The Tuskegee Syphilis Study: What It Means to Conduct Unethical Research on Human

The Tuskegee Syphilis Study: What It Means To Conduct Unethical Research On Human

Beings

Dr. Joseph Costa, D.H.Sc., PA-C

Health Policy and Management

MPH 525

Diana Pinney

April 2013 2

Table of Contents

Chapter Page

1. Introduction: The Tuskegee Syphilis Study……………...………………...…...………3

2. How to Study Humans and Current Policies..……...…………………………….…….5

The Nuremburg Code……………………………….………………………….....5

The Belmont Report…………………...………………………………………...... 6

Respect for Persons and Individual Autonomy………….……………………...... 6

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

Justice……….…………………………………………………………….….…...8

Informed Consent……………………………..…………………………..…...... 9

3. The Tuskegee Study from and Ethical Perspective…………….……………….…….10

Why did the Medical Profession Pursue this Study?…….………………………10

What Went Wrong?...... 11

Scenarios in Which Informed Consent is Not Needed...... 13

Waiving Consent for Some Areas of Clinical Investigation……...... 14

4. Summary.………………………………………………………………………..…….17

Recommendations……………………………………………..…………………17

References………………………………………………………………………………..20 3

Chapter 1

Introduction: The Tuskegee Syphilis Study

The Tuskegee Syphilis Study is named after the town and institution in Macon

County, Alabama in which this United States Public Health Service (USPHS) research took place (Tuskegee University, 2013). The actual name given the study when it began in 1932 was the “Tuskegee Study of Untreated Syphilis in the Negro Male” (Centers for

Disease Control [CDC], 2011). Six hundred African American men enrolled in the study.

Of the 600, 399 had syphilis, and 201 controls did not (CDC, 2011).

Syphilis, the disease this study was designed to observe, is a sexually transmitted infection that is passed from contact with sores the bacterial infection causes (US

Department of Health and Human Services [HHS] 2013). Syphilis is easily cured with a dose of penicillin, an antibiotic that was not in use when this study started (Tuskegee

University, 2013).

Alexander Fleming discovered the antibacterial agents of the penicillin mold in

1928 (PBS, 1998). It would not be until 1938 that Fleming would publish his findings

(PBS, 1998). Having seen the effects of bacterial infections during his experience in

World War I, it was Fleming’s goal to allay this danger for the young men on the fronts of World War II (PBS, 1998). United States chemical manufacturers started the mass production and distribution of penicillin in 1943 (PBS, 1998). Penicillin was discovered to be a curative agent for the disease in 1948 (Tuskegee University, 2013).

Perhaps the most egregious aspect of the Tuskegee Syphilis Study is the fact that it continued until November of 1972. The participants were not informed of the benefits of penicillin, nor were they offered the opportunity to leave the study (Tuskegee 4

University, 2013). Jean Heller, a reporter for the Associated Press released a story about a

“study” on African American males in Alabama that was not treating their syphilis, but instead letting them languish with the symptoms and continue to sexually transmit it

(Tuskegee University, 2013). The backlash was great. Six months later and after a federal interagency review, the Tuskegee Syphilis Study was declared “ethically unjustified” and was shut down by Assistant Secretary for Health and Scientific Affairs (Tuskegee

University, 2013).

This perpetration of human rights violations by academic researchers continued without internal censure until it was forcibly ended by the federal government and only after being revealed by the press. 5

Chapter 2

How To Study Humans and Current Policies

There are very specific designs for the use of humans as research participants.

These designs are intended to protect individual rights, and preserve the ethics of science

(National Institutes of Health [NIH], 2011). The overarching idea that encompasses the policies surrounding the use of people as research participants is that humans shall never be used “as means to an end” (NIH, 2011).

This form of study and its governing policies are necessary because human subjects are essential for the progress of science, medicine, and our health. It is for this reason that the relationship between researchers and their participants “should be based on honesty, trust, and respect” (NIH, 2011, p. 3). It is also for this reason that conventions have been put in place governing studies using human subjects.

Two of the most significant and predominant collections of ethics pertaining to biomedical research are the Nuremberg Code and the Belmont Report.

