CASE 16

Eileen Clark

An 82-year-old African American woman with a stroke

Scott Kasner, MD, and Horace DeLisser, MD

University of Pennsylvania School of Medicine, Philadelphia, PA, USA

Educational Objectives

TACCT Domains: 1, 3, 4

Case Summary, Questions and Answers

Mrs. Clark is an 82-year-old African American woman with hypertension who collapses at home with right-sided weakness and inability to speak. Her family initially put her in bed and tried to get her to take her blood pressure medications, but she was unable to swallow. When she did not improve after several hours, emergency medical services was called and she was transported to the Emergency Department (ED). In the ED, an acute stroke is strongly suspected, although the initial CT scan was normal. The stroke team is called and agrees with the diagnosis of a probable acute stroke, but determines that too much time (>8 hours) has elapsed for her to receive thrombolytic therapy. Dr. Stuart Kottler, the head of the stroke team, is currently an investigator in a clinical trial to assess the efficacy of a potential new stroke medication. He approaches the patient’s 55-year-old son and four grandchildren, saying, “It is too late for standard therapy, but she may be eligible to participate in a research study using a new medication. Unlike standard therapy, this medication can be used for up to 12 hours after a stroke. Timing is critical, though, so we do not have much more time to make a decision.”

The son responds, “Why do you want to treat my mother like a guinea pig? What are you really going to do to help her?”

1 What would be an appropriate response to this question?

Most Americans, regardless of their race or ethnicity, are typically hesitant about participating in a research study or using an experimental medication because of a concern that things might not be done in their best interest or for their well-being. These fears may be more pronounced in Blacks, because of the well-documented abuse that occurred in the Tuskegee Syphilis Study, which has had a tremendous impact on the collective psyche of a large number of African Americans. It has led to an undercurrent of suspicion toward medicine in general, and biomedical research in particular, and has been one of the factors that has hampered the recruitment of African Americans into clinical trials, particularly those involving HIV and AIDS. The underrepresentation of blacks in these studies, in turn, may contribute to health-related disparities, since the results may not be generalizable to understudied populations who do not have access to novel therapies. These cultural dynamics need to be kept in mind as physicians seek consent, not just for a clinical trial, but for any medical intervention. Given the various governmental responses to address the abuses of the Tuskegee study, some clinicians may believe that this study should be viewed as a sad historical occurrence that is no longer relevant. However, the data pointing to undertreatment and the evidence of institutional racism mean fear of exploitation and abuse will continue to be issues of concern for a significant number of patients from minority communities.

With these issues in mind, the goal is to obtain informed consent in a way that accurately represents the trial without using coercive or manipulative language. Respect, patience, truthfulness, and a genuine effort to listen and respond to patients’ concerns will go a long way to ensuring a good outcome when issues of race may be part of the dynamic. Further, it is important to avoid responding with anger or defensiveness if the motivations of the physicians or institution are questioned. It is also helpful to stress that the patient will receive the best possible care regardless of the decision that is made. It is useful to recognize that patients and their families appreciate hearing, in plain language, the benefits rather than a focus on the risk of the treatment or procedure. Lastly, although the goal is to recruit the patient into the research study, if the patient or family declines to participate, they should know that all potential treatment options have been fully considered.

Tuskegee Syphilis Study

The Tuskegee study, a Public Health-sponsored observational study of the effects of untreated syphilis on African American men, is now recognized as one of the saddest and most regrettable enterprises in biomedical research. The study was launched in 1932 at the Tuskegee Institute in Alabama, using African American men with untreated latent syphilis to document the presence or absence of destructive syphilitic lesions. In 1932, standard treatment consisted only of potentially toxic arsenic agents, whose effectiveness was questionable. At the time, it was widely believed that there were racial differences in the natural history of syphilis, supposedly more benign in blacks. This study aimed, in part, to generate data that would challenge that belief and thus support efforts to increase governmental funding of public health efforts targeted at blacks. The study consisted of 399 poor black men with syphilis, along with 201 controls, and was originally designed to last only 6 to 9 months.

