FDA approves aducanumab – do not get carried away!

By Erik Gustavsson, Pauline Raaschou, Gerd Lärfars, Lars Sandman, Niklas Juth.

In spring 2019 Gerd Lärfars (head of the pharmaceutical division at the Stockholm Region in Sweden) suggested that we put together an interdisciplinary group consisting of clinicians, medical ethicists, and scholars with experience in health care administration. The aim for this group would be to analyze, from an ethical perspective, new drug candidates targeting Alzheimer disease as some of these drugs were approaching approval. Her surmise turned out to be a very precise prediction. Last week Food and Drug Administration (FDA) approved aducanumab, the first disease-modifying drug that targets Alzheimer’s disease.

Alzheimer’s disease may be devastating for individual patients and their significant others. Therefore, the approval of aducanumab could be interpreted as a step closer to diminish some of this suffering. This is good news. However, while there are several unanswered questions about the effects over time, our paper focuses on the ethical questions that arise from the way in which the relevant population is to be identified. These include the ethical challenges associated with the fact that the test for determining your risk for Alzheimer’s disease remain reliable. Hence, tests will may inform patient they will develop Alzheimer’s disease, when they will not, and vice versa. This causes unnecessary worries and unnecessary treatments as well as infringements on people’s autonomy.

Since the drugs are associated with these potential costs, they should provide significant benefits for their use to be justified. However, there are a number of challenges associated with how to interpret these benefits and who is viewed as a beneficiaries which, we aim to discuss in our next paper. Irrespective of the project undertaken in that next article, our analysis here suggests that, based on what we know today, a broad introduction of aducanumab – especially in cases where early detection of the disease is attempted – do not bring about the benefits necessary to justify these ethical costs.

Title of paper: Novel drug candidates targeting Alzheimer’s disease – ethical challenges with identifying the relevant patient population

Authors: Erik Gustavsson [1, 2], Pauline Raaschou [3], Gerd Lärfars [4], Lars Sandman [2] & Niklas Juth [5].

  1. Centre for Applied Ethics, Department of Culture and Society; Linköping University, Sweden.
  2. The National Centre for Priorities in Health, Department of Health, Medicine and Caring Sciences, Linköping University, Sweden.
  3. Clinical Pharmacology Unit, Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
  4. Health and Medical Care Administration, Region Stockholm, Stockholm, Sweden
  5. LIME, Stockholm Centre for Healthcare Ethics, Karolinska Institutet, Stockholm, Sweden.

 Competing interests: None declare



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