Third Member of FDA Advisory Panel Resigns Over Approval of Alzheimer Drug
By Thomas M. Burton
A prominent Harvard drug researcher on Thursday became the third
member of a Food and Drug Administration advisory committee to
resign over the agency's decision to approve a drug for
Alzheimer's, questioning whether the drug works.
Harvard Medical School professor Aaron S. Kesselheim called the
FDA's approval of the Biogen Inc. drug Aduhelm "probably the worst
drug approval decision in recent U.S. history."
The outside advisory committee that he served on -- the FDA's
panel on peripheral and central nervous-system pharmaceuticals --
had rejected supporting the drug, known generically as aducanumab,
saying the company needed to conduct further study.
Early this week, David S. Knopman, a neurologist at the Mayo
Clinic, and Joel S. Perlmutter, a neurologist at Washington
University in St. Louis, resigned from the advisory committee in
protest over the FDA decision. The recommendations of advisory
panels, which consist of acknowledged experts in their fields, are
generally accepted by the FDA.
Dr. Perlmutter said in his resignation letter to Stat, a health
news organization, that he was quitting "due to this ruling by the
FDA without further discussion with our advisory committee."
The resignations follow criticism of the FDA decision from some
Alzheimer's researchers and doctors. The FDA issued the approval
over the doubts among some researchers and doctors who questioned
The agency said it was approving the drug on the basis that it
lowered levels of a sticky substance in the brain linked to
Alzheimer's called amyloid, which the critics said hasn't been
proven to be a driver of the disease.
The FDA on Monday said it gave the green light under its process
of accelerated approval because Aduhelm is a drug for a "serious or
life-threatening illness that provides a meaningful therapeutic
advantage over existing treatments."
The principle behind accelerated approval is that it makes
medicines available to severely ill patients faster while a company
does further research.
The agency said the drug showed benefit in reducing amyloid
plaque, which may play a role in Alzheimer's, which ravages memory
and thinking skills.
But the question over Aduhelm is whether it provides any benefit
at all, and the role of amyloid in the disease isn't clear.
Dr. Kesselheim said in his resignation letter that the FDA
decision was "based on the debatable premise that the drug's effect
on brain amyloid was likely to help patients with Alzheimer's
"This pivotal question was not discussed at the advisory
committee meeting, and its premise was specifically excluded from
discussion," he wrote in his letter of resignation to FDA Acting
Commissioner Janet Woodcock.
Calling the agency's decision a "debacle," Dr. Kesselheim said
the move "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."
Biogen has set the cost of the injectable drug at about $56,000
annually, another issue that has contributed to criticism of the
Write to Thomas M. Burton at firstname.lastname@example.org
(END) Dow Jones Newswires
June 10, 2021 20:30 ET (00:30 GMT)
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