The Nuremberg Code

The unfortunate need for the creation of the Nuremberg Code was instigated by countless human rights violations perpetrated upon individuals residing in Nazi concentration camps during World War II (NIH, 2011). The War Crimes Tribunal at

Nuremberg of December 1946 found that, “‘medical experiments’ were performed on thousands of concentration camp prisoners and included deadly studies and tortures such as injecting people with gasoline and live viruses, immersing people in ice water, and forcing people to ingest poisons” (NIH, 2011, p. 4).

The judges of this trial wrote the verdict in August of 1947. In a section of their 6 decision called “permissible medical experiments” they created 10 “directives for human experimentation.” These directives are collectively called the Nuremberg Code (NIH,

2011). The Nuremberg Code represents “the basic principles that must be observed in order to satisfy moral, ethical, and legal concepts in the conduct of human subject research” (NIH, 2011, p. 5). It is still used today as a model for numerous institutions, projects, and as an internationally shared foundation. The Nuremberg Code also influenced the United States’ first federal policy regarding testing human subjects created at the Clinical Center of the National Institutes of Health (NIH, 2011).

The Belmont Report

The Belmont Report is the HHS’s form of ethics relating to human subjects compiled in the tenuous time following the end of the Tuskegee Syphilis Study (NIH,

2011). In 1974, the National Research Act established the National Commission for the

Protection of Human Subjects of Biomedical and Behavioral Research (HHS, 2013). This commission was given the task of highlighting ethical ideals that would form a standard of behavior surrounding human research subjects (HHS, 2013). This compilation of bioethics would come to be known as the Belmont Report and officially included in

HHS’s policy.

The Belmont report made official and commonplace the bioethical ideas of respect for persons, beneficence, and justice. The final report also references the importance of informed consent and assessment of risks and benefits (HHS, 2013).

Respect For Persons and Individual Autonomy

According to the Belmont Report, there are two aspects of ethics involved when considering respect of persons. These are “first, that individuals should be treated as 7 autonomous agents, and second, that persons with diminished autonomy are entitled to protection” (HHS, 2013).

The concept of individual autonomy was born of Enlightenment humanism and has highly influenced contemporary liberal political philosophy (Stanford Encyclopedia of Philosophy, 2009). In our modern, western tradition, individual autonomy is the basis of ethical considerations. “To be autonomous is to be one's own person, to be directed by considerations, desires, conditions, and characteristics that are not simply imposed externally upon one, but are part of what can somehow be considered one's authentic self” (Stanford Encyclopedia of Philosophy, 2009).

Not all people are able to grasp the concept of individual autonomy. Some individuals may experience “diminished autonomy” depending on one’s cognitive, emotional, physical, or mental state (HHS, 2013). It is for this reason that, out of respect for persons, individuals with diminished autonomy are “in need of extensive protection” which may mean discounting them from research involving human subjects (HHS, 2013).

A necessary component of ethical human subject research is that participation is informed and voluntary, because of the requirement for respect and autonomy. Researchers must confirm the subjects understand the risks and benefits of the study while not influencing their decision to participate in any way (NIH, 2011).

Essentially, the basis of the Belmont Report’s ethical ideal regarding respect for persons is not based simply on the presence of individual autonomy, but also on the absence of oppression.

Beneficence

The root word of beneficence, benefit, assists in its definition because beneficent 8 behavior is displayed with the intent to benefit others (Stanford Encyclopedia of

Philosophy, 2008). This definition links beneficent behavior to understanding the potential risks and benefits to a set of planned actions (NIH, 2011). Principles of beneficence codified by many philosophers can potentially provide a basis for decisions made on what is right, or what is wrong (Stanford Encyclopedia of Philosophy, 2008).

The Belmont Report conveys two ways in which beneficence shall be utilized in scientific studies. The first is “do not harm,” and the second, “maximize possible benefits and minimize possible harms” (NIH, 2011, p. 19).

Beneficence comes into play during the construction of a therapeutic study as members of the scientific community consider what they hope to learn, how they hope to learn it, and how it will potentially benefit their subjects’ health and the health of the greater population. This must all be considered with the great responsibility of upholding individual rights and avoiding unnecessary risks.

Justice

The concept of justice in its application to biomedical research addresses the requirement for participants to “be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research” (NIH, 2011, p. 19).