The study, however, took on a life of its own and continued until it was terminated in 1973 following its disclosure in the press. By that time, 28 of the men had died directly from syphilis; 100 were dead from associated complications; 40 of their wives had become infected; and 19 of their children had been born with congenital syphilis. Even judged by the standards of the time, the study was problematic on a number of fronts. By labeling their diagnosis as “bad blood,” a term used by black people in the rural south to describe a variety of ailments, study participants were led to believe they had something other than a venereal disease. Potentially coercive incentives such as free physical examinations, food, and transportation were used to induce participation in the study. Lumbar punctures were misrepresented as treatment and were performed without local anesthesia. And although effective antibiotics for the treatment of latent syphilis became available in the 1940s, the syphilitic subjects were not informed of this treatment, and extreme measures were often taken to ensure that they did not receive antibiotic therapy.

The continuance of this study over 40 years was driven by investigators who saw a unique scientific “opportunity” to acquire data, and was enabled by well-meaning, but naïve black health care providers and community institutions. The study also would not have been possible if not for the poverty of Macon county; the lack of adequate health care in the area; and the trusting nature of the community that made these men vulnerable to deception, exploitation, and manipulation. Certainly this kind of research endeavor could only have continued for four decades in the context of societal and institutional racisms that did not acknowledge the humanity of these men.

The knowledge of this study and its abuses has had a profound impact on much of the collective psyche of African Americans and has helped to reinforce distrust and suspicion of physicians and medicine in general. These feelings have been further increased by the widespread misbelief that the Tuskegee men were part of an experiment in which they were injected with syphilis. Discontent and anger around the Tuskegee study has helped to fuel beliefs in the African American community that AIDS is a man-made disease intentionally inflected on blacks for the purpose of genocide. This, in turn, has led to resistance to HIV education programs and other efforts to limit the spread of HIV among African Americans. Knowledge of this study and a resulting fear of abuse have also contributed to unwillingness on the part of many African Americans to participate in clinical trials.

One of Mrs. Clark’s granddaughters then asks, “How do you know if this new drug will work in an elderly African American woman?”

2 What would be an appropriate response to this question?

For these kinds of situations, where there is suspicion or distrust, the most effective approach is one of honesty, openness, and truthfulness. A possible response might be:

“That is an excellent question. To be honest, this drug has only been studied in a relatively small number of people. In these studies, the drug does appear to be safe and potentially effective, but there were very few African American patients enrolled in the studies. This is precisely why we have approached you. Stroke affects people of all ages and races, particularly African Americans, and so we feel it is important that we include patients, such as your mother and grandmother, in these studies. This is the only way to find out if this medication works in general, regardless of things like age, race, or gender.”

As the discussion continues it becomes clear that, although her son is comfortable giving consent, the grandchildren are uncomfortable with her participation in the study.

3 As time is critical, how do you get consensus among family members?

The conversation must begin with a clear and concise description of the patient’s condition and the relevant treatment options that enables real understanding on the part of the family. First, ask the family how they make medical decisions, and second, what is their understanding of what is going on and what options exist. Active listening instead of telling or speaking is more time effective because it affords the clinician the opportunity to query health literacy levels, expectations, and understanding. It is often helpful to reframe the information several times, and then use that understanding to frame the conversation in terms of how the patient had lived her life and the values and beliefs she had. This is particularly important because families in times of medical crises may tend to make decisions in terms of their fears, guilt, grief, anger, etc. Negotiating and affirming the difficulty of handling emotions is as important as the content of the message. So, at this point, Dr. Kottler may have said:

“I need you to first think about who your mother and grandmother was before she had this stroke. And then imagine if she could, in fact, speak for herself. What would she want for herself? What do you think she would say?”

After nearly 45 minutes of discussion with the physicians and among themselves, the family agreed that it would be in the best interest of Mrs. Clark to participate in the trial.

4 Now that you have consent, how do you maintain this rapport with the family?

Having developed rapport and gained some measure of trust (at least enough to obtain consent), it is important to continue to actively build on this relationship between the health care team and the family. Trust is maintained and supported when the communication from the physician to the patient and/or family is goal-oriented and patient-centered, understandable, jargon-free, truthful, honest, timely, and consistent. Communicating effectively in this way will go a long way toward building the kind of trust that helps to prevent conflicts or misunderstandings over care.

References: Case 16

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