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email article In June, the FDA approved aducanumab (Aduhelm) to treat patients with Alzheimer s disease using the agency s accelerated approval pathway, despite significant concerns about the evidence regarding the drug s safety and effectiveness. The agency s approval decision contradicted the recommendations of its own advisory committee, which voted overwhelmingly against the evidence presented in support of the drug. Soon after approval, three members of the committee resigned in protest. In his resignation letter, Aaron Kesselheim, MD, JD, MPH, of the Harvard School of Medicine, called the aducanumab decision probably the worst drug approval decision in recent U.S. history. Tia Powell, MD, director of the Montefiore Einstein Center for Bioethics, called the FDA decision a failure of scientific integrity.

Aaron kesselheimMatia powellHarvard school of medicineMontefiore einstein centerHarvard schoolதியா போவல்ஹார்வர்ட் பள்ளி ஆஃப் மருந்துமான்டிஃபியோர் ஐன்ஸ்டீன் மையம்ஹார்வர்ட் பள்ளி