FDA Advisor Who Resigned Sounds Off On Agency’s Work In Last 6 Months

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Dr. Aaron Kesselheim, who resigned from the FDA’s advisory committee over the approval of a controversial drug meant to treat Alzheimer’s disease, called out the FDA on CBS This Morning for their work over the past six months.

In early June, the FDA approved Aduhelm, a drug manufactured by Biogen for the treatment of Alzheimer’s. The FDA approved it under their Accelerated Approval pathway for its “anticipated clinical benefit” despite intense debate among researchers over whether or not it could actually benefit Alzheimer’s patients.

Three members of the FDA’s independent advisory committee, which recommended that the FDA not approve the drug, resigned after the FDA ignored their advice. Kesselheim is one of the committee members who resigned over the drug’s approval. (RELATED: FDA Panel Votes To Recommend Johnson & Johnson’s Coronavirus Vaccine For Emergency Authorization)

“The drug showed no good evidence that it worked,” he told CBS News Senior Medical Correspondent Tara Narula. “If the FDA allows companies to get approved on the basis of trials that are stopped early, trials that are re-analyzed, that sets a precedent because it tells other companies, ‘well I don’t need to run a rigorous trial either.'”

He said that it’s important for the FDA to maintain “reasonable standards” when approving drugs.

“In the majority of cases, I like to think that the FDA makes the right decision,” he added. “In cases like this, where the FDA makes what I think is the wrong decision, I think that we need to understand better why the decisions were made in this way.”

Narula said that it’s “pretty rare” for the FDA to approve a drug without the recommendation of its committee. She said that Kesselheim resigned because he felt that the FDA was not following the science and “significant concern” over side effects. One-third of patients had brain hemorrhages or bleeding, Narula added.

Kesselheim also said that Biogen was given too long after approval to prove that the drug is effective and that it was tested on patients with “mild Alzheimers” but the labeling says it can be used for all patients. He also worried that the approval would push research away from other, potentially more effective treatments.