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Mayvee
2021-06-11

Must be a subjective type of decision made for the approval hence a resignation took place.

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

WASHINGTON (BLOOMBERG) - A prominent Harvard Medical School professor has resigned from a US Food an

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

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overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nHarvard expert quits US FDA panel as furore over Biogen's Alzheimer's drug grows\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-06-11 08:54 GMT+8&nbsp;&nbsp;&nbsp;<a href=http://www.straitstimes.com/world/united-states/harvard-expert-quits-us-fda-panel-as-furore-over-biogens-alzheimer-drug-grows><strong>The Straits Times</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>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 ...</p>\n\n<a href=\"http://www.straitstimes.com/world/united-states/harvard-expert-quits-us-fda-panel-as-furore-over-biogens-alzheimer-drug-grows\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"BIIB":"渤健公司"},"source_url":"http://www.straitstimes.com/world/united-states/harvard-expert-quits-us-fda-panel-as-furore-over-biogens-alzheimer-drug-grows","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2142346278","content_text":"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 Alzheimer's drug Aduhelm.\nThe doctor, Aaron Kesselheim, announced his departure in a letter to FDA Acting Commissioner Janet Woodcock. 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. Both Dr Perlmutter and Dr Kesselheim voted against the drug, while Dr Knopman was recused from the November hearing as he had already staked out a public position critical of the drug's trial results.\nDr Perlmutter resigned \"due to the FDA approval of aducanumab without further discussion with the advisory panel,\" a spokeswoman for Washington University said in an e-mail.\nDr Knopman's resignation was confirmed by the Mayo Clinic.","news_type":1},"isVote":1,"tweetType":1,"viewCount":153,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"EN","currentLanguage":"EN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":76,"xxTargetLangEnum":"ORIG"},"commentList":[],"hasMoreComment":false,"orderType":2}

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

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