Hostname: page-component-8448b6f56d-xtgtn Total loading time: 0 Render date: 2024-04-24T23:07:36.444Z Has data issue: false hasContentIssue false
  • English
  • Français

Patient Requests for Off-Label Bioprediction of Dementia

Published online by Cambridge University Press:  16 September 2016

MATTHEW L. BAUM
Get access Rights & Permissions [Opens in a new window]

Abstract:

In 2012, the FDA approved for the differential diagnosis of Alzheimer’s disease a brain-imaging technology, Amyvid-PET (aka florbetapir-PET), capable of non-invasively estimating the burden of amyloid plaques; this approval for one indication renders the technology a candidate for off-label use for another indication according to a physician’s judgment. What should a physician do if an educated, pro-active, and concerned patient requests off-label use of Amyvid-PET to help her estimate the likelihood that her mild memory complaints are “just normal aging” or are likely to profoundly worsen? I consider reasons that a physician might justify denial of such a request, including concerns of safety, uncertain benefit, and fair resource allocation, but cautiously conclude that there may be certain cases where off-label bioprediction would be permissible.

Keywords

neuroethicsbiomarkersAlzheimers diseaseflorbetapir-PEToff-label use
Type
Articles
Information
Cambridge Quarterly of Healthcare Ethics , Volume 25 , Special Issue 4: Clinical Neuroethics , October 2016 , pp. 686 - 690
Copyright
Copyright © Cambridge University Press 2016 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Notes

1. Johnson, K, Minoshima, S, Bohnen, N, Donohoe, K, Foster, N, Herscovitch, P, et al. Appropriate use criteria for amyloid PET: A report of the amyloid imaging task force, the society of nuclear medicine and molecular imaging, and the Alzheimer’s association. Alzheimer’s & Dementia 2013:1–15.CrossRefGoogle Scholar

2. Chetalat, G, La Joie, R, Villain, N, Perrotin, A, de La Sayette, V, Eustache, F, et al. Amyloid imaging in cognitively normal individuals, at-risk populations and preclinical Alzheimer’s disease. NeuroImage: Clinical 2013;2:356–65.CrossRefGoogle Scholar

3. Hope, T, Savulescu, J, Hendrick, J. Medical Ethics and Law: The Core Curriculum. Philadelphia, PA: Elsevier Health Sciences; 2008.Google ScholarPubMed

4. Roberts, JS, Dunn, L, Rabinovici, G. Amyloid imaging, risk disclosure and Alzheimer’s disease: Ethical and practical issues. Neurodegenerative Disease Management 2013;3(3):219–29.CrossRefGoogle ScholarPubMed

5. Foster, C. Medical Law: A Very Short Introduction. Oxford: Oxford University Press; 2014.Google Scholar

6. See note 4, Roberts et al. 2013.

7. See note 4, Roberts et al. 2013.

8. Pankratz, VS, Roberts, RO, Mielke, MM, Knopman, DS, Jack, CR Jr, Geda, YE, et al. Predicting the risk of mild cognitive impairment in the Mayo Clinic Study of Aging. Neurology 2015 Apr 7;84(14):1433–42. doi:10.1212/WNL.0000000000001437.CrossRefGoogle ScholarPubMed