Harvard expert quits US FDA panel as furore over Biogen's Alzheimer's drug grows

The Straits Times2021-06-11

WASHINGTON (BLOOMBERG) - A prominent Harvard Medical School professor has resigned from a US Food and Drug Administration advisory panel in protest over the agency's decision to approve Biogen's ...

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Comments

Endlesstory
2021-06-12
Endlesstory
Nicea
Longshot
2021-06-11
Longshot
Nice
GuyNextDoor
2021-06-11
GuyNextDoor
Amazing
CWJ
2021-06-11
CWJ
?
Bryan_lyc
2021-06-11
Bryan_lyc
Cool
Alfred1007
2021-06-11
Alfred1007
Respect! More studies should be conducted before they granted approval..

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He is the third committee member to quit in the wake of the highly controversial approval.\nTwo big trials of the drug produced conflicting results on whether it could slow cognitive decline. The advisory panel voted almost unanimously in November that a single trial wasn't enough to conclude that the drug works.\nBut the FDA granted conditional approval to the drug on Monday (June 7), on the basis that it could remove a bad protein called amyloid from the brain.\nThe decision \"was probably the worst drug approval decision in recent US history,\" Dr Kesselheim said in the letter. \"The agency owes it to the nation to provide a detailed justification\" for going against the advice of the panel, he said.\nDuring the November advisory committee meeting, concerns about the data \"were not given adequate time for discussion\" and the crucial question of whether an Alzheimer's drug should be approved based on amyloid lowering alone \"was specifically excluded from discussion,\" Dr Kesselheim wrote.\nThe doctor also made broader criticisms of the agency, saying it needed to reassess its decision-making process.\nDr Kesselheim is the third member to quit the committee, following Joel Perlmutter from the Washington University School of Medicine and David Knopman from the Mayo Clinic. 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More studies should be conducted before they granted approval..","listText":"Respect! More studies should be conducted before they granted approval..","text":"Respect! More studies should be conducted before they granted approval..","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/181262248","repostId":2142346278,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"EN"}],"isCommentEnd":false,"newsSizeData":{"likeSize":61,"commentSize":17,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.24.2","shortVersion":"4.24.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2142346278"}