Rep. Katie Porter Calls for Investigation Into FDA Approval of Controversial Alzheimer’s Drug

Home Technology Rep. Katie Porter Calls for Investigation Into FDA Approval of Controversial Alzheimer’s Drug
Rep. Katie Porter Calls for Investigation Into FDA Approval of Controversial Alzheimer’s Drug
A nurse holds the hands of a person suffering from Alzheimer’s disease on September 21 2009 at the Les Fontaines retirement home in Lutterbach, France
A nurse holds the hands of a person suffering from Alzheimer’s disease on September 21 2009 at the Les Fontaines retirement home in Lutterbach, France
Photo: Sebastien Bozon/AFP (Getty Images)

Lawmakers are asking questions about the process that led the Food and Drug Administration to approve a controversial drug for Alzheimer’s disease. The latest is House Representative Katie Porter (D-CA), who released an open letter late Tuesday calling for the inspector general of Health and Human Services to investigate the relationship between the FDA and the drug’s makers, Biogen.

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In early June, the FDA approved Biogen’s antibody-based treatment aducanumab for Alzheimer’s. Now marketed as Aduhelm, the drug is given through infusion once a month and is the first ever treatment intended to slow the progression of the incurable, ultimately fatal neurological condition, rather than simply treat its surface symptoms. While hailed by some Alzheimer’s patient groups and organizations, many scientists expressed concerns about the actual effectiveness of Aduhelm long before its approval—concerns that have only gotten louder since.

“Patients should have confidence that their treatment plans are based on science, not cozy relationships between Big Pharma and FDA officials,” Porter said in a tweet announcing her letter.

In November 2020, the FDA assembled an expert panel to review the clinical trial evidence of Adhulem, a step often taken before they weigh in themselves. The experts were unanimous in not recommending the drug for approval (one expert voted uncertain, while the other 10 voted no). At the time, it seemed to doom the drug’s chances, since the FDA seldom disagrees with an advisory committee’s verdict.