{"id":3422,"date":"2022-01-14T17:52:24","date_gmt":"2022-01-14T17:52:24","guid":{"rendered":"https:\/\/seniorfitness.blog\/?p=3422"},"modified":"2022-07-24T14:38:53","modified_gmt":"2022-07-24T14:38:53","slug":"alzheimer-medicinen-aduhelm-blev-godkendt-via-en-smutvej-i-usa","status":"publish","type":"post","link":"https:\/\/seniorfitness.blog\/?p=3422","title":{"rendered":"Alzheimer-medicinen Aduhelm blev godkendt i USA via en ‘smutvej’"},"content":{"rendered":"

For omkring et halvt \u00e5rs tid siden var det fremme i medierne, at der for f\u00f8rste gang i flere \u00e5r var kommet et potentielt gennembrud i forhold til behandling af Alzheimers sygdom. Jeg skrev ogs\u00e5 et indl\u00e6g<\/a> om det i den forbindelse.<\/p>\n

‘Gennembruddet’ var Aduhelm<\/strong> (aducanumab), som er et monoklonalt antistof, der kan binde aggregater af beta-amolyoid, som i mange tilf\u00e6lde ses i hjernen hos Alzheimers patienter – og h\u00e6mme dets akkumulering.<\/p>\n

Midlet er udviklet af Biogen og fik i juni en betinget godkendelse i USA af FDA (Food and Drug Administration), p\u00e5 baggrund af at det endnu ikke var bevist, at det rent faktisk ogs\u00e5 afhj\u00e6lper symptomer p\u00e5 Alzheimers sygdom.<\/p>\n

Da jeg forleden h\u00f8rte podcasten The Joe Rogan Experience #1756, hvor l\u00e6gen John Abramson var inviteret, blev jeg opm\u00e6rksom p\u00e5, at FDAs godkendelse af Adulhelm rent faktisk var yderst kontroversiel. John Abramson (time tag: 2:09:15 i podcasten) fortalte, at 10 ud af 11 medlemmer i FDAs r\u00e5dgivende kommit\u00e9 stemte for ikke<\/em> at godkende Aduhelm, og at der efterf\u00f8lgende blev lavet en aftale med Biogen om en betinget godkendelse (ved en s\u00e5kaldt accelerated approval pathway<\/em>) uden om kommit\u00e9ens anbefalinger. At godkendelsen kom p\u00e5 plads er m\u00e5ske endnu mere overraskende da der ses markante bivirkninger ved midlet, inklusive \u00f8demer (hos 35% vs hos 3%, der fik placebo) og sm\u00e5 bl\u00f8dninger i hjernen (hos 19% vs hos 7%, der fik placebo), med symptomer som hovedpine, \u00e6ndringer i mental-tilstand, forvirring, opkast og rystelser. Episoden fik 3 medlemmer af FDAs kommit\u00e9 til at tr\u00e6kke sig i protest over beslutningen. If\u00f8lge John Abramson ligger prisen for en behandling med Aduhelm p\u00e5 over $50.000 pr. patient pr. \u00e5r. Biogen har siden reduceret prisen til omkring $28.000. Ikke desto mindre forst\u00e5r man godt, at Biogen meget gerne ville have godkendt det potentielle ‘guld\u00e6g’.<\/p>\n

“There continue to be concerns raised, however, regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the form correspondence process. To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” fungerende FDA direkt\u00f8r, Dr Janet Woodcock (gengivet fra CNN<\/a>).<\/p><\/blockquote>\n

Den fungerende direkt\u00f8r for FDA, Janet Woodcock, har \u00e5bent opfordret til at h\u00e6ndelsesforl\u00f8bet bliver gransket af en uafh\u00e6ngig myndighed. Politikere har til g\u00e6ng\u00e6ld opfordret Woodcock til at tr\u00e6de tilbage som f\u00f8lge af episoden, som dog endnu ikke er blevet fuldt afd\u00e6kket.<\/p>\n

I mellemtiden er Aduhelm blevet godkent af sundhedsmyndighederne i de Forenede Arabiske Emirater, mens EUs EMA (European Medicines Agency) afviste en godkendelse i december 2021.<\/p>\n

Noget tyder p\u00e5, at der et godt stykke vej til et gennembrud for en effektiv behandling af Alzheimers.<\/p>\n

I \u00f8vrigt, hvis man skulle have mod p\u00e5 at l\u00e6se mere om nogle af medicinalindustriens eskapader, s\u00e5 udkommer John Abramsons nyeste bog Sickening<\/a><\/em> den 8. februar 2022.<\/p>\n","protected":false},"excerpt":{"rendered":"

For omkring et halvt \u00e5rs tid siden var det fremme i medierne, at der for f\u00f8rste gang i flere \u00e5r var kommet et potentielt gennembrud […]<\/a><\/p>\n<\/div>","protected":false},"author":1,"featured_media":3430,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[166],"tags":[550,501,31,29],"class_list":["post-3422","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicin","tag-aducanumab","tag-aduhelm","tag-alzheimers","tag-demens"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/seniorfitness.blog\/wp-content\/uploads\/2022\/01\/2022-01-adu.jpg?fit=1280%2C720&ssl=1","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p8lpEz-Tc","jetpack-related-posts":[],"_links":{"self":[{"href":"https:\/\/seniorfitness.blog\/index.php?rest_route=\/wp\/v2\/posts\/3422","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/seniorfitness.blog\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/seniorfitness.blog\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/seniorfitness.blog\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/seniorfitness.blog\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3422"}],"version-history":[{"count":11,"href":"https:\/\/seniorfitness.blog\/index.php?rest_route=\/wp\/v2\/posts\/3422\/revisions"}],"predecessor-version":[{"id":3888,"href":"https:\/\/seniorfitness.blog\/index.php?rest_route=\/wp\/v2\/posts\/3422\/revisions\/3888"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/seniorfitness.blog\/index.php?rest_route=\/wp\/v2\/media\/3430"}],"wp:attachment":[{"href":"https:\/\/seniorfitness.blog\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3422"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/seniorfitness.blog\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3422"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/seniorfitness.blog\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3422"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}