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Drug Approval Sparks Resignation

A member of the US Food and Drug Administration advisory panel that voted against approving the Alzheimer's disease treatment aducanumab has resigned following the agency's decision to approve the drug, according to Stat News.

The approval of aducanumab, Biogen's Aduhelm, was controversial, as whether it was effective is unclear. Biogen terminated trials of the drug after it appeared not to work as expected. But as Time magazine reported in 2019, a re-analysis of the data then suggested to the company that one trial showed that cognitive decline slowed among some Alzheimer's disease patients given the treatment and prompted it to seek FDA approval. FDA officials appeared to be in favor of approving the drug, as Stat News reported last November, but an outside advisory panel was not convinced the drug was effective, as NPR reported then, noting that the agency usually follows the recommendations of its outside advisors.

The agency, though, announced this week that it was approving Aduhelm under its accelerated approval pathway. According to Stat News, the agency had specifically told the panel in the fall that it was not considering accelerated approval and now in a letter to the panel chair says additional discussions later led it to consider that route.

Stat News reports that Washington University in St. Louis' Joel Perlmutter has now resigned from the advisory panel. In an email, Perlmutter tells it that he is stepping down "due to this ruling by the FDA without further discussion with our advisory committee."

The Scan

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.