It is important for investigators to take a step back and attempt to, as objectively as they can, consider why a certain group is being sought out for participation in a study.

The principle of justice is employed when considering if a cohort is aptly suited for the matter of the research or if they are being considered because of proximity, or are poor, or a member of a vulnerable population (NIH, 2011). Research subjects’ participation cannot be coerced or taken advantage of and the potential benefits of the research must be 9 accordingly shared among them.

Informed Consent

Informed consent is not a principle of the Belmont Code, but is an exceedingly important facet of respect for persons, beneficence and justice. Correct procedure of gaining informed consent from a research participant involves information, comprehension, and voluntariness (HHS, 2013).

Information must be provided to the subjects regarding how the study will be undertaken and for what purpose. The subject is provided with the knowledge they may ask any questions or decide to abstain at anytime from the study (HHS, 2013).

The subject (or their third party representative) must also comprehend all of these stipulations in order to act for their own concern (HHS, 2013).

Informed consent also does not end once a participant agrees to be part of a study.

Informed consent is a progression that investigators and participants experience together throughout the course of the study (NIH, 2011).

Informed consent must be documented with a signed form. There are also extra considerations taken into account when considering pregnant women, children, those with diminished autonomy, and incarcerated individuals (NIH, 2011). 10

Chapter 3

The Tuskegee Syphilis Study From an Ethical Perspective

Why did the Medical Profession Pursue This Study?

During the era that saw the inception of the Tuskegee Syphilis Study, Darwin’s theories of evolution had been transcribed to the human race and termed “Social

Darwinism” (Brandt, 2013). African Americans were seen to be increasingly subject to crime, disease, poverty, and therefore to be devolving into primitive ways that would eventually lead to their extinction (Brandt, 2013). There are writings by doctors of this time that predicted tuberculosis and syphilis “will be the end of the negro problem”

Brandt, 2013, p. 3). These attitudes within the medical and anthropological fields were incredibly pervasive and “scientifically” linked to the physicality of African Americans, their religious beliefs (i.e. lack of morality), and their social organization (Brandt, 2013).

These attitudes combined with the high prevalence of syphilis among the African

American population of Macon County, Alabama created an ideal cohort for a study on the possibility of “mass treatment” (Brandt, 2013). It was not necessarily the effects of treatment these scientists desired to understand, though. The late stages of syphilis are often symptomatically quiet. This fact, combined with the opinion of the time that

African Americans would not actually respond to treatment made this cohort perfect for observing the long term effects of untreated syphilis (Brandt, 2013).

The Tuskegee Syphilis Study was also shaped by the “premise that blacks, promiscuous and lustful, would not seek or continue treatment” and that the high prevalence of syphilis in African American males was proof of general immorality and expected apathy in regards to treatment (Brandt, 2013, p. 6). It was also thought that the 11 progression of the disease was different between races and once determined latent, syphilis required less, if any, vigorous treatment (Brandt, 2013). One of the hopes of this study’s findings was that syphilis, once “in remission” did not require any treatment at all and illegitimate, hopeless members of a lesser race were the perfect subjects to watch suffer.

The United States Public Health Service (USPHS) pursued this study design because there was no medical consensus on the need for the treatment of latent syphilis, for which no proven therapy had been found. Syphilis was endemic in many populations and easily transmitted, therefore a major public health issue of the day. The population of

Macon County, Alabama intersected perfectly a potential study’s needs because of the convenient social theories relating to its inherent worth coupled with its high prevalence of syphilis.

It should be noted that while syphilis treatments using arsenic and mercury had their own toxic dangers and were largely ineffective, previous studies (namely, the Oslo

Study) had already proven that up to 30% of untreated syphilis cases suffer dire consequences (Brandt, 2013). At the same time the Tuskegee study was started, the

USPHS supported and published research by “syphilis experts that strongly argued for treating latent syphilis” (Brandt, 2013, p. 5).

What Went Wrong?

The driving hypothesis of the study (that African Americans were apathetic to treatment) was immediately contradicted by the large amounts of people who showed up for treatment, worrying the investigators of the financial solvency of their undertaking and forcing them to pretend as if this study was meant to be therapeutic (Brandt, 2013). 12

Potential enrollees were either sent away without treatment or provided almost ineffectual creams to keep their interest because free care was so highly desired (Brandt,

2013). This was never really a scientific foray into the treatment of syphilis, but more of a

“study in nature” (Brandt 2013, p. 4).

