{"id":4178,"date":"2021-07-01T14:57:03","date_gmt":"2021-07-01T13:57:03","guid":{"rendered":"https:\/\/blogs.bmj.com\/medical-ethics\/?p=4178"},"modified":"2021-07-01T14:59:13","modified_gmt":"2021-07-01T13:59:13","slug":"fda-approves-aducanumab-do-not-get-carried-away","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/","title":{"rendered":"FDA approves aducanumab \u2013 do not get carried away!"},"content":{"rendered":"

By Erik Gustavsson, Pauline Raaschou, Gerd L\u00e4rfars, Lars Sandman, Niklas Juth.<\/p>\n

In spring 2019 Gerd L\u00e4rfars (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<\/a>, the first disease-modifying drug that targets Alzheimer’s disease.<\/p>\n

Alzheimer\u2019s 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<\/a> 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\u2019s disease remain reliable. Hence, tests will may inform patient they will develop Alzheimer\u2019s disease, when they will not, and vice versa. This causes unnecessary worries and unnecessary treatments as well as infringements on people\u2019s autonomy.<\/p>\n

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,<\/strong> a broad introduction of aducanumab \u2013 especially in cases where early detection of the disease is attempted \u2013 do not bring about the benefits necessary to justify these ethical costs.<\/p>\n

Title of paper: <\/strong>Novel drug candidates targeting Alzheimer\u2019s disease \u2013 ethical challenges with identifying the relevant patient population<\/a><\/p>\n

Authors<\/strong>: Erik Gustavsson [1, 2], Pauline Raaschou [3], Gerd L\u00e4rfars [4], Lars Sandman [2] & Niklas Juth [5].<\/p>\n

    \n
  1. Centre for Applied Ethics, Department of Culture and Society; Link\u00f6ping University, Sweden.<\/li>\n
  2. The National Centre for Priorities in Health, Department of Health, Medicine and Caring Sciences, Link\u00f6ping University, Sweden.<\/li>\n
  3. Clinical Pharmacology Unit, Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.<\/li>\n
  4. Health and Medical Care Administration, Region Stockholm, Stockholm, Sweden<\/li>\n
  5. LIME, Stockholm Centre for Healthcare Ethics, Karolinska Institutet, Stockholm, Sweden.<\/li>\n<\/ol>\n

    \u00a0<\/strong>Competing interests:<\/strong> None declare<\/p>\n

     <\/p>\n

     <\/p>\n","protected":false},"excerpt":{"rendered":"

    By Erik Gustavsson, Pauline Raaschou, Gerd L\u00e4rfars, Lars Sandman, Niklas Juth. In spring 2019 Gerd L\u00e4rfars (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 […]<\/p>\n

