FDA approval of Alzheimer’s drug ‘rife with irregularities’

FDA approval of Alzheimer’s drug ‘rife with irregularities’

Three FDA advisers resigned in protest over Aduhelm’s approval.

By Ben Whedon

The Food and Drug Administration in 2021 granted approval to a controversial treatment for Alzheimer’s disease, but a congressional investigation has called into question whether the agency followed proper procedure in granting its seal of approval.

Aduhelm, which pharmaceutical company Biogen produces, secured FDA approval after the agency overruled its independent scientific advisers, according to the Associated Press. Numerous studies had questioned the product’s efficacy.

Three FDA advisers resigned in protest over Aduhelm’s approval and the acting chief demanded an internal investigation, per the outlet.

FDA headquarters in Maryland

A congressional report has further shown the FDA’s approval of Aduhelm to have been “rife with irregularities.” The House Oversight Committee along with the Energy and Commerce Committee documented the process by which the FDA and Biogen worked together to secure approval for the drug over internal objections within the federal agency.

None of the advisers on an independent advisory committee voted in a November 2020 meeting to assert the drug’s effectiveness in treating Alzheimer’s. One attendee told CNN that the FDA and Biogen were “fully in line with each other in support of the drug.”

The report further observed that the FDA granted approval to “people with Alzheimer’s disease” but that the clinical trials had only studied the drug’s effects on a narrower target group.

Ultimately, the FDA approved Aduhelm “despite internal reservations about the lack of evidence of clinical benefit for patients at disease stages outside of the clinical trials and an unknown safety profile,” according to the report.

Both the FDA and Biogen have denied any wrongdoing.


(TLB) published  this article  with permission of John Solomon at Just the News.  Click Here to read about the staff at Just the News

Header featured image (edited) credit: FDA building/Getty Images

Emphasis and pictorial content added by (TLB) editors



Stay tuned to …


The Liberty Beacon Project is now expanding at a near exponential rate, and for this we are grateful and excited! But we must also be practical. For 7 years we have not asked for any donations, and have built this project with our own funds as we grew. We are now experiencing ever increasing growing pains due to the large number of websites and projects we represent. So we have just installed donation buttons on our websites and ask that you consider this when you visit them. Nothing is too small. We thank you for all your support and your considerations … (TLB)


Comment Policy: As a privately owned web site, we reserve the right to remove comments that contain spam, advertising, vulgarity, threats of violence, racism, or personal/abusive attacks on other users. This also applies to trolling, the use of more than one alias, or just intentional mischief. Enforcement of this policy is at the discretion of this websites administrators. Repeat offenders may be blocked or permanently banned without prior warning.


Disclaimer: TLB websites contain copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available to our readers under the provisions of “fair use” in an effort to advance a better understanding of political, health, economic and social issues. The material on this site is distributed without profit to those who have expressed a prior interest in receiving it for research and educational purposes. If you wish to use copyrighted material for purposes other than “fair use” you must request permission from the copyright owner.


Disclaimer: The information and opinions shared are for informational purposes only including, but not limited to, text, graphics, images and other material are not intended as medical advice or instruction. Nothing mentioned is intended to be a substitute for professional medical advice, diagnosis or treatment.

Be the first to comment

Leave a Reply

Your email address will not be published.