The design of this study is the first thing that went wrong. Collecting ill participants under the guise of receiving care they were never going to obtain is just one of countless ethical missteps that defines the Tuskegee Syphilis Study. The idea that people are never to be used as means to an end was shattered by the form and goals of

The Tuskegee Syphilis Study.

The enrollees were also lied to about what they were being “treated” for. The opinion may have existed among the investigators that participants would not understand anyway, but investigators used local colloquialisms such as ‘bad blood’ to define their malady (CDC, 2011). The participants were not even told what was actually being studied. Even though this study intended to document the effects of syphilis on an untreated individual, it is unclear exactly how many perished from the horrific symptoms of late-stage syphilis. The number is estimated to be between 28 and 100 men, although the effect of the continued transmission of syphilis to sexual partners and to unborn children will never be known (University of Virginia Health System, 1996).

The participants were also targeted for this study because of popular opinion of the state of their cognition and morality. They were essentially taken advantage of. While such international standards such as the Nuremberg Code and the Belmont Report had not yet been compiled, it is still significant that not one aspect of the Tuskegee Syphilis

Study complied with the currently accepted ways to treat human subjects. 13

“Coercion through excessive compensation” is currently prohibited as a part of the

Belmont Code. (NIH, 2011, p. 19) These participants were subtly coerced because they desperately needed what they got in exchange, which were free meals, medical exams, and burial insurance (CDC, 2011).

The idea of beneficence says that all test subjects must know the risks. Not only were these test subjects not treated and continuing to sexually transmit syphilis, but they were also subjected to debilitating tests, such as spinal taps (Brandt, 2013). There was not even a control group until one year into the study. By 1936 this control group helped the investigators to the conclusion that the life expectancy of people with syphilis is 20% less than those without (Brandt, 2013). The participants were also prevented from seeking treatment elsewhere, especially when penicillin became a simple and commonplace treatment for syphilis (Brandt, 2013).

What went wrong is that every aspect of beneficence, informed consent, and justice was obliterated in order to observe how an untreated disease behaves in an undervalued population.

Seemingly everything about this study should be changed; studying the effects of untreated disease is inherently unethical. The policy of informed consent would naturally lead a participant to desire treatment and most likely not voluntarily forgo it. The only way this study could have been conducted in an ethical manner was if the investigators ignorantly studied differences between how each race physically responds to treatment or socially reacts to it.

Scenarios in Which Informed Consent Is Not Needed

In 1996, the federal government waived the need for documented informed 14 consent in emergency situations. When “a strictly limited class of research” related to emergency therapy is required and no legal consent can be completed, an Institutional

Review Board (IRB) may approve research (HHS, 1996). This emergency stipulation is not applicable to pregnant women, children, or prisoners (HHS, 1996). The case,

Canterbury v Spence, created a precedent that informed consent may be waived for

“cases in which it is reasonably believed that disclosure to the patient would pose a serious threat to the patient’s well being” (Hartman and Lang, 1999, p. 53).

Other situations in which informed consent is not required is when research is done in a school setting to test the efficacy of curricula, teaching methods, or testing for achievement (HHS 2009). Food tasting tests or the evaluation of public services also does not require documented informed consent (HHS, 1996).

In general, besides emergency studies, no informed consent is required if a study using humans does not directly affect or augment their current physical state.

Waiving Consent For Some Areas of Clinical Investigation

Though there are many regulations overseeing medical experiments that are based on morality with respect to human beings, unethical studies still take place today. For example, researchers at the University of California, Davis were punished recently not for failing to obtain informed consent, but for conducting their study without the oversight of an IRB (Smith, 2012). Even the Tuskegee Syphilis Study was “widely reported for forty years without evoking any significant protest within the medical community” (Brandt,

2013, p. 13).

Kottow (2003) argues that there still exists “a limited form of paternalism” in clinical research settings that eat away at patients’ autonomy. This is a foreseeable 15 problem. There is a broadly held view that, for participants that are already sick, a doctor knows best (Kottow, 2003). Vulnerable populations are still abused by the medical profession as “unacceptable conditions are offered to destitute populations on the presumption that poverty and lack of education entail the inability to exercise autonomy and make decisions” (Kottow, 2003, p. 565). It is also argued that the use of placebos as a control erases individual autonomy because the potential benefits of participating in the trial are removed (Kottow, 2003).

