• The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug.
  • Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.
  • Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm.
  • Biogen’s reputation may be damaged beyond repair.
Biogen is in deep trouble and may not survive


  • Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. Source: Fierce Pharma
  • If that enthusiasm pans out in the long run, it could mean at least 300,000 patients taking the drug, or $10 billion to $15 billion in peak Aduhelm from U.S. sales alone, which is above consensus estimates of around $7 billion to $8 billion, the team said.
  •  One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. history.” Source: STAT News
  • Our healthcare system can’t continue to support drugs that don’t have good clinical outcomes behind them.
<strong>The <strong>FDA</strong> and Aduhelm:</strong><em> <strong>WTF</strong>?</em>

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. In the meantime, caregivers are going to put their hope in a drug that doesn’t work and in garbage science with cherry-picked data.

A sad day for us all as the <strong>FDA</strong> continues to lose credibility

QUICK THOUGHT: Pfizer has already made $24 billion from their COVID vaccine, but that’s not enough; they want more, a lot more. They are planning to increase the vaccine price, and they’re working on an oral pill that could bring in as much as an additional $2 billion. While the U.S. Government didn’t pay for development, the German Government did. It is about providing a need at one hell of a profit margin.

Pfizer wants it all