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This special issue addresses the legacy of the United States Public Health Service Syphilis Study on health reform, particularly the Affordable Care Act (ACA). The 12 manuscripts cover the history and current practices of ethical abuses affecting American Indians, Latinos, Asian Americans and African Americans in the United States and in one case, internationally. Commentaries and essays include the voice of a daughter of one of the study participants in which we learn of the stigma and maltreatment some of the families experienced and how the study has impacted generations within the families. Consideration is given in one essay to utilizing narrative storytelling with the families to help promote healing.
This article provides the reader a roadmap to the themes that emerged from the collection of articles. These themes include population versus individual consent issues, need for better government oversight in research and health care, the need for overhauling our bioethics training to develop a population level, culturally driven approach to research bioethics. The articles challenge and inform us that some of our assumptions about how the consent process best works to protect racial/ethnic minorities may be merely assumptions and not proven facts. Articles challenge the belief that low participation rates seen in biomedical studies have resulted from the legacy of the USPHS Syphilis Study rather than a confluence of factors rooted in racism, bias and negative treatment. Articles in this special issue challenge the “cultural paranoia” of mistrust and provide insights into how the distrust may serve to lengthen rather than shorten the lives of racial/ethnic minorities who have been used as guinea pigs on more than one occasion. We hope that the guidance offered on the importance of developing a new framework to bioethics can be integrated into the foundation of health care reform.
This year 2012, represents 80 years since the US Public Health Service Study (now CDC) of Untreated Syphilis in African American men. It is also 40 years since the study was stopped thanks to a reporter and it is also the 15th year anniversary of President Clinton’s public apology at the White House to the remaining survivors acknowledging the wrong doing of this study by the federal government to these men and their family. While the study was stopped 40 years ago the egregiousness of the study is often remembered as well as cited as the cause of the low level of participation by African Americans in biomedical research. Some has taken the position that 40 years is a long time and that we need to move on and put what happened at Tuskegee in perspective given the changes mandated by the Belmont report and the checks and balances that are in place through Institutional Review Boards. Yet for many reasons which hopefully this special issue will underscore there are many reasons to not forget and put behind what began 80 years ago as a study of whose initial goal was to understand and develop a treatment for syphilis. Somewhere during the study which continued 40 years, with many of those years being after a treatment was found but denied to the African American participants so that the outcome could become studying the clinical process through to death.
Bioethicist’s and historians such as Susan Reverby even today talk about Tuskegee as a metaphor (Reverby, 2010; Brandt, 1978; Caplan & Annas, 1999; Corbie-Smith, 1999; Corbie-Smith, 1999b; Fairchild & Bayer, 1999) for racism, experimentation, deception by the federal government, paternalism and in general a disvaluing of the lives of African Americans. Dr. Reverby one of the authors in this special issue remind us, “If we only look at what happened in that study as the past, or learn from it in narrow ways, we are in danger of re-creating the thinking that made it possible in the first place” (Reverby, 2010). We conceived of this special issue within that very warning and coupled with the promise of President Clinton’s apology in which he committed the federal government to make sure that such a study as the Syphilis Study at Tuskegee should never happen again.
This special issue of Ethics and Behavior represents a set of manuscripts that are well poised to make a significant contribution to increasing the understanding of researchers, policy makers, medical school and public health educators of the powerful role that a population based, community oriented, research bioethics can play in transforming health care reform, health research and public health services for the elimination of health disparities in racial and ethnic minorities. Papers in this special issue such as those of former Surgeon General Jocelyn Elders, President of Morehouse School of Medicine, John Maupin and Director of the Tuskegee National Center for Bioethics in Research and Health Care, Rueben Warren point out, while the United States Public Health Service Study of Syphilis in African American men was egregious, there is hope that the lessons which keep unfolding as we move further out from the conduct of the study, can be a driver in health care reform (Elders, 2012; Maupin & Warren, 2012; Warren, Williams & Wilson, 2012). Former Surgeon General Joceyln Elders expresses so passionately in her commentary her hope that the Patient Protection Affordable Care Act will provide healthcare regardless of skin color, economic status or sexual orientation but cautions that we must learn from the past in order not to make the same mistakes (Elders, 2012). Similarly former Surgeon General Satcher (2012) in his commentary encourages that we must remain vigilant going forward to ensure that we will not lose ground. His words are particularly poignant as he was at the Presidential Apology and as the people’s doctor actively worked to ensure that the Apology would take place. In many of the papers they cite Dr. Satcher’s work as evidence of the widening disparity gap in the health of African Americans which he urges must be addressed.
