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Former FDA advisor critical of Alzheimer’s drug approval

JACKSONVILLE, Fla. – A former advisor of the Food and Drug Administration is criticizing the approval of a drug to treat Alzheimer’s disease.

He is one of three experts who resigned when the drug was approved in spring.

Dr. Aaron Kesselheim called it, “Probably the worst drug approval decision in recent U.S. history” when he resigned June 11.

Kesselheim is describing the advisory committee meeting he attended as unprecedented, in part because, he says, of the close relationship between drug maker Biogen and the FDA representatives at the meeting.

After looking at Biogen’s own study on effectiveness from the drug, the entire committee voted that the FDA should reject the drug.

That was November last year.

Then in June, the FDA gave Biogen final approval to treat patients with Aduhelm.

Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in the announcement:

“Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s.”

Reporter Jeff Toobin, a legal analyst, calls it an awful decision patients have to make.

“There has not been a new drug approved for Alzheimer since 2003, until Aduhelm, which is this drug made by Biogen a company in Cambridge, Massachusetts was approved this year,” Toobin said. “But the question is, does this drug even work? And the answer according to the experts was, no. And now patients are stuck with this terrible dilemma of, do they ask their doctors to try this drug, or do they respect the experts and say it’s not going to do any good anyway?”

Big money is involved, with treatments expected to cost about $56,000 per year.

If Medicare approved the drug, taxpayers would pay much of the cost.

Some Alzheimer’s care organizations, however, are defending the approval.

The Alzheimer’s Association sent a statement on the issue Monday, saying:

“We firmly believe that the FDA’s accelerated approval was the right decision, given the publicly available science, especially for such a devastating and fatal disease — one that otherwise has no treatment to even slow it down. Having the availability of such an option and access to it are needs we’ve long heard from the patient and caregiver community that we serve.”

Aduhelm was approved in the FDA’s “accelerated approval pathway.” That can be used for a drug for a serious or life-threatening illness.


About the Author:

Kent Justice co-anchors News4Jax's 5 p.m., 10 and 11 p.m. newscasts weeknights and reports on government and politics. He also hosts "This Week in Jacksonville," Channel 4's hot topics and politics public affairs show each Sunday morning at 9 a.m.