Cheap Shots and Pricey Propositions: Evidence, Disclosure, and Treatment of Age-Related Macular Degeneration

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Excerpt

Should retinal specialists offer off-label use of a drug (bevacizumab) to treat exudative age-related macular degeneration when another nearly identical product (ranibizumab) has already been approved for the indication? And given that most retinal specialists use bevacizumab to treat their patients with age-related macular degeneration, is it ethical for physicians who prefer one drug to keep their patients “in the dark” about the other?
In their editorial, Klein and Klein1 answer the second question in the negative, and, in so doing, seem to endorse an affirmative answer to the first. Some retinal specialists will likely find their position, which I will call “disclose the controversy,” problematic. Klein and Klein1 argue that the existence of a “ disparity in the way retinal physicians treat their patients” obligates them to inform patients of the controversy. But is controversy itself sufficient grounds for requiring disclosure? How confident are we that the practitioners who favor bevacizumab are providing their patients optimal care? Some ophthalmologists might regard the off-label use of bevacizumab as reckless and inconsistent with the norms of medical practice, which demand adherence to a reliable evidence base. To them, “disclosing the controversy” seems of a species with the suggestion that, because questions surrounding evolution remain unresolved and certain educators are resorting to a sort of “off-label” pedagogy (intelligent design), biology teachers ought to “teach the controversy.”
Without wanting to presume any privileged insight into what is, at its core, a technical debate, I suggest a sort of backdoor approach to the question of disclosure. Rather than looking for answers in (future) results of a National Eye Institute–funded randomized, controlled trial comparing the two drugs, we might look to (present day) assumptions and values that, to this outside observer at least, appear embedded in the design of the study. Together with some rudimentary principles of informed consent, they provide some indication of what clinicians should tell their patients.
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