One of the most pervasive themes throughout all of the papers is how far we must still go in educating ourselves and instituting a different approach to bioethics training in order to ensure benefit of research and medical care for racial/ethnic minorities. The papers are rich in their ability to teach us about the history as well as the current perspectives and dilemmas faced by racial/ethnic minorities. As you read the papers they each tell a story, helping us to better understand why some racial/ethnic minority populations hesitate to participate in research studies or in the case of the Lee (2012) commentary we learn how within racial/ethnic group cultural rules of relationships and status make it difficult if not impossible for some to say no to requests to participate in research. It is hoped that in reading these papers those responsible for implementing health care reform will take away the lesson that if you build it they, often the most vulnerable may not come despite their need. If the foundation of health care reform does not address training that addresses the metaphors of the Syphilis Study that have left some fearful of accessing care then disparities will still remain with little hope of their elimination.
As 2012 represents the 15th year anniversary of President Clinton’s Apology to the remaining survivors of The Tuskegee Study of Untreated Syphilis in Negro Men, these manuscripts examine whether as we attempt to move forward in health care reform we have sufficiently met the promises of President Clinton to those survivors—that this would never happen again. In this special issue we are driven by questions posed by President Clinton promises in his Apology. Have we produced a research workforce sufficiently trained in the lessons learned from events at Tuskegee so that this will never happen again? Has the federal government met the President’s goal of increasing the number of racial and ethnic minority biomedical researchers as one of the strategies to prevent what happened at Tuskegee from happening again. Has the legacy of what happened at Tuskegee for 40 years served as a reminder to the federal government of its required stewardship of bioethics in its research enterprise such that it will never again value the collection of data in the name of science over the protection of the lives of some of its’ most vulnerable in society, namely poor and uneducated racial and ethnic minorities?.
Sadly we must say that there has been a failure to achieve some of the promises made by President Clinton in his 1997 Apology. The year 2010 saw Head of State Hillary Clinton, Secretary of Health and Human Service Kathleen Sebelius and President Obama apologizing to Guatemalan President Alvaro Colom for newly emerging documentation of a study similar to the US Public Health Tuskegee Syphilis Experiment in African American men that occurred between 1946–1948 by the US Public Health Service, NIH and Pan American Health Sanitary Bureau (WHO) in Guatemalans (McNeil, 2010; Stein, 2010; Presidential Commision for the Study of Bioethical Issues, 2011). The National Institute of Health appointed a panel designed to explore why there are so few African American PI’s who receive NIH funding. This occurred after a publication in Science which included the former acting Director of NIH indicated that regardless of the type of grant mechanism, African Americans were the least likely to be Principal Investigators compared to Whites and other racial/ethnic minority groups (Ginther, 2011) Is any of this relevant to health care reform and the Affordable Care Act. Hopefully the papers in this issue will help readers to understand that while much has been invested in changing the accessibility and affordability of health care services and making sure that research participants are protected we still have a ways to go. However what the papers in this special issue offer is guidance in search of leadership on how to better achieve the goals of PPACA. The papers when taken as a set call for developing research bioethics training that is population-based, culturally driven and has as one of its goals the achievement of optimal health.
