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Tuesday, May 20, 2014

Translating Preclinical Test Results into “Real World” Consequences

By Jalayne J. Arias, JD, MA



Jalayne J. Arias is the Associate Director of the NeuroEthics Program and Assistant Professional Staff in the Department of Bioethics at the Cleveland Clinic. Ms. Arias’ work incorporates empirical and conceptual projects addressing critical legal and ethical issues inherent in diagnosing, treating, and researching Alzheimer’s disease and other neurodegenerative conditions. Most recently, she served as the principal investigator for the study Stakeholders’ Perspectives on Preclinical Alzheimer’s Diagnosis: Patients, Families and Care Givers. Her recent publication, Confidentiality in preclinical Alzheimer disease studies (Neurology), addresses confidentiality concerns relevant to biomarker testing in Alzheimer’s.



In 2007, Dr. Dubois and co-authors introduced the concept of prodromal Alzheimer’s disease in their Lancet article revising diagnostic criteria. In 2011, the National Institutes of Aging and the Alzheimer’s Association supported a series of papers introducing a new paradigm for diagnostic criteria, including Mild Cognitive Impairment and preclinical Alzheimer’s disease. Both papers and new definitions of Alzheimer’s disease incorporate the discovery of Amyloid beta, a biomarker that purports to indicate disease pathology. The concept of using biomarkers, which are detectible years before a patient begins experiencing symptoms, offers the potential for offering preclinical testing in the clinical context. Yet, as researchers continue to validate biomarkers, little is known about how preclinical test results may affect patients and their families.



The Reveal Studies have examined the potential consequences of disclosing genetic disposition to Alzheimer’s to patients. Results indicated that individuals who learned they were APOE positive were more likely to purchase long-term care insurance. Additionally, an assessment of psychological outcomes resulted in data supporting that there were no long-term psychological consequences for individuals who learned they were APOE positive. Important differences between genetic markers for Alzheimer’s and biomarkers, including amyloid beta, should be acknowledged. First, a genetic disposition indicates a risk factor. Comparatively, a biomarker is purported to indicate active disease process. Whether this distinction will have psychological impacts is not yet know. However, another key difference must be highlighted. Unlike genetic information, biomarkers are not protected under the Genetic Information Non-Discrimination Act. This raises questions about individuals who have or will have biomarker status documented in their medical records. Are there legal mechanisms that protect again discrimination based on biomarker status? Could, or even should, insurers or employers use biomarker status to make decisions regarding employment and insurance eligibility?



While these questions seem premature, given the fact that biomarkers are not currently being used in clinical settings to detect Alzheimer’s at the preclinical state, they are being used in other contexts. A recent task force of the Society of Nuclear Medicine and Molecular Imaging and the Alzheimer’s Association evaluated the appropriate use for Amyloid PET. Their conclusions indicate that Amyloid PET imaging may be appropriate in a sub-population of patients. Additionally, biomarker testing is done in the research context. In some studies, researchers are using biomarker status as an inclusion criterion. Given this, by definition, those enrolled in such studies are biomarker positive, which effectively discloses biomarker status. An initial evaluation of the potential legal protections showed that there are minimal and potentially no federal protections for individuals who are enrolled in these studies. As a result, if biomarker status becomes a part of a research participant’s medical record, which is then disclosed to employers or insurers, there may be adverse consequences for participants without viable recourse.






Arias JJ and Karlawish J (2014)



Additional research is needed in this area, including gaining a better understanding of the legal consequences and protections for individuals who are amyloid positive or positive for other biomarkers that indicate disease pathology. This research should also examine if and how insurers and employers would use this information. Another research question is whether biomarker status should be a factor in determining whether an individual may pose a public safety risk in the future should they continue to remain employed and develop cognitive impairment. For example, should an employer be able to use biomarker status when considering employment decisions for a bus driver or an accountant? While researchers continue to work towards validating biomarkers that purport to indicate active disease pathology, parallel research on the consequences for individuals with positive biomarker status will be imperative.





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Arias, J. (2014). Translating Preclinical Test Results into “Real World” Consequences. The Neuroethics Blog. Retrieved on , from http://www.theneuroethicsblog.com/2014/05/translating-preclinical-test-results.html

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