Tuskegee Syphilis Study

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

Health Policy and Management

MPH 525

Abigail Smith

December 2012 The Tuskegee Syphilis Study was a medical study that occurred in Tuskegee, Alabama which dealt with monitoring African-American subjects to discover the effects of untreated syphilis. The main goal of the study was to seek out African-American males in the second stage of syphilis, and then to sporadically perform exams on these men to determine the effects that syphilis had on their bodies. The test subjects were told that they were receiving medical treatment for “bad blood,” but in reality, they never received penicillin, which was the most effective treatment for syphilis (The Tuskegee syphilis study, 2010).

After 40 years of this race-based experiment, the story broke nationwide, and for the first time the test subjects realized that they had been involved in this experiment and that they had not received treatment. By this time, many of the participants had died, but a group of survivors led by Charlie Pollard began to gather information to put together a law suit against the doctors who performed the medical experiment and the federal government who had financially supported the project. Fred D. Gray was the lawyer who represented the participants of the study. In 1973, the lawsuit ended in victory for the participants and they were collectively awarded $10 million to split between the living syphilitics and families of the deceased. In 1997,

President Bill Clinton formally apologized for the terrible injustice done to these African-

American men, but only seven of them were alive to witness it (The Tuskegee syphilis study,

2010).

The study began in 1932, when word spread throughout Macon County that government doctors were going to provide free exams to start a new health program. Out of the 3,684 African

Americans tested, 1,468 cases of syphilis were found, and that number was narrowed down to

408 subjects for the test. These men were told they had “bad blood,” and they were offered free medical care and treatments. Although the main purpose of the study was to discover the effects

2 of untreated syphilis, the doctors continued to lead the participants to believe that they were receiving treatment for “bad blood” (The Tuskegee syphilis study, 2010).

In the second phase of the experiments, a control group of 200 men was added as a comparison to the syphilitics. These men were also not informed about the basis of the study, but instead were told that they would be receiving free treatment from government doctors. Both the syphilitic group and the control group were not to receive any medication or treatment of any kind from local hospitals or doctors. Their names were put onto lists given to local hospitals, and they were told not to treat the patients. Instead, the participants had to schedule appointments with the government doctors, and while they were told they were receiving penicillin, in actuality they were just receiving aspirin or other ineffective means of treatment.

During this period, many of the participants began to die because of the effects of untreated syphilis, and autopsies were performed by doctors without permission from the deceased (The

Tuskegee syphilis study, 2010).

The final phase of the study occurred from 1965 to 1972, and the end of the experiment was in sight. Over two-thirds of the original participants were deceased, and the other 200 were very difficult to locate. The climate of race relations had also changed, and many of the people involved in the study were beginning to reexamine the morality of the study. Even with these differenced and difficulties, the study continued on until the summer of 1972, when the story was revealed nationwide and abruptly stopped. Even with the end of the study and the settlement, the survivors were not satisfied. It was not until May 16, 1997 when President Clinton publicly apologized for the harmful and prejudice injustices that the government had committed against the participants of the study. Only seven survivors were alive to hear the apology, but it still represented closure for them (A Hard Lesson Learned, 1998). 2 3

In the 25 years since the details of this study were first revealed, the study has become a powerful symbol of racism in medicine, ethical misconduct in human research, and government abuse of the vulnerable. According to some physicians, lust and immorality, unstable families, and reversion to barbaric tendencies made African Americans especially prone to venereal diseases. One doctor estimated that over 50 percent of all African Americans over the age of twenty-five were syphilitic. Virtually free of disease as slaves, they were now overwhelmed by it, according to informed medical opinion. Moreover, doctors believed that treatment for venereal disease among African Americans was impossible, particularly because in its latent stage the symptoms of syphilis become dormant (Brandt, 2009).

Even the best educated African Americans could not be convinced to seek treatment for syphilis. Venereal disease, according to some doctors, threatened the future of the race. The medical profession attributed the low birth rate among African Americans to the high prevalence of venereal disease which caused stillbirths and miscarriages. Moreover, the high rates of syphilis were thought to lead to increased insanity and crime. One doctor writing at the turn of the century estimated that the number of insane African Americans had increased thirteen-fold since the end of the Civil War (Crenner, 2011).

This particular configuration of ideas formed the core of medical opinion concerning

African Americans, sex, and disease in the early twentieth century. Doctors generally discounted socioeconomic explanations of the state of black health, arguing that better medical care could not alter the evolutionary scheme. These assumptions provide the backdrop for examining the

Tuskegee Syphilis Study (Crenner, 2011).