    Read More…<\/a><\/p>\n","protected":false},"author":353,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[8081,8083,8057],"tags":[],"class_list":["post-4178","post","type-post","status-publish","format-standard","hentry","category-dementia","category-drug-policy","category-medical-ethics"],"yoast_head":"\nFDA approves aducanumab \u2013 do not get carried away! - Journal of Medical Ethics blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA approves aducanumab \u2013 do not get carried away! - Journal of Medical Ethics blog\" \/>\n<meta property=\"og:description\" content=\"By Erik Gustavsson, Pauline Raaschou, Gerd L\u00e4rfars, Lars Sandman, Niklas Juth. In spring 2019 Gerd L\u00e4rfars (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 [...]Read More...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/\" \/>\n<meta property=\"og:site_name\" content=\"Journal of Medical Ethics blog\" \/>\n<meta property=\"article:published_time\" content=\"2021-07-01T13:57:03+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-07-01T13:59:13+00:00\" \/>\n<meta name=\"author\" content=\"Mike King\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mike King\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2021\\\/07\\\/01\\\/fda-approves-aducanumab-do-not-get-carried-away\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2021\\\/07\\\/01\\\/fda-approves-aducanumab-do-not-get-carried-away\\\/\"},\"author\":{\"name\":\"Mike King\",\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/#\\\/schema\\\/person\\\/b107957622bc42b2097d15e5e02a112c\"},\"headline\":\"FDA approves aducanumab \u2013 do not get carried away!\",\"datePublished\":\"2021-07-01T13:57:03+00:00\",\"dateModified\":\"2021-07-01T13:59:13+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2021\\\/07\\\/01\\\/fda-approves-aducanumab-do-not-get-carried-away\\\/\"},\"wordCount\":435,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/#organization\"},\"articleSection\":[\"Dementia\",\"Drug policy\",\"Medical ethics\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2021\\\/07\\\/01\\\/fda-approves-aducanumab-do-not-get-carried-away\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2021\\\/07\\\/01\\\/fda-approves-aducanumab-do-not-get-carried-away\\\/\",\"url\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2021\\\/07\\\/01\\\/fda-approves-aducanumab-do-not-get-carried-away\\\/\",\"name\":\"FDA approves aducanumab \u2013 do not get carried away! - Journal of Medical Ethics blog\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/#website\"},\"datePublished\":\"2021-07-01T13:57:03+00:00\",\"dateModified\":\"2021-07-01T13:59:13+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2021\\\/07\\\/01\\\/fda-approves-aducanumab-do-not-get-carried-away\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2021\\\/07\\\/01\\\/fda-approves-aducanumab-do-not-get-carried-away\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2021\\\/07\\\/01\\\/fda-approves-aducanumab-do-not-get-carried-away\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FDA approves aducanumab \u2013 do not get carried away!\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/#website\",\"url\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/\",\"name\":\"Journal of Medical Ethics blog\",\"description\":\"A blog to discuss the ethics of medicine in its many guises and formats.\",\"publisher\":{\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/#organization\",\"name\":\"Journal of Medical Ethics blog\",\"url\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/files\\\/2026\\\/04\\\/jme-logo.png\",\"contentUrl\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/files\\\/2026\\\/04\\\/jme-logo.png\",\"width\":200,\"height\":50,\"caption\":\"Journal of Medical Ethics blog\"},\"image\":{\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/#\\\/schema\\\/person\\\/b107957622bc42b2097d15e5e02a112c\",\"name\":\"Mike King\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/8caa7ddd85361ccfd46160d9dd41e9ff9aadde6fd8379b80c066d095d69f9f7b?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/8caa7ddd85361ccfd46160d9dd41e9ff9aadde6fd8379b80c066d095d69f9f7b?