While the emergence of biomarkers offers novel possibilities for prevention, diagnosis, and treatment of difficult diseases, both potential advantages and disadvantages of using biomarkers to determine disability are to be determined. Invited panelists from a variety of backgrounds provided their perspectives in a discussion moderated by Sarah Ruiz, associate director of the Office of Research Sciences at the National Institute on Disability, Independent Living, and Rehabilitation Research. This chapter outlines, from an ethical and legal perspective, the potential benefits and harms of using biomarkers and offers suggestions for SSA as it considers using biomarkers for the determination of disease and disability.
With the right supports, Ruiz said, “people with disabilities can participate fully in society. Yet, we know that entrenched ableism and discrimination against people with disabilities is a longstanding challenge and barrier to full participation.” As we consider the legal and ethical implications of the use of biomarkers, she said, it is important to take a holistic, even macro approach in our concerns. Disability is not just about the individual—it can also affect families, communities, and society. During their remarks, panelists covered both the potential harms and benefits of SSA using biomarkers to assist in disability determination.
Jerome Bickenbach, professor of law in the Department of Health Sciences and Medicine at the University of Lucerne, described much of his work with former Soviet countries to move away from a purely medical approach to one that identifies disability as a clear function of the environmental context in which a person lives. In other words, he said, while a medical determination is crucial for a disease diagnosis and prognosis, it often has nothing to do with a disability assessment. In the countries he works with, the goal has become to more fully integrate disability assessment into overall disability policy more seamlessly and regard the individual’s environmental context as a series of assets that can be built to fully include the person in society. For example, you would not assess someone with paraplegia without considering their wheelchair, he said.
Judith Cook, director of the Center on Mental Health Services Research and Policy at the University of Illinois at Chicago, added that the social model of disability asserts that the same types and levels of impairment in different people may or may not be disabling due to a variety of factors. She said that people with high levels of psychiatric symptoms may be able to work their entire lives in a job that provides accommodations and a supportive social environment, so the use of biomarkers to truly predict disability will require biological, environmental, and social factors. Big
data may be helpful in modeling these complex associations, but she cautioned against an oversimplified application of mental illness biomarkers.
Cook added that the use of biomarkers in this determination process could actually increase objectivity and reduce the subjectivity of judgements about whether a person has a disabling mental health condition. Kristi Kirschner, clinical professor at the University of Illinois College of Medicine, highlighted that many chronic fatigue patients live with incredible pain and significant disability, but they lack objective findings, which contributes to their stigma and shame because people often ask if the conditions are real. Kirschner was concerned that biomarkers could exacerbate the disparities between diseases that have objective findings and those that do not, making it more difficult for people to recognize a condition even in the absence of a marker.
Andrew Peterson, assistant professor of philosophy and public policy at George Mason University, shared his research on patients who have experienced traumatic brain injuries resulting in comas and required the use of assessment tools to understand prognosis (Peterson and Bayne, 2018; Peterson et al., 2015, 2020a). More recently, he and his colleagues have explored biomarkers in Alzheimer’s to identify clinical signs of cognitive decline even if a patient has been asymptomatic for years (Largent et al., 2019, 2020). “So how do you tell patients this,” he asked, and added, “What is the right way to disclose this sensitive information?” He said, “biomarkers can be really difficult for patients to process and understand upon exposure.” Clinicians and researchers need to carefully consider the best way to disclose this information (Mozersky et al., 2018; Peterson et al., 2020b), he added. Another consideration he shared, which echoed other panelists, is that biomarkers can be both stigmatizing and empowering at the same time. The relationship between biomarkers and stigma is complex, he emphasized.
A few speakers cautioned about potential harms for using biomarkers. Cook noted that some of the medical conditions discussed are associated with high levels of social stigma, including in hiring and employment. She referenced literature citing concerns of who has access to biomarker information and how that information might be misused (Jurjako et al., 2018; Lakhan et al., 2010; Lehrner and Yehuda, 2014; Rothenberger et al., 2015). There is also controversy in certain illnesses, such as PTSD or major depression, about people exaggerating the effects of mental illnesses on their functional capacity—malingering, she said. She said evidence suggests that the predictive validity of self-perception is important to include in models; Davillas and Pudney (2020) found the effects of biomarkers
as disability predictors dropped by a range of 20 to 40 percent when the person’s self-assessed health was introduced to the model.
Cook noted that it is very difficult to define the level of confidence for a biomarker, and asked who decides when the confidence level is strong enough in disability determination or continuing review. Peterson added that there is a need to acknowledge the risk of being wrong within the biomarker system. Similar to discussions in Chapter 3, Kirschner worried that people may rely too much on biomarkers to learn about the disease and the patient rather than what the biomarker is capable of, especially for people without health insurance or low levels of health literacy.
“Disability is a complex interactive phenomenon that has biological, social, and contextual elements,” said Kirschner. While some patients with disabilities have clear objective findings to document their conditions, disease categories are reductive, she said, and we want to understand the lived experience of the disease in a person. Rosenbaum commented that the definition of disability that SSA has to grapple with requires establishing that there is an impairment that can be named. It also requires proving that impairment prevents an individual from being able to engage in substantial activity. She asked the panelists what considerations SSA may have for both of these issues. Kirschner replied that “in the absence of objective data, we are in the realm of clinical diagnosis, and within the SSA system, there is no lab test or X-ray available,” so she called for embracing the limitations of our knowledge. Lieberman suggested that if someone has a condition that lacks confirmation, yet has clinical credibility, that might be sufficient. He asked if SSA could track longitudinal disease course and outcomes for these types of patients to ensure monitoring, similar to how insurance companies follow people to ensure no fraud is committed.
Bickenbach called attention to the issue of multiple morbidities. Individually certain diseases may not be too bad, but when combined, the sum is greater than the whole of the parts in terms of the overall effect on life, he said. A person may not have a condition or disability that meets the threshold, he said, but they have lives that are unlivable because they are dealing with so many conditions at once. Cook suggested that the use of biomarkers for disability determination needs to occur in the context of an interdisciplinary discussion that includes people with disabilities who can help inform how the intersecting social model of disability and biological model of disability work to influence important life functions.
Finally, Bickenbach noted that the concern in the disability field is
that new technologies and findings in medicine may divert attention from what is actually needed and emphasized that anything being explored should be fit for its purpose. In Europe, there is an increasing focus on integration and a participatory role—understanding what can help people live their lives more fully, he said.
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