Jun 14, 2021 14:00:00

Three Regulatory Advisors Resigned to Protest Alzheimer's Drug Approval

The FDA's advisory board over the approval of the Alzheimer drug '

ADUHELM ' jointly developed by Eisai in Japan and Biogen, a long-established drug manufacturer in the United States, by the US Food and Drug Administration (FDA), which has jurisdiction over domestic drug regulations. Three people have resigned. One of the resigned advisors said it was 'probably the worst drug approval in modern American history.'

Three experts resign as FDA advisers over approval of Alzheimer's drug | Ars Technica
https://arstechnica.com/science/2021/06/three-experts-resign-as-fda-advisors-over-approval-of-alzheimers-drug/

Biogen says FDA didn't push for trial before Alzheimer's approval --Axios
https://www.axios.com/biogen-interview-fda-alzheimers-aduhelm-approval-8666ee56-6294-4365-9e68-43ba84045c8b.html

On June 8, 2021, the FDA approved the Alzheimer's drug 'Aducanumab (trade name: ADUHELM)' jointly developed by Eisai and Biogen. ADUHELM is a drug that acts on Alzheimer's disease by reducing amyloid β plaque, which is known to be abundant in the brains of Alzheimer's disease patients. I am very pleased to be able to open it. '

However, the approval of this ADUHELM has been criticized by experts one after another. According to media reports, a Phase III trial in the first half of 2019 showed 'no effect,' and the FDA itself has up to 10 of the 11 members of the Independent Inquiry Committee. He said he had voted 'No' to the question 'whether to consider the data submitted by Biogen as primary evidence that aducanumab is valid.' Despite this background, the FDA suddenly changed its opinion and issued this approval.

Researchers criticize 'Alzheimer's drug' approved by the regulatory authority, 'The risk of brain swelling is very high' --GIGAZINE

Following this approval, David Knopman of the Mayo Clinic, a major medical institution, and Joel Perlmutter of the University of Washington announced their resignation from the advisory board. Then, on June 10, 2021, Professor Aaron Kesselheim of Harvard Medical School submitted his resignation. In a letter to the acting FDA Secretary, Professor Kesselheim reported that 'the advisory board and reviewers have'no convincing evidence that the drug is effective,'but FDA leaders said. He dismissed the report and approved the drug based on considerations not included in the advisory board discussion, 'and accused the decision of' probably the worst drug approval in modern American history, 'and' the FDA. Has an obligation to provide the public with detailed justification for this approval. '

This approval is 'quick approval' and requires verification by future clinical trials, but ADU HELM can be sold until the FDA revokes the approval.