(HealthDay News) — In a position statement published online Nov. 17 in Neurology, the authors address ethical considerations for the use of aducanumab for Alzheimer disease following the recent U.S. Food and Drug Administration approval of the drug without convincing evidence of clinical benefit.
Noting that the FDA based its decision for accelerated approval on the effects of aducanumab on brain ß-amyloid levels as a surrogate marker of reasonably likely clinical benefit, Winston Chiong, M.D., Ph.D., from the University of California at San Francisco, and colleagues examined ethical considerations bearing on the use of aducanumab.
The authors note that based on the ethical principle of beneficence, there are insufficient grounds to warrant offering aducanumab for moderate or advanced dementia due to Alzheimer disease or for patients without biomarker evidence of brain ß-amyloid. Aducanumab will not restore cognitive function or cure Alzheimer disease. The duty of beneficence in patient care may be compromised by potential financial conflicts of interest. Based on the principle of nonmaleficence, neurologists must communicate potential adverse effects and monitoring burdens to patients. Extended discussions may be necessary to assist patients in weighing these burdens. Neurologists also have a responsibility to inform patients and families that the full costs of treatment may not be covered and to discuss potential financial ramifications if treatment is pursued. Because of the lack of racial and ethnic diversity in clinical trials of aducanumab, the informed consent process for members of underrepresented populations should disclose the absence of safety and efficacy data in these groups.
“The purpose of this position statement is to offer ethical guidance on how neurologists can help patients make informed decisions about this treatment,” Chiong said in a statement.
Several authors disclosed financial ties to the biopharmaceutical industry.