In 1929, under a grant from the Julius Rosenwald Fund, the USPHS conducted studies in the rural South to determine the prevalence of syphilis among African Americans and explore the 3 4 possibilities for mass treatment. The USPHS found Macon County, Alabama, in which the town of Tuskegee is located, to have the highest syphilis rate of the six counties surveyed. The

Rosenwald Study concluded that mass treatment could be successfully implemented among rural blacks. Although it is doubtful that the necessary funds would have been allocated even in the best economic conditions, after the economy collapsed in 1929 the findings were ignored. It is, however, ironic that the Tuskegee Study came to be based on findings of the Rosenwald Study that demonstrated the possibilities of mass treatment (Brandt, 2009).

Three years later, in 1932, Dr. Taliaferro Clark, Chief of the USPHS Venereal Disease

Division and author of the Rosenwald Study report decided that conditions in Macon County merited renewed attention. Clark believed the high prevalence of syphilis offered an unusual opportunity for observation. From its beginning, the USPHS regarded the Tuskegee Study as a classic study in nature, rather than an experiment. As long as syphilis was so prevalent in

Macon and most of the African Americans went untreated throughout life; it seemed only natural to Clark that it would be valuable to observe the consequences. He described it as a “ready-made situation" (Brandt, 2009).

Although no formal protocol appears to have been written, several letters of Clark and

Cumming suggest what the USPHS hoped to find. Clark indicated that it would be important to see how disease affected the daily lives of the men. It also seems that the USPHS believed the experiment might demonstrate that anti-syphilitic treatment was unnecessary. As Cumming noted, "It is expected the results of this study may have a marked bearing on the treatment, or conversely the non-necessity of treatment, of cases of latent syphilis." The immediate source of

Cumming's hypothesis appears to have been the famous Oslo Study of untreated syphilis

(Brandt, 2009). 4 5

The doctors who devised and directed the Tuskegee Study accepted the mainstream assumptions regarding African Americans and venereal disease. The premise that African

Americans would not seek or continue treatment shaped the study. A test of untreated syphilis seemed natural because the USPHS presumed the men would never be treated; the Tuskegee

Study made that a self-fulfilling prophecy (Crenner, 2011).

When the USPHS evaluated the status of the study in the 1960s they continued to rationalize the racial aspects of the experiment. For example, the minutes of a 1965 meeting at the Center for Disease Control recorded included statements such as "Racial issue was mentioned briefly. Any questions can be handled by saying these people were at the point that therapy would no longer help them. They are getting better medical care than they would under any other circumstances” (Brandt, 2009).

A group of physicians met again at the CDC in 1969 to decide whether or not to terminate the study. Although one doctor argued that the study should be stopped and the men treated, the consensus was to continue. A memo prepared by the Assistant Chief of the Venereal

Disease Branch, stated that nothing learned will prevent, find, or cure a single case of infectious syphilis or bring us closer to our basic mission of controlling venereal disease in the United

States. When the first accounts of the experiment appeared in the national press in July 1972, data was still being collected and autopsies performed (Crenner, 2011).

By focusing on the issues of penicillin therapy and informed consent, the final report and the investigation betrayed a basic misunderstanding of the experiment's purposes and design. The report implied that the failure to provide penicillin constituted the study's major ethical misjudgment, implied was the assumption that no adequate therapy existed prior to penicillin.

Nonetheless medical authorities firmly believed in the efficacy of arsenotherapy for treating 5 6 syphilis at the time of the experiment's launch in 1932. The panel further failed to recognize that the entire study had been predicated on non-treatment. Provision of effective medication would have violated the rationale of the experiment, which was to study the natural course of the disease until death. On several occasions, in fact, the USPHS had prevented the men from receiving proper treatment.

One of the most chilling aspects of the experiment was how passionately the USPHS kept these men from receiving treatment. When several nationwide campaigns to eradicate venereal disease came to Macon County, the men were prevented from participating. Even when penicillin was discovered in the 1940s, the first real cure for syphilis, the Tuskegee men were deliberately denied the medication. During World War II, 250 of the men registered for the draft and were consequently ordered to get treatment for syphilis, only to have the USPHS exempt them.

Undeniably, there is no evidence that the USPHS ever considered providing penicillin.

