Biogen Wouldn't Shop for a Friendly Review Would They?
Mar 16, 2022 19:13:01 GMT
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Post by icemandios on Mar 16, 2022 19:13:01 GMT
March 16, 2022 09:29 AM EDTUpdated 02:19 PM Pharma
Updated: Biogen finally publishes PhIII results for Aduhelm as critics chastise low-ranking journal, ‘gentle and unrevealing’ peer review
Zachary Brennan
Senior Editor
Biogen quietly announced at a conference in Spain today that a manuscript of the Phase III results for the company’s controversial Alzheimer’s drug Aduhelm has finally been published in a tiny journal with a conflicted chief editor, almost a year after the drug won its accelerated approval.
The manuscript was published Wednesday in the Journal of Prevention of Alzheimer’s Disease, a spokesperson told Endpoints News, pointing to the release’s link to a company presentation today at the 2022 International Conference on Alzheimer’s and Parkinson’s Diseases.
Baird biotech analyst Brian Skorney noted that considering the impact of the results and how the approval hinges on such data, the journal isn’t exactly a top-flight publication, as the impact factor for this journal is 4.5, whereas JAMA’s impact factor is 56, and the New England Journal of Medicine’s is 91.
“It was a distraction how long it took” to publish, Anton Porsteinsson, director of the University of Rochester Alzheimer’s program told Endpoints. “It’s been a journal that’s been kind of growing within the Alzheimer’s field within last 5 years, but you can’t say its a journal that competes with New England or JAMA or the Lancet.
“I also expect that there will be some conversation about why it took so long and why it might not be in a broader journal,” he added.
What’s more, Paul Aisen, one of the editors in chief of the journal and director of the Alzheimer’s Therapy Research Institute at the University of Southern California, Los Angeles, is a paid Biogen consultant and received almost $40,000 in payments from the company since 2014.
Biogen declined to comment on whether the manuscript had been submitted to other journals prior to this publication.
The data may finally offer researchers and potentially prescribing doctors a better view of how to use Aduhelm and what the safety data show.
Madhav Thambisetty, a senior investigator at NIH’s National Institute on Aging, previously told Endpoints that the published data “will enable clinicians like myself in our decision-making. For instance, it would be important to understand whether the drug accelerated brain atrophy in the clinical trial participants.”
But other experts who read the publication had their doubts. Rob Howard, an old age psychiatrist at University College London, told Endpoints:
“It doesn’t look to me as though this has undergone the rigorous peer review that such an important and controversial study should receive. Where, for example, is discussion of the random faster deterioration of EMERGE placebo participants post protocol amendment 4, identified by the FDA statistician as the most likely explanation for high dose-placebo group differences at that point? Where is a consideration of the potential unblinding linked to ARIA events and the increased MRI monitoring that would have accompanied them, even if they didn’t cause symptoms? These were tricky questions for Biogen that they failed to answer at the FDA and it is noteworthy that reviewers and the Editor didn’t make them answer them as a condition of publication in this journal. This is a shame. Many of us had asked repeatedly that Biogen submit their data to peer reviewed publication. By the looks of things, they have now done so – but the peer review has apparently been so gentle and unrevealing that they might as well not have bothered. Too little and too late to save aducanumab from obscurity now, I fear.”
While announcing the publication, the company also released new data showing that Aduhelm continues to reduce amyloid beta in the brain for two-and-a-half years (FDA’s accelerated approval was based on 1.5 years of data). But still, the company did not offer additional data on whether this reduction in amyloid can slow cognitive decline.
Updated: Biogen finally publishes PhIII results for Aduhelm as critics chastise low-ranking journal, ‘gentle and unrevealing’ peer review
Zachary Brennan
Senior Editor
Biogen quietly announced at a conference in Spain today that a manuscript of the Phase III results for the company’s controversial Alzheimer’s drug Aduhelm has finally been published in a tiny journal with a conflicted chief editor, almost a year after the drug won its accelerated approval.
The manuscript was published Wednesday in the Journal of Prevention of Alzheimer’s Disease, a spokesperson told Endpoints News, pointing to the release’s link to a company presentation today at the 2022 International Conference on Alzheimer’s and Parkinson’s Diseases.
Baird biotech analyst Brian Skorney noted that considering the impact of the results and how the approval hinges on such data, the journal isn’t exactly a top-flight publication, as the impact factor for this journal is 4.5, whereas JAMA’s impact factor is 56, and the New England Journal of Medicine’s is 91.
“It was a distraction how long it took” to publish, Anton Porsteinsson, director of the University of Rochester Alzheimer’s program told Endpoints. “It’s been a journal that’s been kind of growing within the Alzheimer’s field within last 5 years, but you can’t say its a journal that competes with New England or JAMA or the Lancet.
“I also expect that there will be some conversation about why it took so long and why it might not be in a broader journal,” he added.
What’s more, Paul Aisen, one of the editors in chief of the journal and director of the Alzheimer’s Therapy Research Institute at the University of Southern California, Los Angeles, is a paid Biogen consultant and received almost $40,000 in payments from the company since 2014.
Biogen declined to comment on whether the manuscript had been submitted to other journals prior to this publication.
The data may finally offer researchers and potentially prescribing doctors a better view of how to use Aduhelm and what the safety data show.
Madhav Thambisetty, a senior investigator at NIH’s National Institute on Aging, previously told Endpoints that the published data “will enable clinicians like myself in our decision-making. For instance, it would be important to understand whether the drug accelerated brain atrophy in the clinical trial participants.”
But other experts who read the publication had their doubts. Rob Howard, an old age psychiatrist at University College London, told Endpoints:
“It doesn’t look to me as though this has undergone the rigorous peer review that such an important and controversial study should receive. Where, for example, is discussion of the random faster deterioration of EMERGE placebo participants post protocol amendment 4, identified by the FDA statistician as the most likely explanation for high dose-placebo group differences at that point? Where is a consideration of the potential unblinding linked to ARIA events and the increased MRI monitoring that would have accompanied them, even if they didn’t cause symptoms? These were tricky questions for Biogen that they failed to answer at the FDA and it is noteworthy that reviewers and the Editor didn’t make them answer them as a condition of publication in this journal. This is a shame. Many of us had asked repeatedly that Biogen submit their data to peer reviewed publication. By the looks of things, they have now done so – but the peer review has apparently been so gentle and unrevealing that they might as well not have bothered. Too little and too late to save aducanumab from obscurity now, I fear.”
While announcing the publication, the company also released new data showing that Aduhelm continues to reduce amyloid beta in the brain for two-and-a-half years (FDA’s accelerated approval was based on 1.5 years of data). But still, the company did not offer additional data on whether this reduction in amyloid can slow cognitive decline.