Third member of U.S. FDA advisory panel resigns over Alzheimer’s drug approval

Re:Third member of U.S. FDA advisory panel resigns over Alzh... by readams on Friday June 11, 2021 @10:06AM (#27473501)

Only if you make untrue claims. If you claim only what is proven, then it is not fraud.

[ Parent | on HN ]

Re:Third member of U.S. FDA advisory panel resigns over Alzh... by burkaman on Friday June 11, 2021 @10:10AM (#27473563)

> ADUHELM is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.

- https://www.biogencdn.com/us/aduhelm-pi.pdf

I believe the advisory panel's position is that it is not indicated for the treatment of Alzheimer's and that Biogen should not be allowed to say this.

In their press release (https://investors.biogen.com/news-releases/news-release-deta...), they explicitly describe it as an "Alzheimer's disease treatment". Again, I think the advisory panel considers this untrue, and certainly unproven.

The FDA could have said "this drug is safe and may be sold, but you may not describe it as an Alzheimer's treatment, and you must explicitly state that it has been found to be ineffective as an Alzheimer's treatment in clinical trials".

[ Parent | on HN ]

Re:Third member of U.S. FDA advisory panel resigns over Alzh... by danso on Friday June 11, 2021 @12:54PM (#27475715)

So how is Biogen going to get doctors to prescribe and people to pay $50K for a drug with no brand recognition nor eligibility for insurance, and no claims of actual effectiveness?

[ Parent | on HN ]