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The controversial approval of an Alzheimer's drug reignites the battle over the underlying cause of the disease


The controversial approval of an Alzheimer’s drug reignites the battle over the underlying cause of the disease
Laurie McGinley
© Jessica Rinaldi/Pool/Via Reuters
Marc Archambault, who has early-stage Alzheimer s disease, receives his first dose Wednesday of the newly approved intravenous drug Aduhelm at Butler Hospital in Providence, R.I. (Jessica Rinaldi/Pool/Reuters)
Neurologist Matthew S. Schrag was surprised when he heard the Food and Drug Administration had approved a controversial Alzheimer’s drug. There was scant evidence the treatment worked, in his view.
Even more concerning to Schrag: the FDA’s apparent embrace of a long-debated theory about Alzheimer’s disease, which afflicts more than 6 million Americans. The amyloid hypothesis, which has dominated the field for decades, holds that toxic clumps in the brain, called amyloid beta, are the main driver of the disease and that removing them will slow cognitive decline. ....

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FDA releases fresh details on internal debate over controversial Alzheimer's drug


FDA releases fresh details on internal debate over controversial Alzheimer’s drug
Laurie McGinley
© Jessica Rinaldi/Pool/Via Reuters
Marc Archambault, who has early-stage Alzheimer s disease, receives his first dose Wednesday of the newly approved intravenous drug Aduhelm at Butler Hospital in Providence, R.I. (Jessica Rinaldi/Pool/Reuters)
The Food and Drug Administration on Tuesday released fresh details on why it approved a controversial Alzheimer’s drug in hopes of quelling a fierce debate over whether the agency should have cleared the costly treatment.
But the new information, included in interviews with agency officials and 83 pages of internal documents, might not quiet a furor over the drug Aduhelm that has drawn in Alzheimer’s doctors and patients, members of Congress, Medicare officials, and the agency itself. ....

United States , White House , District Of Columbia , Peter Stein , Aaron Kesselheim , Janet Woodcock , Matthew Schrag , Marc Archambault , Jamese Galvin , Ri Jessica Rinaldi , Patrizia Cavazzoni , Drug Administration On , Office Of New Drugs , Vanderbilt University Medical Center , University Of Miami , Harvard Medical School , Butler Hospital , Via Reuters Marc Archambault , Drug Administration , New Drugs , Drug Evaluation , President Biden , ஒன்றுபட்டது மாநிலங்களில் , வெள்ளை வீடு , மாவட்டம் ஆஃப் கொலம்பியா , பீட்டர் ஸ்டீன் ,