promoting or improving the situation for others. Beneficence is an important aspect on how physicians deliver care on a daily basis. Physicians have an obligation to help their patients and to not cause harm. A difficult task for health care providers knowing what action will benefit your patient, and which ones would be negative. Not all situations are black and white such as prescribing a medication for pain. The ultimate goal here is to make the patient healthy and independent again but not disrupting individual autonomy ("Beneficence," 2013).

Individual Autonomy

Individual autonomy is the freedom of a rational person to make an informed decision in regards to their healthcare. In nursing there is a strong emphasis in maintain a patient’s individual autonomy and is highly valued. An important value to this in regards to healthcare is that the physician is obligated to not only discuss the procedure with the patient but in order to make an informed decision they must discuss less expensive or less harmful options too. In the past this was not always discussed or reviewed with the patient. Having such as strong emphasis on Individual Autonomy can also limit the healthcare provider’s interventions out of fear. There are occasions where the provider can see that the patient lacks drive and motivation but decides not to address the issue order interventions to circumvent the issues associated with it. An example of this is avoiding detailed nutritional counseling in an obese patient because recommending limiting food can be construed as infringing on personal autonomy (U.S. National Library of Medicine National Institute of Health [NCBI], 2010).

Chapter 3

Summary

This experimental study was a moment in U.S. history that is disgraceful and inhuman. To imagine our government openly taking advantage of sickly illiterate black men and allowing them to die for “research” is just not comprehendible. For over four decades PHS repeatedly denied treatment, performed unnecessary tests, and mislead the participant’s which then affected their families. Many spouses and unborn children contracted syphilis from these men and some of them died too. After the whistle blower journalist printed a national article regarding this unethical study is was shut down by the government. Once all the details were released an important law was later passed in response to this tragedy. The law that was passed was the National Research Act which made National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The guided principal of this law is the ethical principal and guidelines forprotecting human subjects in research studies.

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The other side of this situation is that we all are looking back at this study from a distance times were different back then and racism was alive and in full force. When the social norm is to look at black Americans as a lesser person and not of any worth then it would be more socially acceptable to perform such a study. We perform many similar tests on animals and other sub species every day even in the 20thcentury. Yes, they are animals but don’t the same ethics go for them? Or no because they are a sub species to us and do not have a say. In my opinion there is no difference just because we say it is for the betterment of man does not mean that it is ethical.

Review

What went wrong? The beginning of the original study the participants were gathered under the program of increasing health care access to the poor black people in the south. When the money ran out our government stepped in with the idea of a short term study on the effects of the disease they already had. At the time when PHS took over the study there really was not any proven therapy in the treatment of syphilis but the controversial injection of heavy metals. The study got off on the wrong foot by promising these men treatment for their bad blood and healthcare. In defense of PHS as I said before racism was active in the south and they really believed black men were inferior. I would have been upfront in the beginning explaining to them the disease that they had, the ineffective treatment available and the purpose of the study. After initial testing of the participants the treatment would have been made available to all who needed it. In order to receive the treatment they must sign on to participate in the study until its conclusion. During the study the men would have been educated on transmission of the disease and how to prevent. In terms of the postmortem exam the free burial service would be offered if they would donate their body to science in the event of their death. During the course of the study when penicillin became available I would have offered the treatment to the men andthen changed the study to a smaller scale. The study would follow the men until their natural death logging health issues and events. I do believe Dr. Clark’s original intention was in the name of science but that was lost and replaced with just plain cruelty. In looking at current times informed consent is required in all research projects involving humans except for research that only causes minimal disruption in the person’s life or if the research is for the public benefit and the research could not be conducted without the waiver. This gray area sounds awfully tricky to me because back in the beginning of the Tuskegee study they all thought that it was in the interest of the public to complete this. These types of studies need to be examined closely and monitored frequently for any discrepancies. In science we need studies to grow and learn but there is always a way to perform the study with morals and ethics in the forefront.

References

About the USPHS Syphilis Study. (2014). Retrieved from

James, J. H. (1981). Bad blood: The Tuskeegee syphilis experiment: A tragedy of race and medicine. New York, NY: The Free Press.

Millenson, M. L. (2012). The history of informed consent. Retrieved from _2

The Principle of Beneficence in Applied Ethics. (2013). Retrieved from

The emergency exception. (n.d.). Retrieved from

U.S. National Library of Medicine National Institute of Health. (2010). Supporting Patient Autonomy: The Importance of Clinical-patient Relationships. Retrieved from

U.S. Public Health Service Syphilis Study at Tuskegee. (12/2013). Retrieved from