This special issue starts with a set of papers driven by the goals of helping to educate all of us about both the history of research and medical care abuses in the past and also policy choices we make today in our research and clinical care enterprises that for some racial/ethnic groups is similar to the Syphilis Study. In the introduction of the Mays, Coles & Cochran (2012) paper it provides a review of studies conducted post 2000 in which data is cited showing that African Americans are still concerned and believe that they will be given experimental medications by their health care providers, that they are more likely to be guinea pigs and that their health care providers do not share information with them about what is going on in terms of their health care (Brown & Topcu, 2003; Corbie-Smith, Thomas, Williams, & Moody-Ayers, 1999; Corbie-Smith, Thomas & St. George, 2002; Green, Partridge, & Fouad, 2000; Katz et al., 2008; Scharff, 2010). These concerns are not unfounded as illustrated in the Unequal Treatment Report (Smedley, Nelson & Stith, 2003). The stunning study by Shulman in which African American and White patients played by actors were given the same set of symptoms of a CVD event but African Americans consistently were given less intensive treatment than Whites supported the fears expressed by African Americans. The IOM Unequal Treatment Report (Smedley, Nelson & Stith, 2002) burst onto the scene gathering several instances of differences in health care services for African Americans (Ayanian et al., 1993; Ayanian, Weissman, Chasen-Taber, & Epstein, 1999; Hannan et al., 1999; Ramsey et al., 1997; Johnson et al., 1993; Canto et al., 2000; Kasiske, London, & Ellison, 1998; Barker-Cummings, McClellan, Soucie & Krisher, 1995; Gaylin, et al., 1993; Todd et al., 2000; Todd, Samaroo, & Hoffman, 1993; Ayanian, Weissman, Chasen-Taber, & Epstein, 1999; Peterson et al., 1997). So before we are too quick to dismiss their concerns as cultural paranoia or to blame the legacy of the USPHS Syphilis Study data supports that such concerns are wise and to act differently may be within the community of African Americans considered to be foolish. If we do not address these concerns whether real or perceived despite access through provisions in the Affordable Care Act African Americans may be reluctant to pursue the opportunities designed to reduce poor health outcomes targeted to their needs.
We learn in the Hodge (2012) article about equally horrendous medical experimentation in the past with Native Americans. Through the inclusion of the history of abuses in research and medical care Native American Indians had similar experiences. What we learn is President Obama issued an Apology to Native American Indians for atrocities that they experienced at the hands of the federal government. Yet few know of this Apology as it is buried, was not carried out at the White House. It has lacked the healing that some have felt that Clinton’s apology brought about for some in the African American community.
The dilemma that Latinos who are classified as undocumented face in being participants in biomedical research is well presented in the Cacari-Stone & Avila article (2012). While this group’s classification allow them to participate in NIH research it does not provide them with the benefit of the population level evidence based findings because they will be excluded at the federal level from the benefits of the Affordable Care Act. They had done a stellar job in this paper in helping us to better understand how policies which allow inclusion and exclusions create inequities and develop for some racial/ethnic groups a sense of being treated differently, unfairly and inequitably. Like with the Hodge paper there is a wealth of examples to help us to understand the abuses and experiences of Latinos as research participants.
A second theme of the papers is the notion of the need for a reexamination of the individual versus the community or population level of informed consent and protection. In the Lee paper (2012) she illustrates well in the case of the Millennium how within the Chinese community research participation can be influenced by hierarchy and status characteristics. A Harvard postdoc sent back to a small village was able to gain an usually high participation rate because of his male learned status at a prestigious American institution. She raises a question for IRB’s as well as researchers to think about how social relations within racial/ethnic minority communities can override true individual consent based on gender and social status norms. This paper challenges our customary thinking that having a member of the person’s racial/ethnic group would increase the quality of the consent process by familiarity, increased comfort in asking questions and greater dialogue about the study before deciding.
We have devoted so little research to empirically assessing racial/ethnic population dynamics in research. Instead we are guided by a number of assumptions about intra and interpersonal relationships that may influence or enhance the consent process. I published an article on ethical training to enhance research participation and indicated that for African American heterosexual, gay and MSM men participating in an HIV study of their sexual and drug behavior, when allowed to choose the gender, race and sexual orientation status of their interviewers the majority of the men chose a heterosexual white female (Mays, 2007). The reason is that she was the least likely to know anyone they knew and hence the likelihood was high that what they shared would not get back into their networks. It was also the case that the quality of the data was enhanced as they felt little in the way of social desirability to either exaggerate or obscure their risk-taking behaviors. Interestingly in this same study they were also given the same opportunity to choose who after the interview and HIV testing would give them their HIV results, they again chose the white female interviewer but in subsequent follow ups if they were HIV positive wanted to talk with an African American male interviewer especially if he too were positive. The Lee (2012) article helps us to understand how our assumptions of the value of race matching to enhance the ethical consent process may not be working as we imagine.
