Skip to main content
Premium Trial:

Request an Annual Quote

Another Resignation

A third member of an outside advisory panel to the US Food and Drug Administration has resigned following the agency's controversial approval of an Alzheimer's disease drug, the Wall Street Journal reports.

The agency announced its approval of aducanumab (Biogen's Aduhelm) last week. Biogen moved forward with seeking FDA approval after it originally halted trials of the drug for not working as hoped -- a re-analysis of one trial indicated that it might slow cognitive decline in some Alzheimer's disease patients, as Time magazine reported. Regulators seemed to support the drug's approval, though the outside advisory panel was less convinced the drug was effective.

Following FDA's announcement it was approving the drug under its accelerated approval pathway, Stat News reported that Washington University in St. Louis' Joel Perlmutter had resigned from the advisory panel.

According to the Journal, the Mayo Clinic's David Knopman and Harvard Medical School's Aaron Kesselheim have also now resigned. It adds that in his resignation letter, Kesselheim said the approval was "based on the debatable premise that the drug's effect on brain amyloid was likely to help patients with Alzheimer's disease," a scenario the panel was not able to discuss.

The Journal adds that Kesselheim further called the approval a "debacle" and said it "will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the healthcare system."

The Scan

Genetic Tests Lead to Potential Prognostic Variants in Dutch Children With Dilated Cardiomyopathy

Researchers in Circulation: Genomic and Precision Medicine found that the presence of pathogenic or likely pathogenic variants was linked to increased risk of death and poorer outcomes in children with pediatric dilated cardiomyopathy.

Fragile X Syndrome Mutations Found With Comprehensive Testing Method

Researchers in Clinical Chemistry found fragile X syndrome expansions and other FMR1 mutations with ties to the intellectual disability condition using a long-range PCR and long-read sequencing approach.

Team Presents Strategy for Speedy Species Detection in Metagenomic Sequence Data

A computational approach presented in PLOS Computational Biology produced fewer false-positive species identifications in simulated and authentic metagenomic sequences.

Genetic Risk Factors for Hypertension Can Help Identify Those at Risk for Cardiovascular Disease

Genetically predicted high blood pressure risk is also associated with increased cardiovascular disease risk, a new JAMA Cardiology study says.