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

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.