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“Phase 4” and Aduhelm
Biogen’s Aduhelm has been approved along the line of pratice in cancer drugs field where barely promissing drugs are allowe to go on with the caveat of phase 4 – post approval verification that the efficay is there when patient numbers are large enough. No wonder that Big Pharma loves this cancer treatment paradigm, test and approve drugs with ever increasing efficay but a long way from cure and be always under patent protection. All with sufficiently high price tag for people who face the stark choice between certain death and possible cure. The Aduhelm label did not limit the drug to carriers of APOEe4e4. It opened the gates for virtual everybody witht the diagnosis. Biogen claims that it needs a decade in order to confirm that the drug works against Alzheimer’s as it claimes. In 3 years there should be undeniable proof that the drug does not work, or works as $BIIB maintains. Due to the dispersion of testing data and outcomes after 3 years there should be sufficient data to determine the efficacy of any Alzheimer’s drug. You can find this information in a paper link: https://pubmed.ncbi.nlm.nih.gov/10404988/. This is a brazen raid on Medicare and by extension the federal budget. The politics around this will become intense. On one side we have Biogen, FDA reputation and lots of free money (see new allies sharing the spoils), on the other side almost dead politics of limited resources as represented by some in the Congress, honest scientists and doctors, perhaps rank and file FDA bureaucrats, may be even federal bureaucracy, and companies like $AVXL and $ANVS. Depending on the pull of one or the other side in this contest of clout the approval of other Alzheimer’s drugs can be either accelerated or delayed, and it is hard to say who will prevail here. I do think that Dr Misslings emphasis on Autism Spectrum Disorders might be a way of advancing Blacamesine forward without relying too much on the Alzheimer’s market alone to creat value as Alzheimer’s Phase 2b/3 slowly comes to its reading of top data.
