'About as true as saying the earth is flat': Alzheimer's expert picks apart Biogen's Aduhelm manuscript – Endpoints News
'About as true as saying the earth is flat': Alzheimer's expert picks apart Biogen's Aduhelm manuscript
'About as true as saying the earth is flat': Alzheimer's expert picks apart Biogen's Aduhelm manuscript
Amber Tong
Senior Editor
Lon Schneider, the University of South California professor who directs the California Alzheimer’s Disease Center, has been one of the most vocal critics of Biogen’s development program for aducanumab. Wary from the beginning, he picked apart the data that Biogen presented along the way and, when the FDA stamped its approval on Aduhelm, was among a group of experts to call for its “accelerated withdrawal” and applauded the CMS’ decision to restrict coverage.
So when Biogen finally published its Phase III results in a journal, you could be sure Schneider would be on it. And he didn’t mince words.
Writing in the Journal of Prevention of Alzheimer’s Disease — the same place where Biogen published the Aduhelm manuscript — Schneider dissected the paper and blasted the central message as “so wrong on many levels.”
The bottom line:
Biogen and the FDA dropped an unfinished, undertested, potentially unsafe product, without evidence of benefit, on a vulnerable American public, as if to say, “We’re done here, you deal with it”.
He is not alone. A host of critics had roasted Biogen’s lengthy delay in publishing its results, its choice of a low-ranking publication the lack of rigorous peer review that should be reserved for data as important and anticipated as these. That’s not to mention the issues with the content of the paper, which some researchers found wanting as it didn’t really grapple with the big questions many had.
Schneider’s editorial — titled “Aducanumab Trials EMERGE But Don’t ENGAGE” in a tongue-in-cheek reference to the names of the Phase III trials — also took time to reflect on just how long it took for Biogen to publish the trial results at all.
“The Emerge (302) and Engage (301) manuscript appears to have been withheld over two years because the Biogen and academic authors would not respond or comply with reviewers and editors,” he wrote, adding later: “Clearly, the authors wanted complete control of their message and not to have to acknowledge the substantial limitations of their trials, outcomes, and inferences they make,” he wrote.
'About as true as saying the earth is flat': Alzheimer's expert picks apart Biogen's Aduhelm manuscript
'About as true as saying the earth is flat': Alzheimer's expert picks apart Biogen's Aduhelm manuscript
Amber Tong
Senior Editor
Lon Schneider, the University of South California professor who directs the California Alzheimer’s Disease Center, has been one of the most vocal critics of Biogen’s development program for aducanumab. Wary from the beginning, he picked apart the data that Biogen presented along the way and, when the FDA stamped its approval on Aduhelm, was among a group of experts to call for its “accelerated withdrawal” and applauded the CMS’ decision to restrict coverage.
So when Biogen finally published its Phase III results in a journal, you could be sure Schneider would be on it. And he didn’t mince words.
Writing in the Journal of Prevention of Alzheimer’s Disease — the same place where Biogen published the Aduhelm manuscript — Schneider dissected the paper and blasted the central message as “so wrong on many levels.”
The bottom line:
Biogen and the FDA dropped an unfinished, undertested, potentially unsafe product, without evidence of benefit, on a vulnerable American public, as if to say, “We’re done here, you deal with it”.
He is not alone. A host of critics had roasted Biogen’s lengthy delay in publishing its results, its choice of a low-ranking publication the lack of rigorous peer review that should be reserved for data as important and anticipated as these. That’s not to mention the issues with the content of the paper, which some researchers found wanting as it didn’t really grapple with the big questions many had.
Schneider’s editorial — titled “Aducanumab Trials EMERGE But Don’t ENGAGE” in a tongue-in-cheek reference to the names of the Phase III trials — also took time to reflect on just how long it took for Biogen to publish the trial results at all.
“The Emerge (302) and Engage (301) manuscript appears to have been withheld over two years because the Biogen and academic authors would not respond or comply with reviewers and editors,” he wrote, adding later: “Clearly, the authors wanted complete control of their message and not to have to acknowledge the substantial limitations of their trials, outcomes, and inferences they make,” he wrote.