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Detailed text transcripts for TV channel - CNN - 20210611:17:36:00

Causing substantial side effects, 20% to 30% of people given the dose of drug that s been recommended developed swelling or small hemorrhages in the brain. this is not trivial. and so we re the cost of this is huge and our efforts, i believe, would be better spent trying to either prove that this thing works, this drug, or developing a different drug that works more effectively, and safer. dr. joel perlmutter, thank you very much for sharing your expertise with us, i appreciate you taking the time today. thank you very much. moments ago the royals arriving for this event with the g-7 leaders. there s the queen, the prince is there too. we re waiting for president biden to arrive at the dinner. and so stay with us. you re watching cnn. meantime, harassing phone calls, emails, texts, chilling death threats, it has been months since president biden s ....

Side Effects , Joel Perlmutter , Nothing Works , Joe Biden , E Mails , Death Threats , Phone Calls ,

Detailed text transcripts for TV channel - CNN - 20210611:17:31:00

Committee. three members have resigned in protest. they say clinical trials of this first new treatment in decades showed it was ineffective in treating the disease. dr. joel perlmutter is one of those former advisers, a neurologist at washington university in st. louis. i appreciate you taking the time today, doctor, why did you resign from this committee? well, i thought this decision by the fda was really quite egregious. we had reviewed all of the data for clinical benefit and ten of 11 of us thought the data did not indicate benefit, clinical benefit. one was uncertain. nobody thought on this committee that this drug had clinical benefit. and then what happened is the fda used what they call accelerated approval. they changed what they used as a measure of benefit. instead of saying clinical benefit they thought there was ....

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Two members of U.S. FDA advisory panel resign over Alzheimer's drug approval | WSAU News/Talk 550 AM · 99.9 FM


By Syndicated Content
By Deena Beasley
(Reuters) – Two members of a panel of outside advisors to the U.S. Food and Drug Administration have resigned in protest at the agency’s decision to approve Biogen Inc’s Aduhelm for treatment of Alzheimer’s disease despite the committee’s recommendation against doing so.
Mayo Clinic neurologist Dr. David Knopman, a panel member who had been recused from the advisors’ November meeting to review the drug because he was an investigator in clinical trials of Biogen’s drug, said he resigned on Wednesday.
“I was very disappointed at how the advisory committee input was treated by the FDA,” Dr. Knopman told Reuters. “I don’t wish to be put in a position like this again.” ....

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FDA adviser resigns over approval of new Alzheimer's drug

FDA adviser resigns over approval of new Alzheimer's drug
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Biogen to begin shipping newly approved Alzheimer's treatment in two weeks

Biogen to begin shipping newly approved Alzheimer's treatment in two weeks
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