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/8caa7ddd85361ccfd46160d9dd41e9ff9aadde6fd8379b80c066d095d69f9f7b?s=96&d=mm&r=g\",\"caption\":\"Mike King\"},\"sameAs\":[\"https:\\\/\\\/www.otago.ac.nz\\\/bioethics\\\/people\\\/academic\\\/profile\\\/index.html?id=774\"],\"url\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/author\\\/mking\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"FDA approves aducanumab \u2013 do not get carried away! - Journal of Medical Ethics blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/","og_locale":"en_US","og_type":"article","og_title":"FDA approves aducanumab \u2013 do not get carried away! - Journal of Medical Ethics blog","og_description":"By Erik Gustavsson, Pauline Raaschou, Gerd L\u00e4rfars, Lars Sandman, Niklas Juth. In spring 2019 Gerd L\u00e4rfars (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 [...]Read More...","og_url":"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/","og_site_name":"Journal of Medical Ethics blog","article_published_time":"2021-07-01T13:57:03+00:00","article_modified_time":"2021-07-01T13:59:13+00:00","author":"Mike King","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Mike King","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/#article","isPartOf":{"@id":"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/"},"author":{"name":"Mike King","@id":"https:\/\/blogs.bmj.com\/medical-ethics\/#\/schema\/person\/b107957622bc42b2097d15e5e02a112c"},"headline":"FDA approves aducanumab \u2013 do not get carried away!","datePublished":"2021-07-01T13:57:03+00:00","dateModified":"2021-07-01T13:59:13+00:00","mainEntityOfPage":{"@id":"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/"},"wordCount":435,"commentCount":0,"publisher":{"@id":"https:\/\/blogs.bmj.com\/medical-ethics\/#organization"},"articleSection":["Dementia","Drug policy","Medical ethics"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/","url":"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/","name":"FDA approves aducanumab \u2013 do not get carried away! - Journal of Medical Ethics blog","isPartOf":{"@id":"https:\/\/blogs.bmj.com\/medical-ethics\/#website"},"datePublished":"2021-07-01T13:57:03+00:00","dateModified":"2021-07-01T13:59:13+00:00","breadcrumb":{"@id":"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/blogs.bmj.com\/medical-ethics\/2021\/07\/01\/fda-approves-aducanumab-do-not-get-carried-away\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/blogs.bmj.com\/medical-ethics\/"},{"@type":"ListItem","position":2,"name":"FDA approves aducanumab \u2013 do not get carried away!"}]},{"@type":"WebSite","@id":"https:\/\/blogs.bmj.com\/medical-ethics\/#website","url":"https:\/\/blogs.bmj.com\/medical-ethics\/","name":"Journal of Medical Ethics blog","description":"A blog to discuss the ethics of medicine in its many guises and formats.","publisher":{"@id":"https:\/\/blogs.bmj.com\/medical-ethics\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/blogs.bmj.com\/medical-ethics\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/blogs.bmj.com\/medical-ethics\/#organization","name":"Journal of Medical Ethics blog","url":"https:\/\/blogs.bmj.com\/medical-ethics\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/blogs.bmj.com\/medical-ethics\/#\/schema\/logo\/image\/","url":"https:\/\/blogs.bmj.com\/medical-ethics\/files\/2026\/04\/jme-logo.png","contentUrl":"https:\/\/blogs.bmj.com\/medical-ethics\/files\/2026\/04\/jme-logo.png","width":200,"height":50,"caption":"Journal of Medical Ethics blog"},"image":{"@id":"https:\/\/blogs.bmj.com\/medical-ethics\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/blogs.bmj.com\/medical-ethics\/#\/schema\/person\/b107957622bc42b2097d15e5e02a112c","name":"Mike King","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/8caa7ddd85361ccfd46160d9dd41e9ff9aadde6fd8379b80c066d095d69f9f7b?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/8caa7ddd85361ccfd46160d9dd41e9ff9aadde6fd8379b80c066d095d69f9f7b?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/8caa7ddd85361ccfd46160d9dd41e9ff9aadde6fd8379b80c066d095d69f9f7b?s=96&d=mm&r=g","caption":"Mike King"},"sameAs":["https:\/\/www.otago.ac.nz\/bioethics\/people\/academic\/profile\/index.html?id=774"],"url":"https:\/\/blogs.bmj.com\/medical-ethics\/author\/mking\/"}]}},"_links":{"self":[{"href":"https:\/\/blogs.bmj.com\/medical-ethics\/wp-json\/wp\/v2\/posts\/4178","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.bmj.com\/medical-ethics\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.bmj.com\/medical-ethics\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.bmj.com\/medical-ethics\/wp-json\/wp\/v2\/users\/353"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.bmj.com\/medical-ethics\/wp-json\/wp\/v2\/comments?post=4178"}],"version-history":[{"count":0,"href":"https:\/\/blogs.bmj.com\/medical-ethics\/wp-json\/wp\/v2\/posts\/4178\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.bmj.com\/medical-ethics\/wp-json\/wp\/v2\/media?parent=4178"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.bmj.com\/medical-ethics\/wp-json\/wp\/v2\/categories?post=4178"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.bmj.com\/medical-ethics\/wp-json\/wp\/v2\/tags?post=4178"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}