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# 2 Advisory Panel Members Resign Over Alzheimer’s Approval
- URL: https://www.fdaweb.com/2-advisory-panel-members-resign-over-alzheimers-approval/
- Published: 2021-06-10T12:00:00.000Z
- Updated: 2026-09-14T17:02:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149503

*\[Report by David McFarland and Jim Dickinson\]* In the wake of FDA’s [controversial decision](https://www.fdaweb.com/fda-approves-biogens-alzheimers-drug/) to approve Biogen’s Alzheimer’s drug, two members of the advisory committee that reviewed data and voted against approving the therapy have resigned in protest. Mayo Clinic (Rochester, MN) professor **David Knopman** and Washington University School of Medicine professor **Joel Perlmutter** turned in their resignations from the agency’s Peripheral and Central Nervous System Drugs Advisory Committee due to irregularities with the panel process, according to a *Washington Post* [article](https://www.washingtonpost.com/health/2021/06/09/alzheimers-drug-controversy/?ref=fdaweb.com).

Knopman told the *Post* that he did not “wish to be part of a sham process” that led to the agency’s 6/7 approval of Aduhelm (aducanumab). In an email to FDA, he said: “The whole saga of the approval of aducanumab … made a mockery of the \[advisory\] committee’s consultative process. While I realize that the committee is advisory, the approval of aducanumab appears \[to\] have been foreordained.” Perlmutter told [*Stat News* in an email ](https://www.statnews.com/2021/06/08/fda-expert-panel-resigns-alzheimers-approval/?ref=fdaweb.com)that he resigned “due to this ruling by the FDA without further discussion with our advisory committee.” Another panel member, Harvard Medical School professor **Aaron Kesselheim**, was critical of the approval and posted on Twitter: “Accelerated approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval.”

The resignations are the latest uproar ([see earlier story](https://www.fdaweb.com/uproar-greets-fdas-aduhelm-ok-for-alzheimers/)) facing FDA as it defends itself in approving the Alzheimer’s drug. FDA watchers are reacting vigorously, with many pointing to the unusual turn to accelerated approval following FDA’s 11/2020 advisory committee meeting that voted down Biogen’s study data. Interestingly, panel members were not asked for their input on whether accelerated approval was a viable option. Panel members also were concerned about FDA’s statistical reviewer, **Tristan Massie**, who wrote in a briefing paper that the one positive trial of aducanumab could not overcome the negative one ([see earlier story](https://www.fdaweb.com/panel-thumbs-down-on-biogen-alzheimers-drug/)). “There is no compelling evidence of treatment effect or disease slowing and … another study is needed to confirm or deny the positive study and the negative study,” Massie wrote.

Knopman, who was recused from the 11/2020 panel meeting because he was a site investigator in an aducanumab trial, cited “biased questions” posed by FDA’s review staff during the meeting. He also took issue with the agency’s reliance on a “biomarker” — the elimination of amyloid beta. “Biomarker justification for approval in the absence of consistent clinical benefit after 18 months of treatment is indefensible,” he told the *Post*.

Knopman has long doubted aducanumab’s effectiveness. He said [in a comment](https://www.regulations.gov/document?D=FDA-2018-N-0410-0034&ref=fdaweb.com) filed to the advisory committee docket that evidence of a benefit from the drug is “terribly weak,” adding, “Perfection may be the enemy of the good, but for aducanumab, the evidence doesn’t even rise to ‘good.’”

Meanwhile, an *Endpoints News* [survey](https://endpts.com/what-does-a-clear-majority-of-the-biopharma-industry-think-of-the-fda-approval-of-aducanumab-horrifying-dangerous-confusing-disaster/?ref=fdaweb.com) found that 80% of respondents, mostly biopharma staffers and executives, did not agree with FDA’s decision to approve aducanumab. The respondents’ top criticisms: the lack of any clear efficacy data, worrying signs of a safety hazard, an outrageous timeline for completing a confirmatory study, and a price that would allow Biogen to reap billions of dollars from desperate patients with an unproven drug. “Meanwhile, a number noted that the FDA was essentially endorsing a likely dead end with amyloid, adopting a surrogate endpoint that’s never been validated, damaging any attempt to find a real answer to Alzheimer’s and establishing a precedent that would lead to more mistakes,” according to the survey.

Its findings are fully consistent with general top-tier industry and FDA practice attorneys’ attitudes toward the agency historically, notwithstanding frequent criticism of and lawsuits against individual FDA actions from time to time. Industry management traditionally recognizes that a strong, objective and even aggressive regulatory presence is needed to curb lawbreakers and maintain a level playing field for product approvals and subsequent marketing. The Aduhelm approval shakes that premise to its core.