Failure to place the study in a historical context also made it impossible for the investigation to deal with the essentially racist nature of the experiment. The panel treated the study as an irregularity, well-intentioned but misguided. The final report ignored many of the essential ethical issues which the study poses. The Tuskegee Study reveals the persistence of beliefs within the medical profession about the nature of African Americans, sex, and disease. These beliefs had tragic repercussions long after their alleged scientific bases were known to be incorrect. Most strikingly, the entire health of a community was jeopardized by leaving a communicable disease untreated. There can be little doubt that the Tuskegee researchers regarded their subjects as less than human. As a result, the ethical principles of experimenting on human subjects were completely disregarded. 6 7

Obtaining informed consent is a basic ethical obligation for researchers. The process of consent should ensure that potential subjects are provided with information about the research project that is understandable and permits the subject to make an informed and voluntary decision about whether or not to participate. The amount of information and the manner of presentation is generally related to the complexity and risk involved in the research study. While the initial process is prospective and takes place prior to any research activity, consent should also be an ongoing educational interaction between the investigator and the research subject that continues throughout the study. It is not an exercise in persuasion. If an investigator has a relationship with potential subjects, care should be taken to avoid recruitment methods that may be seen as coercive due to the special relationship between parties (Informed Consent, 2008).

Except in certain minimal risk studies, the Informed Consent Document is typically signed after the investigator has verbally explained the purpose and procedures involved in the study, answered questions, and otherwise provided information that permits the subject to make a prospective, informed decision. The Informed Consent Document must be signed before any study data collection procedures begin. The Informed Consent Document itself serves as a written source of information for the subject and documents the fact that the process of consent occurred. Consent is a legal concept. Only legally competent adults can give legally effective informed consent (Informed Consent, 2008).

Minors and those individuals who are not competent to provide consent should be given the opportunity to assent to participate in the research project. Assent is a knowledgeable agreement to participate in the project. Adequate provisions should be made for soliciting the independent, non-coerced assent from minors or cognitively impaired persons who are capable of a knowledgeable agreement. In general, the IRB recommends that children age seven and 7 8 older, and most cognitively impaired adults, be given the opportunity to assent. In cases where assent is obtained from a minor or cognitively impaired subject, permission must also be obtained from a legally authorized representative (Informed Consent, 2008).

Some common problems with the Informed Consent Document include the use of jargon, technical, or scientific terms that a lay person would not understand, and units of measure given in metric rather than the lay equivalents. Ordinary language should replace technical terms. But perhaps the most common problem with Informed Consent Documents is that they are written at a reading level several grades higher than the average subject would understand. Informed

Consent Documents should be written at a reading level that potential subjects would understand.

For most projects, an eighth grade reading level is suggested. Waiver of documentation of consent may mean that no written document is provided to the subject at all (Informed Consent,

2001).

Waiving the requirement for obtaining informed consent or parental permission means that the IRB has determined that investigators do not need obtain the subjects’ informed consent to participate in research. The conditions under which an IRB may waive the requirement for obtaining informed consent or parental permission or may approve a consent procedure that leaves out or alters some or all of the elements of informed consent derive from four sources in the HHS regulations (Informed Consent, 2001).

The informed consent process is designed to inform the human research subjects of, among other things, the risks, rights, and benefits of participation in clinical research studies.

Informed consent, while not always necessary, is a critical component of ethical research involving human subjects. Unless a subject is presented with and understands the various elements of the study through the informed consent process, the subject cannot exercise his or 8 9 her right to make that informed decision to participate in a research study. The challenge of determining whether the subject truly understands the research project and its risks and benefits remains, even when the legal requirements are met. If the informed consent is waived, researchers have the possibility of taking advantage of vulnerable populations as well as possibly violating regulations including the Nuremburg Code and the Belmont Report.

Certain groups of human research participants such as children, prisoners, individuals with questionable capacity to consent, students, or employees of the institution conducting the research are considered to be either relatively or absolutely incapable of protecting their own interests. Because children have not legally attained an age where they can consent on their own to research or treatment, a parent or legal guardian may provide consent for a child to participate in a study. Above the age of seven, the child must also show willingness to participate by assenting to the study. Although many college students are below the age of twenty-one, they are generally treated as emancipated adults for the purpose of consenting to participate in research studies (Wallston, 2012).

