Third member of US FDA advisory panel resigns over Alzheimer's drug approval
Jun 11, 2021
Washington [US], June 11 : A third member of the US Food and Drug Administration (FDA) expert advisory panel resigned from the body after it approved a controversial Alzheimer's drug named Aduhelm recently.
United States FDA has approved a new drug for Alzheimer's which is the first new medicine against the disease in almost two decades.
"The US Food and Drug Administration on Monday (June 7) approved the use of the experimental drug Aducanumab for early phases of Alzheimer's disease -- despite an FDA advisory committee concluding last year that there is not enough evidence to support the effectiveness of the treatment," the CNN reported.
Nathaniel Weixel in The Hill said that the member of FDA expert panel in his resignation letter which was sent to acting FDA Commissioner Janet Woodcock on Thursday (local time) stated that Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the approval of Biogen's Alzehimer's drug "was probably the worst drug approval decision in recent U.S. history."
FDA approved Aduhelm, over the objections of its 11-member outside advisory panel, which voted nearly unanimously last November not to recommend approval, citing a lack of evidence that the drug is effective.
Ten members voted no, while one voted uncertain, The Hill added.
The agency is not required to follow the group's advice, but the overwhelmingly negative vote made the agency's endorsement a surprise. The decision set off a firestorm of criticism, especially when Biogen announced the price tag would be 56,000 dollars for the treatment course.
A study conducted by the researchers at The Pennsylvania State University finds evidence of sleep-dependent low-frequency (<0.1 Hz) global brain activity in the clearance of Alzheimer's disease-related toxin buildup.
According to researchers, the findings could serve as a potential imaging marker for clinicians in evaluating patients. The research has been published in the open-access journal PLOS Biology by Xiao Liu and colleagues.
This neuronal activity was more strongly linked with cerebrospinal fluid flow in healthy controls than higher-risk groups and patients.
The development of Alzheimer's is believed to be driven by the buildup of the toxic proteins amyloid-b and tau in the brain.