Similarly this theme of population dynamics vs. individual consent is also raised in the Hodge (2012) article. Any researcher conducting research in American Indian tribal groups must understand how sovereignty changes the consent process, the ownership of the research data as well as the IRB review process. As indicated by Hodge a legacy of the USPHS Syphilis Study at Tuskegee is that tribal groups developed their own IRB’s in which studies are reviewed in the context of tribal governance procedures. Permission is granted for research that is beneficial to tribes. Tribes within the context of the review in addition to assessing whether the research is conducted in a manner that benefit outweighs harm, can determine if the research is of value to the tribe, and answers questions that are of value and priority for the tribe’s welfare..
In the Mays (2012) article this theme of the importance of population versus individual factors is discussed within the context of ethnic/racial classification in the design of the research. Research that continues to classify all Blacks together despite their racial/ethnic diversity is not helpful to developing efficacious physical and mental health care and treatment. She provides evidence of when within group diversity is taken into account in areas of race/ethnicity classification, nativity and socioeconomic status it makes a difference in findings (Mays, 2012). If health reform is to be successful taking into account population as well as individual characteristics are necessary.
A third theme in this issue is the need for better government oversight and monitoring of how its policies can negatively affect vulnerable populations in the area of research and medical care. In reading through the papers as a whole most of the injustices cited by the authors were either lack of oversight of internal government research, or promotion of government policies that convey a bias toward racial/ethnic minorities groups that create implicit bias that is carried over into research, care and treatment. Maupin and Warren (2012) as well as the Warren, Williams & Wilson (2012) discuss how the very foundation of our bioethics training and ways of training the next generation of health providers needs overhauling. Both articles call for aspirational changes in which leadership is needed by the federal government. In medical education there have been a number of precedent setting reports such as the Flexner report or the recent Frenk et al (2010) report on transforming health professionals and the health care system that serve as examples of how changes in medical education approaches can benefit the health care system. What the Maupin and Warren papers are calling for is something equally as important in the bioethics training of health care professionals.
Another theme of this issue that both editors thought important in thinking about the legacy of the USPHS Syphilis Study is need to remember the people, the participants and their families. I am of the firm belief that as long as we discuss the USPHS Syphilis Study as a study and leave off that it occurred in African American men we make it easier for it to happen again. We make it more about science, less about the inhumanity of that science. In the commentaries and essays section we start with a powerful reminder of the legacy of the USPHS Syphilis in “Untreated Negro Men” by hearing from the daughter of one of the participants (Head, 2012). Ms. Head’s article entitled, “One Voice” is a powerful voice for researchers to hear and learn that their research can have negative consequences intergenerationally in their participants family. We learn of the stigma that the families experience from their relative being a participant in the USPHS Syphilis Study. The driving force for completing this special issue was my attendance at one of the Tuskegee University National Center for Bioethics in Research and Health Care annual meetings. I was privileged to sit at a table with several of the family members. It was a humbling and powerful experience as I listened to their stories, heard feelings of promises unfulfilled, heard questions and concerns of potential hidden health problems that might emerge in later generations and the uniqueness of their experience which they shared with each other. Their stories are a part of the legacy but researchers particularly those who are not minorities quit listening to their voices in favor of their own experiences of woe and inadequacy in collecting data and say it is the legacy of Tuskegee. There are several articles in this special issue that challenge that the legacy of Tuskegee really accounts for the low participation rate of African Americans in research. Rather it is how bias, discrimination and other acts of inhumanity result in a lack of trust in the stewardship our federal should have in protecting those who participate in research and protecting the civil rights of those who receive health care. The One Voice commentary helps us to understand this. Ms. Heard also helps us to realize that our responsibilities may last beyond the time that participants are in our studies if there is long term consequences. Reverand Dr. Wimberly (2012) in his article has proposed cautiously to employ narrative story telling among the survivor families to promote healing. What we learn from this paper is that there is much that is still needed to address the USPHS Syphilis Study in the families of the African American study participants, a hidden adverse event.. We still have a ways to go to keep President Clinton’s commitment to the survivors and their families. Hopefully these articles can educate us all about the ways forward to complete President Clinton’s promises in time to serve as a foundation in health care reform.