Foreseeable problems definitely lead to vulnerable populations being taken advantage of especially because of the current shift of investigations being spearheaded by for-profit entities instead of universities (Kottow, 2003). While wanting to trust in the experience and ethical growth of the medical field, it is the author’s opinion that further curtailing of informed consent will only lead to ethical missteps within our borders and outside of them as the oversight of IRBs is diminished.

Something concerning about the idea of waiving consent for some areas of clinical investigation is the ambition of the medical community to research and publish.

The Nuremberg Code did not influence the single-minded and goal-oriented investigators of the Tuskegee Syphilis Study. Why would it influence today a team of US-based biomedical investigators conducting studies in developing nations where population health and health outcomes are poor anyway?

It does not matter that beneficence, informed consent, or justice had not yet been officially defined when the Tuskegee Syphilis Study took place. Basic human decency did not exist in this situation and the pervasive idea that some people are lesser than others still exists today. This is why it is more pragmatic to put one’s trust in a set of 16 morals and ethics than the sometimes flawed and ambitious nature of human conduct. For this reason, it is not ethically acceptable to further erode any aspect of informed consent, even if this process slows down the forward progress of medicine and curative possibilities. 17

Chapter 4

Summary

The Tuskegee Syphilis ‘Study’ was a wholly unethical observation of untreated syphilis in African American males. Participation was coerced and proved detrimental to their health and the surrounding population’s. Backlash from the media outing of this 40- year study incited the creation of the Belmont Code of bioethics, which the study at

Tuskegee violates every aspect of.

One of the main stipulations of the Belmont Code is that of informed consent.

This provision is under pressure to be relaxed by paternalistic ideals still present in the scientific community. Because of past and present erosions of individual autonomy relating to informed consent, and because utmost trust can only be placed in ethics and not the actions of humans, it is the author’s opinion that the present regulations regarding consent and autonomy remain.

Recommendations

When considering recommendations for the future of therapeutic clinical testing using human subjects, the first concept that comes to mind is that of paternalism.

From the Latin, pater, or father, paternalism means to act like a father or treat another as if they were a child. These are two distinct ideas. One represents the idea that

“father knows best,” or know better than you. The other idea, to treat another like a child is, “benevolent, but its means coercive” (Gray, 1999). The overarching idea is that paternalism protects people from their own “harmful” choices.

The concept and presence of paternalism (especially in medicine) is nothing new.

What is new is the era of modern medicine, modern diseases, and with them a negative 18 paternalistic influence on the autonomy of individuals.

Individuals are not absolved of the reason for the presence of paternalism. The way in which many treat their bodies (abuse them and then check them in for a medical tune-up) exacerbates the demand for paternalistic oversight. There may be little need for philosophical discussions surrounding autonomy or informed consent free of paternalistic coercion if every individual was an active advocate for their own health and well-being.

If only.

Official apologies have already been made for the crimes of the Tuskegee

Syphilis Study and retributions paid to survivors and their affected relations. What recommendations are there to make? Recommendations aimed at preventing such human rights violations from being perpetrated upon clinical study participants again.

Recommendations in this vein beg for broad, systemic change and not a policy band-aid.

Suppose our national discourse was augmented. What if “patients” became

“consumers?” The era of engaging in an intimate and advisory relationship with one’s physician is over. We are sitting and eating ourselves to death and thusly the individual has made a seat at the table for paternalistic oversight. If individuals saw themselves as consumers, they would find it more appropriate to advocate for proper treatment, ask questions, become informed, and not be taken advantage of.

The author is not necessarily suggesting that patients as consumers will make everyone healthy and reduce the need for paternalism. The suggestion is that scientific travesties large and small will not occur if the individual is unable to be coerced or misinformed.

It is recommended that vulnerable populations and the population as a whole 19 transform the national discourse from “patients in need of help,” to “consumers in need of information.” With continued oversight by Institutional Review Boards and federal policies, the prevention of the breakdown of individual rights in clinical studies would be more effective. 20

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