Agency Inappropriately Collaborated With Biogen, Approved Unproven Alzheimer’s Treatment
WASHINGTON, D.C. — Top U.S. Food and Drug Administration (FDA) officials responsible for the reckless approval of aducanumab for Alzheimer’s, including Acting Commissioner Janet Woodcock, should immediately resign, Public Citizen said in a letter to U.S. Department of Health and Human Services Secretary Xavier Becerra.
Last week, the FDA announced its approval of aducanumab for treatment of Alzheimer’s disease despite the nearly unanimous conclusion of an independent advisory panel of experts that there was insufficient evidence that the drug was effective and following an inappropriate and unprecedented collaboration between the agency and Biogen during the data analysis stage of key clinical trials.
Public Citizen contends that the FDA should have rejected the drug and required that the company conduct another large, placebo-controlled clinical trial before giving any further consideration to approving aducanumab to treat Alzheimer’s disease. Approving aducanumab despite the lack of evidence of effectiveness has raised false hope for millions of Alzheimer’s disease patients and threatens to bankrupt the Medicare program because of the drug’s exorbitant price ($56,000 per year).
Public Citizen’s letter urged Becerra to request the resignations of, or seek the removal of, the three officials most responsible for the decision: Woodcock, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni and CDER’s Office of Neuroscience (ON) Director Billy Dunn.
“The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The sheer recklessness of the FDA’s approval of aducanumab cannot be overstated. This decision is a disastrous blow to the agency’s credibility, public health and the financial sustainability of the Medicare program.”