The federal regulations state that even immature or mentally incompetent persons must be given the opportunity to choose, to the extent they are able, whether to participate in research. These and other vulnerable persons, however, may participate only if proper safeguards are in place. Regarding pregnant women and prisoners, the FDA and DHHS regulations differ. While the FDA does not address these populations, the DHHS regulations contain mandatory safeguards that must be in place before pregnant women or prisoners may participate in human subject research. For studies that involve greater-than-minimal risk that have a prospect of direct benefit to the subjects, the IRB must find and document that the risk is justified by the 10 anticipated benefit to the subject, and the relation of the anticipated benefit to the risk is at least as favorable to subjects as that presented by available alternative approaches (Smith, 2007).

Without the Informed Consent there to protect these vulnerable populations’ things can quickly go wrong. This is not to say that researchers will do everything they can to ensure they are performing an ethical experiment. I think there still needs to be the Informed Consent to ensure that the participants fully understand what they are signing themselves up for as well as having a copy of what is to be expected throughout the study. This is important to guarantee all participants are prepared for the upcoming events of the study and that they are able to show others to help them make the right decision for themselves.

In 1979, the Belmont Report was issued in the United States. This report summarized the basic ethical principles identified by the National Commission for the Protection of Human

Subjects of Biomedical and Behavioral Research, which was established as a result of the

National Research Act in 1974. Three major principles emerged from the Belmont Report including beneficence, justice, and respect for persons. A human subject is a living individual that an investigator obtains either data through interaction or intervention with the person, or identifiable private information. Each investigator must decide if their study is to include human participants. If human participants are to be involved, the researcher is ethically obligated to become familiar with and adhere to the regulations governing the rights and safety of the human research participants. The Belmont Report also discusses the voluntary nature of informed consent and explains that the information must be complete, understandable, and presented in an unhurried fashion. Importantly, the investigator is responsible for determining whether the subject really understands this information (Smith, 2007). 10 11

The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the subsequent Nuremberg Trials held at the end of the Second World War. Today, the Nuremberg Code is the most important influence on U.S. law governing human medical research. Even so, marginalized groups have frequently been coerced into studies that violate their right to consent (The Nuremberg Code, 2012).

The first tenet of the code is very clear and states that the voluntary consent of the human subject is absolutely essential. The code goes on to state that the experiment should yield fruitful results for the good of society, should be designed and based on the results of animal experimentation and a knowledge of the natural history of the disease, should be conducted as to avoid all unnecessary physical and mental suffering and injury. As well as including that no experiment should be conducted where there is a reason to believe that death or disabling injury will occur. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment and proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. The experiment should be conducted only by scientifically qualified persons and during the course of the experiment the human subject should be at liberty to bring the experiment to an end. Lastly, during the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject (The Nuremberg Code, 2012).

Waiving the Informed Consent I do not see as ethically acceptable or responsible. It is important to lay everything out for those willing to participate to ensure they make the right 11 12 decision. In there is no informed consent participants may begin to feel more like lab animals with no rights of their own. I think it is also important for participants of studies to have a copy of the informed consent so they know what exactly they have signed and in what type of research they have agreed to participate. 12 13

References

A hard lesson learned: the Tuskegee syphilis study. (1998). Newsmine.org. http://newsmine.org/content.php?ol=deceptions/experimentation/tuskegee/tuskegee- syphilis-study-timeline.txt.

Brandt, A.M. (2009). Racism and research: the case of the Tuskegee syphilis study. http://sociology101.net/readings/Racism-And-Research.pdf.

Crenner, C. (2011). The Tuskegee syphilis study and the scientific concept of racial nervous resistance. J. Hist Med Allied Sci. 10: 1093.

Informed consent. (2001). U.S. Department of Health and Human Services. http://answers.hhs.gov/ohrp/categories/1566.

Informed consent and related issues. (2008). University of Iowa. http://www.ncope.org/assets/pdfs/InformedConsentInstructions.pdf.

Smith, J.T. (2007). Informed consent, confidentiality, and subject rights in clinical trials. Proc Am Thorac Soc. 4: 2; 189-193.

The Nuremberg Code. (2012). www.emfbioeffects.org/images/ Nuremberg .doc.

The Tuskegee Syphilis Study. (2010). http://www.history.ucsb.edu/faculty/marcuse/classes/33d/projects/medicine/The %20Tuskegee%20Syphilis%20Study.htm.

Wallston, K. (2012). Human protection for research teams. National Institutes for Health. http://cme.nci.nih.gov.